Redline, Drug Price Negotiation for Initial Price Applicability Year 202820XX under Sections 11001 and 11002 of the Inflation Re

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Drug Price Negotiation for Initial Price Applicability Year 202820XX
under Sections 11001 and 11002 of the Inflation Reduction Act (IRA) Information
Collection Request (ICR) Forms (CMS-10849, OMB 0938-1452)
Under the authority in sections 11001 and 11002 of the Inflation Reduction Act of
2022 (P.L. 117-169), the Centers for Medicare & Medicaid Services (CMS) is
implementing the Medicare Drug Price Negotiation Program (“the Negotiation
Program”), codified in sections 1191 through 1198 of the Social Security Act (“the
Act”). The Act establishes the Negotiation Program to negotiate a maximum fair
price (MFP), defined at section 1191(c)(3) of the Act, for certain high expenditure,
single source drugs payable under Medicare Part B and/or covered under Medicare
Part D (each a “selected drug”).1 As discussed in section 20 of the Medicare Drug
Price Negotiation Program: Final Guidance, Implementation of Sections 1191 – 1198
of the Social Security Act for Initial Price Applicability Year 2028 and Manufacturer
Effectuation of the Maximum Fair Price (MFP) in 2026, 2027, and 2028 (“the
Medicare Drug Price Negotiation Program Final Guidance” or “final guidance”), for
initial price applicability year 2028, CMS will select up to 1542 CFR 429.101, for
initial price applicability year 2029 and each initial price applicability year thereafter,
CMS will select up to 20 high expenditure, single source drugs payable under Part B
and/or covered under Part D for negotiation. For each such initial price applicability
year 2028, CMS will also renegotiate MFPs for drugs selected for renegotiation (if
any), in accordance with section 1194(f)(4) of the Act. Any MFPs that are
negotiatedrenegotiated for these drugs will apply beginning inwith the initial price
applicability year 2028. Thefor which the drug was selected for renegotiation (see 42
CFR 429.610). For a drug selected for negotiation and with respect to that specific
selected drug, the negotiation period for the initial price applicability year 2028
begins February 28, 2026 of the calendar year of the selected drug publication date
for such initial price applicability year, or when the manufacturerPrimary
Manufacturer of asuch selected drug enters into a Medicare Drug Price Negotiation
Program Agreement with CMS for such selected drug, whichever is sooner. For a
drug selected for renegotiation and with respect to that specific selected drug, the
renegotiation period for the initial price applicability year begins February 28 of the
calendar year of the selected drug publication date for such initial price applicability
year.
This ICR Form includes twothree parts: Part 1—Negotiation Data Elements ICR
Form, Part 2—Temporary Floor for Small Biotech Drugs ICR Form, and Part 23—
Counteroffer ICR Form.
PART 1: NEGOTIATION DATA ELEMENTS ICR FORM
Section In accordance with sections 1194(e) and 1194(f)(4)(B) of the Act and
sections 50 and 130.4 of the final guidance require42 CFR 429.500(a)(2), 429.505(a),
1

Hereinafter, “drug” includes drugs and biological products pursuant to the definition of a “qualifying
single source drug” at section 1192(e)(1) of the Act.

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and 429.620(c), CMS to considerconsiders two sets of factors as the basis for
determining initial offer(s) and counteroffer(s) throughout the negotiation process
and renegotiation process in accordance with sections 1194(e) and 1194(f)(4)(B) of
the Act and sections 60 and 130.4 of the final guidance, which includes renegotiation
of any selected drug: (1) certain data that must be submitted by the manufacturer of
each drug (as described in section 1194(e)(1)) of the Act); and (2) evidence about
alternative treatments, as available, with respect to each selected drug and therapeutic
alternative(s) for each selected drug (as described in section 1194(e)(2) of the Act).
In accordance with section 1193(a)(4) and section 1194(b)(2)(A) of the Act and
sections 50 and 130.3.2 of the final guidance,42 CFR 429.405(a) and
429.615(b)(1)(ii), the manufacturer must submit, in a form and manner specified by
CMS, information on the non-Federal average manufacturer price (“non-FAMP”) as
defined in 38 U.S.C. § 8126(h)(5) for the selected drug and information that CMS
requires to carry out the negotiation process, including the factors outlined in section
1194(e)(1) of the Act, which, in conjunction with the available evidence on the
factors outlined in section 1194(e)(2), will serve as the basis for determining initial
offers and counteroffers. In addition, manufacturers and the public may submit
information on the factors outlined in section 1194(e)(2) of the Act, which describe
evidence about the selected drug and its therapeutic alternative(s). In accordance with
section 1194(f)(4)(B) of the Act and section 130.3 of the final guidance,42 CFR
429.615(b), CMS will apply a similar approach regarding data collection once a drug
is selected for renegotiation of the MFP, if any drugs are selected for renegotiation.
For the purposes of this ICR, references to a selected drug subject to the data
collections in this form include drugs included selected for negotiation and
renegotiation on the selected drug list published by CMS by February 1, 2026 and
anythe selected drugs fromdrug publication date for the initial price applicability
years 2026 or 2027 that are selected for renegotiation pursuant to section 1194(f)(3)
of the Act. year for which this ICR is submitted.
In section 1191(c)(1) of the Act, the statute adopts the definition of a manufacturer
established in section 1847A(c)(6)(A) of the Act. Section 1193(a)(1) of the Act
establishes that CMS will negotiate, or renegotiate, as applicable, an MFP with “the
manufacturer” of the selected drug. In accordance with section 40 of the final
guidance42 CFR 429.20, to the extent that more than one entity meets the statutory
definition of manufacturer for a selected drug for purposes of initial price
applicability year 2028, CMS will designate the entity that holds the New Drug
Application(s) (NDA(s)) / Biologics License Application(s) (BLA(s)) for the selected
drug to be “the manufacturer” of the selected drug (hereinafter the “Primary
Manufacturer”).
Likewise, in accordance with section 40 of the final guidance42 CFR 429.20, CMS
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will refer to any other entity that meets the statutory definition of manufacturer forof
a drug product included onin the selected drug list, that is not the Primary
Manufacturer for the selected drug, and that either (1) is listed as a manufacturer in
an NDA or BLA for the selected drug; or (2) markets the selected drug pursuant to in
accordance with an agreement with the Primary Manufacturer but is not listed on an
NDA or BLA of the selected drug as a “Secondary Manufacturer.”2.”
In accordance with sections 5042 CFR 429.100(d), 429.405(a), 429.505(b)(1), and
130.3.2 of the final guidance,429.615(b)(1), CMS will collect certain data from the
Primary Manufacturer, including information on non-FAMP and the data identified
in section 1194(e)(1) of the Act, and will collect information on evidence about a
selected drug and its therapeutic alternative(s) per section 1194(e)(2) of the Act from
any interested party. in accordance with 42 CFR 429.505(d)(1) and 429.615(b)(3).
This ICR Form serves as one of multiple ways that CMS will collect data described
in section 1194(e)(2) (see the Supporting Statement for further details). Submission
of the information collected in this ICR Form is due by 11:59 PM PT on March 1,
2026. of the year of the selected drug publication date for the initial price
applicability year for which this ICR is submitted (consistent with 42 CFR
429.100(d), 429.405, 429.505, and 429.615(b)).
Note: This ICR focuses on information required and optional for selected drugs for
negotiation and renegotiation for initial price applicability year 202820XX.
General Instructions
Overview
In accordance with sections 5042 CFR 429.100(d), 429.405(a), 429.505(b)(1), and
130.3.2 of the final guidance,429.615(b)(1), the Primary Manufacturer of each
selected drug must complete Sections A through H for each of its selected drug(s),
which are specifically:
• A: Selected Drug Information,
• B: Non-FAMP Data Collection,
• C: Research and Development Costs and Recoupment,
• D: Current Unit Costs of Production and Distribution,
• E: Prior Federal Financial Support,
• F: Patents, Exclusivities, and Approvals,
• G: Market Data and Revenue and Sales Volume Data, and
• H: Certification of Submission of Sections A through G for Primary Manufacturers.
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As specified in section 40 of the final guidance42 CFR 429.20, a manufacturer that is not listed as a manufacturer on
the NDA / BLA and without an agreement in place with the Primary Manufacturer would not be considered a
Secondary Manufacturer. Examples of agreements that could result in a Secondary Manufacturer relationship may
include, but are not limited to, royalty agreements, licensing agreements, revenue sharing agreements, marketing
agreements, supply agreements, purchasing agreements, or parent / affiliate agreements.

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The Primary Manufacturer is responsible for aggregating and reporting all necessary data on its
selected drug(s) from other parties, as applicable.
Section I (“Evidence on Alternative Treatments”) collects available evidence on the selected drug
and its therapeutic alternative(s), as applicable. Any interested party, including but not limited
to patients and caregivers, Part D plan sponsors and Medicare Advantage organizations,
Primary Manufacturers, Secondary Manufacturers, manufacturers of therapeutic
alternative(s) for a selected drug, hospitals and health care providers, wholesalers,
pharmacies, researchers, and other members of the public, is permitted, but not required, to
submit information for Section I. Any interested party who submits evidence in Section I must
complete Section J (“Certification of Submission of Section I for All Respondents”) as well.
Submission Method
Primary Manufacturers will submit the information for Sections A through J via the CMS Health
Plan Management System (“the CMS HPMS”), which can be accessed here:
https://hpms.cms.gov/. Manufacturers of high-expenditure, single source drugs may register for
access to the CMS HPMS and are encouraged to do so before the questions for this ICR are
available to access in the CMS HPMS. Instructions for manufacturers to gain access to the CMS
HPMS can be found in the “Instructions for Requesting Drug Manufacturer Access in the CMS
Health Plan Management System (HPMS) for the Medicare Drug Price Negotiation Program”
PDFdocument.3 Instructions for gaining signatory access to the CMS HPMS are also included in
this PDFdocument. Technical assistance will also be made available.
All respondents who are not Primary Manufacturers will use a separate web application to access
the questions in Sections I and J. This application will be accessible from an entry point on
CMS.gov, as well as on the CMS HPMS landing page, which is publicly accessible at
https://hpms.cms.gov. Additional instructions to access this public web application will be
available on CMS.gov.
Submissions may be saved while work is in progress. Primary Manufacturers and interested
parties may also wish to draft their submission outside of the web application and then copy their
submissions into the appropriate fields to complete the formal submission.
Questions about CMS HPMS user access should be sent to [email protected]. For
technical assistance related to the submission of information in HPMS, questions should be sent to
[email protected]. Technical assistance for Primary Manufacturers and other interested parties
will also be made available.
Additional Instructions
• The instructions in this section apply to all Sections A through J. If a term included in this
ICR is also included and defined in final guidance42 CFR 429.20, the term’s definition in
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https://www.cms.gov/files/document/instructions-requesting-drug-manufacturer-access-cms-health-planmanagement-system-cms-hpms-medicare.pdf.

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•
•
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this ICR is the same as in the final guidance.42 CFR 429.20. Questions about title 42, part
429 of the final guidanceCFR, including questions about terms defined in this ICR, should
be sent to [email protected].
For Sections A through G of this form, the Primary Manufacturer must provide data only
with regard to the selected drug as identified under section 1192 of the Act. If a
Primary Manufacturer has more than one selected drug, the Primary Manufacturer is
required to make a separate submission of the information required in Sections A through
G of this ICR for each selected drug.
All response fields are limited to a character count. The field and response format sections
provide a character count and an estimated word count. Total character counts include all
characters within the response, including spaces between words.
Certification is required for submissions. Section H includes the Certification of
Submission of Sections A through G for Primary Manufacturers. Section J includes the
Certification of Submission of Section I for All Respondents.
For Sections A through G of this form, the Primary Manufacturer must submit, as
indicated in the section, the applicable data for all dosage forms and strengths of the
selected drug, including for dosage forms and strengths that were sold,
labeledmanufactured, marketed, controlled, or packagedsold by a Secondary
Manufacturer.
Technical assistance will be available in a CMS HPMS Negotiation Data Elements ICR
Form User Guide, including additional instructions on submitting data for applicable
sections via a template upload.
For non-monetary numeric amounts, include up to three decimal places.
Response formats are indicated within any charts included in Sections A through G and
Section I (e.g., # to indicate a numerical response is required).
Primary Manufacturers must timely notify CMS, after the initial submission of data in this
ICR Form, if any of the information submitted changes, as set forth in sections 40.2, 50.1,
and 130.3 of the final guidance.42 CFR 429.100(e), 429.405(b), 429.505(c), and
429.615(b)(2). Please timely notify CMS via the IRA Mailbox at
[email protected] if any such changes are applicable to the
selected drug.
o If a Primary Manufacturer of a drug selected for renegotiation has
updates to the Primary Manufacturer’s originalprior full
submission(s) of section 1194(e)(1) data for the negotiation period in
which the selected drug’s MFP was negotiated, the Primary
Manufacturer should notify CMS of these updates separately from
this ICR Form in accordance with section 50.1 of the revised
guidance for initial price applicability year 2026, the final guidance
for initial price applicability year 2027, and the final guidance for
initial price applicability year 2028, and 42 CFR 429.100(e),
429.405(b), 429.505(c), and 429.615(b)(2), as applicable.
Throughout this form, references to “the most recent full submission” in instructions
specific to submissions for a drug selected for renegotiation refer to the Primary
Manufacturer’s most recent submission of the Negotiation Data Elements Form for the
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selected drug and do not include any submissions of updates or corrections to information
submitted in the Negotiation Data Elements Form, as set forth in 42 CFR 429.100(e),
429.405(b), 429.505(c), and 429.615(b)(2), or submissions through the Identification and
Selection of Renegotiation-Eligible Drugs ICR Form.
Section 1193(c) of the Act states that CMS must determine which information submitted to
CMS by a manufacturer of a selected drug is proprietary information of that manufacturer.
As described in section 40.2.1 of the final guidance42 CFR 429.300, CMS will treat certain
data elements submitted by a Primary Manufacturer of a selected drug in accordance with
section 1194(e)(1) and section 1194(e)(2) of the Act as proprietary if the information
constitutes confidential commercial or financial information of the Primary Manufacturer
or a Secondary Manufacturer.4 In order to identify information within a response that a
respondent believes should be withheld by CMS under the Freedom of Information Act
(FOIA) Exemptions 3 and/or 4 (5 U.S.C. § 552(b)(3), (4)),5 Primary Manufacturers are
instructed to complete Question 26 regarding such applicable information provided in
response to Sections A through G, and any interested party is instructed to complete
Question 57 regarding such applicable information provided in Section I. Sections 40.2.1,
60.4,42 CFR 429.300(d) and 60.6 of the final guidance429.705 discuss the situations in
which CMS may share submitted data related to the section 1194(e)(2) data
submittedfactors publicly, without sharing any personally identifiable information6 (PII) or
protected health information7 (PHI), proprietary information, or information that is
protected from disclosure under other applicable law. CMS will not include Questions 29
and 62, and any responses submitted to CMS for Question 29 and 62, within the evidence
published alongside the explanation of the MFP (as set forth in 42 CFR 429.705(b)). For

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Specifically, as described in section 40.2.1 of the final guidance,42 CFR 429.300(c), CMS will treat non-FAMP and
associated non-FAMP data collection, research and development costs and recoupment,of the Primary Manufacturer
for the selected drug, current unit costs of production and distribution, of the selected drug, data on pending patent
applications, for the selected drug, and market data, and revenue, and sales volume datafor the selected drug in the
United States as proprietary, unless the information that is provided to CMS is already publicly available, in which
case it would be considered non-proprietary. CMS will treat the data on prior Federal financial support and approved
patent applications, exclusivities, and approved applications under section 505(c) of the FD&C Act or section 351(a)
of the PHS Act that are publicly available as non-proprietary because CMS understands these data are publicly
available..
5
See: https://www.justice.gov/oip/doj-guide-freedom-information-act-0.
6
Personally identifiable information (PII) is information that can be used to distinguish or trace an individual’s
identity, either alone or when combined with other information that is linked or linkable to a specific individual. PII
can include sensitive data, such as medical, financial, or legal information; “neutral” information such as name, facial
photos, or work address; and, contextual information, such as a file for a specific health condition that contains a list
of treated patients. See: https://www.hhs.gov/web/policies-and-standards/hhs-web-policies/privacy/index.html#whatis-pii.
7
Protected health information (PHI) is), consistent with 42 CFR 429.20, has the as the meaning set forth at 45
CFR 160.103. For example, PHI includes individually identifiable health information held or transmitted by a covered
entity or its business associate, in any form or media, whether electronic, paper, or oral. Individually identifiable
information is information, including demographic data, that relates to the individual’s past, present, or future
physical or mental health or condition; the provisions of health care to the individual; or the past, present, or future
payment for the provision of health care to the individual, and that identifies the individual or for which there is a
reasonable basis to believe it can be used to identify the individual. PII includes many common identifiers such as
name, address, birth date, Social Security Number, etc. See https://www.hhs.gov/hipaa/forprofessionals/privacy/laws-regulations/index.html.

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example, this means that when publishing the explanation of MFP, CMS will not publish a
Primary Manufacturer’s identification of which data should be withheld in response to
Question 29, but CMS still retains the authority to determine whether such data may be
published in accordance with CMS’ confidentiality policy as set forth in 42 CFR 429.300.
Definitions included in this ICR are intended for purposes only related to this ICR and the
Medicare Drug Price Negotiation Program.

Instructions for Reporting Monetary Amounts
• When calculating and reporting monetary values, the information must be determined using
the methodologies described throughout the document and consistent with the Generally
Accepted Accounting Principles (GAAP), when applicable. Describe the policies and
methodologies used in the calculations in the free response field for the relevant question,
as well as the standard used if it is inconsistent with GAAP.
• When calculating and reporting monetary values, do not adjust for cost of capital.
• Monetary amounts must be reported in United States dollars (USD) and include two
decimal places (i.e., dollars and cents), unless otherwise specified in Section D or Section G.
Use the free response field of an applicable question, when it is available, to clarify any
rounding limitations or alternative rounding standard relied on.
• The geographic area for data on United States (U.S.) Commercial markets, Medicare
markets, and Medicaid markets is based on the definition of the United States in 42 C.F.R
§ CFR 400.200, unless the geographic area is specified in the authority for the data source
(e.g., for Federal Supply Schedule8 (FSS) pricing and “sales to specified Federal agencies
(“Big Four Agency” price9 (“Big Four price”)).”) described in 38 U.S.C. 812610).
• When converting another currency to USD, use the exchange rate in effect on the date the
cost was incurred. If that rate is unavailable, use the monthly or annual average exchange
rate for the year in which the cost was incurred.
o All new conversions should follow the principles of the GAAP
Accounting Standard Certification (ASC) 830, the U.S. accounting
standard for translating foreign currency values.
o If a currency conversion was completed prior to this instruction using a
different method, and recalculating using ASC 830 would impose a
significant burden, CMS will accept the previously calculated value
without requiring recalculation. In the free response field, report the
amount, the currency, the exchange rate, and time period(s) used in the
calculation.
• Do not report the same costs in multiple places unless the additional specific instructions
for that question instruct you to do so.
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The price offered by the VA in its FSS program, by delegated authority of the General Services Administration. The
most recently published pharmaceutical price for the selected drug as included in the Federal Supply Schedule as
managed by the Department of Veterans Affairs per 48 CFR part 38. See: https://department.va.gov/administrationsand-offices/acquisition-logistics-and-construction/freedom-of-information-actrequests/#toc_Historical_VA_Pharmaceutical_Prices.
9
The Big Four price is described in section 8126 of title 38 of the U.S. Code.
10
The Big Four price is described in section 8126 of title 38 of the U.S. Code.

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Do not include any costs that are unallowable under an applicable law or costs that are
otherwise expressly excluded from this ICR.
Do not make any adjustments for inflation to any dollar amounts reported unless the
additional specific instructions for that question instruct you to do so. When reporting an
inflation adjusted value, inflation adjustments should be made to 2025the most recent full
calendar year preceding the calendar year in which this ICR is due by using the annual
percentage increase of the consumer price index for all urban consumers (CPI-U)11 for
2025.such preceding calendar year (e.g., 2026 for initial price applicability year 2029).

A. Selected Drug Information
Primary Manufacturer Response Required
In Section A, for each drug selected drug for negotiation and renegotiation for initial price
applicability year 202820XX, CMS will populate the CMS HPMS with the list of the 11-digit
National Drug Codes (NDC-11s) marketedassociated with the NDA(s) / BLA(s) of the selected
drug that is identified by the CMS as the baseline list of NDC-11s in accordance with 42 CFR
429.100(c)(1).
•

For Primary Manufacturer and any Secondary Manufacturer and publishedManufacturers
of drugs selected for renegotiation only: The baseline list of NDC-11s for drugs selected for
renegotiation will reflect updates provided by Primary Manufacturers in accordance with
section 30.4 of40.2 of the revised guidance for initial price applicability year 2026, the final
guidance, meaning those for initial price applicability year 2027, the final guidance for initial
price applicability year 2028, and 42 CFR 429.100(e).

CMS includes in Section A, the NDC-11s of the selected drug that:
(1) are associated with Healthcare Common Procedure Coding System
(HCPCS) codes that had Part B claims with utilizationappear on NDCHCPCS code crosswalks published by CMS12 for the most recent quarter
in the 12-month period beginning November 1, 2024 of the two calendar
years prior to the selected drug publication date for the initial price
applicability year and ending October 31, 2025 from the calendar year
prior to the selected drug publication date for the initial price applicability
year, or
(2) had Part D PDE utilization in the 12-month period beginning November 1,
2024 of the two calendar years prior to the selected drug publication date
for the initial price applicability year and ending October 31, 2025 from
the calendar year prior to the selected drug publication date for the initial
price applicability year, or
(3) any additional NDC-11s CMS identifies that are associated with
11

The “CPI-U” means, consistent with 42 CFR 429.20, the consumer price index for all urban consumers
(United States city average) as published by the Bureau of Labor Statistics
(https://www.bls.gov/cpi/data.htm).
12
See: https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files.

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the NDA(s) / BLA(s) of the selected drugs as found in recent
updates of the NDC Structured Product Labeling (SPL) Data
Elements file (NSDE) file or the NDC Directory (including its
NDC Excluded Drugs Database file).
Pursuant to section 30.4 of the final guidance, CMS will not include in this list any NDC-11s for
which CMS has evidence suggesting a lack of coverage under Part D and Part B (e.g., NDC-11s
for which there are no PDE records with a coverage status code of “C” and which are not
associated with any HCPCS codes).
For each of these NDC-11s of the selected drug, including any NDC-11s that are marked as
“discontinued,” CMS will also populate the CMS HPMS with the Product Name and the Labeler
Code..
If a Primary Manufacturer believes that an NDC-11 that has been populated by CMS within
Section A of the CMS HPMS should not be populated, or an error has occurred, they can submit an
email to [email protected]
For Section A, for Primary Manufacturers of drugs selected for renegotiation only: The list of
NDC-11s for drugs selected for renegotiation should reflect updates provided by Primary
Manufacturers for drugs covered under Part D in accordance with sections 40.2 and 50.1 of the
final guidance. As applicable to the data populated in the CMS HPMS, please follow the
instructions in Section A.
Definitions for Section A:
• Average Manufacturer Price (AMP) unit: The unit type, as reported monthly by the
manufacturer, used by the manufacturer to calculate AMP (42 C.F.R. §CFR 447.504) and
best price (42 C.F.R. §CFR 447.505) for purposes of the Medicaid Drug Rebate Program
(MDRP): injectable anti-hemophilic factor, capsule, suppository, gram, milliliter, tablet,
transdermal patch, each, millicurie, or microcurie.
• Drug sample: A unit of a prescription drug that is not intended to be sold and is intended to
promote the sale of the drug (Section 503(c)(1) of the Federal Food, Drug, and Cosmetics
Act).
• Labeler code: The first segment of the U.S. Food and Drug Administration (FDA)assigned NDC (21 C.F.R. § 207.33(b)(1)(i)). Each person who engages in manufacturing,
repacking, relabeling, or private label distribution of a drug subject to listing under 21
C.F.R. Part 207 must apply for an NDC labeler code (21 C.F.R. § 207.33(c)(1)).
• Private label distributor: With respect to a particular drug, a person who did not
13

Separately, and as specified in the “Additional Instructions” within this ICR Form, after the initial
submission of data in this ICR Form, Primary Manufacturers must timely notify CMS, if any of the
information submitted changes, as set forth in sections 40.2, 50.1 and 130.3 of the final guidance.42 CFR
429.305(c).

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manufacture, repack, relabel, or salvage the drug but under whose label or trade name the
drug is commercially distributed (21 C.F.R. § 207.1).
Private label distributor, consistent with 42 CFR 429.20, has the meaning set forth in 21
CFR 207.1.
Total AMP Units per Package: The total number of AMP units per NDC-11 package size.
Total National Council for Prescription Drug Programs (NCPDP) Units per Package: The
total number of NCPDP units per NDC-11 package size.

Instructions for Section A:
• Review the list of NDC-11s populated by CMS, and if any NDC-11s associated with the
NDA(s) / BLA(s) of the selected drug that are covered under Part D and/or payable under
Part B are missing from the list (e.g., because they are new NDC-11s, discontinued NDC11s), including any missing NDC-11s of a Secondary Manufacturer of the selected drug,
provide the missing NDC-11 and corresponding Product Name and Labeler Code..
• For each of the listed NDC-11s or any additional NDC-11s added by the Primary
Manufacturer, provide the NCPDP Unit, Total NCPDP Units Per Package, and the AMP
Unit and Total AMP Units Per Package.
• If the NCPDP Unit is “EA” (Each), please specify the unit of measure represented by
one “EA” in the Explanation of Unit response to Question 13.
• For each of the listed NDC-11s or any additional NDC-11s added by the Primary
Manufacturer, indicate whether:
o any of the listed NDC-11s or additional NDC-11s are neithernot
manufactured, marketed nor, controlled, or sold by the Primary
Manufacturer or a Secondary Manufacturer,
o any of the listed NDC-11s or additional NDC-11s are distributed by
or under the name of a private label distributor,
o any of the listed NDC-11s or additional NDC-11s have been
discontinued and the date of discontinuation14, and
o any of the listed NDC-11s or additional NDC-11s are a sample
package, outer package, or inner package. If the NDC-11 is neither an
inner package nor an outer package, select “No” in response to both
the inner package and the outer package data fields. “Yes” may not be
selected for both an inner and outer package because an NDC-11
cannot be categorized as both an inner and an outer package.
• If an NDC-11 is neithernot manufactured, marketed nor, controlled, or sold by the Primary
Manufacturer or a Secondary Manufacturer, select “Yes” in response to the field labeled
“NeitherNot Manufactured, Marketed nor, Controlled, or Sold by the Primary
Manufacturer or a Secondary Manufacturer.” Otherwise, select the “No” response option.
o If “Yes” is selected in response to whether the NDC-11 is
“NeitherNot Manufactured, Marketed nor, Controlled, or Sold” by
the Primary Manufacturer or a Secondary Manufacturer,” the
Primary Manufacturer should not provide information about this
14

Please provide the date of discontinuation that was reported to FDA pursuant to 21 C.F.R. §§CFR 314.81(b)(3)(iii)
and (iv).

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NDC-11 in the remainder of the data fields within Section A or
within any other section in this ICR Form.
Product
Name

NDC-11
Numbers

NeitherNot
Manufacture
d, Marketed
nor,
Controlled, or
Sold by the
Primary
Manufacturer
or a
Secondary
Manufacturer

Discontinued
(Select if NDC11 has been
discontinued
and provide
date of
discontinuation)

Sample
Package
(Select if
NDC-11
is a
sample
package)

Inner
Package
(Select if
NDC-11
is an inner
package)

Outer
Package
(Select if
NDC-11
is an outer
package)

Private
Label
(Select
if
NDC11 is a
private
label)

NCPDP
Unit
(EA,
mL,
GM)

Total
NCPDP
Units
per
Package

Text to
be prepopulate
d by
CMS

Numbers
to be prepopulated
by CMS

Yes/No

Yes/No

Yes/No

Yes/No

Yes/No

Yes/No

EA, mL,
GM

#

AMP Unit
(Injectable
antihemophiliac
factor,
capsule,
suppository,
gram,
milliliter,
tablet,
transdermal
patch, EC,
millicurie,
microcurie)
Text

Total
AMP
Units
per
Packa
ge

Labeler
Deleted Cells
Code

#

Number
s to be
prepopulat
ed by
CMS

Date if
Applicable

Primary Manufacturer to add data fields and identify any NDC-11s of the selected drug that are
not pre-populated by CMS
Primary Manufacturers must provide the information, as directed in Sections B through G of this
ICR Form, about all NDC-11s marked as “discontinued,” a “sample package,” an “inner package,”
an “outer package,” and a “private label,” in Section A.
B. Non-FAMP Data Collection
Primary Manufacturer Response Required
For Section B, for Primary Manufacturers of drugs selected for negotiation: the Primary
Manufacturer is required to report the non-FAMP for its selected drug for the four quarters of
calendar years 2021 (or, in the case that there is not an average non-FAMP available for such
selected drug for calendar year 2021, the Primary Manufacturer is required to report average nonFAMP for the first full calendar year following the market entry for such drug), as well as
calendar year 2025 (i.e., the calendar year prior to the selected drug publication date, February 1,
2026). (as defined in 42 CFR 429.20) for the initial price applicability year for which this ICR is
submitted .
CMS plans to use the reported NDC-11s, quarterly non-FAMP, and total NDC-11 package
volume in the data fields below to calculate the average non-FAMP for calendar year 2021 (or for
the first full calendar year following the market entry of the selected drug) and the calendar year
2025prior to the selected drug publication date for a drug selected for negotiation for the initial
price applicability year 2028.for which this ICR is submitted (for additional information regarding
the collection of non-FAMP for negotiation refer to 42 CFR 429.405).
For Section B, for Primary Manufacturers of drugs selected for renegotiation that were
selected originally for negotiation for initial price applicability year 2026 or 2027 and have
not previously been renegotiated in initial price applicability year 2028 or thereafter only:
11

the Primary Manufacturer is required to report the non-FAMP for all NDC-11s included in
Section A that are payable under Part B, if applicable, for itsbut not covered under Part D, and for
which the Primary Manufacturer did not originally report non-FAMP for these NDC-11s payable
under Part B for the initial price applicability year for which the selected drug that are included in
Section A. was first selected for negotiation. If there is no non-FAMP to report in response to
Section B, select “Not Applicable”. For additional information regarding the collection of nonFAMP for renegotiation refer to 42 CFR 429.615(b)(1)(ii).
Definitions for Section B:
• Non-FAMP: Section 1194(c)(6) of the Act defines “average non-Federal
average manufacturer price” as the average of the non-FAMP (as defined in
38 U.S.C. § 8126(h)(5)) for the four calendar quarters of the year involved.15
For initial price applicability year 2028Specifically, for drugs selected for
negotiation, these are the quarters of 2021 (or of the first full calendar year
following marketing entry of the drug) and 2025 (i.e., the calendar year prior
to the statutorily-defined selected drug publication date, February 1, for a
specific initial price applicability year. For drugs selected for renegotiation
that were selected originally for initial price applicability year 2026). and
2027 and have not previously been selected for renegotiation in initial price
applicability year 2028 or thereafter, these are the quarters for the same
calendar years for which non-FAMP data was reported in the Primary
Manufacturer’s data submission for the negotiation period in which the
selected drug’s MFP was negotiated. When there are less than 30 days of
commercial sales data for all NDC-11s of the selected drug in calendar year
2021, the applicable year will be the first full calendar year following market
entry of such drug. When there are at least 30 days of commercial sales data
but less than a calendar quarter of data to calculate the non-FAMP in calendar
year 2021, the Primary Manufacturer should submit 2021 data—to the extent
that it exists—for all NDC-11s of the selected drug. For a given NDC-11 of
such drug, when there are at least 30 days of commercial sales but less than a
calendar quarter of data to calculate the non-FAMP in calendar year 2021 (or
the first full year following market entry of such drug, when applicable) or
2025an applicable year, the non-FAMP reported by the Primary Manufacturer
to CMS should reflect the temporary non-FAMP predicated upon the first 30
days of commercial sales data. of such year. The temporary non-FAMP
should be calculated following the same methodology used to calculate the
temporary non-FAMP amount used to determine the Temporary Federal
Ceiling Price, as described in the Department of Veterans Affairs (VA) 2025
Updated Guidance for Calculation of Federal Ceiling Prices (FCPs) for New
15

The term “non-Federal average manufacturer price” means, with respect to a covered drug and a period
of time (as determined by the Secretary), the weighted average price of a single form and dosage unit
of the drug that is paid by wholesalers in the United States to the manufacturer, taking into account any
cash discounts or similar price reductions during that period, but not taking into account— (—(A) any
prices paid by the Federal Government; or (B) any prices found by the Secretary to be merely nominal
in amount. 38 U.S.C. § 8126(h)(5).

12

•

Drugs subject to Public Law 102-585.16 Any restatements of the non-FAMP
made in any manufacturer non-FAMP submissions to the VA must be
reflected in the non-FAMP submitted to CMS.
Non-FAMP package: Non-FAMP package is the package unit as described
in 38 U.S.C. § 8126(h)(6) and represents the NDC-11 package (e.g., for an
NDC-11 that represents a bottle of 30 tablets, the non-FAMP package would be
the bottle; for an NDC-11 that represents a single dose vial containing 25
mg/mL, the non-FAMP package would be the vial).

Instructions for Section B:
Please follow the instructions below when completing the data fields below.
• Please complete the data fields immediately below:
o 2021 or First Other Full Year of Market Entry after 2021: please fill in the
information for non-FAMP for each calendar quarter of 2021 for the
selected drug if at least one NDC-11 of the selected drug has an average
non-FAMP available for at least one quarter in 2021 (or, in the case that
there is not an average non-FAMP available for any NDC-11 of such drug
for 2021, please fill in the information for the applicable calendar quarters
for the first full year following the market entry for such drug).
• If the first full year following the market entry happens to be
2025,the calendar year prior to the selected drug publication date
for the initial price applicability year for which this ICR is
submitted then please proceed to fill in the data for 2025the
calendar year prior to the selected drug publication date (as defined
in 42 CFR 429.20) for the initial price applicability year for which
this ICR is submitted only.
o 2025: please fill in the information for non-FAMP for calendar year 2025.
o The calendar year prior to the selected drug publication date for the initial
price applicability year for which this ICR is submitted: please fill in the
information for non-FAMP for the calendar year prior to the selected drug
publication date (as defined in 42 CFR 429.20) for the initial price
applicability year for which this ICR is submitted, as applicable.
• Please note that when filling in the data, there may be a different number of
NDC-11s with available data in 2021 (or first other full year of market entry)
versus 2025.the calendar year prior to the selected drug publication date for a
drug selected for negotiation (or renegotiation, as applicable) for the initial price
applicability year for which this ICR is submitted. As an example, if any NDC11s of the selected drug have non-FAMP data in at least one quarter of 2021, all
associated NDC-11s should be reported for the four quarters of 2021 (in that
scenario, if there is no data for all quarters in 2021 for a given NDC-11, please
do not enter any data in the data fields for “2021 or First Other Full Year of
Market Entry After 2021” for that NDC-11 and provide an explanation of why
16

See: https://www.va.gov/opal/docs/nac/fss/pl102585-2025-pbm-fcp-guidance-for-new-covered-drugs.pdf.
Archived Dear Manufacturer Letters from the VA are available at: https://www.va.gov/opal/nac/fss/publicLaw.asp.

13

•

•

•

•

there is no data). Additionally, all NDC-11s for the four quarters of 2025the
calendar year prior to the selected drug publication date for the initial price
applicability year for which this ICR is submitted, even if an NDC-11 was
available in 2025the calendar year prior to the selected drug publication date for
the initial price applicability year for which this ICR is submitted but not
available during any quarter of 2021, should be reported.
Please report the non-FAMP and total non-FAMP package volume for each
NDC-11 of the selected drug. Primary Manufacturers are responsible for
reporting the calendar year as either calendar year 2021 or the calendar year of
first year post market entry.
o If an NDC-11 was not marketed, sold, or distributed in a particular
calendar quarter, including for any NDC-11s that are marked as
“discontinued,” a “sample package,” an “inner package,” an “outer
package,” and a “private label” in Section A, enter “0” in the total NDC-11
package volume field and leave the non-FAMP field blank. In these
situations, please provide an explanation in the “Explanation of why nonFAMP was not reported (if applicable)” field of why the NDC-11 had no
non-FAMP for that calendar quarter (e.g., first marketed in a later
calendar quarter; discontinued prior to 2021; sample).
Non-FAMP and total non-FAMP package volume information must be
provided by the Primary Manufacturer for its own NDC-11s and the NDC11s of the selected drug manufactured, marketed, controlled, or sold by any
Secondary Manufacturer(s).
Any restatements of the non-FAMP for the four calendar quarters of 2021 (or,
in the case that there is not an average non-FAMP available for such drug for
2021, for calendar quarters for the first full year following the market entry
for such drug) and for 2025the calendar year prior to the selected drug
publication date for a drug selected for negotiation (or renegotiation, as
applicable) for the initial price applicability year for which this ICR is
submitted made in any manufacturer non-FAMP submissions to the VA must
be reflected in the data fields below.
Please indicate the total number of NDC-11 packages sold during the quarter
and that are used in the calculation of the non-FAMP in the total non-FAMP
package volume field.

14

2021 or First Other Full Year of Market Entry after 2021
NDC-11 Calendar
Calendar Total Non- NonExplanation of why non-FAMP
Quarters
Year
FAMP
FAMP
was not Reported (if applicable)
of 2021 or
Package
First
Volume
Calendar
Year Post
Market
Entry
(e.g.,
Calendar
Quarters
in one of
2022,
2023, or
2024),
2025
[20XX])
12345QQ
Select One: #
$
Text (12,000 character count limit,
6789-01
2021, 2022,
which is approximately 1,000 words)
2023, 2024,
2025,
[20XX]
Note: If the Primary Manufacturer indicates that 2025the calendar year prior to the selected drug
publication date for the initial price applicability year for which this ICR is submitted is the
“First Other Full Year of Market Entry after 2021,” then the CMS HPMS will only display the data
fields for 2025the calendar year prior to the selected drug publication date for the initial price
15

applicability year for which this ICR is submitted for completion.
202520XX
NDC-11 Calendar
Quarter
for
202520X
X
12345QQ
6789-01

Total NonFAMP
Package
Volume

Non-FAMP Explanation of why non-FAMP was not
Reported (if applicable)

#

$

Text (12,000 character count limit, which is
approximately 1,000 words)

[ ] For a drug selected for renegotiation for which there is no non-FAMP to report in
response to Section B: Not Applicable.
C. Research and Development (R&D) Costs and Recoupment
Primary Manufacturer Response Required
This section contains three data questions related to global research and development (R&D) costs
incurred by the Primary Manufacturer related to the selected drug and the Primary Manufacturer’s
global and U.S. net revenue for the selected drug for CMS’ consideration of the extent to which
R&D costs have been recouped by the Primary Manufacturer related to the selected drug.
Definitions for Section C:
•

•

R&D costs is defined as a combination of costs incurred by the Primary
Manufacturer for a drug falling into two categories: (1) Costs Related to the
Selected Drug, Including Basic Pre-Clinical Research of the Selected Drug, PostInvestigational New Drug (IND) Costs of the Selected Drug, and Other Allowable
Costs; and (2) Costs for Failed and Abandoned Products Related to the Selected
Drug.
Basic pre-clinical research costs are defined as the sum of (1) direct research
expenses; and (2) the appropriate proportion of indirect research expenses
(defined below).
o Direct basic pre-clinical research costs are costs that can be specifically
attributed to the discovery and pre-clinical development of the selected
drug. Direct research expenses could include personnel (monetary and
non-monetary compensation for investigators and staff) researching the
selected drug, materials for conducting basic pre-clinical research, and the
costs of in vivo and in vitro studies on the selected drug before an IND
application went into effect.
o Indirect basic pre-clinical research costs and relevant general and
administrative expenses are operating costs for basic pre-clinical research
beyond the basic pre-clinical research costs for the selected drug,
including administrative personnel and overhead costs (expenses for
16

•

•

•

clinical facilities and equipment) that are shared across multiple potential
drugs or biological products.
Post-IND costs are defined as direct costs associated with dosing and preparing
the selected drug for clinical trials and the selected drug’s Phase I, Phase II, and
Phase III clinical trials. Post-IND costs also include direct costs associated with
completed FDA-required, postmarketing trials that are conducted after the FDA
has approved a product.
o Direct post-IND costs are defined as Institutional Review Board (IRB)
review and amendment costs, user fees, patient recruitment, per-patient costs,
research and data collection costs, personnel (compensation for investigators
and staff) researching the selected drug, and facility costs that are directly
related to conducting the dosing and Phase I, Phase II, and Phase III clinical
trials. Direct post-IND costs also include personnel, patient recruitment, and
per-patient costs, research and data collection costs, and facility costs that are
directly related to conducting the completed FDA-required, postmarketing
trial.
▪ Personnel, patient recruitment, and per-patient costs include
monetary and non-monetary compensation. Any non-monetary
compensation for investigators and staff included in the total amount
should reflect the fair market value for such compensation at the
time it was provided.
Other allowable costs for costs related to the selected drug are defined as direct
costs associated with conducting FDA-required postmarketing trials and other
FDA post-marketing requirements and commitments that were not completed,
Phase IV postmarketing studies , direct post-IND costs (following the definitions
and instructions for calculating direct post-IND costs above), direct costs
associated with researching and utilizing devices for the selected drug, direct
costs to support or satisfy a postmarketing requirement or commitment, and direct
costs for patient recruitment, per-patient costs, research and data collection costs,
personnel, and facility costs that are directly related to conducting Phase IV and
postmarketing trials.
Failed or abandoned product costs are defined as the sum of (1) direct basic preclinical research costs on drugs with the same mechanism of action as the
selected drug that did not make it to clinical trials; and (2) direct post-IND costs
for drugs with the same mechanism of action as the selected drug that did not
receive FDA approval.

CMS is including both the Primary Manufacturer’s global and U.S. net revenue for the
selected drug in its consideration of the extent to which the Primary Manufacturer has
recouped R&D costs.
•

Recoupment: Global and U.S. Net Revenue for the Selected Drug.
o Global net revenue for the selected drug is defined as the direct sales and
payments from all other entities, minus the discounts, chargebacks, rebates,
cash discounts, free goods contingent on a purchase agreement, up-front
17

payments, coupons, goods in-kind, free or reduced-price services, grants, other
price concessions or similar benefits offered to any purchasers or any royalty
payments or percentage payments in purchase contracts.
o U.S. net revenue for the selected drug is defined as the direct sales and
payments from U.S. entities, minus the discounts, chargebacks, rebates, cash
discounts, free goods contingent on a purchase agreement, up-front payments,
coupons, goods in kind, free or reduced-price services, grants, other price
concessions or similar benefits offered to any purchasers or any royalty
payments or percentage payments in purchase contracts.
The associated time periods for these terms are included below.
Instructions for Questions 1 through 3:
• For each dollar amount listed below and for the applicable time periods specified, the Primary
Manufacturer must report one dollar amount in the numerical response field. For the dollar
amount provided, the Primary Manufacturer must provide an explanation of the value(s),
including any calculations or conversions and any assumptions made in the free response
field.
o All dollar figures submitted to CMS must be cash-outlay costs to the Primary
Manufacturer. They must exclude any costs to entities that are not the Primary
Manufacturer.
• For Primary Manufacturers of drugs selected for negotiation:
• In Questions 1 and 2, report R&D costs through December 31, 2025 of the
calendar year prior to the selected drug publication date (as defined in 42
CFR 429.20) for a drug selected for negotiation for the initial price
applicability year for which this ICR is submitted.
• In Question 3, report the global and U.S. net revenue for the selected drug
from the date the drug or biological product was first sold globally through
December 31, 2025.17 through December 31 of the calendar year prior to the
selected drug publication date for the initial price applicability year for
which this ICR is submitted.
• If the drug was acquired by the Primary Manufacturer after the selected
drug was first sold globally, start the period from the first month of the
first full quarter the selected drug was owned by the Primary
Manufacturer.
• For Primary Manufacturers of all drugs selected for renegotiation:
o In Questions 1 and 2, report R&D costs that were incurred: (1) after the last date for
which the Primary Manufacturer reported data in the Primary Manufacturer’s original
full submission of section 1194(e)(1) data for the negotiation period in which the
selected drug’s MFP was negotiated through December 31, 2025; and (2)most recent
full submission of section 1194(e)(1) data through December 31 of the calendar year
prior to the selected drug publication date for the initial price applicability year for
which this ICR is submitted; and (2), for Primary Manufacturers of drugs selected for
17

For purposes of this instruction, global revenue is inclusive of U.S. revenue.

18

•

•

•

renegotiation for a drug that was selected for negotiation for initial price applicability
year 2026 or 2027 and the selected drug has not been selected for renegotiation in
initial price applicability year 2028 or thereafter, on or before the last date for which
the Primary Manufacturer reported data in the Primary Manufacturer’s originalmost
recent full submission of section 1194(e)(1) data for the negotiation period in which the
selected drug’s MFP was negotiated that meet the definition of R&D costs specified in
this ICR/Appendix A of the final guidance for initial price applicability year 2028 and
the Primary Manufacturer has not previously reported the same data in the Primary
Manufacturer’s originalany prior full submission of data related to the section
1194(e)(1) data startingfactors from when initial research began, or when the drug was
acquired by the Primary Manufacturer, whichever is later.18 , through December 31 of
the calendar year prior to the selected drug.
o In Question 3, report the global and U.S. net revenue from the last date for
which data was reported for global and U.S. net revenue in the Primary
Manufacturer’s originalmost recent full submission of section 1194(e)(1) data
for the negotiation period in which the selected drug’s MFP was negotiated
through December 31, 2025 the calendar year prior to the selected drug
publication date for the initial price applicability year for which this ICR is
submitted.
o If there are no costs to report in response to Questions 1, 2 and/or 3, select
“Not Applicable” for each relevant question.
For Questions 1 through 3, if R&D costs and/or net revenue for the selected drug
are not available for the exact dates specified above in these instructions, the R&D
costs and/or net revenue may be reported through the most recent quarter for which
such data are available. The Primary Manufacturer should specify the time period
used in the free response field for each question.
If the Primary Manufacturer received any prior Federal financial support, as defined
in Section E in this ICR, for any of the costs listed in Questions 1 through 2 below
(e.g., basic pre-clinical research, clinical trials, etc.), deduct such funding from the
final calculated numerical amount before answering the relevant question and note
that deduction in the applicable free response field. CMS will be collecting
additional information on prior Federal financial support in Questions 6, 7, and 8.
Please reference Section E for instructions on reporting prior Federal financial
support.
• Do not include prior Federal financial support and costs associated with applying for and
receiving foreign approvals in Section E.
If the Primary Manufacturer shared the expenses described in Questions 1 through 2

18

For initial price applicability year 2026 and initial price applicability year 2027, CMS did not permit costs to be
reported for indications that had not yet received FDA approval at the time of ICR submission; however, CMS will
permit reporting of such R&D costs related to the selected drug for initial price applicability year 2028. Therefore, this
Section C also permits the Primary Manufacturer to report R&D costs that may have occurred on or before the last date
for which the Primary Manufacturer reported data in the Primary Manufacturer’s original full submission of section
1194(e)(1) data for the negotiation period in which the selected drug’s MFP was negotiated that a Primary Manufacturer
has not reported as an R&D cost for the selected drug previously.

19

•

•

(after any acquisition of the selected drug, if relevant) for any period of time or
activity with any entity that is not the Primary Manufacturer, then the Primary
Manufacturer must report only costs the Primary Manufacturer incurred. Report
how shared expenses were allocated among the Primary Manufacturer and any
other entity or entities in the free response field for the relevant question.
Follow the instructions for Reporting Monetary Amounts, including those related to
converting to USD if R&D costs occurred in other countries. While R&D may occur
in other countries and those costs may be included and reported in USD, costs
associated with applying for and receiving foreign approvals must not be included.
Acquisition costs are not allowable in Section C.

Question 1: Costs Related to the Selected Drug, Including Basic Pre-Clinical Research Costs of
the Selected Drug, Post-IND Costs of the Selected Drug, and Other Allowable Costs
Provide the following information about R&D costs (for the time periods as specified
in the instructions above) incurred by the Primary Manufacturer for the selected drug
related to basic pre-clinical research, post-IND costs for the selected drug, and other
allowable costs.
[ ] (For a drug selected for renegotiation only) If there are no costs to report, select:
Not Applicable.
Instructions for Question 1a:
• In the numerical response field for “Cost Related to the Selected Drug,” report the
sum of the (1) direct and the proportion of indirect costs for basic pre-clinical
research for the selected drug; (2) direct post-IND costs; and (3) direct costs for
other allowable costs.
o To calculate the proportion of pre-clinical indirect costs, the Primary
Manufacturer must use proportional allocation, whereby the same
proportion of spending allocated for direct research on the selected drug is
used to estimate the proportional spending for indirect research.19, 20 For
example, if the direct pre-clinical research costs spent on the selected drug
were approximately 10 percent of a Primary Manufacturer’s total direct
basic pre-clinical research costs for that period of time, then indirect costs
should be allocated proportionally. Thus, for the selected drug, they
should be 10 percent of the total spending on indirect pre-clinical research
costs during that time period.
19

Wouters OJ, McKee M, Luyten J., Estimated Research and Development Investment Needed to
Bring a New Medicine to Market, 2009-2018. JAMA. 2020;323(9):844–853.
doi:10.1001/jama.2020.1166.
20
Drummond MF, Sculpher MJ, Torrance GW, O’Brien BJ, Stoddart GL., Methods for the
Economic Evaluation of Health Care Programme. 3rd ed. Oxford, UK: Oxford University Press, 2005,
https://pure.york.ac.uk/portal/en/publications/methods-for-the-economic-evaluation-of-health-careprogramme-third-edition(e43f24cd-099a-4d56-97e6-6524afaa37d1)/export.html.

20

•

In the response field for “Cost Related to the Selected Drug Adjusted for
Inflation,” report the cost included for the “Cost Related to the Selected Drug”
data field adjusted for inflation.
Costs Related to the Selected Drug
$

Costs Related to the Selected Drug Adjusted for
Inflation
$

Instructions for Question 1b:
• List the direct and indirect costs for the selected drug that were included in the reported
amount in Question 1a.
FIELD
List of the direct and indirect costs for the selected
drug included in Question 1a

RESPONSE FORMAT
Text (6,000 character count limit, which is
approximately 500 words)

Instructions for Question 1c:
• Explain how the numerical value reported in Question 1a was calculated, including the
allocation and apportionment methods.
• For Primary Manufacturers of drugs selected for renegotiation: this explanation
should include whether any of the reported costs are costs incurred on or before the
last date for which the Primary Manufacturer reported data in the Primary
Manufacturer’s originalmost recent full submission of section 1194(e)(1) data and the
total costs for this period of data.
• Explain any methodology relevant to the cost included in response to Question 1a
adjusted for inflation in the free response.
FIELD
RESPONSE FORMAT
Explanation of Costs Related to the Selected Drug,
Text (30,000 character count limit, which
Including Allocation and Apportionment Methods, and is approximately 2,500 words)
an Explanation of the Methodology for the Inflation
Adjustment
Question 2: Costs of Failed or Abandoned Products Related to the Selected Drug
The Primary Manufacturer may report direct costs spent on basic pre-clinical research
and clinical research for failed or abandoned products that are related to the selected
drug (for the time periods as specified in the instructions above).
[ ] (For a drug selected for renegotiation only) If there are no costs to report, select:
Not Applicable.
Instructions for Question 2a:
21

•

In the numerical response field for “Costs of Allowable Failed or Abandoned
Products Related to the Selected Drug,” only include basic pre-clinical research
and post-IND costs that can be directly attributed to failed or abandoned
product(s) with the same mechanism of action as the selected drug that did not
receive FDA approval.
In the response field for “Cost Allowable Failed or Abandoned Products Related
to the Selected Drug Adjusted for Inflation,” report the cost included for the
“Costs of Allowable Failed or Abandoned Products Related to the Selected Drug”
data field adjusted for inflation.

•

Costs of Allowable Failed or Abandoned
Products Related to the Selected Drug
$

Costs of Allowable Failed or Abandoned
Products Related to the Selected Drug
Adjusted for Inflation
$

Instructions for Question 2b:
• List all the applicable direct costs included in the numerical value given in Question 2a.
FIELD
List of the direct costs included in this question

RESPONSE FORMAT
Text (6,000 character count limit, which
is approximately 500 words)

Instructions for Question 2c:
In the free response field, detail how these costs were determined, what portion of direct
costs was included for basic pre-clinical research and direct post-IND costs, and how
any allocation was done.
• Explain any methodology relevant to the cost included in the response to Question 2a
adjusted for inflation in the free response.
•

FIELD
Explanation of Costs on Allowable Failed or Abandoned Products
Related to the Selected Drug, Including Allocation and
Apportionment Methods, and an Explanation of the Methodology for
the Inflation Adjustment

RESPONSE FORMAT
Text (30,000 character
count limit, which is
approximately 2,500
words)

Question 3: Global and U.S. Net Revenue for the Selected Drug
CMS will use both the Primary Manufacturer’s global and U.S. net revenue for the selected
drug to determine the extent to which the Primary Manufacturer has recouped R&D costs
for the selected drug (for the time periods as specified in the instructions above).
[ ] (For a drug selected for renegotiation only) If there is no revenue to report, select:
Not Applicable.
22

Instructions for Question 3a:
• In the numerical response field for “Global Net Revenue for the Selected Drug” in
Question 3a, report the global net revenue.
• In the numerical response field for “Global Net Revenue for the Selected Drug
Adjusted for Inflation” in Question 3a, report the global net revenue reported adjusted
for inflation.
Global Net Revenue for the Selected Drug
$

Global Net Revenue for the Selected Drug
Adjusted for Inflation
$

Instructions for Question 3b:
• In the free response field, explain how the global, net revenue was calculated, including
any relevant currency conversions.
• Explain any methodology relevant to the net revenue included in the response to
Question 3a adjusted for inflation in the free response.
FIELD
RESPONSE FORMAT
Explanation of Global Net Revenue for the Selected Drug Text (30,000 character count limit,
and an Explanation of the Methodology for the Inflation
which is approximately 2,500 words)
Adjustment
Instructions for Question 3c:
• In the numerical response field for “U.S. Net Revenue for the Selected Drug” in
Question 3c, report the U.S. net revenue.
• In the numerical response field for “U.S. Net Revenue for the Selected Drug Adjusted
for Inflation” in Question 3c, report the U.S. net revenue reported adjusted for inflation.
U.S. Net Revenue for the Selected Drug
$

U.S. Net Revenue for the Selected Drug
Adjusted for Inflation
$

Instructions for Question 3d:
• In the free response field, explain how the U.S. net revenue was calculated.
• Explain any methodology relevant to the net revenue included in the response to
Question 3c adjusted for inflation in the free response.
FIELD
Explanation of U.S. Net Revenue for the Selected Drug and
an Explanation of the Methodology for the Inflation
Adjustment

RESPONSE FORMAT
Text (30,000 character count limit,
which is approximately 2,500
words)
23

D. Current Unit Costs of Production and Distribution
Primary Manufacturer Response Required
Section D contains two questions on current unit costs of production and distribution for the
selected drug (for the time period as specified in the instructions below). Question 4 includes data
fields in which to report the average unit costs of production and distribution for each NDC-11 of
the selected drug. Question 5 provides a free response field for explaining the methodology for
calculating the amount reported in Question 4.
Definitions for Section D:
• In accordance with section 1191(c)(6) of the Act, the term “unit” means, with respect to a
drug or biological product, the lowest identifiable amount (e.g., capsule or tablet, milligram
of molecules, grams, international units) of the drug or biological product that is dispensed,
furnished, or administered.
• Units must be reported in one of the three NCPDP Billing Unit Standard (BUS).21 The three
NCPDP BUS are: each (EA), milliliter (mL), and gram (GM). For certain volume data of the
selected drug, CMS is requesting units be reported using the NCPDP BUS to facilitate
comparison with the amounts in the quantity dispensed field found in PDE data, which also
uses the NCPDP BUS.
• Costs of production are defined as all (direct and allocation of indirect) costs related to:
o Purchase of raw ingredients, including intermediates, active pharmaceutical
ingredients, excipients, and other bulk chemicals;
o Formulation and preparation of the finished drug product;
o Quality control and testing of the drug; and
o Operating costs for personnel, facilities, transportation, importation (if any), and
other expenses related to the preparation of the finished drug product for the
selected drug.
• Costs of distribution are defined as all (direct and allocation of indirect) costs
related to:
o Packaging and packaging materials;
o Labeling (e.g., the mechanical aspects of printing and affixing the approved label);
o Shipping to any entity (e.g., distributor, wholesaler, retail or specialty pharmacy,
physician office or hospital, etc.) that acquires the drug from the Primary
Manufacturer or any Secondary Manufacturer; and
o Operating costs for facilities, transportation, and other expenses related to
packaging, labeling, and shipping to any entity that acquires the drug from the
Primary Manufacturer or any Secondary Manufacturer.
• Current unit costs of production and distribution of the selected drug are
defined to include:
21

See: https://standards.ncpdp.org/BillingUnitRequest.aspx#:~:text=Billing%20Unit%20Requests,grams%22%20or%20%22milliliters.%22. See:
https://standards.ncpdp.org/Billing-UnitRequest.aspx#:~:text=Billing%20Unit%20Requests,grams%22%20or%20%22milliliters.%22.

24

•

•

•

o Units (and associated costs) marketed by the Primary Manufacturer and any
Secondary Manufacturer(s);
o Only units (and associated costs) produced and distributed for U.S. sales; costs
incurred outside of the U.S. are included, provided that they are incurred for the
production or distribution of units produced and distributed for use in the U.S.;
o Only costs incurred by the Primary Manufacturer and any Secondary
Manufacturers; such costs may include payments to third-party vendors (e.g.,
contractors) performing activities that qualify as production or distribution, as
specified above; and
o Allocated shared operating and other indirect costs (such as capitalized production
facility costs, benefits, generalized and administrative costs, and overhead expenses)
specific to each NDC-11 based on unit volume.
Current unit costs of production and distribution of the selected drug do not
include:
o R&D costs;
o Marketing costs; and
o Transfer prices.
“Marketing costs” are defined as expenditures incurred in the introduction or delivery for
introduction into interstate commerce of a drug product, specifically including media
advertisements, direct-to-consumer promotional incentives including patient assistance
programs, promotion of the drug to health professionals, including providing free products
to health professionals or patients, and other paid promotion.
“Transfer prices” are defined as prices charged for goods, services, or other intangible
assets in transactions between two members of the same controlled group of the Primary
Manufacturer or any Secondary Manufacturer, including sales of a drug product, provision
of services (e.g., contract manufacturing), or transfer of intellectual property. For the
purposes of the definition of transfer prices, “controlled group” of the Primary
Manufacturer or any Secondary Manufacturer refers to all entities that were treated as a
single employer under subsection (a) or (b) of section 52 of the Internal Revenue Code and
the Department of the Treasury regulations thereunder.

Instructions for Section D:
Follow the instructions below when answering Questions 4 and 5:
• Production and distribution unit costs must be reported separately for each NDC-11 of the
selected drug, including any NDC-11 of the selected drug manufactured, marketed,
controlled, or sold by a Secondary Manufacturer.
• Unit costs reported must represent the average per unit cost (1) within the time period
specified below, (2) across all package types, and (3) calculated according to the
instructions and using the definitions specified below.
• Use the response field in Question 5 to explain any shared operating and other indirect costs
that were included in the response to Question 4.
• Costs may be reported up to three decimal places (USD).
Question 4: Per Unit Production and Distribution Costs
25

•

•
•

Please complete the following data fields using additional rows as necessary for the
following periods: 12-month period ending December 31 of the calendar year prior to
the selected drug publication date (as defined in 42 CFR 429.20) for the initial price
applicability year for which this ICR is submitted.
for drugs selected for negotiation, the 12-month period ending December 31, 2025,
and
for drugs selected for renegotiation, the 12-month period ending December 31, 2025.

Include NDC-11s that were marked in Section A as sample packages, inner packages,
outer packages and NDC-11s that are discontinued.
NDC11

Average
Per Unit
Production
Cost
12345- $XX.XXX
678901

Average Per
NCPDP Unit
Unit Distribution (EA, mL, GM)
Costs

Total
Unit
Volume

Costs are
Not
Available

Explanation of
Why Costs are
Not Available

$XX.XXX

#

Select if
applicable

Text (30,000
character count
limit, which is
approximately
2,500 words)

Text

Question 5: Explanation of Calculation of Per Unit Production and Distribution Costs
Please describe the methodology used to calculate the average per unit costs of production
and distribution reported in Question 4, including which indirect costs were included,
specific allocation methodologies, assumptions, and whether such assumptions apply to all
or a subset of the data reported.
Specifically, include any other assumptions about costs, if applicable, including but not limited to:
• Allocated general and administrative overhead;
• Cost of capital;
• Labor compensation;
• Any included costs that were incurred outside of the U.S.;
• Allocated shared facility costs;
• Allocated shared transportation or other operational costs;
• Depreciation of facilities, equipment, or other assets involved in the
production and distribution of the selected drug; and
• Number of units of drug samples and how their cost was determined.
FIELD
Explanation of Unit Production and
Distribution Costs

RESPONSE FORMAT
Text (30,000 character count limit, which is
approximately 2,500 words)
26

E. Prior Federal Financial Support
Primary Manufacturer Response Required
Section E focuses on capturing prior Federal financial support for novel therapeutic discovery and
development with respect to the selected drug.
Definitions for Section E:
• “Federal financial support for novel therapeutic discovery and development” refers to tax
credits, direct financial support, grants or contracts, in-kind contributions (e.g., support in the
form of office/laboratory space or equipment), and any other funds provided by the
federalFederal government that support discovery, research, and/or development related to the
selected drug.
• Prior Federal financial support includes the manufacturer’s reasonable estimate of the dollar
value of in-kind contributions and Cooperative Research and Development Agreements
(CRADAs) that do not have a readily ascertainable value.
• Direct prior federalFederal financial support costs are costs that can be specifically attributed to
the discovery, pre-clinical development, and clinical trials of the selected drug.
Instructions for Section E:
Follow the instructions below when answering Questions 6, 7, and 8.
•

The applicable time period is as follows:
o For Primary Manufacturers of drugs selected for negotiation:
• Include all prior Federal financial support provided by U.S. federalFederal agencies or
Federally-supported grants or contracts that contributed to any of the costs described
in response to Question 1 of this ICR Form of the selected drug to the Primary
Manufacturer only (do not include Federal financial support provided to Secondary
Manufacturers of a selected drug) that was received during the time period from when
initial research began, or when the drug was acquired by the Primary Manufacturer,
whichever is later, through December 31, 2025 of the calendar year prior to the
selected drug publication date (as defined in 42 CFR 429.20) of the initial price
applicability year for which this ICR is submitted.
o For Primary Manufacturers of drugs selected for renegotiation:
• Include all prior Federal financial support provided by U.S. federalFederal agencies or
Federally-supported grants or contracts that contributed to any of the costs described
in response to Question 1 of this ICR Form of the selected drug to the Primary
Manufacturer only (do not include Federal financial support provided to Secondary
Manufacturers of a selected drug) that was received during the time period from the
last date for which the Primary Manufacturer reported data in the Primary
Manufacturer’s originalmost recent full submission of section 1194(e)(1) data for the
negotiation period in which the selected drug’s MFP was negotiated through
December 31, 2025 of the calendar year prior to the selected drug publication date (as
defined in 42 CFR 429.20) of the initial price applicability year for which this ICR is
27

submitted.
Include each licensing agreement, pricing agreement, purchasing agreement, and other
agreement in place between your company and any Federal government agency related
to the discovery, research, and/or development of the selected drug that was entered
into during the time period from the last date for which the Primary Manufacturer
reported data in the Primary Manufacturer’s most recent full submission of section
1194(e)(1) data through December 31 of the calendar year prior to the selected drug
publication date (as defined in 42 CFR 429.20) of the initial price applicability year for
which this ICR is submitted.
• As described in Section C, for Primary Manufacturers of drugs selected for
renegotiation for a drug that was selected originally for negotiation for initial
price applicability year 2026 or 2027, and the selected drug has not previously
been selected for renegotiation in initial price applicability year 2028 or
thereafter, if the Primary Manufacturer incurred R&D costs on or before the last date
for which the Primary Manufacturer reported data in the Primary Manufacturer’s
originalmost recent full submission of section 1194(e)(1) data for the negotiation
period in which the selected drug’s MFP was negotiated that meet the definition of
R&D costs specified in this ICR/Appendix A of the final guidance for initial price
applicability year 2028 and, the Primary Manufacturer has not previously reported the
same data in the Primary Manufacturer’s originalany prior full submission of data
related to the section 1194(e)(1) datafactors, and the Primary Manufacturer is
reporting such R&D costs under Section C, include all applicable prior Federal
financial support from when initial research began, or when the drug was acquired by
the Primary Manufacturer, whichever is later, through December 31, 2025 of the
calendar year prior to the selected drug publication date of the initial price
applicability year for which this ICR is submitted.22
• If there are no costs to report in response to Questions 6, 7 and/or 8, select “Not
Applicable” for each relevant question.
For Question 6, if prior Federal financial support for the selected drug is not available for the
exact dates specified above in these instructions, the prior Federal financial support may be
reported through the most recent quarter for which such data are available. The Primary
Manufacturer should specify the time period used in Question 7.
Include prior Federal financial support received for indirect costs of developing the selected
drug. These indirect costs are operating costs such as administrative personnel and overhead
costs (expenses for clinical facilities and equipment) that are shared across multiple potential
•

•

•

22

For initial price applicability year 2026 and initial price applicability year 2027, CMS did not permit R&D costs to
be reported for indications that had not yet received FDA approval at the time of ICR submission; however, CMS will
permit , consistent with the definitions in this ICR, now permits reporting of such prior Federal financial support R&D
costs related to the selected drug for initial price applicability year 2028.. Therefore, if such R&D costs were reported
under Section C, this Section E also permitsrequires a Primary Manufacturer to report supportprior Federal financial
support associated with such R&D costs that may have occurred on or before the last date for which the Primary
Manufacturer reported data in the Primary Manufacturer’s originalmost recent full submission of data related to the
section 1194(e)(1) datafactors for the negotiation period in which the selected drug’s MFP was negotiated that a
Primary Manufacturer has not reported for the selected drug previously.

28

•

drugs or biological products.
o To calculate the proportion of indirect costs, the Primary Manufacturer must use
proportional allocation, whereby the same proportion of spending allocated for direct
research on the selected drug is used to estimate the proportional spending for indirect
research.23, 24 For example, if the direct costs spent on the selected drug were
approximately 10 percent of a Primary Manufacturer’s total direct basic pre-clinical
research costs, then indirect costs must be allocated proportionally, thus for the selected
drug they must be 10 percent of the total spending on indirect costs during that time period.
o For grants, Primary Manufacturers should use the indirect cost rate at the time of data
submission to calculate the proportion of funds that should be allocated to indirect costs.
This indirect cost rate could be the fixed rate, provisional/final rate, or predetermined rate.
o For in-kind contributions and CRADAs, if the dollar value of the in-kind contribution or
CRADA is not readily ascertainable, the recipient should provide a reasonable estimate.
If the Primary Manufacturer shared the prior Federal financial support described in Questions 6
through 8 for any period of time or activity with any entity that is not the Primary
Manufacturer, then the Primary Manufacturer must report support received only for costs the
Primary Manufacturer incurred. ExpensesPrior Federal financial support should be allocated
across entities based on each entity’s respective stake in the selected drug’s discovery and
development. The allocation to the Primary Manufacturer should be reported as a dollar
amount and the percentage of the total amount allocated to the Primary Manufacturer should be
included in the free response field in Question 8. For example, if the Primary Manufacturer
was allocated 80 percent of the prior Federal financial support for a period of the selected
drug’s development, the Primary Manufacturer would include 80 percent of that support in its
total number for prior Federal financial support in Question 6. Then, it would note the source
of the shared prior Federal financial support and that it received 80 percent of that support in
Question 7. If the shared support came in the form of an agreement, the Primary Manufacturer
would include this in the “Nature of Agreement” section of Question 8.

Question 6: Federal Funding Support Amount
[ ] (For a drug selected for renegotiation only) Not Applicable.
Instructions for Question 6:
• In the numerical response field for “total Federal financial support,” report the total Federal
financial support.
• In the numerical response field for “total Federal financial support adjusted for inflation,”
23

Wouters OJ, McKee M, Luyten J., Estimated Research and Development Investment Needed to Bring
a New Medicine to Market, 2009-2018. JAMA. 2020;323(9):844–853. doi:10.1001/jama.2020.1166.
24
Drummond MF, Sculpher MJ, Torrance GW, O’Brien BJ, Stoddart GL., Methods for the Economic
Evaluation of Health Care Programme. 3rd ed. Oxford, UK: Oxford University Press, 2005,
https://pure.york.ac.uk/portal/en/publications/methods-for-the-economic-evaluation-of-health-careprogramme-third-edition(e43f24cd-099a-4d56-97e6-6524afaa37d1)/export.html..

29

report the total Federal financial support reported adjusted for inflation.
Total Federal Financial Support
$

Total Federal Financial Support
Adjusted for Inflation
$

Question 7: Explanation of Calculation of Federal Financial Support
Instructions for Question 7a:
• In the free response field, disaggregate the total Federal financial support amount reported
above by the amounts allocated to the sources in the list below. Please list amounts in order of
highest to lowest.
o In addition, describe assumptions, methodological steps, and other information needed to
calculate the estimates provided in Question 6.
o If you report a value for “other Federal financial support not otherwise included elsewhere”
in your response to this question, please list the source(s) of that Federal financial support.
o Please include the identification number for grants and comparable awards.

List of sources for Question 7a
• Tax credits (General, R&D)
• Orphan Drug Act and other specific tax credits
• National Institutes of Health (NIH) funding
• Department of Defense (DOD) Congressionally Directed Medical Research
(CDMR) funding
• Biomedical Advanced Research and Development Authority (BARDA) funding
• Defense Advanced Research Projects Agency (DARPA) funding
• Federal financial support for failed or abandoned indications for the selected
drug
• CRADA support
• In-kind contributions not included elsewhere
• Other Federal financial support not included elsewhere
FIELD
Explanation of Federal Financial
Supportfinancial support,
including disaggregated amounts
as applicable

RESPONSE FORMAT
Text (36,000 character count limit, which is
approximately 3,000 words)

Instructions for Question 7b:
• Explain any methodology relevant to the total Federal financial support adjusted for inflation
included in the response to Question 6 in the free response.
30

•

Report each total Federal financial support disaggregated amount adjusted for inflation, and
explain the methodology used to adjust for inflation.
FIELD
Explanation of methodology used to adjust
for inflation

RESPONSE FORMAT
Text (6,000 character count limit, which is
approximately 500 words)

Question 8: Agreements Between Primary Manufacturer and Federal Government
List and describe each licensing agreement, pricing agreement, purchasing
agreement, and other agreement in place between your company and any
federalFederal government agency related to the discovery, research, and/or
development of the selected drug. Add additional rows to your response to Question
8 as needed.
•

In the “Nature of Agreement” field, please provide details on the terms of the
agreement, such as information on pricing, the nature and amount of
goods/services agreed upon, an explanation of the allocation methodology to the
selected drug, timelines to delivering goods/services, conditions on the
agreement (exclusivity, sole supplier, etc.) and effective dates and expiration
dates, if applicable. For example, this field could detail an agreement between
the Primary Manufacturer and Federal Government where the Primary
Manufacturer agrees to produce a certain quantity of a drug that is being
developed and has not yet been approved or licensed, deliver it to the Federal
Government within a specified timeline, and not contract with other state or local
governmental entities or insurers while this agreement is in place.

Type of Agreement

Federal Agency(ies)
Participating in
Agreement
Select the agreement option:
Text (1,200 character count
licensing, pricing, purchasing, limit, which is approximately
other, none
100 words)
[ ] (For a drug selected for renegotiation only) Not Applicable.

Nature of
Agreement
Text (12,000 character count
limit, which is approximately
1,000 words)

F. Patents, Exclusivities, and Approvals
Primary Manufacturer Response Required
Section F focuses on capturing data on the selected drug related to pending and approved patent
applications, exclusivities recognized by the FDA, and applications and approvals under section
505(c) of the Federal Food, Drug, and Cosmetic (FD&C) Act or section 351(a) of the Public
Health Service (PHS) Act. Follow the instructions below when answering Questions 9 through 11.
Definitions for Section F:
31

•

•

•
•

Patents Exclusivities and Approvals. CMS considers relevant patents, both expired and
unexpired, and relevant patent applications to include:
▪ All patents issued by the United States Patent and Trademark Office (USPTO)), both
expired and unexpired, for which a claim of patent infringement could reasonably be,
or has been, asserted against a person or manufacturer engaged in the unlicensed
manufacture, use, or sale of the selected drug in any form or any person or
manufacturer seeking FDA approval of a product that references the selected drug.
▪ All patents relevant to the selected drug, both expired and unexpired, where the
Primary Manufacturer is not listed as the assignee/applicant (for example, for a joint
venture product or if any patents related to the selected drug are held by a
federalFederal agency).
▪ All patent applications related to the selected drug that are pending issuance by the
USPTO.
Patents and patent applications relevant to the selected drug include, but are not limited to,
any patents that are, have been, or may be listed for the selected drug in the FDA Orange
Book or Purple Book;25 patents that claim the composition of matter (e.g., active ingredient,
including its chemical or biological structure), drug product (e.g., the final product taken by
or administered to a patient), drug substance (e.g., active ingredient) or other chemicals
related to the active ingredient of a selected drug (e.g., crystalline forms, polymorphs, salts,
metabolites or intermediates); patents that claim a formulation of the drug; method-of-use
patents (e.g., patents that claim an indication or use of the drug for treating a particular
disease); process patents (e.g., patents that claim technologies and method(s) of
manufacturing the drug); device patents (e.g., patents that claim the device used to
administer the selected drug); and design patents (e.g., patents that claim a design on the
packaging of the selected drug).
Relevant patents and patent applications do not include patent applications that were denied
by the USPTO.
Exclusivity periods under the FD&C Act or the PHS Act refer to certain delays on the
submission or approval of applications for competitor drug products. An NDA or BLA
holder is eligible for exclusivity if statutory requirements are met. Exclusivities include:
o Orphan Drug Exclusivity (ODE);26
o New Chemical Entity Exclusivity (NCE);27
o Generating Antibiotic Incentives Now (GAIN) Exclusivity for
Qualified Infectious Disease Products (QIDP);28
o New Clinical Investigation Exclusivity (NCI);29
o Pediatric Exclusivity (PED);30 and

25

FDA serves a ministerial role with regard to the listing of patent information in the Orange Book and
Purple Book.
26
Section 527 of the FD&C Act.
27
Section 505(c)(3)(E)(ii) and Section 505(j)(5)(F)(ii) of the FD&C Act.
28
Section 505E(a) of the FD&C Act.
29
Section 505(c)(3)(E)(iii) & (iv) and Section 505(j)(5)(F)(iii) & (iv) of the FD&C Act.
30
Section 505A(b) & (c) of the FD&C Act.

32

•

o Reference Product Exclusivity for Biological Products.31
Active and pending FDA applications and approvals include all applications for approval
under section 505(c) of the FD&C Act or section 351(a) of the PHS Act, including those
not yet decided.

Instructions for Section F:
• For Questions 9 through 11, the relevant time period for reporting is:
o For Primary Manufacturers of drugs selected for negotiation:
• The time period begins on the later of the date that basic pre-clinical research began on
the selected drug or the date the selected drug was acquired by the Primary Manufacturer
and ends on December 31, 2025.
• Consistent with the definitions above, include patents, approvals and exclusivities issued
or filed (and related items) as of December 31 of the calendar year prior to the selected
drug publication date (as defined in 42 CFR 429.20) of the initial price applicability year
for which this ICR is submitted.
o For Primary Manufacturers of drugs selected for renegotiation:
o for a drug that was originally selected for negotiation for initial price applicability year
2026, include (1)Include any patents, approvals and exclusivities not previously
reported to CMS in any prior full submission of section 1194(e)(1) data issued or filed
(as of December 31 of the calendar year prior to the selected drug publication date (as
defined in 42 CFR 429.20) of the initial price applicability year for which this ICR is
submitted; and related items) after September 1, 2023 through December 31, 2025 and
(2) patents
o Include any patents, approvals, and exclusivities (and related items) issued or filed on
or before September 1, 2023 for whichthat were previously reported to CMS in any
prior full submission of section 1194(e)(1) data where there has been a change after
September 1, 2023 throughsince the most recent full submission as of December 31,
2025, if requested below; and of the calendar year prior to the selected drug
publication date (as defined in 42 CFR 429.20) of the initial price applicability
year for which this ICR is submitted. If there are no data to report in response to
Questions 9, 10 and/or 11, select “Not applicable” for each relevant question.
for a drug that was originally selected for negotiation for initial price applicability year
2027, include (1) patents, approvals and exclusivities issued or filed (and related items)
after February 1, 2025 through December 31, 2025 and (2) patents and exclusivities
(and related items) issued or filed on or before September 1, 2023 for which there has
been a change after February 1, 2025 through September 30, 2025, if requested below.
Question 9A: Patents (Expired and Non-Expired)
In the data fields below, please list each patent that is relevant to the selected drug for the
applicable time periodas specified in the instructions above. For each patent (expired or unexpired)
listed in the data fields below, in the patent explanation field, please provide a clear and concise
written description of the patented invention and, if relevant, of the manner and process of making
and using the invention, as well as how a patent relates to any other patents listed in the data fields.
31

Section 351(k)(7) of the PHS Act.

33

For example, if a listed patent is a parent or child of another patent, include the patent number and
how the two patents relate to each other. If the patent was previously listed in the FDA Orange
Book or Purple Book but is no longer listed, please explain why.
For drugs selected for renegotiation, do not report relevant patents included in the Primary
Manufacturer’s originalprior full submission(s) of data reported by the Primary Manufacturer
related to the section 1194(e)(1) data where nofactors unless a change has occurred following the
most recent full submission and prior to December 31 of the calendar year prior to the selected
drug publication date (as defined in 42 CFR 429.20) of the initial price applicability year for which
this ICR is submitted. Information may include, for example, a new patent issued after the last date
for which the Primary Manufacturer reported data in the Primary Manufacturer’s originalmost
recent full submission of section 1194(e)(1) data for the negotiation period in which the selected
drug’s MFP was negotiated, and any patent where there has been a change since the last date for
which the Primary Manufacturer reported data in the Primary Manufacturer’s originalmost recent
full submission of section 1194(e)(1) data for the negotiation period in which the selected drug’s
MFP was negotiated (e.g., patent was removed from the Orange Book).
A Zip file of the PDF file(s) of the USPTO patent application(s) may be uploaded but is not
required for this question 9A. Add additional rows to your response to Question 9A as needed.
Patent
Expiry
Date

Patent
Numb
er

Date
Filed

#Text

MM/
MM/
DD/
DD/Y
YY
YYY*
YYYYY
Y
(not
applic
able
itif
patent
expire
d)

Patent Type

Select patent
type (allow more
than one to be
selected):
composition of
matter patent;
drug product
patent; drug
substance
patent;
formulation
patent; process
patent; methodof-use patent;
device patent;

Never,
Previously,
or
Currently
Listed in
FDA
Orange
Book/Purple
Book
Never/
Previously
/
Currently

Patent
Patent
Explanation Application
or
Explanation
of What
Changed
Since Last
Submission
Text (3,600
character
count limit,
which is
approximat
ely 300
words

Optional.
Upload
corresponding
patent
application

34

Patent
Numb
er

Date
Filed

Patent
Expiry
Date

Patent Type

Never,
Previously,
or
Currently
Listed in
FDA
Orange
Book/Purple
Book

Patent
Patent
Explanation Application
or
Explanation
of What
Changed
Since Last
Submission

other (e.g.,
patent that
claims other
chemicals
related to the
active
ingredient,
design patent)
[ ] (For a drug selected for renegotiation only) Not Applicable.
*If no expiration date is available, enter 12/31/9999.
Question 9B: Patent Applications
In the data fields below, please list each patent application that is relevant to the selected drug for
the applicable time period specified in the instructions. For each patent application listed in the
data fields below, in the patent explanation field, please provide a clear and concise written
description of the invention and, if relevant, of the manner and process of making and using the
invention, as well as how a patent application relates to any other patents. Do not include patent
applications that were denied.
For drugs selected for renegotiation, do not report relevant patent applications included in the
Primary Manufacturer’s originalprior full submission(s) of data reported by the Primary
Manufacturer related to the section 1194(e)(1) data where no factors unless a change has occurred.
following the most recent full submission of section 1194(e)(1) data and prior to December 31
of the calendar year prior to the selected drug publication date (as defined in 42 CFR 429.20) of the
initial price applicability year for which this ICR is submitted. Information may include, for
example, a new application or applications that have experienced a change since the last date for
which the Primary Manufacturer reported data in the Primary Manufacturer’s originalmost recent
full submission of section 1194(e)(1) data for the negotiation period in which the selected drug’s
MFP was negotiated)..
Please upload a Zip file of a PDF file of the USPTO patent application(s). Add additional rows to
your response to Question 9B as needed.
35

Patent
Number

Date
Filed

Patent Type

Patent Explanation, Patent Application
or Explanation of
What Changed Since
Last Submission

#Text

MM/
DD/ YY
YY
(not
applica
ble if
patent
pending
)

Select patent type (allow
more than one to be
selected): composition of
matter patent; drug
product patent; drug
substance patent;
formulation patent; process
patent; method-of-use
patent;
device patent; other (e.g.,
patent that claims other
chemicals related to the
active ingredient, design
patent)

Text (3,600
character count
limit, which is
approximately 300
words)

Upload
corresponding
patent
application.

[ ] (For a drug selected for renegotiation only) Not Applicable.
Question 10: Exclusivity Periods
As applicable, please report all exclusivity periods under the FD&C Act or the PHS Act that are listed
or were listed in the Orange Book or the Purple Book and are in effect or have expired for the selected
drug for the applicable time period specified in the instructions.
For drugs selected for renegotiation, do not report exclusivity periods listed in the Primary
Manufacturer’s originalprior full submission(s) of data reported by the Primary Manufacturer
related to the section 1194(e)(1) data where nofactors unless a change has occurred following the
most recent full submission of section 1194(e)(1) data and prior to December 31 of the calendar
year prior to the selected drug publication date (as defined in 42 CFR 429.20) of the initial price
applicability year for which this ICR is submitted. Information may include, for example, a new
exclusivity since the last date for which the Primary Manufacturer reported data in the Primary
Manufacturer’s originalmost recent full submission of section 1194(e)(1) data for the negotiation
period in which the selected drug’s MFP was negotiated.
Complete the data fields for Question 10 by adding rows as needed.

36

Type of Exclusivity

Select exclusivity type: Orphan
Drug Exclusivity, New Chemical
Entity Exclusivity, Generating
Antibiotic Incentives Now
Exclusivity for Qualified
Infectious Disease Products, New
Clinical Investigation Exclusivity,
Pediatric Exclusivity, Reference
Product Exclusivity for Biological
Products

Exclusi
Application
vity
(NDA /
Expira
BLA)
tion
Number
Date
MM/DD/YY #
YY*

NDC-9s
Comments
Covered
by
Exclusivity
Text

Text
(3,600
character
count
limit,
which is
approxim
ately 300
words)

[ ] (For a drug selected for renegotiation only) Not Applicable.
*If no expiration date is available, enter 12/31/9999.
Question 11: All Active and Pending FDA Applications and Approvals
List all active and pending FDA applications and approvals for the selected drug under section
505(c) of the FD&C Act or section 351(a) of the PHS Act for the time period specified in the
instructions.
o Include all applications for approval under section 505(c) of the FD&C Act or section
351(a) of the PHS Act, including those not yet decided. Leave approval date blank for those
applications not yet approved. [Complete the data fields for Question 11 by adding rows as
needed using the indicated format]
o Please submit any efficacy supplements that have been approved or are pending FDA
approval but exclude manufacturing supplements.
For drugs selected for renegotiation, do not report active or pending FDA applications listed in the
Primary Manufacturer’s originalprior full submission(s) of data reported by the Primary
Manufacturer related to the section 1194(e)(1) data where nofactors unless a change has occurred
following the most recent full submission of section 1194(e)(1) data and prior to December 31 of
the calendar year prior to the selected drug publication date (as defined in 42 CFR 429.20) of the
initial price applicability year for which this ICR is submitted. Information may include, for
example, a new application or applications that have experienced a change since the last date for
which the Primary Manufacturer reported data in the Primary Manufacturer’s originalmost recent
full submission of section 1194(e)(1) data for the negotiation period in which the selected drug’s
MFP was negotiated.

37

Classification Code32

Applica
tion
(NDA /
BLA)
Number

Applica
tion
Type
(NDA;
BLA)

Appr
oval
Date

Indic
ation

#

Select the Select one or more of
MM
Text
applicatio the following options:
DD,
n type:
Options: Type 1 — New YYYY
NDA,
Molecular Entity, Type
(an
BLA
2
approv
— New Active
al date
Ingredient, Type 3 —
entry
New Dosage Form,
is not
Type 4
requir
— New Combination,
ed if
Type 5 — New
patent
Formulation or Other
pendin
Differences (e.g., new
g)
indication, new
applicant, new
manufacturer)
, Type 6 — New
Indication or Claim,
Same Applicant, Type 7
— Previously Marketed
But Without an Approved
NDA, Type 8
— Rx to OTC, Type
9—
—
New Indication or
Claim, Drug Not to be
Marketed Under Type 9
NDA After Approval,
Type 10 — New
Indication or Claim,
Drug to be Marketed
Under Type 10 NDA
After Approval

Dosage
Form
and
Strength

Spon
sor

Applicatio
n Status

Comments

Text

Text

Select one
of the
following
ng options:
approved,
tentatively
approved,
pending,
withdrawn,
or other

Text
(3,600
character
count
limit,
which is
approxim
ately 300
words)

32

These classification code options will only be available if the “NDA” application type is selected. If
“BLA” is selected, this dropdown will be grayed out as BLAs do not use classification codes.

38

[ ] (For a drug selected for renegotiation only) Not Applicable.
Question 12: Predicted Loss of Exclusivity
Provide and explain the Primary Manufacturer’s best estimate for loss of exclusivity (earliest
expected date on which a generic drug or biosimilar of the selected drug33 would be allowed to
enter the market) for the selected drug. The Primary Manufacturer may choose to include the
following information in providing a “best estimate” and explaining such estimate: how specific
patents reported in response to Question 9A and/or exclusivities reported in response to Question
10 may protect the selected drug for a given length of time for different strengths, formulations,
and indications, the role of any legal decisions or settlement agreements with the manufacturer(s)
of or other applicable third-party, that may impact when generic drug(s) or biosimilar(s) of the
selected drug are or may be coming to market, or references to public documents (e.g., a Form 10K
filing pursuant to section 13 or 15(d) of the Securities and Exchange Act of 1934) or public
statements where the Primary Manufacturer has provided commentary on the expected loss of
exclusivity of the selected drug.
FIELD
Predicted loss of exclusivity

RESPONSE FORMAT
Text (6,000 characters which is approximately 500
words)

G. Market Data and Revenue and Sales Volume Data
Primary Manufacturer Response Required
The purpose of Section G is to collect the market data and revenue and sales volume data described
in section 1194(e)(1)(E) of the Act.
Definitions for Section G:
• The three NCPDP BUS34 are: each (EA), milliliter (mL), and gram (GM). For certain volume
data of the selected drug, CMS requests units be reported using the NCPDP BUS for all but
Medicaid best price to facilitate comparison with the amounts in the quantity dispensed field
found in PDE data, which also uses the NCPDP BUS. If an NCPDP BUS of EA is used, one
EA must represent a single individual dosage form or dispensable unit (e.g., one tablet,
capsule, vial, syringe, or patch) and should match what is reported in Section A. If the
NCPDP Unit is “EA”, please specify the unit of measure represented by one “EA” in the
Explanation of Unit response to Question 13.
• Wholesale Acquisition Cost (WAC) unit price: The manufacturer’s list price for the drug or
biological product to wholesalers or direct purchasers in the United States, not including
33

Refer to 42 CFR 429.20 for definitions of “generic drug” and “biosimilar”.
See: https://standards.ncpdp.org/Billing-UnitRequest.aspx#:~:text=Billing%20Unit%20Requests,grams%22%20or%20%22milliliters.%22. See:
https://standards.ncpdp.org/Billing-Unit-Request.aspx.
34

39

prompt pay or other discounts, rebates or reductions in price, for the most recent month for
which the information is available, as reported in wholesale price guides or other publications
of drug or biological product pricing data (as defined in section 1847A(c)(6)(B) of the
Act).in42 CFR 429.20). The WAC unit price is reported at the NDC-11 level using NCPDP
BUS.
• The three NCPDP BUS35 are: each (EA), milliliter (mL), and gram (GM). For certain
volume data of the selected drug, CMS requests units be reported using the NCPDP BUS
for all but Medicaid best price to facilitate comparison with the amounts in the quantity
dispensed field found in PDE data, which also uses the NCPDP BUS.
• Average sales price (ASP): The manufacturer’s average sales price is defined in 42 C.F.R.
§CFR 414.902.
• ASP Unit: The unit type used by the manufacturer to report ASP as specified in 42 C.F.R.
§CFR 414.802.
• Medicaid best price: The Medicaid best price is defined in 42 C.F.R. §CFR 447.505. The
Medicaid best price is reported at the NDC-9 level.
• AMP unit: The unit type used by the manufacturer to calculate AMP (42 C.F.R. §CFR
447.504) and best price (42 C.F.R. §CFR 447.505) for purposes of the Medicaid Drug Rebate
Program (MDRP): injectable anti-hemophilic factor, capsule, suppository, gram, milliliter,
tablet, transdermal patch, each, millicurie, microcurie. Such units are reported by the
manufacturer on a monthly basis at the NDC-9 level.
• Federal supply schedule (FSS) price: The most recently published pharmaceutical price
offeredfor the selected drug as included in the Federal Supply Schedule as managed by the
VA in its FSS program, by delegated authorityDepartment of the General Services
AdministrationVeterans Affairs per 48 CFR part 38.36 The FSS price is reported at the NDC11 package level.
• Big Four price: The Big Four price is described in 38 U.S.C. § 8126.37 The Big Four price is
reported at the NDC-11 package level.
• Manufacturer U.S. commercial average net unit price: For the sole purpose of data collection
under section 1194(e)(1)(E) of the Act, the average net unit price of the selected drug for
privateto commercial health insurance plans, including small group and individual plans onand off-Exchange and large group plans, excluding Original Medicare fee-for-service (Parts
A and B), Medicare Advantage, Medicare Part D, Medicaid fee-for-service, and Medicaid
managed care. The following items should be deducted from gross revenue in your
calculation: discounts, chargebacks or rebates, cash discounts, free goods contingent on a
purchase agreement, up-front payments, goods in kind, free or reduced-price services, grants,
or other price concessions or similar benefits offered by the Primary Manufacturer and any
35

See: https://standards.ncpdp.org/Billing-UnitRequest.aspx#:~:text=Billing%20Unit%20Requests,grams%22%20or%20%22milliliters.%22. See:
https://standards.ncpdp.org/Billing-Unit-Request.aspx.
36
See: https://department.va.gov/administrations-and-offices/acquisition-logistics-andconstruction/freedom-ofinformation-act-requests/#toc_Historical_VA_Pharmaceutical_Prices. See:
https://www.va.gov/opal/nac/fss/pharmprices.asp.
37
The Big Four price is the maximum price a drug manufacturer is allowed to charge the Big Four federalFederal
agencies, which are the Department of Veterans Affairs, the Department of Defense, the Public Health Services, and
the Coast Guard. See: https://www.cbo.gov/publication/57007.

40

•

•

•

Secondary Manufacturer(s) to any commercial payer in the U.S. The following items should
not be deducted from gross revenue in your calculations: payments to wholesalers, group
purchasing organizations (GPOs), pharmacies, or other purchasers and manufacturer-run
patient assistance programs that provide financial assistance such as coupons, co-payment
assistance, or free drug products to patients offered by the Primary Manufacturer and any
Secondary Manufacturer(s). The U.S. commercial average net unit price is reported at the
NDC-11 level using NCPDP BUS.
Manufacturer U.S. commercial average net unit price─ net of patient assistance program: For
the sole purpose of data collection under section 1194(e)(1)(E) of the Act, the manufacturer
U.S. commercial average net unit price─ net of patient assistance program is the
manufacturer U.S. commercial average net unit price, with the additional following items
deducted: manufacturer-run patient assistance programs that provide financial assistance
such as coupons, co-payment assistance, or free drug products to patients offered by the
Primary Manufacturer and any Secondary Manufacturer(s). The U.S. commercial average net
unit price─ net of patient assistance program is reported at the NDC-11 level using NCPDP
BUS.
Manufacturer U.S. commercial average net unit price─ best: For the sole purpose of data
collection under section 1194(e)(1)(E) of the Act, the manufacturer U.S. commercial average
net unit price─ best is the lowest U.S. commercial average net unit price offered by the
Primary Manufacturer and any Secondary Manufacturer(s) to any commercial payer in the U.S.
The following items should be deducted from gross revenue in your calculations: discounts,
chargebacks or rebates, cash discounts, free goods contingent on a purchase agreement, upfront payments, goods in-kind, free or reduced- price services, grants, or other price
concessions or similar benefits offered by the Primary Manufacturer or any Secondary
Manufacturer(s) to any purchasers.commercial payer. The following items should not be
deducted from the gross revenue in your calculations: payments to wholesalers, GPOs,
pharmacies, or other purchasers and manufacturer-run patient assistance programs that provide
financial assistance such as coupons, co-payment assistance, or free drug products to patients
offered by the Primary Manufacturer and any Secondary Manufacturer(s). The U.S.
commercial average net unit price – best is reported at the NDC-11 level using NCPDP BUS.
Manufacturer net Medicare Part D average net unit price: For the sole purpose of data
collection under section 1194(e)(1)(E) of the Act, the manufactureraverage net unit price of
the selected drug to Medicare Part D average unit price as calculated by the Primary
Manufacturerplans, including standalone prescription drug plans (PDPs) and Medicare
Advantage prescription drug (MA-PD) plans. The following items should be deducted from
gross revenue in your calculation: coverage gap discounts for calendar years prior to the
calendar year date specified in the applicable information collection and discounts under the
Manufacturer Discount Program for the same calendar year as specified in the applicable
information collection, and other supply chain concessions (e.g., wholesale discounts,
chargebacks or rebates, cash discounts, free goods contingent on a purchase agreement, upfront payments, goods in kind, free or reduced-price services, grants, or other price
concessions) of similar benefits offered by the Primary Manufacturer orand any Secondary
Manufacturer(s)). The following items should not reflectedbe deducted from gross revenue in
41

•

•

your calculations: payments to wholesalers, group purchasing organizations (GPOs),
pharmacies, or other purchasers offered by the sum of the plan-specific enrollment weighted
amounts calculation and utilization, that may differ from the PDE data.Primary Manufacturer
and any Secondary Manufacturer(s). The manufacturer net Medicare Part D average net unit
price is reported at the NDC-11 level using NCPDP BUS.
Manufacturer net Medicare Part D average net unit price – best: For the sole purpose of data
collection under section 1194(e)(1)(E) of the Act, the manufacturer net Medicare Part D
average net unit price – best is the lowest manufacturer net Medicare Part D average net unit
price of the selected drug offered by the Primary Manufacturer orand any Secondary
Manufacturer(s) to any Medicare Part D plan sponsors in the U.S. The following items
should be deducted from gross revenue in your calculation: coverage gap discounts for
calendar years prior to the calendar year date specified in the applicable information
collection and discounts under the Manufacturer Discount Program for the same calendar
year as specified in the applicable information collection, and other supply chain concessions
(e.g., wholesale discounts, chargebacks or rebates, cash discounts, free goods contingent on a
purchase agreement, up-front payments, goods in kind, free or reduced-price services, grants,
or other price concessions) of similar benefits offered by the Primary Manufacturer orand
any Secondary Manufacturer(s)). The following items should not reflectedbe deducted from
gross revenue in your calculations: payments to wholesalers, group purchasing organizations
(GPOs), pharmacies, or other purchasers offered by the sum of the plan-specific enrollment
weighted amounts calculation and utilization, that may differ from the PDE data.Primary
Manufacturer and any Secondary Manufacturer(s). The manufacturer net Medicare Part D
average net unit price – best is reported at the NDC-11 level using NCPDP BUS.
Maximum fair price (MFP): The maximum fair price (MFP) has the meaning set forth in
section 1191(c)(3) of the Act. The MFP should be reported in 30-day equivalent supply.

Instructions for Section G:
• For Question 1213 through 2528, information for the Primary Manufacturer and any Secondary
Manufacturer(s) must be reported.
• For Questions 1213 through 2526 and Question 28, for the sole purpose of data collection
under section 1194(e)(1)(E) of the Act, as applicable, the total unit volume must be reported at
the NDC-9 or NDC-11 level and reflect the NCPDP BUS and the AMP unit. The total unit
volume must include the total unit volume sold by the Primary Manufacturer and any
Secondary Manufacturer(s) in the U.S. for the data reported.
• For Question 27, the Primary Manufacturer may choose a methodology for estimating payer
mix by volume (e.g., by percentage of units dispensed) and should explain the methodology
used in question 27b.
• If an NCPDP BUS of EA is used, one EA must represent a single individual dosage form or
dispensable unit (e.g., one tablet, capsule, vial, syringe, or patch) and should match what is
reported in Section A. If the NCPDP Unit is “EA”, please specify the unit of measure
represented by one “EA” in the Explanation of Unit response to Question 13.
• Include NDC-11s that were marked in Section A as sample packages, inner packages, outer
42

•

packages and NDC-11s that are discontinued.
For each section, detail in the free response an explanation of the unit used (e.g., unit is one
syringe in a four-pack of syringes).

Follow the specific instructions for each question below. The applicable reporting time periods are
as follows (except unless otherwise instructed for a specific question):
• forFor drugs selected for negotiation , a row for each applicable calendar quarter for
initial price applicability year 2028, the calendar three years 2023, 2024, and 2025
throughof data ending December 31 of the calendar quarter ending with December 31,
2025,
• for a drug that was year prior to the selected for negotiation for drug publication date
(defined at 42 CFR 429.20) for the initial price applicability year 2026 and has been selected
for renegotiation for initial price applicability year 2028, calendar years 2024 and 2025 through
the calendar quarter ending with December 31, 2025, andfor which this ICR is submitted.

•

•

for a drug that was selected for negotiation for initial price applicability year 2027 and
has been selected for renegotiation for initial price applicability year 2028, calendar
year 2025 through the calendar quarter ending with December 31, 2025.
For drugs selected for renegotiation, a row for each applicable calendar quarter,
beginning with the calendar quarter after the last calendar quarter of data that was
submitted to CMS in the most recent full section 1194(e)(1) submission and ending
December 31 of the calendar year prior to the selected drug publication date (defined at 42
CFR 429.20) for the initial price applicability year for which this ICR is submitted. If the
period beginning with the calendar quarter after the last calendar quarter of data that was
submitted to CMS in the most recent full submission of section 1194(e)(1) data and ending
December 31 of the calendar year prior to the selected drug publication date (defined at 42
CFR 429.20) for the initial price applicability year for which this ICR is submitted is longer
than three years, the reporting period is the three calendar years ending with December 31
of the calendar year prior to the selected drug publication date (defined at 42 CFR 429.20)
for the initial price applicability year for which this ICR is submitted.

If the required data for the selected drug is not available for the exact dates specified above in
these instructions, the Primary Manufacturer should report the date through the most recent quarter
for which such data are available. The Primary Manufacturer should specify the time period used
in the question’s free response field.
Question 1213: Wholesale Acquisition Cost Unit Price
Follow the instructions below when providing responses in the following data fields
about the WAC unit price of the selected drug:
• Units must be reported in one of the three NCPDP BUS: each (EA), milliliter (mL), or
gram (GM). Total unit volume must be the total number of units sold to wholesalers and
direct purchasers during the quarter. Please do not include units associated with free
samples in the calculated prices or reported total unit volume. If an NCPDP BUS of EA is
used, one EA must represent a single individual dosage form or dispensable unit (e.g., one
43

•

•

•

•

•

tablet, capsule, vial, syringe, or patch) and should match what is reported in Section A. If
the NCPDP Unit is “EA”, please specify the unit of measure represented by one “EA” in
the Explanation of Unit response.
If the NDC-11 had multiple WACs for a given quarter, please calculate an average WAC
per unit for the quarter using the following methodology. For each WAC per unit available
in the quarter, please multiply the WAC per unit by the proportion of the total units sold in
that quarter at that WAC out of total unit volume sold in the quarter. Then sum these values
across all WACs available in the quarter to calculate the average WAC per unit for the
quarter.
Any deviation from the reported WAC unit price in the data fields below and the WAC unit
price as reported in wholesale price guides or other publications of drug or biological price
data must be explained in Question 1314 so that CMS can understand the reasons for these
differences.
Units must be reported in one of the three NCPDP BUS: each (EA), milliliter (mL), or
gram (GM). Total unit volume must be the total number of units sold to wholesalers and
direct purchasers during the quarter. Please do not include units associated with free
samples in the calculated prices or reported total unit volume.
If the NDC-11 was marketed, sold, or distributed at any time during the quarter (including
NDC-11s that were marked in Section A as sample packages, inner packages, outer
packages and NDC-11s that are discontinued), please complete all requested fields. If the
NDC-11 was not marketed, sold, or distributed to any wholesaler or direct purchaser in a
particular calendar quarter, please enter “0” in the total unit volume field and provide an
explanation in the “Explanation of why WAC was not reportedUnit and Explanation of
Why WAC Was Not Reported (if applicable)” field of why the NDC-11 had no WAC for
that calendar quarter (e.g., the NDC-11 was first marketed in a later calendar quarter).
In the “Explanation of Unit and Explanation of Why WAC Was Not Reported” field, for
each NDC-11 provide a written explanation of the specific unit provided for this
submission (e.g., the unit EA refers to a single capsule in a bottle of 30).

NDC-11

Quarter

WA NCPDP Unit Total
C
(EA, mL, GM) Unit
Volume

12345-6789-01

QQ/YYYY $
-QN

Text

#

Explanation of whyUnit and
Explanation of Why WAC was
notWas Not Reported (if applicable)
Text (3,600 character count limit, which
is approximately 300 words)

Question 1314: Explanation of Information Reported in Question 1213: Wholesale
Acquisition Cost Unit Price
If applicable, describe assumptions, methodological steps, and other information necessary to
explain the deviation between the WAC unit price provided in response to Question 1213 and
those found in available drug databases (e.g., Medi-Span, First Databank, RED BOOK).
Additionally, if the WAC unit price has changed between December 31, 2025, and the date of the
submission of this ICR form of the calendar year prior to the selected drug publication date
44

(defined at 42 CFR 429.20) of the initial price applicability year for which the drug is selected for
negotiation (or renegotiation, as applicable) and for which this ICR is submitted and January 31 of
the calendar year this ICR form is submitted, provide the updated WAC unit price. Please indicate
not applicable (N/A) in the free response field if no explanation is necessary.
FIELD
Explanation of WAC unit price data

RESPONSE FORMAT
Text (12,000 character count limit, which is
approximately 1,000 words)

Question 1415: Average Sales Price (ASP)
Has ASP ever been reported for a calendar quarter for the selected drug during the applicable time
period specified in the instructions above?
RESPONSE FORMAT
Yes/No
(If response is Yes, please fill out the following data fields. If response is No, please
skip to Question 17) Follow the instructions below when providing responses in the
following table about each ASP unit of the selected drug:
• Report the ASP, the ASP Unit, and Total Units Sold for the last two sales
quarters in calendar year 2025 ending with December 31, 2025the calendar
year prior to the selected drug publication date (defined at 42 CFR 429.20)
of the initial price applicability year for which the drug is selected for
negotiation (or renegotiation, as applicable) and for which this ICR is
submitted.
• The information provided in the data fields must reflect the same data that was
submitted to CMS consistent with 42 C.F.R. §CFR 414.800 et seq.(. (subpart
J – Submission of Manufacturer’s Average Sales Price Data), including, for
example, the ASP Unit(s) reported in accordance with 42 C. F.R §CFR
414.802.
• ASP Unit refers to the ASP Unit type used by the manufacturer to report ASP as specified
in 42 C.F.R. § CFR 414.802 (e.g. EA, mL, IU).
• If an ASP is reported and “0” is entered for Total Units Sold, explain why “0”
units are reported.
• If the NDC-11 was marketed, sold, or distributed at any time during a quarter
(including NDC-11s that were marked in Section A as sample packages, inner
packages, outer packages and NDC-11s that are discontinued), please
complete all requested fields.
• If the NDC-11 was not marketed, sold, or distributed to any wholesaler or
direct purchaser in a particular calendar quarter, please enter “0” in the total
unit volume field and provide an explanation in the “Explanation of why ASP
was not reported (if applicable)” field of why the NDC-11 had no ASP for
that calendar quarter (e.g., the NDC-11 was first marketed in a later calendar
45

•

•

quarter).)
If ASP was not reported for a specific NDC-11 for a specific quarter, select
the checkbox for “Not Applicable” for the NDC-11 and enter an explanation
in the “Explanation of Unit and Explanation of why ASP was not reported (if
applicable)” field.
If an ASP reported is negative, provide an explanation in the “Explanation of
Unit and Explanation of why ASP was not reported (if applicable)” field of
why the ASP is negative.

•

In the “Explanation of Unit and Explanation of Why ASP Was Not Reported”
field, for each NDC-11 provide a written explanation of the specific unit
provided for this submission (e.g., the unit EA refers to a single capsule in a
bottle of 30).
NDC-11
Sales
ASP ASP Unit (the Total
Explanation of whyUnit and
Quarter
same ASP unit Units
Explanation of Why ASP was notWas
as reported in
Sold
Not Reported (if applicable)
the ASP Data
Collection
System)
12345-6789-01 QQ/YYYY $$* Text*
##*
Text (3,600 character count limit, which
-QN
is approximately 300 words)
[ ] Not
Applicabl
e
* Data field is not populated if “Not Applicable” is selected for the “Sales Quarter” for an NDC-11.

Question 1516: Explanation of Information Reported in Question 1415: ASP
If applicable, describe other information you feel is necessary to interpret reported information in
response to Question 1415. Please indicate not applicable (N/A) in the free response field if no
explanation is necessary.
FIELD
Explanation of ASP data

RESPONSE FORMAT
Text (12,000 character count
limit, which is approximately
1,000 words)

Question 1617: Medicaid Best Price
Was a Medicaid best price determination ever made for a calendar quarter for the selected drug
during the applicable time period specified in the instructions above?
46

RESPONSE FORMAT
Yes/No
(If response is Yes, please fill out the following data fields. If response is No, please skip to
Question 1819) Follow the instructions below when providing responses in the following data
fields about the Medicaid best price of the selected drug:
• The Medicaid best price information must reflect what was submitted to Medicaid under the
MDRP in accordance with the Medicaid National Drug Rebate Agreement and as described
in 42 C.F.R. §CFR 447.505 – Determination of best price. The reported Medicaid best price
in the data fields below must reflect any restatements that have been certified under the
MDRP.
• Total unit volume for the quarter is the sum of monthly AMP units reported to the MDRP
for the quarter.
• If a Medicaid best price determination was made during the calendar quarter for that NDC9 (including corresponding NDC-11s that were marked in Section A as sample packages,
inner packages, outer packages and NDC-11s that are discontinued), please complete all
requested fields. If the NDC-9 did not have a Medicaid best price determination in a
particular calendar quarter, please enter “0” in the total unit volume field and provide an
explanation in the “Explanation of why Medicaid best price was not reported (if
applicable)” field of why the NDC-9 had no Medicaid best price determination for that
calendar quarter (e.g., the NDC-9 was first marketed in a later quarter).
NDC-9

Quart Medicaid
er
Best Price

123456789

QQYY $ (up to 6
YYYYY decimal
Y-QN places)

AMP Unit
(injectable antihemophilic factor,
capsule, suppository,
gram, milliliter,
tablet, transdermal
patch, each,
millicurie,
microcurie)
Text

Total
Unit
Volume

Explanation of why Medicaid Best
Price was not Reported (if
applicable)

#

Text (3,600 character count limit,
which is approximately 300 words)

Question 1718: Explanation of Information Reported in Question 1617: Medicaid Best Price
If applicable, describe other information you feel is necessary to interpret reported
information in response to Question 1617. Please indicate not applicable (N/A) in the
free response field if no explanation is necessary.
FIELD
Explanation of Medicaid Best Price data

RESPONSE FORMAT
Text (12,000 character count
limit, which is approximately
47

FIELD

RESPONSE FORMAT
1,000 words)

Question 1819: Federal Supply Schedule (FSS) Price
Was a FSS price for the selected drug ever available during the applicable time
period specified in the instructions above?
RESPONSE FORMAT
Yes/No
(If response is Yes, please fill out the following data fields. If response is No, please skip to
Question 2021) Follow the instructions below when providing responses in the following data fields
about FSS prices of the selected drug:
• The FSS price information must reflect whatthe published pharmaceutical price(s) for the
selected drug as included in the Federal Supply Schedule as managed by the Department of
Veterans Affairs per 48 CFR part 38, which can be found online in the pharmaceutical
pricing data for all VA National Acquisition Center programs, and inclusive of the
Industrial Funding Fee (IFF).38 We note that the FSS price information should be for the
NDC-11 package (e.g., .39 We note that the FSS price information should be for the NDC11 package (e.g., for a bottle of 30 tablets, please report the FSS price for the bottle).
• Units must be reported in one of the three NCPDP BUS: each (EA), milliliter (mL), or
gram (GM). Total unit volume is the total number of NCPDP units (i.e., EA, ML, or GM)
for each NDC-11 sold indirectly (e.g., through a wholesaler) or directly to federal
purchasers. Please do not include units associated with free samples in the reported total
unit volume.
• For each NDC-11, please include a row for each price period that occurred during an
applicable calendar quarter specified in the instructions above, and fill out the requested
information.
o If the NDC-11 did not have a FSS price during an applicable calendar quarter specified
in the instructions above, please enter “0” in the total unit volume field. Also provide
an explanation in the “Explanation of why FSS price was not reported (if applicable)”
field of why the NDC-11 had no FSS price during an applicable calendar quarter
specified in the instructions above (e.g., the NDC-11 was discontinued before the
period for the requested data began).
• If an NDC-11 had a FSS price for a reported price period but no units were sold, please
enter “0” in the Total Unit Volume Field and provide the FSS in the “Explanation of why
FSS price was not reported (if applicable)” field.
• Please complete Questions 1819 and 1920 for the FSS price of the selected drug and
Questions 2021 and 2122 for the Big Four price of the selected drug even if the Primary
Manufacturer or the Secondary Manufacturer is considered a “single pricerprice.”
38
39

See: https://www.va.gov/opal/nac/fss/pharmprices.asp.
See: https://www.va.gov/opal/nac/fss/pharmprices.asp.

48

NDC-11

Price Start Federal
Date to
Supply
End Date Schedule
Price

12345-6789-01

MMDDYYY $
YMMDDYYY
Y

NCPDP
Tota
Unit (EA, l
mL,
Unit
GM)Packa Volu
ge
me
Descriptio
n
Text
#

Explanation of why
FSS price was not
Reported (if
applicable)

Text (3,600 character count
limit, which is
approximately 300 words)

Question 1920: Explanation of Information Reported in Question 1819: Federal Supply
Schedule Price
If applicable, describe other information you feel is necessary to interpret reported information in
response to Question 1819. Please indicate not applicable (N/A) in the free response field if no
explanation is necessary.
FIELD
Explanation of Federal Supply Schedule price data

RESPONSE FORMAT
Text (12,000 character count limit, which
is approximately 1,000 words)

Question 2021: Big Four Price
Was a Big Four price ever available for the selected drug during the applicable time period
specified in the instructions above?
RESPONSE FORMAT
Yes/No
(If response is Yes, please fill out the following data fields. If response is No, please skip to
Question 2223) Follow the instructions below when providing responses in the following data fields
about the Big Four price of the selected drug:
• The Big Four price information must reflect the information that can be found online in the
pharmaceutical pricing data for all VA National Acquisition Center programs., and
inclusive of the Industrial Funding Fee (IFF).40 We note that the Big Four price information
should be for the NDC-11 package (e.g., for a bottle of 30 tablets, please report the Big
Four price for the bottle).
• Units must be reported in one of the three NCPDP BUS: each (EA), milliliter (ML), or
gram (GM). Total unit volume is the total number of units (i.e., EA, ML, or GM) for each
NDC-11 indirectly (e.g., through a wholesaler) or directly sold to the Big Four federal
40

See: https://www.va.gov/opal/nac/fss/pharmprices.asp.

49

•

•

agencies (Department of Veterans Affairs, Department of Defense, the Public Health
Service, and the Coast Guard). Please do not include units associated with free samples in
the reported total unit volume.
For each NDC-11, please include a row for each price period that occurred during an
applicable calendar quarter specified in the instructions above (including NDC-11s that
were marked in Section A as sample packages, inner packages, outer packages and NDC11s that are discontinued), and fill out the requested information. If the NDC-11 did not
have a Big Four price during an applicable calendar quarter specified in the instructions
above, please enter “0” in the total unit volume field and provide an explanation in the
“Explanation of why Big Four price was not reported (if applicable)” field of why the
NDC-11 had no Big Four price during an applicable calendar quarter specified in the
instructions above (e.g., the NDC-11 was discontinued before the period for the requested
data began).
Please complete Questions 1819 and 1920 for the FFS FSS price of the selected drug and
Questions 2021 and 2122 for the Big Four price of the selected drug even if the Primary
Manufacturer or the Secondary Manufacturer is considered a “single pricerprice.”

NDC-11

Price Start Date to Price Big
End Date
Four
Price

123456789-01

MMDDYYYYMMDDYYYY

$

NCPDP Unit
(EA, mL,
GM)Packag
e
Description
Text

Total Unit
Volume

Explanation of why Big
Four price was not
Reportedreported (if
applicable)

#

Text (3,600 character
count limit, which is
approximately 300 words)

Question 2122: Explanation of Information Reported in Question 2021: Big Four Price
If applicable, describe other information you feel is necessary to interpret reported information in
response to Question 2021. Please indicate not applicable (N/A) in the free response field if no
explanation is necessary.
FIELD
Explanation of Big Four price data

RESPONSE FORMAT
Text (12,000 character count limit,
which is approximately 1,000 words)

Question 2223: Manufacturer U.S. Commercial Average Net Unit Price
Follow the instructions below when providing responses in the following date fields about the
Manufacturer U.S. commercial average net unit price:
• For each NDC-11, please include a row for each quarter during the applicable time period
specified in the instructions above, based on the Primary Manufacturer’s responses in
Section A (including NDC-11s that were marked in Section A as sample packages, inner
50

•

•

•

packages, outer packages and NDC-11s that are discontinued).
o If the NDC-11 was ever marketed, sold, or distributed at any time during the quarter,
please complete all requested fields.
o If the NDC-11 was not marketed, sold, or distributed in a particular quarter, please enter
“0” in the total unit volume field provide an explanation in the “Explanation of why
Manufacturer U.S. Commercial prices were not reported (if applicable)” field of why
the NDC-11 had no Manufacturer U.S. commercial prices for that calendar quarter
(e.g., the NDC-11 was first marketed in a later quarter).
Exclude price and volume information for the selected drug for any entity not included in
Medicaid best price (e.g. Medicare fee-for-servicethe following plans: Original Medicare
(Parts A and B), Medicare Advantage, Medicare Part D, Medicaid fee-for-service, and
Medicaid managed care)..
If the Primary Manufacturer and Secondary Manufacturer(s) did not provide financial
assistance to patients, please leave the “U.S. commercial average net unit price─ net of
patient assistance programs” field blank. Use “$0” as the price for a unit provided by the
manufacturer at no charge to the patient.
Units must be reported in one of the three NCPDP BUS: each (EA), milliliter (mL), or
gram (GM). Please do not include units associated with free samples in the calculated
prices or reported total unit volume. If the NCPDP Unit is “EA”, please specify the unit of
measure represented by one “EA” in the Explanation of Unit response.

•

In the “Explanation of Units and Why Manufacturer U.S. Commercial Prices Were Not
Reported (if applicable” field, for each NDC-11 provide a written explanation of the
specific unit provided for this submission (e.g., the unit EA refers to a single capsule in a
bottle of 30).
NDC Quarte Manufactu Manufactu Manufactu NCP
Total
Total
Explanatio
-11
r
rer U.S.
rer U.S.
rer U.S.
DP
Unit
Unit
n of
Commerc Commerci
Commerci Unit
Volu
Volume
whyUnits
ial
al Average
al
(EA,
me
for U.S.
and Why
Average
Net Unit
Average
mL,
Commer
Manufactu
Unit Net
Price- Net
Net Unit
GM)
cial
rer U.S.
Price
of Patient
PriceAverage
Commerci
Assistance
Best
Net Unit
al prices
Programs
Price were
Best
notPrices
Were Not
Reported
(if
applicable)
1234 QQY
$
$
$
Text
#
#
Text (3,600
5YY
character
6789- YYYY
count limit,
01
Y-QN
which is
approximately
51

NDC Quarte Manufactu Manufactu
-11
r
rer U.S.
rer U.S.
Commerc Commerci
ial
al Average
Average
Net Unit
Unit Net
Price- Net
Price
of Patient
Assistance
Programs

Manufactu
rer U.S.
Commerci
al
Average
Net Unit
PriceBest

NCP
DP
Unit
(EA,
mL,
GM)

Total
Unit
Volu
me

Total
Unit
Volume
for U.S.
Commer
cial
Average
Net Unit
Price Best

Explanatio
n of
whyUnits
and Why
Manufactu
rer U.S.
Commerci
al prices
were
notPrices
Were Not
Reported
(if
applicable)
300 words)

Question 2324: Explanation of Information Reported in Response to Question 2223:
Manufacturer U.S. Commercial Average Net Unit Price
Describe assumptions, methodological steps, and other information for the following topics related
to Question 2223:
• How sales to enrollees of private health insurance plans, including small group and
individual plans on- and off-Exchange and large group plans were determined.
• How discounts, chargebacks or rebates, cash discounts, free goods contingent on a purchase
agreement, up-front payments, goods in-kind, free or reduced-price services, grants, or
other price concessions or similar benefits offered to any commercial payer were allocated
across NDC-11s and calendar quarters.
• If applicable, how financial assistance, such as coupons or co-payment assistance, to
patients was allocated across NDC-11s and calendar quarters.
• How information was used to calculate the “U.S. commercial average net unit price” the “U.S.
commercial average net unit price─ net of patient assistance programs,” and the “U.S.
commercial average net unit price─ best.”.
• Please indicate not applicable (N/A) in the free response field if no explanation is necessary.
FIELD
Explanation of manufacturer U.S. commercial
average net unit price data

RESPONSE FORMAT
Text (12,000 character count limit,
which is approximately 1,000 words)

Question 2425: Manufacturer Net Medicare Part D Average Net Unit Price
Follow the instructions below when providing responses in the following data fields about the
manufacturer net Medicare Part Dnet price of the selected drug.
52

•

For each NDC-11, please include a row for each quarter during the applicable time period
specified in the instructions above, based on the Primary Manufacturer’s responses in
Section A (including NDC-11s that were marked in Section A as sample packages, inner
packages, outer packages and NDC-11s that are discontinued).
o If the NDC-11 was ever marketed, sold, or distributed at any time during the quarter,
please complete all requested fields.
o If the NDC-11 was not marketed, sold, or distributed in a particular quarter, please enter
“0” in the total unit volume field and provide an explanation in the “Explanation of why
manufacturer net Medicare Part D Pricenet price was not reported (if applicable)” field
of why the NDC-11 had no manufacturer net Medicare Part Dnet price for that calendar
quarter (e.g., the NDC-11 was first marketed in a later quarter).
Only include price and volume information of the selected drug for Part D plan sponsors.
Units must be reported in one of the three NCPDP BUS: each (EA), milliliter
(mL), or gram (GM). Please do not include units associated with free samples
in the calculated prices or reported total unit volume.
In the “Explanation of Unit and Explanation of Why Manufacturer Medicare
Average Net Unit Price Was Not Reported” field, for each NDC-11 provide a
written explanation of the specific unit provided for this submission (e.g., the
unit EA refers to a single capsule in a bottle of 30).

•
•
•

NDC Calend Manufactur Manufactur Medicare
-11
ar
er Net
er Net
Manufactu
Quarte Medicare
Medicare
rer
r
Part D
Part D
Discount
Average
Average
Program or
Net Unit
Net Unit
Coverage
Price
Price - Best Gap
Discount
Program
Amount
Paid (Per
NCPDP
Unit)

NCPD
P Unit
(EA,
mL,
GM)

Total
Unit
Volu
me

Total
Unit
Volum
e for
Net
Medica
re Part
DNet
Averag
e Unit
Price Best

1234 QQYY
5Y
6789- YYYY
01
Y-QN

Text

#

#

$

$

$

Explanatio
n of why
manufactu
rer
netUnits
and Why
Manufactu
rer
Medicare
Part D
price was
notAverage
Net Unit
Price Was
Not
Reported
(if
applicable)
Text (3,600
character count
limit, which is
approximately
300 words)
53

Question 2526: Explanation of Information Reported in Response to Question 2425:
Manufacturer net Medicare Part D priceNet Price
Describe assumptions, methodological steps, and other information for the following topics related
to Question 2425:
• How sales to Medicare Part D enrollees of Part D plan sponsors sales were determined.
• How discounts, including the applicable discount amount provided under the Coverage
Gap Discount Program or Medicare Manufacturer Discount Program, chargebacks or
rebates, cash discounts, free goods contingent on a purchase agreement, up-front payments,
goods in-kind, free or reduced-price services, grants, or other price concessions or similar
benefits offered to any commercial payer were allocated across NDC-11s and calendar
quarters.
• If applicable, how unit price was separated for enrollee and/or plan type.
• How information was used to calculate the “Manufacturer Net Medicare Part D Average Net
Unit Price” and the “Manufacturer Net Medicare Part D Average Net Unit Price – best.”
• Please indicate not applicable (N/A) in the free response field if no explanation is
necessary.
FIELD
Explanation of “manufacturer Net
Manufacturer Medicare Part D priceNet
Price” data

RESPONSE FORMAT
Text (12,000 character count limit, which is
approximately 1,000 words)

Question 2627: Payer Mix by Volume of the Selected Drug
Question 27a: Payer Mix by Volume of the Selected Drug
Estimate the percentage of total volume for all indications for the Selected Drug that were paid for
by each payer type for the calendar year prior to the selected drug publication date (defined at 42
CFR 429.20) for the initial price applicability year for which this ICR is submitted. The Primary
Manufacturer may choose a methodology for estimating payer mix by volume (e.g., by percentage
of units dispensed) and should explain the methodology used in question 27b. Percentage
estimates should be based on volume (not revenue) for the primary payer (for example, volume
associated with an individual who is eligible for Medicare and Medicaid (commonly referred to as
“dual eligible”) should be included in Medicare, not Medicaid). Percentages entered should sum to
100 percent.

54

PAYER TYPE(S)

Select Option (Medicare (inclusive of Medicare Parts A, B, and D, and
Medicare Advantage), Medicaid (inclusive of Medicaid fee-for-service and
Medicaid managed care), Commercial (private health insurance plans,
including small group and individual plans on- and off-Exchange and large
group plans, excluding Medicare Parts A, B, and D, and Medicare
Advantage), Cash self-pay, Other)

PERCENT OF
TOTAL
VOLUME PAID
FOR BY PAYER
TYPE
#

Question 27b: Explanation of Payer Mix by Volume of the Selected Drug
Describe assumptions, methodological steps, and other information relied on to provide the
responses to Questions 27a. If “Other” was selected above, please explain what that refers to.
FIELD
Explanation

RESPONSE FORMAT
Text (12,000 character count limit, which is
approximately 1,000 words)

Question 28: Maximum Fair Price
For drugs selected for renegotiation only, report the single agreed upon MFP for the 30-day
equivalent supply of the selected drug. The single agreed upon MFP must reflect the information
that can be found online in the most recent published file, Selected Drug List and Negotiated
Prices, also known as Maximum Fair Prices in Statute, and inclusive of any annual inflation
adjustments.
FIELD
RESPONSE FORMAT
MFP as a 30-Day Equivalent Supply for
$
the Selected Drug
Question 29: Primary Manufacturer Identification of Information Submitted in Sections A
through G that the Primary Manufacturer Believes Should be Withheld as Proprietary
Information41
Section 1193(c) of the Act states that CMS must determine which information submitted to CMS
by a manufacturer of a selected drug is proprietary information of that manufacturer. As described
in section 40.2.1 of the final guidance42 CFR 429.300, CMS will treat certain data elements
submitted by a Primary Manufacturer of a selected drug in accordance with section 1194(e)(1) and
section 1194(e)(2) of the Act as proprietaryconfidential if CMS deems the information
constitutesis proprietary including trade secrets and confidential commercial or financial

41

Primary Manufacturer’s response to Question 29 will not be included in the MFP Explanations (which are
described in 42 CFR 429.705(b)).

55

information of the Primary Manufacturer or a Secondary Manufacturer.42
In addition to the information CMS already designates as proprietary consistent with section
40.2.1 of the final guidance42 CFR 429.300: For information submitted that the Primary
Manufacturer believes should also be withheld by CMS consistent with existing federal
requirements for protecting proprietary information, including under Exemption 3 and/or 4 of the
Freedom of Information Act (FOIA) (5 U.S.C. § 552(b)(3), (4)),43 follow the instructions below to
identify this information for CMS. This identification of information by the Primary Manufacturer
will be used during CMS’ process to determine which information submitted by a manufacturer is
proprietary and which information may be disclosed in the public explanation of the MFP
consistent with section 60.6.1 of the final guidance.42 CFR 429.300.
• In the “Location” data field, identify the location of the information the Primary
Manufacturer believes should be withheld in Sections A through G by either:
o Using [brackets] at the start and end of any full sentence(s) within a free response
field(s) that contains information the Primary Manufacturer believes should be
withheld. Also use [brackets] at the start and end of any data provided, if permitted
in the data entry field (for example, because the field is a text field), to identify
information the Primary Manufacturer believes should be withheld.
▪ Label the end of each bracketed sentence with a number in sequential order
and use the same number originally assigned to a bracket throughout
Sections A through G each time the same justification will be used in
response to Question 2629 as the reason the manufacturer believes the
information should be withheld (e.g., {1}, {2}). To differentiate references
in response to Question 2629 from citations, use different symbols for
numbering (for example, a {curly brace} for Question 26 and (parenthesis)
for citations).
o For a data response field where brackets cannot be entered (for example, the field
requires a numerical response) (in other words, a “non-bracketed location”), listing
the specific location of the information by identifying the Section letter, Question
number, data entry field, and/or line number to specifically identify the starting and
ending point, of information the Primary Manufacturer believes should be withheld.
• In the “Justification” data field, provide a brief explanation regarding why the Primary
Manufacturer believes the information should be withheld as proprietary information.
o For a bracketed item, provide the Justification for each separate number used within
Sections A through G (e.g., {1}, {2}). Do not repeat the same Justification.
o For a non-bracketed location, if the Justification is the same Justification as a
42

Specifically, as described in section 40.2.1 of the final guidance42 CFR 429.300, CMS will treat research
and development costs and recoupment, unit costs of production and distribution, pending patent applications,
market data, revenue, and sales volume data as proprietary, unless the information that is provided to CMS is
already publicly available, in which case it would be considered non-proprietary. CMS will treat the data on
prior Federal financial support and approved patent applications, exclusivities, and approved applications
under section 505(c) of the FD&C Act or section 351(a) of the PHS Act that are publicly available as nonproprietary because CMS understands these data are publicly available.
43
See: https://www.justice.gov/oip/doj-guide-freedom-information-act-0.

56

bracketed item, the Primary Manufacturer should use the number assigned to the
bracketed item with the corresponding justification as the response to the
“Justification” data field. For example, if a non-bracketed item’s Justification is the
same as the Justification for bracketed item {1}, the Primary Manufacturer should
enter “{1}” in the Justification response field for that non-bracketed item.
LOCATION (List the Bracket Number (E.g. {1}, {2}) or
Question/Section/Data Entry Field/Line Number))
List of Bracket Locations, in Order of First Appearance
(E.g. {1}, {2}); Add a row for each additional item
List of Non-Bracketed Locations, Identified by the Section,
Question, Data Entry Field and/or Line Number; Add a
row for each additional item

JUSTIFICATION
Text (each item 2,400 character count
limit, which is approximately 200 words)
Text (each item 2,400 character count
limit, which is approximately 200 words)

H. Certification of Submission of Sections A through G for Primary Manufacturers
An individual eligible to certify this submission on behalf of the Primary Manufacturer must be
one of the following: (1) the chief executive officer (CEO) of the Primary Manufacturer, (2) the
chief financial officer (CFO) of the Primary Manufacturer, (3) an individual other than a CEO or
CFO, who has authority equivalent to a CEO or a CFO of the Primary Manufacturer, or (4) an
individual with the directly delegated authority to perform the certification on behalf of one of the
individuals mentioned in (1) through (3).
an Authorized Representative of the Primary Manufacturer as defined in 42 CFR 429.20.
Required for Primary Manufacturers:
Certification:
I hereby certify, to the best of my knowledge, that the information being sent to CMS in this
submission is complete and accurate, and the submission was prepared in good faith and after
reasonable efforts. I reviewed the submission and made a reasonable inquiry regarding its content.
I understand the information contained in this submission is being provided to and will be relied
upon by CMS for Medicare payment purposes, including determination of a maximum fair price,
as defined in section 1191(c)(3) of the Social Security Act. I also certify that I will timely notify
CMS if I become aware that any of the information submitted in this form has changed or is
otherwise inaccurate. I also understand that any misrepresentations may also give rise to liability,
including under the False Claims Act and/or in the form of civil monetary penalties pursuant to
section 1197(c) of the Act.
Checkbox for certification [ ]
Contact Information to be entered:
57

Field
Name of the Person Responsible for the
Submission
Signature
Date

Response
Text
Text (Electronic Dated Signature)
MMDDYYYY

I. I. Evidence About Alternative Treatments
Optional for All Respondents, Including Primary Manufacturer
While CMS is seeking public input under section 1194(e)(2) of the Act to consider information on
the selected drug and its potential therapeutic alternative(s), respondents are not required to include
personally identifiable information44 (PII), protected health information45 (PHI) or proprietary
information that includes confidential or trade-secret information. CMS seeks to collect only the
minimum necessary information related to the selected drug and its potential therapeutic
alternatives for the purpose of implementing and operating the Negotiation Program. CMS will not
retrieve evidence for manufacturer negotiations by personal identifier (PII or PHI). CMS will not,
through this collection, create or maintain a system of records as understood by the Privacy Act of
1974 and accompanying Office of Management and Budget guidance. Section I is applicable to
drugs selected for negotiation and drugs selected for renegotiation.
For Primary Manufacturers of drugs selected for renegotiation that choose to respond to
Section I, the applicable time period to provide the requested responses is from the last date for
which the Primary Manufacturer reported data in the Primary Manufacturer’s originalmost recent
full submission of data related to section 1194(e)(2) datafactors to CMS for the negotiation period in
which the selected drug’s MFP was negotiated through December 31, 2025 of the calendar year
prior to the selected drug publication date (defined at 42 CFR 429.20) of the initial price
applicability year for which the drug is selected for negotiation (or renegotiation, as applicable)
and for which this ICR is submitted.
Question 2730: Respondent Information
44

Personally identifiable information (PII) is information that can be used to distinguish or trace an individual’s
identity, either alone or when combined with other information that is linked or linkable to a specific individual. PII
can include sensitive data, such as medical, financial, or legal information; “neutral” information such as name, facial
photos, or work address; and, contextual information, such as a file for a specific health condition that contains a list of
treated patients. See: https://www.hhs.gov/web/policies-and-standards/hhs-web-policies/privacy/index.html#what-ispii.
45
Protected health information (PHI)), consistent with 42 CFR 429.20, is individually identifiable health information
held or transmitted by a covered entity or its business associate, in any form or media, whether electronic, paper, or
oral. Individually identifiable information is information, including demographic data, that relates to the individual’s
past, present, or future physical or mental health or condition; the provisions of health care to the individual; or the
past, present, or future payment for the provision of health care to the individual, and that identifies the individual or
for which there is a reasonable basis to believe it can be used to identify the individual. PII includes many common
identifiers such as name, address, birth date, Social Security Number, etc. See https://www.hhs.gov/hipaa/forprofessionals/privacy/laws-regulations/index.html.https://www.hhs.gov/hipaa/for-professionals/privacy/lawsregulations/index.html.

58

Required: Individuals or organizations, including manufacturers, that wish to provide
information in this Section I must provide the following information.46
FIELD
Selected Drug
Respondent Name
Organization Name (if applicable)
Respondent Email

RESPONSE FORMAT
TEXT [Select from list]
TEXT
TEXT
TEXT

Select from the following: Which of the following best describes the person completing this
form? You may select more than one option if applicable.

[ ] Representative of a manufacturer of the selected drug [this category is
pre-selected for a Primary Manufacturer when submitting information about its
selected drug]
[ ] Representative of a manufacturer of a potential therapeutic alternative(s)
to the selected drug
[ ] Representative of a manufacturer that does not manufacture the selected drug or
a potential therapeutic alternative(s)
[ ] Representative of a trade association
[ ] Representative of a patient advocacy organization
[ ] A health care provider who has experience prescribing, dispensing, or
administering the selected drug or its potential therapeutic alternative(s) or treating
conditions pertinent to the selected drug or its potential therapeutic alternative(s)
[ ] A patient who has experience taking the selected drug or a potential therapeutic alternative(s)
[ ] A caregiver for an individual who has experience taking the selected drug or a
potential therapeutic alternative(s)
[ ] Academic researcher or other subject matter expert on topics including but not
limited to pharmaceutical policy, comparative effectiveness research, and/or clinical
value assessment
[ ] Other
If “Other” is selected, provide a brief description of the person completing this form:
[Text (960 character count limit, which is approximately 80 words)]
•

[For all options (except this question does not populate for a Primary Manufacturer
when submitting about its selected drug)] Are you or your organization affiliated
with the manufacturer of the selected drug or its potential therapeutic

46

This section will be included in the Primary Manufacturer’s CMS HPMS negotiation module, and
the Primary Manufacturer must submit any responses to the questions in this section there.

59

alternative(s)?47
General Instructions for Section I
•

•

•
•
•
•

•

All questions are optional.

Any interested party may answer Questions 27 through 57. Each interested party will be able
to answer each of Questions 27 through 57 in Section I one time for each selected drug.
Instructions and questions in this section include the language “selected drug” in [brackets]
to indicate that the information displayed will be used for each of the selected drugs.
You may answer some or all of the questions. If you do not wish to respond to a given
question you may skip the question or enter “no response.”
Any interested party may answer Questions 30 through 61. Each interested party will be able
to answer each of Questions 30 through 61 in Section I one time for each selected drug.
Any respondent that answers any of Questions 2730 through 5660 should also review
Question 5761 and respond as applicable.
CMS has grouped Questions 2831 through 5459 in five categories of topics that are
addressed by the set of questions. Specifically, these categories by question number are:
o Questions 28-3331-37: Patient- or Caregiver-Focused Input
o Questions 34-3938-43: Manufacturer-Focused Input
o Questions 40-4544-49: Clinical-Focused Input
o Questions 46-5150-56: Health Research-Focused Input
o Questions 52-5457-59: Other Public Input
CMS provides the following examples of individuals and organizations that may choose to
address a category of questions based on personal and/or professional insight and expertise.
ANY AND ALL INTERESTED PARTIES may respond to ANY AND ALL QUESTIONS
2831 through 5659. These examples are intended as illustrative; a respondent is not limited to
any category of questions based on the individual’s or organization’s insight and/or
experience.
o Patient or Caregiver-Focused Input—for example, an individual with experience
taking the selected drug or a different medicine that may be used to treat the same
condition or disease state (which is also called a potential therapeutic alternative(s) to
the selected drug), a caregiver’s experience caring for someone taking such drugs,
patient organizations with insight into patients’ lived experience of taking such drugs
or living with a condition the drugs treat.
o Manufacturer-Focused Input—for example, a Primary Manufacturer of a selected
drug.
o Clinical-Focused Input—for example, clinicians, pharmacists, hospitals, or other
entities with clinical experience related to the selected drug, its therapeutic
alternatives, or the condition(s) the drugs treat.
o Health Research-Focused Input—for example, researchers, academic centers, patient
groups, or other entities with evidence-based input regarding the selected drug or its

47

For the purpose of this ICR, an individual or organization is “affiliated with the manufacturer” if the individual or
organization receives or has received funding from the manufacturer for research, speaking, or other engagements,
and/or any other purpose related to the drug or its potential therapeutic alternative(s) or if the individual or
organization has been asked by the manufacturer to respond to this ICR or to advise the manufacturer on the
Negotiation Program, regardless of compensation.

60

•

•
•
•
•

•

•

therapeutic alternative(s).
o Other Public Input—any other interested party that wishes to respond to the questions
in Section I, along with citations for any responses in Section I and visual
representations.
The Additional Instructions and the Instructions for Reporting Monetary Amounts included
in this ICR apply to Section I. These instructions are for respondents providing original
data but are not applicable when a respondent provides citations for existing published data.
If known to you, indicate in your response if a portion of a response applies to specific
dosages, forms, strengths, and/or indications of a selected drug or its therapeutic
alternative(s).
Please answer each question in narrative (text) form. Your responses will be limited to the
character count maximum specified for a specific question. The total character count
includes all characters, such as spaces between words and symbols.
Information provided in response to an individual question does not need to be
duplicated across additional responses. CMS will review submissions holistically
across the entire submission.
All declarative statements should be supported by evidence with a citation, unless you are
sharing a personal experience with prescribing or taking the selected drug and/or its
therapeutic alternative(s) or you are a caregiver describing the experience of the person
taking the selected drug and/or its therapeutic alternative(s).
Submissions for Section I may include but are not limited to published or unpublished
material such as peer-reviewed articles, whitepapers, case studies, and government reports.
o CMS prefers publicly available, peer reviewed literature rather than poster abstracts
and non-peer reviewed literature. When providing non-peer reviewed literature, CMS
must be provided sufficient information on these studies in order to assess their
applicability to the Negotiation Program. Information should, at a minimum, include
methods, data sources, and limitations for unpublished evidence.
o Please note that CMS reserves the right to review submitted materials for relevance
and in accordance with the standards outlined in section 50.2 of the final guidance.42
CFR 429.505(e).
o Please provide citations to published material rather than copies of articles. The
respondent is responsible for ensuring that their submission complies with applicable
law, including but not limited to copyright law. If data are unpublished, clearly
indicate this in the citation. For unpublished data without a citation, please summarize
key findings as appropriate in your response.
When citing studies to support responses, briefly summarize the study context and relevant
comparator or therapeutic alternative drug(s) studied, as applicable.
o When information in the free text response is supported by a citation provided in
response to that question, please label the end of the sentence in the free text response
with a number in the order the citation first appears (e.g., [1], [2]) and submit the
citations in the same order in response to Question 5661. Use the number originally
assigned to for the same source citation each time the citation is used throughout
Section I.
61

In response to Question 56,61, CMS requests that respondents are requested to
provide the list of all citations. Additional instructions are included with Question
5661 to link and format citations.
CMS will review submitted studies that use cost-effectiveness measures or methods to
determine if the study is relevant to the selected drug and/or its therapeutic alternative(s)
and to determine if the cost-effectiveness measure used does not value extending the life of
an individual who is elderly, disabled, or terminally ill as of lower value than an individual
who is younger, nondisabled, or not terminally ill.
As described in section 50.2 of the final guidance,42 CFR 429.505(d), CMS will not use
comparative clinical effectiveness research in a manner that treats extending the life of an
elderly, disabled, or terminally ill individual as of lower value than extending the life of an
individual who is younger, nondisabled, or not terminally ill.48 Information submitted that
treats extending the life of individuals in the listed populations as of lower value will not be
used in the Negotiation Program. Moreover, in accordance with section 1182(e) of Title XI
of the Social Security Act and other applicable law, including section 504 of the
Rehabilitation Act, CMS will not use quality-adjusted life-years (QALYs.). In instances
where a study includes a measure that treats extending the life of individuals who are
elderly, disabled, or terminally ill as of lower value but separates such a measure from other
evidence in the report (e.g., clinical effectiveness, risks, harms, etc.) that is relevant to the
factors listed in section 1194(e)(2) of the Act, CMS may consider such separate evidence.
Submissions may include visual representations of the information, including tables, charts,
and/or graphs. The information submitted in the space for visual representations in Question
5560 should only include the table/chart/graph, and no additional text. CMS will not review
any additional text included beyond the titles, labels, legends, and footnotes in the visual
representation. PDF files will be accepted within specified file size limits for visual
representations. List the question number that a submitted table/chart/graph corresponds to
in the free text response provided with the question to submit tables/charts/graphs.
o To upload a PDF file, it must first be converted to a Zip file. Multiple PDF files must
be uploaded together in one Zip file.
CMS will only review the maximum number of citations or upload files permitted in the
instructions.
o

•

•

•

•

Definitions for Section I:
• Therapeutic Advance: CMS intends to examine improvementsConsistent with 42 CFR
429.20, a demonstrated improvement in one or more outcomes to determine the extent to
which a or other clinical considerations for each identified condition of a selected drug
represents a therapeutic advance as compared to its therapeutic alternative(s) (e.g., selected
drug is curative versus a therapeutic alternative that delays progression) and will consider
the costs of the selected drug and its therapeutic alternative(s). CMS may consider the
magnitude of differences in outcomes of interest conferred by the selected drug compared
to the selected drug’s therapeutic alternative(s) for an indication(s) 49 when determining the
48
49

Section 1194(e)(2) of the Social Security Act.
For purposes of the final guidance and this ICR, CMS distinguishes between the use of the word “indication” and

62

extent to which a selected drug represents a therapeutic advance.). For purposes of the
Negotiation Program, anytime CMS considers therapeutic advance, CMS willwould
consider the extent to which the drug represents a therapeutic advance at the time of
consideration based on all available information at such time of consideration.
• Therapeutic Alternative: A therapeutic alternative must beConsistent with 42 CFR 429.20,
a pharmaceutical product or group of pharmaceutical products that is clinically comparable
to the selected drug (in other words, a medicine other than the selected drug that may be
used to treat the same condition or disease state). CMS intends to consider different
therapeutic alternatives for each indication, as applicable. Therapeutic alternatives may be a
brand name drug or biological product, generic drug, or biosimilar and may be on-label or
off-label to treat a given indication. CMS intends to identify therapeutic alternatives within
the same pharmacologic class as the selected drug based on properties such as chemical
class, therapeutic class, or mechanism of action and then also consider therapeutic
alternatives in different pharmacologic classes. In cases where there are many potential
therapeutic alternatives for a given indication of the selected drug, CMS may focus on a
subset of therapeutic alternatives that are clinically comparable to the selected drug.the
selected drug.
• Outcomes: Outcomes may be clinical or related to the functioning, symptoms, quality of
life, or other aspects of a patient’s life. Outcomes of interest to CMS may include direct
clinical outcomes (e.g., cure, mortality) and/or validated or reasonably likely surrogate
endpoints (e.g., serum hemoglobin A1c). In determining outcomes of interest, CMS will
consider patient-reported outcomes and outcomes of importance to patients, if available.
CMS may also consider additional outcomes and contextual factors, such as health-related
quality of life or patient/caregiver preferences regarding treatment, to the extent these
outcomes and factors correspond with benefits or harms to individuals taking the selected
drug or therapeutic alternatives. The caregiver perspective may be considered to the extent
it reflects directly upon the experience or relevant outcomes of the patient taking the
selected drug.
• Outcomes: Consistent with 42 CFR 429.20, the impact of an intervention, which may
be clinical or related to the functioning, symptoms, quality of life, or other aspects of a
patient’s life.
• Patient-centered outcome: An outcome that is important to patients’ survival, functioning,
or feelings as identified or affirmed by patients themselves, or judged to be in patients’ best
interest by providers and/or caregivers when patients cannot report for themselves.50
• Specific populations: Specific populations include individuals with disabilities, the elderly,
individuals who are terminally ill, children, and other patient populations among Medicare
beneficiaries.
• Unmet medical need: AConsistent with 42 CFR 429.20, a circumstance in which the
the term “FDA-approved indication” such that “FDA-approved indication” refers to the information included in drug
labeling per 21 C.F.R. § 201.57(c)(2) or other applicable FDA regulation(s), and “indication” refers to the condition or
disease state for which the selected drug is used.
50
A patient-centered outcome is defined as: An outcome that is important to patients’ survival, functioning, or feelings as
identified or affirmed by patients themselves, or judged to be in patients’ best interest by providers and/or caregivers when patients
cannot report for themselves. (Source: https://www.fda.gov/drugs/development-approval-process-drugs/patient-focuseddrug-development-glossary).

63

relevant disease or condition is one for which no other treatment options exist, or existing
treatments do not adequately address the disease or condition.51 For purposes of the
Negotiation Program, anytime CMS considers an unmet medical need, CMS willwould
consider the extent to which the drug representsaddresses an unmet medical need at the
time of consideration based on all available information at such time of consideration.
Under section 1194(e)(2) of the Act, CMS will consider the extent to which a selected drug
and its therapeutic alternatives address an unmet medical need.
• Indication: Indication refers to the condition or disease state that the selected drug treats.
An indication may include any FDA-approved indication included in drug labeling per 21
C.F.R. §CFR 201.57(c)(2) or other applicable FDA regulation(s) and off-label use(s) that
are included in evidence-based clinical practice guidelines and the off-label use is a
medically-accepted indication covered under Part D and/or payable under Part B or both,
taking into consideration the major drug compendia, authoritative medical literature, and/or
accepted standards of medical practice, or some combination thereof. For the purpose of an
ICR submission, a respondent may combine FDA-approved indications (e.g., identical
adult and pediatric indications) and off-label use(s). The respondent may also choose not to
report on certain FDA-approved indications or off-label uses.
• Off-label Use: OffConsistent with 42 CFR 429.20, off-label use means a use offor a
condition for a selected drug or therapeutic alternative that is not an FDA-approved by the
FDAindication but is included in evidence-based clinical practice guidelines and the offlabel use is a medically- accepted use indication payable under Part B or covered under
Part D or payable under Part Bboth, taking into consideration the major drug compendia,
authoritative medical literature and/or, accepted standards of medical practice, or some
combination thereof.
FDA-Approved Indications and Off-label Uses for [the selected drug]
For reference by respondents to Section I, CMS is providing the FDA-approved
indications for [the selected drug].. CMS notes that individuals may be prescribed [the
selected drug] for conditions not listed as an FDA-approved indication (i.e., an off-label
use). When responding to questions, please note which indications (including an FDAapproved indication or an off-label use) are relevant to your response or experience. If
you are responding about more than one indication, please clearly note which indication
your response refers to.
The selected drug is approved by the FDA for the following indications: [CMS to
provide a prepopulated list of all FDA-approved indications that will be accessible to
respondents]
Questions 2831 through 5762: Optional for All Respondents
Questions 2831 through 3337: Patient-Focused Experience
51

CMS will consider the nonbinding recommendations in the FDA “Guidance for Industry Expedited Programs for
Serious Conditions – Drugs and Biologics” (May 2014) when considering if a drug addresses an unmet medical need
for the purpose of the Negotiation Program.

64

CMS would like your input to better understand patients’ and caregivers’ experiences
with [the selected drug].. In this section, CMS is interested in your experience with [the
selected drug],, the health condition(s) that [the selected drug] may be used to treat, and
other medications that may be used to manage those condition(s). Individual patients
and caregivers, and organizations representing patients and/or caregivers are
encouraged to answer the following.
Question 2831: Background
Question 28a31a: Have you or someone you provide care for ever taken [the selected drug]??
Field
Response
Response to Question 28a31a Check box: YES or NO
If you answer yes, review Questions 28a131a1 and 28a231a2. If you answer no, skip to Questions
28a331a3 and 28a431a4.
Question 28a131a1: [If YES] For which condition(s) (including FDA-approved
indication(s) or off-label use as defined in the instructions) was [the selected drug]
taken?
Field
Response to Question
28a131a1

Response
Text (6,000 character count limit, which is approximately
500 words)

Question 28a231a2: [If YES] When wereHow long have you or someone you
provide care for given a diagnosis related tolived with this condition or conditions?
You may write an approximate date, or if you never received a diagnosis write
“N/A.”
Field
Response to Question
28a231a2

Response
Text (6,000 character count limit, which is approximately
500 words)

Question 28a331a3 [If NO] What condition(s) (including FDA-approved
indication(s) or off-label use as defined in the instructions) treated by [the selected
drug] would you like to provide input on?
Field
Response to Question
28a331a3

Response
Text (6,000 character count limit, which is approximately
500 words)

Question 28a431a4: [If NO] What is your experience with this condition or conditions?
• Please include how long you or someone you provide care for have lived with the condition or
conditions, if applicable.
65

Field
Response
Response to Question 2a431a4 Text (3612,000 character count limit, which is
approximately 31,000 words)
Question 2932: Information on Your Condition(s) or Condition(s) of Someone You Care For
Question 29a32a: How do the condition(s) you listed in Question 28a131 impact
your daily life and well-being or the daily life and well-being of someone you
provide care for?
•

For example,
o What are your symptoms related to the condition(s) on a “good” or “bad” day?
o How do these symptoms impact daily routines, work, family, and/or hobbies?
o What other activities are impacted by your symptoms?

Field
Response to Question 29a32a

Response
Text (3612,000 character count limit, which is
approximately 31,000 words)

Question 29b: How has the condition(s) you listed in Question 28 changed or
progressed over time?
•

For example,
o Have you, or someone you provide care for, experienced changes in severity
of the condition(s)?
o Have you, or someone you provide care for, experienced changes in how
often you feel symptoms?

Question 32b
Field
Response to Question 29b

Response
Text (36,000 character count limit, which is approximately
3,000 words)

Question 29c: What is important to you or those you provide care for in managing
the condition(s) you listed in Question 2831?
• This may be how you feel or function in your daily life, how long you live, or other goals you
have related to your medication(s) or condition(s). These may be short- or long-term
considerations.
• For example, this could mean fewer symptoms, better ability to complete daily tasks such as
chores, fewer visits to your doctor or hospital, fewer side effects, lower health care costs,
worrying less about your health, or other things.
Field
Response to Question 29c32b

Response
Text (3612,000 character count limit, which is
66

Field

Response
approximately 31,000 words)

Question 29d32c: What challenges do you, or someone you care for, face in managing thisthe
condition(s)?) you listed in Question 31?
Field

Response

Field
Response to Question 29d

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (12,000 character count limit, which is approximately
1,000 words)

Response to Question 32c

Question 3033: Information on the Current Medication to Treat Your Condition
Question 30a33a: Are you, or someone you care for, currently taking medication(s)
to manage the condition(s) you listed in Question 2831?
Field

Response

Field
Response
Response to Question 30a
YES or NO
Response to Question 33a
YES or NO
If you answer yes, review Questions 30a233a2 through 30a433a4. If you answer no, skip to
Question 3134.
Question 30a133a1: [If YES] What medication(s) are you, or someone you provide
care for, currently taking to manage the condition(s) you listed in Question 2831?
• If more than one medication is currently taken, please list medications in the
order you started them.
• If possible, please indicate how long you have taken your current medication(s),
to the best of your knowledge.
Field
Response to Question 33a1

Response
Text (6,000 character count limit, which is approximately
500 words)

Field
Response to Question 30a1

Response
Text (6,000 character count limit, which is approximately
500 words)

67

Question 30a233a2: [If YES] How did What factors, if any, affected the choice of
medication(s) you or someone you care for decide to start taking the medication(s)are
currently usedusing to manage the condition(s) you listed in Question 28?
What factors, if any, affected the choice of medication(s) currently used to manage the condition(s)
you have selected31?
• For example, this could mean side effects, cost, interactions with other medication, whether
your local pharmacy or mail-order pharmacy could provide it, family influence, interference
with your work or life, other health condition(s), whether the medication was covered by your
insurance, whether your medical provider recommended the medication based on clinical
guidelines or clinical experience, or other things that influenced your choice.
Field
Response to Question
30a233a2

Response
Text (3612,000 character count limit, which is
approximately 31,000 words)

Question 30a333a3: [If YES] What has been your experience, or the experience of
someone you provide care for, with the medication(s) currently used to manage the
condition(s) you listed in Question 2831?
• What are benefits of the medication(s)? What do you like about it?
• What are drawbacks of the medication(s)? What do you wish was different?
• How do the medication(s) impact daily life? Does the medication(s) make you feel better in
your daily life?
• How easy or difficult is it to take the medication(s)? What is difficult about taking your
medication(s)?
• Has taking this medication impacted your emotional or mental well-being? How?
Field
Response
• What are benefits of the medication(s)? What do you like about it?
• What are drawbacks of the medication(s)? What do you wish was different?
• How do the medication(s) impact daily life? Does the medication(s) make you feel better in
your daily life?
• How easy or difficult is it to take the medication(s)? What is difficult about taking your
medication(s)?
• Has taking this medication impacted your emotional or mental well-being? How?
Field
Response to Question 30a3
Response to Question 33a3

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (12,000 character count limit, which is approximately
1,000 words)

Question 30a433a4: [If YES] How satisfied are you, or someone you care for, with
the medication(s) you take noware currently taking to manage your condition(s)?
68

Field
Response to Question 30a4

Response
Text (36,000 character count limit, which is approximately
3,000 words)

) listed in Question 31?
Field
Response to Question 33a4

Response
Text (12,000 character count limit, which is approximately
1,000 words)

Question 34: Information on the Medication(s) Used in the Past to Treat Your Condition
Question 31a34a: Have you, or someone you care for, taken other medication(s) in
the past to manage the condition(s) you listed in Question 2831?
Field

Response

Field
Response
Response to Question 31a
YES or NO
Response to Question 34a
YES or NO
If you answer yes, review Question 31b134b1 through 31b434b4. If you answer no, skip to
Question 3235.
Question 31b134b1: [If YES] What medication(s) have you, or someone you care
for, taken in the past to manage the condition(s) you listed in Question 2831?
• If possible, please indicate whenhow long past medication(s) were started and
stoppedtaken to the best of your knowledge.
Field
Response to Question 34b1

Response
Text (6,000 character count limit, which is approximately
500 words)

Field
Response to Question 31b1

Response
Text (6,000 character count limit, which is approximately
500 words)

Question 31b2: [If YES] How did you, or someone you care for, decide to start
taking the medication(s) used in the past to manage the condition(s) you listed in
Question 28?
Question 34b2: [If YES]
What other factors, if any, affected the choice of medication(s) used in the past to manage the
condition(s) you listed in Question 2831?
69

• For example, factors could include side effects, cost, interactions with other medication,
whether your local pharmacy or mail order pharmacy could provide it, family influence,
interference with your work or life, other health condition(s), whether the medication was
covered by your insurance, whether your medical provider recommended the medication based
on clinical guidelines or clinical experience, or other things that influenced your choice.
Field
Response to Question
31b234b2

Response
Text (3612,000 character count limit, which is
approximately 31,000 words)

Question 31b334b3: [If YES] What was your experience, or the experience of
someone you provide care for, with the medication(s) used in the past to manage the
condition(s) you listed in Question 2831?
• What are benefits of the medication(s)? What do you like about it?
• What are drawbacks of the medication(s)? What do you wish was different?
• How do the medication(s) impact daily life? Does the medication(s) make you feel better in
your daily life?
• How easy or difficult is it to take the medication(s)? What is difficult about taking your
medication(s)?
• Has taking this medication impacted your emotional or mental well-being? How?
Field
Response
• What are benefits of the medication(s)? What do you like about it?
• What are drawbacks of the medication(s)? What do you wish was different?
• How do the medication(s) impact daily life? Does the medication(s) make you feel better in
your daily life?
• How easy or difficult is it to take the medication(s)? What is difficult about taking your
medication(s)?
• Has taking this medication impacted your emotional or mental well-being? How?
Field
Response to Question 31b3
Response to Question 34b3

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (12,000 character count limit, which is approximately
1,000 words)

Question 31b434b4: [If YES] Why did you, or someone you provide care for, stop
taking the medication(s) used in the past to manage the condition(s) you listed in
Question 2831?
Field
Response to Question 34b4

Response
Text (12,000 character count limit, which is approximately
1,000 words)
70

Question 35: Medical Needs Related to Condition(s)
What are important medical needs related to condition(s) you listed in Question
31, and to what extent are these needs being addressed, or not addressed, by
existing treatment options for this condition(s)?
•
•

What medical needs were you hoping treatments for this condition(s) would address?
Do certain medication(s) or treatment(s) address those needs to a greater or lesser extent than others?

Field
Response to Question 31b435

Response
Text (3612,000 character count limit, which is
approximately 31,000 words)

Question 3236: What other information about the condition(s) you have identified or the
medication(s) used to manage these condition(s) do you think CMS should consider while
evaluating [the selected drug]??
Field
Response to Question 3236

Response
Text (3612,000 character count limit, which is
approximately 31,000 words)

Question 3337: Demographic Questions [Only when a respondent selects the “patient” or
“caregiver” option in response to Question 2730.]
To put the above responses into context, CMS is interested in understanding the demographic
information of the individual who has used the selected drug:
Field
Age

Regional Location

Response Options
Select one:
Under 18 years
18-24 years
25-34 years
35-44 years
45-64 years
65-84 years
85-99 years
100 years or older
Select one:
New England: CT, ME, MA, NH, RI, VT
Middle Atlantic: NJ, NY, PA
Midwest-East North Central: IN, IL, MI, OH, WI
Midwest-West North Central: IA, KS, MN, MO,
NE, ND, SD
South-South Atlantic: DE, DC, FL, GA, MD, NC,
SC, VA, WV
South-East South Central: AL, KY, MS, TN
South-West South Central: AR, LA, OK, TX
71

Field

Medicare Beneficiary

Response Options
West-Mountain: AZ, CO, ID, NM, MT, UT, NV,
WY
West-Pacific: AK, CA, HI, OR, WA
U.S. Territory: American Samoa, Guam, Northern
Mariana Islands, Puerto Rico, U.S. Virgin Islands
Other
Select one:
Yes
No

Questions 3438 through 3943: Manufacturer-Focused Questions
CMS is collecting information to support its evaluation of [the selected drug] for the indication(s)
it is used to treat relative to its therapeutic alternative(s) for those indication(s). CMS is interested
in obtaining input and evidence from manufacturers of selected drugs related to [the selected drug]
and its potential therapeutic alternative(s), methodological approaches to evaluation of [the
selected drug] consistent with statutory requirements, and publicly available evidence CMS should
consider related to [selected drug] and the indication(s) it treats.
Instructions for Questions 3438 through 3943
Manufacturers are permitted to submit a dossier in Question 3943. Dossier submission is optional.
Such dossiers may be used to supplement responses provided in Questions 3438 through 3843.
CMS requests that manufacturers submitting a dossier also submit an outline of the location of
information related to Questions 3438 through 3843, to the extent applicable.
Question 3438: Potential therapeutic alternatives
Provide a list of potential therapeutic alternatives CMS should consider for the
indication(s) of [the selected drug].. For the list of potential therapeutic alternatives
and indications, provide a brief explanation of the reason for the identification of the
therapeutic alternative(s) of the selected drug and any indication(s).

Field
Response
List the potential therapeutic alternatives of the Text (12,000 character count limit, which is
selected drug, along with which indication(s) of approximately 1,000 words)
the selected drug the respondent would like
CMS to consider for each of the potential
therapeutic alternatives listed
Question 3539: Use in treatment and clinical comparative effectiveness evidence
Question 35a39a: Describe the selected drug’s use in the course of care for its
72

indication(s) based on current clinical use, clinical practice guidelines, or other
relevant clinical practice standards and provide all supporting citations. When
relevant, please describe the use of each potential therapeutic alternative (identified
in Question 34)38), if any, in the course of care for the indication(s) relative to the
selected drug.
Field
Response to Question 35a39a

Response
Text (3618,000 character count limit, which is
approximately 3,0001,500 words)

Question 35b39b: For the indication(s) identified in the instructions and Question
3438, identify relevant clinical outcome measures CMS should consider in its
evaluation of clinical comparative effectiveness (e.g., clinical efficacy, real-world
effectiveness, or safety). Include references to any supporting citations listed in
Question 5661 for identified clinical outcome measures.
Field
Response to Question 35b39b

Response
Text (18,000 character count limit, which is approximately
1,500 words)

Question 35c39c: For the indication(s) of the selected drug, identify any relevant
evidence evaluating the clinical comparative effectiveness (e.g., clinical efficacy,
real-world effectiveness, or safety) of the selected drug and potential therapeutic
alternatives. Relevant comparative evidence may include but is not limited to: headto-head randomized controlled trials, pragmatic clinical trials, network metaanalyses, observational studies, and real-world evidence. Include references to any
supporting citations listed in Question 5661 for relevant comparative evidence.
Field
Response to Question 35c39c

Response
Text (36,000 character count limit, which is approximately
3,000 words)

Question 3640: Prevalence, utilization, and cost estimates
Question 36a40a: For the indication(s) of the selected drug, provide an estimate of
its prevalence among the Medicare population. Include references to any supporting
citations listed in Question 5661 and/or a brief methodology to support the
estimate(s).
Field
Response to Question 36a40a

Response
Text (3618,000 character count limit, which is
approximately 3,0001,500 words)

Question 36b40b: For the indication(s) of the selected drug, provide an estimate of
73

Medicare utilization of the selected drug for that indication. Estimates of Medicare
utilization can include estimates of total number of patients treated, estimates of
share of selected drug prescriptions dispensed to patients with that indication, or
similar measures. Include references to any supporting citations listed in Question
5661 and/or brief methodology to support the estimate(s).
Field
Response to Question 40b

Response
Text (18,000 character count limit, which is approximately
1,500 words)

Field
Response to Question 36b

Response
Text (36,000 character count limit, which is approximately
3,000 words)

Question 36c40c: For the indication(s) of the selected drug, identify or provide
evidence relevant to Medicare regarding relative health care resource utilization
associated with patients who take the selected drug and its potential therapeutic
alternatives. Relevant evidence of relative health care resource utilization may
include, but is not limited to: patterns of use, disease burden or cost-of-illness
analyses, cost-effectiveness or cost-utility analyses, and/or other analyses of health
care resource utilization relevant to the selected drug and any potential therapeutic
alternatives. Include references to any supporting citations listed in Question 5661
and/or brief methodology to support analyses.
Note, CMS will not use QALYs or any evidence from comparative effectiveness
research in a manner that treats extending the life of an individual who is elderly,
disabled, or terminally ill as of lower value than extending the life of an individual
who is younger, non-disabled, or not terminally ill.
Field
Response to Question 36c40c

Response
Text (3618,000 character count limit, which is
approximately 3,0001,500 words)

Question 3741: Therapeutic advance and unmet medical need
Question 37a41a: For the indication(s) of the selected drug, describe the extent to
which the selected drug currently represents a therapeutic advance as compared to
its potential therapeutic alternative(s). ) taking into consideration differences in
outcomes and costs. Include references to any supporting citations listed in Question
61.
Field
Response to Question 37a41a

Response
Text (36,000 character count limit, which is approximately
3,000 words)
74

Question 37b41b: For the indication(s) of the selected drug, describe any unmet
medical need(s) and the extent to which the selected drug and its potential
therapeutic alternative(s) address an unmet medical need. such need(s). Include
references to any supporting citations listed in Question 61.
Field
Response to Question 37b41b

Response
Text (36,000 character count limit, which is approximately
3,000 words)

Question 3842: Specific populations and patient experience
Question 38a42a: For the indication(s) of the selected drug, identify any specific
populations (e.g., elderly, individuals with disabilities, the terminally ill, children,
and other patient populations) that are impacted by the selected drug and/or its
potential therapeutic alternative(s), and describe how they are impacted. Include
references to any supporting citations listed in Question 5661.
Field
Response to Question 42a

Response
Text (18,000 character count limit, which is approximately
1,500 words)

Response to Question 38a

Text (18,000 character count limit, which is approximately
1,500 words)

Question 38b42b: For the indication(s) of the selected drug, identify evidence
regarding patient experiences related to the indication(s), selected drug, and/or its
potential therapeutic alternative(s). This may include but is not limited to evidence
regarding patient priorities and preferences related to treatment of the indication,
treatment burden, burden of disease, or other patient experience
data. ReferenceInclude references to any supporting citations listed in Question
5661.
Field
Response to Question 42b

Response
Text (18,000 character count limit, which is approximately
1,500 words)

Field
Response to Question 38b

Response
Text (18,000 character count limit, which is approximately
1,500 words)

Question 3943: Dossier Submission
Manufacturers are permitted to submit a dossier in Question 3943. Such dossiers may be
used to supplement responses provided in questions 3438 through 3842, preferably
formatted using an industry standard such as the most current AMCP Format (version 5.0)
75

for Formulary Submissions. CMS requests that manufacturersManufacturers submitting a
dossier alsomay highlight and/or submit an outline ofindicating the location of information
within the drug dossier that the manufacturer suggests is related to Questions 3438 through
3842, to the extent applicable.
While submitted dossiers may include a variety of economic information, CMS will not use
QALYs or any evidence from comparative effectiveness research in a manner that treats
extending the life of an individual who is elderly, disabled, or terminally ill as of lower
value than extending the life of an individual who is younger, non-disabled, or not
terminally ill.
CMS notes that citations included in a dossier submission are not subject to the 250citation limit specified in Question 61, however, like any content included in a dossier
submission, these citations will be considered supplemental to responses provided in
Questions 38 through 42 and citations provided in Question 61. Citations submitted in
Question 61 should directly support the written responses to Questions 38 through 42.
Response
Text (Up to 2 PDF files in a Zip file, one of these files shouldmay include an outline of the
location of the information in the drug dossier related to Questions 3438 through 3842, as
applicable)
Questions 4044 through 4549: Clinical-Focused Experience
CMS is collecting information to support its evaluation of [the selected drug] for the
indication(s) it is used to treat relative to its potential therapeutic alternative(s) for
those indication(s). CMS is interested in obtaining the perspectives of health care
providers who have clinical experience with prescribing or managing use of [the
selected drug] and/or its potential therapeutic alternative(s) for these indication(s).
Question 4044: Background Questions
Question 40a44a: Are you a health care provider (i.e., a person who is trained and
licensed to give health care52)?
Field
Response
Response to Question 40a44a YES or NO
If you answer yes, review Questions 40a144a1. If you answer no, skip to Question 4044.
Question 40a144a1: [If YES] What is your area of specialization? If you are
currently practicing, provide a brief description of the type of practice and your
practice site.

52

Refer to the CMS Glossary for the term of “health care provider” available at: https://www.cms.gov/glossary.

76

Field
Response to Question
40a144a1

Response
Text (6,000 character count limit, which is approximately
500 words)

Question 40b44b: Do you have experience prescribing or managing the use of [the selected
drug]??
Field

Response

Field
Response
Response to Question 40b
YES or NO
Response to Question 44b
YES or NO
If you answer yes, review Question 40b144b1. If you answer no, skip to Question 40b244b2.
Question 40b144b1: [If YES] For which indication(s) (which includes off-label
use(s) per the definition provided in the instructions) have you prescribed or
managed use of [the selected drug] that you would like to provide CMS information
on?
Field
Response to Question
40b144b1

Response
Text (6,000 character count limit, which is approximately
500 words)

Question 40b244b2: [If NO] On which indication(s) (which includes off-label use(s)
per the definition provided in the instructions) would you like to provide input?
Field
Response to Question
40b244b2

Response
Text (6,000 character count limit, which is approximately
500 words)

Question 4145: Treatment-related Questions
Question 41a45a: What are goals of treatment for the condition(s) treated by [the selected drug]??
• Examples of treatment goals may include but are not limited to disease remission, symptom
management, quality of life improvement, or cure.
Field
Response to Question 41a45a

Response
Text (1812,000 character count limit, which is
approximately 1,500000 words)

Question 41b45b: What outcomes do you use to assess improvement or treatment
response for this indication(s)?
• Please provide specific clinical, functional, or patient-reported outcomes.
Field

Response
77

Response to Question 41b45b

Text (1812,000 character count limit, which is
approximately 1,500000 words)

Question 41b145b1: What would you consider to be a meaningful improvement or
treatment response for the outcomes listed in Question 41b45b?
• Is there a widely-accepted minimum clinically important difference for these
outcomes?
Field
Response to Question
41b145b1

Response
Text (12,000 character count limit, which is approximately
1,000 words)

Question 41b245b2: Would you assess improvement or treatment response
differently in certain patient subpopulations? If so, which subpopulations and why?
Field
Response to Question
41b245b2

Response
Text (3612,000 character count limit, which is
approximately 31,000 words)

Question 41c45c: Are there widely used evidence-based clinical practice guidelines for the
condition(s) treated by [the selected drug]?? If so, please cite these guidelines and explain
how they are used to support clinical decision-making. For off-label use, please also
reference any citations listed in Question 5661 for major drug compendia, authoritative
medical literature, and/or accepted standards of medical practice.
Field
Response to Question 41c45c

Response
Text (3612,000 character count limit, which is
approximately 31,000 words)

Question 4246: Additional Treatment-related Questions
Question 42a46a: How does [the selected drug] fit into the current treatment
paradigm for patients with the conditions(s) treated by [the selected drug]??
Field
Response to Question 42a

Response
Text (18,000 character count limit, which is approximately
1,500 words)

Response to Question 46a

Text (12,000 character count limit, which is approximately
1,000 words)

Question 42b46b: At what point in treatment might [the selected drug] be considered
as a treatment option for patients with the condition(s) treated with [the selected
78

drug]?? What other treatments might be considered before [the selected drug] is
considered a clinically appropriate treatment option, if any?
Field
Response to Question 42b

Response
Text (18,000 character count limit, which is approximately
1,500 words)

Field
Response to Question 46b

Response
Text (12,000 character count limit, which is approximately
1,000 words)

Question 42c46c: What medications would you consider to be potential therapeutic
alternatives for [the selected drug] for treatment of the condition(s) treated with [the
selected drug]?? For the list of potential therapeutic alternatives and indications,
provide a brief explanation of the reason for the identification of the potential
therapeutic alternative(s) of the selected drug and any indication(s). Reference any
citations listed in Question 5661 where applicable.
Field
Response to Question
42c46c

Response
Text (12,500000 character count limit, which is
approximately 1,000 words)

Question 42d46d: What considerations drive treatment selection among [the selected
drug] and its potential therapeutic alternative(s) for the indication(s)?
• For example, relative efficacy, safety profile, route of administration, patient
characteristics, patient preferences, cost, formulary placement, etc.
Field
Response to Question 42d46d

Response
Text (1812,000 character count limit, which is approximately
1,500000 words)

Question 42e46e: Are there notable differences between how [the selected drug] or
the potential therapeutic alternative(s) identified in Question 42c46c are prescribed or
managed in your practice setting and how these drugs are used in broader clinical
practice and/or treatment recommendations in current clinical guidelines for the
condition(s) treated with [the selected drug]??
• For example, are there general debates or uncertainties related to selection or use
of these drugs for the indication(s)?
Field
Response to Question 42e46e

Response
Text (1812,000 character count limit, which is approximately
1,500000 words)

79

Question 42f46f: How would you characterize the benefits and risks associated with
[the selected drug]??
Field
Response to Question 42f46f

Response
Text (1812,000 character count limit, which is approximately
1,500000 words)

Question 42f1: What side effects or46f1: In your opinion, how do the benefits and
risks, common or serious, or other safety concerns would you take into consideration
when selecting a treatment option from among [ associated with the selected drug] or
differ from the benefits and risks associated with its potential therapeutic
alternative(s) for the conditionindication(s) treated with [the selected drug]? )?
Field
Response to Question
42f146f1

Response
Text (1812,000 character count limit, which is approximately
1,500000 words)

Question 42f2: In your opinion, how do the benefits and risks associated with [the
selected drug] differ from the benefits and risks associated with its potential
therapeutic alternative(s) for the indication(s)?
Field
Response to Question 42f2

Response
Text (18,000 character count limit, which is approximately
1,500 words)

Question 42f3Question 46f2: What specific populations or patient subgroups may
derive greater benefits or be at risk for greater harms by using [the selected drug] or
any of its potential therapeutic alternative(s) for the indication(s)?
Field
Response to Question 46f2

Response
Text (12,000 character count limit, which is approximately
1,000 words)

Field
Response to Question 42f3

Response
Text (18,000 character count limit, which is approximately
1,500 words)

Question 42g46g: How would you assess whether a patient is tolerating and/or
responding to [the selected drug] or any of its potential therapeutic alternative(s)
when used for each indication(s)?
• When might you consider discontinuing a medication?
• When might you consider switching to a different medication?
• When might you consider adding another medication to the regimen?
80

Field
Response to Question 42g46g

Response
Text (1812,000 character count limit, which is approximately
1,500000 words)

Question 4347: Access and Patient Experience
What health insurance coverage or access issues do patients experience when trying
to obtain [the selected drug] and its potential therapeutic alternative(s) for the
condition(s) treated by [the selected drug]??
Field
Response to Question 4347

Response
Text (3612,000 character count limit, which is
approximately 31,000 words)

Question 4448: Therapeutic Advance and Unmet Medical Need
Question 44a48a: For the condition(s) treated by [the selected drug],, describe the
extent to which [the selected drug] currently represents (or does not represent) a
therapeutic advance as compared to its potential therapeutic alternative(s).) taking
into consideration differences in outcomes and costs. Include references to any
supporting citations listed in Question 61.
Field
Response to Question 48a

Response
Text (36,000 character count limit, which is approximately
3,000 words)

Field
Response to Question 44a

Response
Text (36,000 character count limit, which is approximately
3,000 words)

Question 44b48b: For the conditionindication(s) treated by [of the selected drug],,
describe any unmet medical need(s) and the extent to which [the selected drug]
currently addresses (or does not and its potential therapeutic alternatives address) an
unmet medical need. such need(s). Include references to any supporting citations
listed in Question 61.
Field

Response

Field
Response to Question 44b

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (36,000 character count limit, which is approximately
3,000 words)

Response to Question 48b

81

Question 44c: What unmet medical needs do you believe persist among patients with
the condition(s) treated by [the selected drug], if any?

Field
Response to Question 44c

Response
Text (36,000 character count limit, which is approximately
3,000 words)

Question 45

Question 49: What other information about [the selected drug],, its potential therapeutic
alternative(s), or the indication(s) do you think CMS should consider in its evaluation of [the
selected drug]? Reference? Include references to any supporting citations listed in Question
56 when applicable61.
Field
Response to Question 49

Response
Text (12,000 character count limit, which is approximately
1,000 words)

Field
Response to Question 45

Response
Text (36,000 character count limit, which is approximately
3,000 words)

Questions 4650 through 5156: Research-Focused Experience
CMS is collecting information to support its evaluation of [the selected drug] in the indication(s) it
is used to treat relative to its potential therapeutic alternative(s). CMS is interested in obtaining
input and evidence from individual researchers and research or advocacy organizations related to
[the selected drug] and its potential therapeutic alternative(s), methodological approaches to
evaluation of [the selected drug] consistent with statutory requirements, and publicly available
evidence CMS should consider related to [selected drug] and the indication(s) it treats.
Question 4650: Background
Are you:
(1) An individual or representative of an entity that has conducted research (including clinical
trials or data analyses) related to use of [the selected drug] or its potential therapeutic
alternative(s)?
(2) Familiar with methods used to evaluate use of [the selected drug] or its potential therapeutic
alternatives?
(3) Aware of research-based evidence CMS should consider regarding [the selected drug],, its
potential therapeutic alternatives and/or the indication(s) it treats?
Field

Response
82

Response to Question 50
Field
Response to Question 46

YES or NO for each item 1-3 (listed above in question)
Response
YES or NO for each item 1-3 (listed above in question)

Question 46a50a: On which indication(s) (which includes off-label use(s) per the
definition provided in the instructions) of [the selected drug] would you like to
provide input?
Field
Response to Question 46a50a

Response
Text (6,000 character count limit, which is approximately
500 words)

Question 4751: Potential Therapeutic Alternatives
What medications would you consider to be potential therapeutic alternatives for [the
selected drug] for each indication(s)? For the list of potential therapeutic alternative(s) and
indications, provide a brief explanation of the reason for the identification of the potential
therapeutic alternative(s) of the selected drug and any indication(s). ReferenceInclude
references to any supporting citations listed in Question 56 where applicable61.
Field
Response to Question 4751

Response
Text (12,000 character count limit, which is approximately
1,000 words)

Question 4852: Comparative Clinical Evidence
Question 48a: What methodology, framework, or other analytic approach would you recommend CMS consider
for use in its evaluation of the clinical comparative effectiveness (e.g., clinical efficacy, real-world effectiveness,
or safety) of [the selected drug] and its potential therapeutic alternatives for the indication(s)? Provide supporting
rationale and reference any citations listed in Question 56 where applicable.
Field
Response
Response to Question 48a
Text (36,000 character count limit, which is approximately

3,000 words)
Question 48b52a: What relevant clinical outcome measures should CMS consider in its
evaluation of clinical comparative effectiveness (e.g., clinical efficacy, real-world
effectiveness, or safety) of [the selected drug] and its potential therapeutic alternative(s) for
the indication(s)? ReferenceInclude references to any supporting citations listed in
Question 56 where applicable61.
Field

Response

83

Field
Response to Question 48b
Response to Question 52a

Response
Text (18,000 character count limit, which is approximately
1,500 words)
Text (12,000 character count limit, which is approximately
1,000 words)

Question 48c52b: For the indication(s) of the selected drug, identify any relevant evidence
evaluating the clinical comparative effectiveness (e.g., clinical efficacy, real-world
effectiveness, or safety) of the selected drug and potential therapeutic alternative(s).
Relevant comparative evidence may include but is not limited to: head-to-head randomized
controlled trials, pragmatic clinical trials, network meta-analyses, observational studies,
and real-world evidence. ReferenceInclude references to any supporting citations listed in
Question 5661.
Field
Response to Question
48c52b

Response
Text (36,000 character count limit, which is approximately
3,000 words)

Question 4953: Specific Populations and Patient Experience
Question 49a53a: What evidence are you aware of regarding patient experiences related to
use of [the selected drug],, its potential therapeutic alternative(s), and/or condition(s)
treated by [the selected drug]?? This may include but is not limited to evidence regarding
patient priorities and preferences related to treatment of the condition(s), treatment burden,
burden of disease, or other patient experience data. ReferenceInclude references to any
supporting citations listed in Question 5661.
Field
Response to Question 53a

Response
Text (12,000 character count limit, which is approximately
1,000 words)

Question 53b: What specific populations or patient subgroups are impacted by the selected drug and/or
its potential therapeutic alternative(s) for the condition(s) treated by the selected drug? How are these
populations or subgroups impacted?
Identify studies focused on the impact of the selected drug and its potential therapeutic
alternative(s) on the specific populations. Include references to any supporting citations
listed in Question 61.
Field
Response to Question 53b

Response
Text (12,000 character count limit, which is approximately
1,000 words)

84

Question 53c: What considerations related to health insurance coverage or access to the
selected drug, its potential therapeutic alternative(s), and/or or this condition(s) treated by
the selected drug? Include references to any supporting citations listed in Question 61.
Field
Response to Question 53c

Response
Text (12,000 character count limit, which is approximately
1,000 words)

Question 54: Prevalence, Utilization, and Cost Estimates
Question 54a: For each indication(s), provide an estimate of prevalence among the
Medicare population. Include references to any supporting citations listed in Question 61
and/or provide a brief methodology to support the estimate.
Field
Response to Question 49a54a

Response
Text (3612,000 character count limit, which is
approximately 31,000 words)

Question 49b: What specific populations or patient subgroups are impacted by [the selected
drug] and/or its potential therapeutic alternative(s) for the condition(s) treated by [the
selected drug]?54b How are these populations or subgroups impacted? Identify studies
focused on the impact of [the selected drug] and its potential therapeutic alternative(s) on
the specific populations. Reference any supporting citations listed in Question 56 where
applicable.
Field
Response to Question 49b

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Question 49c: What considerations related to health insurance coverage or access to [the selected drug],
its potential therapeutic alternative(s), and/or or this condition(s) treated by [the selected drug]?
Reference any supporting citations listed in Question 56 where applicable.
Field
Response
Response to Question 49c
Text (36,000 character count limit, which is approximately
3,000 words)
J.
uestion 50: Prevalence, Utilization, and Cost Estimates

Q

Question 50a: For each indication(s), provide an estimate of prevalence among the
Medicare population. Reference any citations listed in Question 56 and/or provide a brief
methodology to support the estimate.
Field
Response to Question 50a

Response
Text (36,000 character count limit, which is approximately
85

Field

Response
3,000 words)

Question 50b: For each indication(s), provide an estimate for Medicare utilization of [the
selected drug] and/or its potential therapeutic alternative(s). Estimates of Medicare
utilization can include estimates of total number of patients treated, estimated share of
[selected drug] prescriptions dispensed, furnished, or administered to patients for a given
indication, or similar measures. ReferenceInclude references to any supporting citations
listed in Question 5661 and/or provide a brief methodology to support the estimate.
Field
Response to Question 50b54b

Response
Text (3612,000 character count limit, which is
approximately 31,000 words)

Question 50c54c: For eachthe indication(s),) of the selected drug, identify or provide
evidence relevant to Medicare regarding relative health care resource utilization
ofassociated with patients who take [the selected drug] and its potential therapeutic
alternative(s).alternatives. Relevant evidence of relative health care resource utilization
may include, but is not limited to: patterns of use, disease burden or cost-of-illness
analyses, cost-effectiveness or cost-utility analyses, and/or other analyses of health care
resource utilization relevant to [the selected drug] and any potential therapeutic
alternative(s). Reference alternatives. Include references to any supporting citations listed
in Question 5661 and/or provide a brief methodology to support the assessments. analyses.
Note, CMS will not use QALYs or any evidence from comparative effectiveness research
in a manner that treats extending the life of an individual who is elderly, disabled, or
terminally ill as of lower value than extending the life of an individual who is younger,
non-disabled, or not terminally ill.
Field
Response to Question 50c54c

Response
Text (3612,000 character count limit, which is
approximately 31,000 words)

Question 51: What other information or evidence do you think CMS should consider in 55:
Therapeutic advance and unmet medical need
Question 55a: For the evaluationindication(s) of [the selected drug]? Reference,
describe the extent to which the selected drug currently represents a therapeutic
advance as compared to its potential therapeutic alternative(s) taking into
consideration differences in outcomes and costs. Include references to any
supporting citations listed in Question 56 when applicable61.
Field

Response
86

Field
Response to Question 55a

Response
Text (36,000 character count limit, which is approximately
3,000 words)

Question 55b: For the indication(s) of the selected drug, describe any unmet medical
need(s) and the extent to which the selected drug and its potential therapeutic
alternative(s) address such need(s). Include references to any supporting citations
listed in Question 61.
Field
Response to Question 51
Response to Question 55b

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (36,000 character count limit, which is approximately
3,000 words)

Question 56: What other information or evidence do you think CMS should consider in the
evaluation of the selected drug? Include references to any supporting citations listed in
Question 61.
Field
Response to Question 56

Response
Text (12,000 character count limit, which is approximately
1,000 words)

Questions 5257 through 5459: Other Public Input
CMS is collecting information to support its evaluation of [the selected drug] relative to potential
therapeutic alternative(s). CMS is interested in obtaining any additional input that CMS should
consider when evaluating [the selected drug]..
Question 5257: For which indication(s) (which includes off-label use(s) per the definition
provided in the instructions) would you like to provide input?
Field
Response to Question 57

Response
Text (6,000 character count limit, which is approximately
500 words)

Question 58: What is your experience with the selected drug or the condition(s) it treats?
Field
Response to Question 5258

Response
Text (612,000 character count limit, which is approximately
5001,000 words)

Question 5359: What is your experience with [information or evidence do you think CMS
should be aware of as it evaluates the selected drug] or the condition for each indication(s) it
87

treats?)? Include references to any supporting citations listed in Question 61.
Field
Response to Question 5359

Response
Text (36,000 character count limit, which is approximately
3,000 words)

K. Question 54: What information or evidence do you think CMS should be aware of
as it evaluates [the selected drug] for each indication(s)? Reference any citations
listed in Question 56 when applicable.
Field
Response to Question 54

Response
Text (36,000 character count limit, which is approximately
3,000 words)

Questions 5560 and 5661: Visual Information and Citations
Question 5560: Visual Representations to Support Responses in Section I
Provide up to 20 visual representations such as tables, charts, and/or graphs that support the
responses in Section I. Indicate which question each file corresponds to. Regardless of the number
of PDF files uploaded in the single Zip file, respondents may not submit more than 20 total visuals
(e.g., tables, charts, and/or graphs).
RESPONSE
Text (Up to 20 PDF files in a single
Zip file)

FIELD
Indicate Question Each File Corresponds To By
Selecting the Applicable Question From a List

Question 5661: Citations to Support Responses in Section I
Provide up to 250 citations that support the responses provided in Section I. Citations should be
labeled with a number corresponding to the number used by the respondent to reference the source
in-text throughout Section I. Citations should be listed in the order the citation is first used within
Section I. For example, the citation #1 included on the citation list, can be referenced in-text as
such (1). CMS notes that the 250-citation limit applies across the submission, including any
citations in the additional attachments for visual representations. If there are citations relevant to
the visual representations, include them in this citation list.
Provide each citation in the National Library of Medicine (NLM) style format appropriate for the
source of information (e.g., a journal article). Information on how to format citations is available
for free through the NLM at: https://www.ncbi.nlm.nih.gov/books/NBK7256/. When available,
please include a Pub Med ID (https://pubmed.ncbi.nlm.nih.gov/) or, if the Pub Med ID is not
available, include the Digital Object Identifier (DOI) (https://www.doi.org/).
(https://www.doi.org/). Additionally, please provide a hyperlink to the source, if possible.
Respondents must upload a single PDF document of the list of citations in a Zip file. To create the
88

PDF document, respondents may use an Excel file that includes the information specified in the
data fields below for each citation listed by the respondent.
RESPONSE
FIELDS
Text (Up to 250 citations within a • Numbered List
PDF file in one Zip file)
• Full Citation
•
•
•

PubMed ID, if available
If the PubMed ID is not available, the Digital Object
Identifier (DOI), if available
Hyperlink, if available

An example of how a respondent may format the response fields within an Excel file is also
included below for reference.
Numbered Full Citation
List

1

Surname First-andMiddle-Initials,
Surname First-andMiddle Initials.
Article Title. Journal
Title. Date of
Publication; Volume
(Issue): Pagination.

PubMed
ID, if
available
[if no
PubMed,
provide
DOI]
123456789

Hyperlink, if available

www.pubmed.com/examplewww.pubmed.com/example

For Any Respondent that Responded to One or More Questions in Section I
Question 5762: Identification of Information Submitted in Section I that the Respondent
Believes Should be Withheld as Proprietary Information53
In addition to the information CMS already designates as proprietary consistent with section
40.2.1 of the final guidance42 CFR 429.300: 54 For each question that a respondent to Section I
53

A respondent’s response to Question 62 will not be included in the MFP Explanations (which is described in
42 CFR 429.705(b)). For clarity, this means that CMS will not publish that a Primary Manufacturer identified
certain data should be withheld in response to Question 62 in publishing the explanation of the MFP, but CMS
still retains the authority to determine whether such data may be published in accordance with its
confidentiality policy as set forth in 42 CFR 429.300.
54
Specifically, as described in section 40.2.1 of the final guidance42 CFR 429.300, CMS will treat research and
development costs and recoupment, unit costs of production and distribution, pending patent applications, market data,

89

believes contains information that should be withheld by CMS consistent with existing federal
requirements for protecting proprietary information, including under Exemptions 3 and/or 4 of the
FOIA, follow the instructions to below to identify this information for CMS. This identification of
information by a respondent to Section I will be used during CMS’ process to determine which
information submitted is proprietary and which information may be disclosed in the public
explanation of the MFP consistent with section 60.6.1 of the final guidance. 42 CFR 429.300.
• Using [brackets] at the start and end of any full sentence(s) within a free response field(s)
that contains information the respondent believes should be withheld. Also use [brackets]
at the start and end of any data provided, if permitted in the data entry field (for example,
because the field is a text field), to identify information the respondent believes should be
withheld.
o Label the end of each bracketed sentence with a number in sequential order and use
the same number originally assigned to a bracket throughout Section I each time the
same justification will be used in response to Question 5761 as the reason the
respondent believes the information should be withheld (e.g., {1}, {2}). To
differentiate references in response to Question 5762 from citations, use different
symbols for numbering (for example, a {curly brace} for Question 5762 and
(parenthesis) for citations).
• In the “Location” data field, identify the location of the information the respondent believes
should be withheld in Section I by either:
o For a data response field where brackets cannot be entered (for example, a visual
representation) (in other words, a “non-bracketed location”), listing the specific
location of the information by identifying the Question number, data entry field,
and/or line number to specifically identify the starting and ending point, of
information the respondent believes should be withheld.
• In the “Justification” data field, provide a brief explanation regarding why respondent
believes the information should be withheld as proprietary information.
o For a bracketed item, provide the Justification for each separate number used within
Section I (e.g., {1}, {2}). Do not repeat the same Justification.
• If a Primary Manufacturer provides a Section I submission and includes a
response to Question 5762, restart numbering at {1} in Section I.
o For a non-bracketed location, if the Justification is the same Justification as a
bracketed item, the respondent should use the number assigned to the bracketed item
with the corresponding justification as the response to the “Justification” data field.
For example, if a non-bracketed item’s Justification is the same as the Justification for
bracketed item {1}, the respondent should enter “{1}” in the Justification response
field for that non-bracketed item.

revenue, and sales volume data as proprietary, unless the information that is provided to CMS is already publicly
available, in which case it would be considered non-proprietary. CMS will treat the data on prior Federal financial
support and approved patent applications, exclusivities, and approved applications under section 505(c) of the FD&C
Act or section 351(a) of the PHS Act that is publicly available as non-proprietary.

90

LOCATION (List the Bracket Number (E.g. {1}, {2}) or
Question/Data Entry Field/Line Number))
List of Bracket Locations, in Order of First Appearance
(E.g. {1}, {2}); Add a row for each additional item
List of Non-Bracketed Locations, Identified by the,
Question, Data Entry Field and/or Line Number; Add a
row for each additional item

JUSTIFICATION
Text (2,400 character count limit,
which is approximately 200
words)
Text (each item 2,400 character
count limit, which is
approximately 200 words)

L.J.
Certification of Submission of Section I for All Respondents

J.

Required for All Respondents of Section I
Certification:
I certify that all information and statements made in this submission are true and current to the best
of my knowledge and belief and are made in good faith. I reviewed the submission and made a
reasonable inquiry regarding its content. I understand the information contained in this submission
is being provided to and will be relied upon by CMS for Medicare payment purposes, including
determination of a maximum fair price, as defined in section 1191(c)(3) of the Social Security Act.
Checkbox to indicate yes [ ]
Contact Information for respondent:
Field
Name of the Person Responsible for the
Submission
Signature
Date

Response
Text
Text
MMDDYYYY

Paperwork Reduction Act Disclosure Statement:
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information
unless it displays a valid OMB control number. The valid OMB control number for this information collection is 09381452 (Expires XX/XX/XXXX). This information collection is both a mandatory and voluntary information collection
and this information will be used to implement Sections 11001 and 11002 of the Inflation Reduction Act. The time
required to complete this information collection is estimated to average 3 hours for individuals and 30 hours for
organizations per response for the general public and 1,000 total hours per response for the manufacturers of selected
drugs for negotiation and 750 hours for manufacturers of selected drugs for renegotiation, including the time to review
instructions, search existing data resources, gather the data needed, and complete and review the information
collection. This information collection is both mandatory and voluntary (sections 1193(a)(4) and 1194(e)(1) and (2) of

91

the Social Security Act) and will be carried out consistent with the confidentiality requirements specified at section
1193(c) of the Social Security Act and section 40.2.1 of the Medicare Drug Price Negotiation Program: Final
Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2028
and Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026, 2027, and 2028.42 CFR 429.300. If you
have comments concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to:
CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop C4- 26-05, Baltimore, Maryland
21244-1850.

****CMS Disclosure**** Please do not send applications, claims, payments, medical records
or any documents containing sensitive information to the PRA Reports Clearance Office.
Please note that any correspondence not pertaining to the information collection burden
approved under the associated OMB control number listed on this form will not be reviewed,
forwarded, or retained. If you have questions or concerns regarding where to submit your
documents, please contact Elisabeth Daniel ([email protected]).

92

PART 2PART 2: TEMPORARY FLOOR FOR SMALL BIOTECH DRUGS ICR
FORM
In accordance with section 1194(d) of the Act and 42 CFR 429.440, in the case of a selected drug
that is a qualifying single source drug described in section 1192(d)(2) of the Act and, with respect
to a drug selected for negotiation, is a drug selected for negotiation for initial price applicability
year 2029 or 2030, or, with respect to a drug selected for renegotiation, is a drug selected for
renegotiation for initial price applicability year 2029 or 2030, for which the Primary Manufacturer
submits information in accordance with 42 CFR 429.440(b)(1), and CMS determines that such
drug meets the requirements of 42 CFR 429.440(b)(2), CMS will not offer or accept an MFP that is
below the temporary floor for small biotech drugs (the “Temporary Floor for Small Biotech
Drugs”). The Temporary Floor for Small Biotech Drugs will be established at 66 percent of the
average non-FAMP price for such drug for 2021, increased by the percentage increase in the
Consumer Price Index for All Urban Consumers (CPI-U)55 from September 2021 to September of
the year prior to the selected drug publication date with respect to the initial price applicability
year. If a selected drug does not have an average non-FAMP for 2021, the average non-FAMP for
the first full year following the market entry for the selected drug will be used, increased by the
percentage increase in the CPI-U from December of the first full year following the market entry to
September of the year prior to the selected drug publication date.
CMS needs to collect information to accurately identify, at the request of the Primary
Manufacturer, whether a given drug selected for negotiation or renegotiation, as applicable, is
eligible for the Temporary Floor for Small Biotech Drugs.
For initial price applicability year 2029 and 2030, section 1194(d) of the Act requires CMS to
evaluate whether a selected drug meets the criteria in section 1192(d) of the Act to qualify as a
“small biotech” drug and be eligible for the Temporary Floor for Small Biotech Drugs. CMS will
make separate determinations with respect to the Part D criteria pursuant to section
1192(d)(2)(A)(i) of the Act (the “Part D Track”) and the Part B criteria pursuant to section
1192(d)(2)(A)(ii) of the Act (the “Part B Track”). For initial price applicability year 2029 and
2030, a selected drug that meets either the Part D or Part B criteria will qualify as a small biotech
drug and be eligible for the Temporary Floor for Small Biotech Drugs.
For purposes of determining if the selected drug is a “small biotech” drug for purposes of
determining if the selected drug is eligible for the Temporary Floor for Small Biotech Drugs, in
accordance with 42 CFR 429.440, CMS needs to collect information to accurately identify the
“Part D 2021 Manufacturer” and/or the “Part B 2021 Manufacturer”, as applicable, as defined in
42 CFR 429.440(a). The Part D 2021 Manufacturer is the entity that either had a Medicare
Coverage Gap Discount Program (CGDP) Agreement under section 1860D-14A of the Act in
effect for the qualifying single source drug on December 31, 2021 or had an arrangement whereby
55

The “CPI-U” means the Consumer Price Index for All Urban Consumers (United States city average) as published
by the Bureau of Labor Statistics (https://www.bls.gov/cpi/data.htm).

93

the manufacturer’s labeler codes were listed on another manufacturer’s Medicare CGDP
Agreement, consistent with section 1860D-14A of the Act, in effect on December 31, 2021. The
Part B 2021 Manufacturer is the NDA holder or the BLA holder for the qualifying single source
drug on December 31, 2021. In addition, the aggregation rule at section 1192(d)(2)(B)(i) of the Act
requires that CMS treat as a single manufacturer all corporations or partnerships, sole
proprietorships, and other entities that, on December 31, 2021, were treated as a single employer
(i.e., part of the same controlled group) under subsection (a) or (b) of section 52 of the Internal
Revenue Code of 1986 (IRC) with the Part D 2021 Manufacturer or Part B 2021 Manufacturer.
The Part D 2021 Manufacturer and its controlled group, as defined in 42 CFR 429.440(a),
comprises all persons that, as of December 31, 2021, were treated as a single employer under
subsection (a) or (b) of section 52 of the Internal Revenue Code of 1986 with the Part D 2021
Manufacturer. CMS also collects information regarding the unique identifier assigned by CMS (P
Number) and labeler code(s) for these entities. The Part B 2021 Manufacturer and its controlled
group, as defined in 42 CFR 429.440(a) comprises all persons that, as of December 31, 2021, were
treated as a single employer under subsection (a) or (b) of section 52 of the Internal Revenue Code
of 1986 with the Part B 2021 Manufacturer. CMS also collects information regarding the NDA(s)
and/or BLA(s) for qualifying single source drugs held by the Part B 2021 Manufacturer and the
Part B 2021 Manufacturer’s controlled group on December 31, 2021. Additionally, the limitation
at section 1192(d)(2)(B)(ii) of the Act states that a qualifying single source drug does not meet the
requirements of section 1192(d) if the manufacturer of such drug is acquired after 2021 by another
entity that does not meet the definition of a specified manufacturer under section 1860D14C(g)(4)(C)(ii) of the Act,56 and therefore such drug would not be eligible for the Temporary
Floor for Small Biotech Drugs under section 1194(d) of the Act.
A determination by CMS that a given selected drug qualifies as a small biotech drug and is
therefore eligible for the Temporary Floor for Small Biotech Drugs for an initial price applicability
year is not based on whether or not CMS previously determined that a selected drug was eligible
for the Small Biotech Exception in initial price applicability years 2026, 2027, and/or 2028.
Instructions:
• A Primary Manufacturer must complete and submit the information requested on this form in
order for the drug to be considered to be a small biotech drug and eligible for the Temporary
Floor for Small Biotech Drugs for initial price applicability year 2029 or 2030. For a selected
drug covered under Part D to be considered under the Part D Track, a Primary Manufacturer
should complete Section A, Section B, and Section D; for a selected drug payable under Part B
to be considered under the Part B Track, a Primary Manufacturer should complete Section A,
Section C, and Section D; to be considered under both the Part D Track and Part B Track, a
Primary Manufacturer should complete Section A, Section B, Section C, and Section D.
• If the Primary Manufacturer holding the NDA(s) / BLA(s) for the drug was acquired by
another entity after December 31, 2021, the Primary Manufacturer must provide information

56

See 42 CFR 423.2716, 423.2720, and 423.2724.

94

•

•

•

regarding that acquiring entity for CMS to assess whether the acquisition triggers the limitation
at section 1192(d)(2)(B)(ii) of the Act.
Primary Manufacturers may submit a request for the Temporary Floor for Small Biotech Drugs
for an initial price applicability year via the CMS Health Plan Management System (the “CMS
HPMS”).
A request for the Temporary Floor for Small Biotech Drugs that is incomplete or not timely
submitted via the CMS HPMS in accordance with these instructions and applicable regulations
will not be accepted.
All submissions require certification. The certification of the ICR should be executed by an
Authorized Representative of the Primary Manufacturer as defined in 42 CFR 429.20.To
complete this form, the Primary Manufacturer must provide the following:
o Disclosure of whether the Primary Manufacturer was acquired by another entity after
2021, and if so, identifying information about the acquiring entity as of the date of
submission, including the acquiring entity’s name, EIN(s), and mailing address, as well as
any P number(s) of the acquiring entity;
o Under the Part D track:
▪ Identifying information as of December 31, 2021 for the entity that had a Medicare
CGDP Agreement for the selected drug covered under Part D in effect on December
31, 2021, and for all members of that entity’s controlled group as of December 31,
2021 that had a Medicare CGDP Agreement in effect on December 31, 2021; and/or
o Under the Part B track:
Identifying information as of December 31, 2021 for the entity that held the NDA(s)
/ BLA(s) for the selected drug payable under Part B as of December 31, 2021, and
all NDA(s) and/or BLA(s) held by that entity and its controlled group as of
December 31, 2021.

A. Primary Manufacturer Information
Section A contains one question regarding the acquisition of the Primary Manufacturer.
Question 1: Acquisition of the Primary Manufacturer
Question 1a: Was the Primary Manufacturer acquired after December 31, 2021? Note: This
question is about the acquisition of the Primary Manufacturer and is not about the acquisition of
the selected drug.
Yes / No
Note: If the answer to question 1a is ‘Yes,’ answer Question 1b. If the answer to Question 1a is
‘No,’ skip Question 1b and proceed to Section B (if applying for the Part D Track) or Section C (if
applying for the Part B Track).
95

Instructions for Question 1b: If you answered “Yes” to Question 1a above, please provide the
following information about the entity that acquired the Primary Manufacturer.
Field
Response
Entity Name
Text
Employer Identification Number(s) (EIN(s)) nn-nnnnnnn
Mailing Address
Text
Unique Identifier Assigned by CMS (P
Pnnnn
number), if any
B. Part D Track: Information for Selected Drugs Covered Under Part D
If requesting the Temporary Floor for Small Biotech Drugs for a selected drug covered under Part
D, please complete Section B of this ICR in its entirety. Otherwise, please skip to the Part B
Track in Section C.
Section B contains two questions for the Part D Track for a selected drug that is covered under Part
D. One question asks about the entity that had a Coverage Gap Discount Program Agreement in
effect for the selected drug as of December 31, 2021 (“Part D 2021 Manufacturer”). The other
question collects information about the members of that entity’s controlled group (if any) as of
December 31, 2021 that had a Coverage Gap Discount Program Agreement in effect on December
31, 2021.
Question 2: Part D 2021 Manufacturer Coverage Gap Discount Program Agreement
Information
Question 2a: On December 31, 2021, did the Primary Manufacturer have a Coverage Gap Discount
Program Agreement in effect for the selected drug?57
Yes / No
Note: If the answer to Question 2a is ‘No,’ answer Question 2b and skip Question 2c. If the answer
to Question 2a is ‘Yes,’ skip Question 2b and answer Question 2c.
Question 2b: Please provide the following information as of December 31, 2021 about the entity
that had a Coverage Gap Discount Program Agreement in effect on December 31, 2021, for the
selected drug.
Field
Entity Name

Response
Text

57

A manufacturer that participated in the Coverage Gap Discount Program (CGDP) in 2021 by means of an
arrangement whereby its labeler codes were listed on another manufacturer’s CGDP Agreement would be considered
to have had an agreement in effect during 2021.

96

Employer Identification Number(s) (EIN(s))
Mailing Address
Unique Identifier Assigned by CMS (P number), if any
Labeler Code(s) owned by this entity that are associated with this
entity’s unique identifier (P number), if any
Labeler Code(s) owned by this entity that are associated with
unique identifier(s) (P number(s)) owned by other entities, if any

nn-nnnnnnn
Text
Pnnnn
nnnnn
nnnnn

Instructions for Question 2c: Please provide the following information as of December 31, 2021
about the Primary Manufacturer.
Field
Entity Name
Employer Identification Number(s) (EIN(s))
Mailing Address
Unique Identifier Assigned by CMS (P number), if any
Labeler Code(s) owned by this entity that are associated with this
entity’s unique identifier (P number), if any
Labeler Code(s) owned by this entity that are associated with
unique identifier(s) (P number(s)) owned by other entities, if any

Response
Text
nn-nnnnnnn
Text
Pnnnn
nnnnn
nnnnn

Question 3: Part D 2021 Manufacturer Controlled Group Information
Question 3a: Did the entity that had a Coverage Gap Discount Program Agreement in effect on
December 31, 2021 for the selected drug (i.e., either the Primary Manufacturer or the entity
identified in Question 2b, as applicable) have other members in its controlled group as of
December 31, 2021 that had a Medicare Coverage Gap Discount Program Agreement in effect on
December 31, 2021? For the purposes of this information collection request, “controlled group”
means all corporations or partnerships, sole proprietorships, and other entities treated as a single
employer under subsection (a) or (b) of section 52 of the Internal Revenue Code of 1986.
Yes / No
Note: If the answer to Question 3a is ‘Yes,’ answer Question 3b. If the answer to Question 3a is
‘No,’ skip Question 3b and proceed to Section C (if applying for the Part B Track) or certification
to complete the Part D Track.
Question 3b: If yes, provide the following information as of December 31, 2021, for each such
member of the controlled group of the entity that had the Coverage Gap Discount Program
Agreement in effect on December 31, 2021, for the selected drug.
Field

Response
97

Entity Name
Text
Employer Identification Number(s) (EIN(s))
nn-nnnnnnn
Mailing Address
Text
Unique Identifier Assigned by CMS (P number), if any
Pnnnn
Labeler Code(s) owned by this entity that are associated with this nnnnn
entity’s unique identifier (P number), if any
Labeler Code(s) owned by this entity that are associated with
nnnnn
unique identifier(s) (P number(s)) owned by other entities, if any
Add a separate entry with the six data elements for each member of the entity’s controlled group
that had a Coverage Gap Discount Program Agreement in effect on December 31, 2021.
C. Part B Track: Information for Selected Drugs Payable Under Part B
If requesting the Temporary Floor for Small Biotech Drugs for a selected drug payable under Part
B, please complete Section C of this ICR in its entirety. Otherwise, please skip to Section D.
Section C contains two questions that pertain to information required to make a determination
under the Part B Track for a selected drug that is payable under Part B. Section C contains one
question about the entity that held the NDA(s) or BLA(s) for the selected drug as of December 31,
2021 (“Part B 2021 Manufacturer”). CMS will populate information regarding the NDA(s) or
BLA(s) that comprise the selected drug as of the selected drug publication date. The other question
collects information about the members of that entity’s controlled group (if any) as of December
31, 2021.
Question 4: 2021 NDA/BLA Holder Information
Question 4a: On December 31, 2021, did the Primary Manufacturer hold the NDA(s) / BLA(s) for
the selected drug?
Yes / No
Note: If the answer to Question 4a is ‘Yes,’ skip to Question 4di and Question 4dii. If the answer to
Question 4a is ‘No,’ answer Question 4b and Question 4c, and skip Questions 4di and 4dii.
Question 4b: Please provide the following information as of December 31, 2021 about the entity
that held the NDA(s) or BLA(s) on December 31, 2021, for the selected drug.
Field
Entity Name
Employer Identification Number(s) (EIN(s))
Mailing Address
Unique Identifier Assigned by CMS (P number), if any

Response
Text
nn-nnnnnnn
Text
Pnnnn
98

Question 4c: Please list the NDA(s) and/or BLA(s) that were held as of December 31, 2021 by the
entity that held the NDA(s) or BLA(s) on December 31, 2021 for the selected drug (i.e., the entity
identified in Question 4b). This list should include the NDA(s) and/or BLA(s) for the selected
drug, as well as all NDA(s) and/or BLA(s) for drugs and biological products other than the selected
drug.
Application Number Application Type
Approval Date
(123456)
(NDA; BLA)
Nnnnnn
Select NDA or BLA
MM/DD/YYYY
Add a separate row for each additional NDA / BLA.

NDA/BLA Holder
Text

Question 4di: Please review the list of NDA(s) and/or BLA(s) of the selected drug that are held by
the Primary Manufacturer as of the selected drug publication date. Use the check box to indicate
whether the NDA or BLA was held by the Primary Manufacturer on December 31, 2021. Add a
separate row for any additional NDA(s) and/or BLA(s) of the selected drug held by the Primary
Manufacturer on December 31, 2021 that were not prepopulated by CMS.
Application
Number
(123456)

Application
Type (NDA;
BLA)

Approval Date

NDA/BLA
Holder

Nnnnnn

Select NDA or
BLA

MM/DD/YYYY

Text

Check Box
if
NDA/BLA
was held on
December
31, 2021
[ ]

Add a separate row for each additional NDA / BLA that is not pre-populated by CMS.

Question 4dii: Please list all NDA(s) and/or BLA(s) for drugs and biological products other than
the selected drug held by the Primary Manufacturer as of December 31, 2021.
Application Number Application Type
Approval Date
(123456)
(NDA; BLA)
Nnnnnn
Select NDA or BLA
MM/DD/YYYY
Add a separate row for each additional NDA / BLA.

NDA/BLA Holder
Text

Question 5: Part B 2021 Manufacturer Controlled Group Information
Question 5a: Did the entity that held the NDA(s) or BLA(s) on December 31, 2021 for the selected
drug (i.e., either the Primary Manufacturer or the entity identified in Question 4b, as applicable)
have other members in its controlled group as of December 31, 2021? For this information
collection request, “controlled group” means all corporations or partnerships, sole proprietorships,
99

and other entities treated as a single employer under subsection (a) or (b) of section 52 of the
Internal Revenue Code of 1986.
Yes / No
Note: If the answer to Question 5a is ‘Yes,’ answer Question 5b. If the answer to Question 5a is
‘No,’ skip to certification.
Question 5b: If yes, provide the following information as of December 31, 2021, for each such
member of the controlled group of the entity.
Field
Response
Entity Name
Text
Employer Identification Number(s) (EIN(s))
nn-nnnnnnn
Mailing Address
Text
NDA(s) and/or BLA(s) the entity held as of December 31, 2021
nnnnn
Add an additional row for each NDA and BLA the entity held as of December 31, 2021.
Add a separate entry with the four data elements for each member of the entity’s controlled group.
D. Certification
I hereby certify, to the best of my knowledge, that the information being sent to CMS in this
submission is complete and accurate, and the submission was prepared in good faith and after
reasonable efforts. I reviewed the submission and made a reasonable inquiry regarding its content.
I understand the information contained in this submission is being provided to and will be relied
upon by CMS for Medicare reimbursement purposes, including to determine whether the selected
drug of the Primary Manufacturer qualifies for the Temporary Floor for Small Biotech Drugs, as
described in 42 CFR 429.440. I also certify that I will timely notify CMS if I become aware that
any of the information submitted in this form has changed or is otherwise inaccurate. I also
understand that any misrepresentations may also give rise to liability, including under the False
Claims Act and/or in the form of civil monetary penalties pursuant to section 1197(d) of the Act.
Check box for certification: [ ]

Contact Information
Field
Name of the Person Responsible for the
Submission
Signature
Date

Response
(information is prepopulated by CMS based on
the CMS HPMS user information)
Text
Date
100

Paperwork Reduction Act Disclosure Statement:
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information
unless it displays a valid OMB control number. The valid OMB control number for this information collection is 09381452 (Expires XX/XX/XXXX). This is a required information collection to retain or obtain a benefit. Specifically, a
manufacturer must submit the ICR in order for its selected drug to be considered for the Temporary Floor for Small
Biotech Drugs. The time required to complete this information collection is estimated to average 9.75 hours per
response for Primary Manufacturer to review instructions, search existing data resources, gather the data needed, and
complete and review the information collection. If you have comments concerning the accuracy of the time estimate(s)
or suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports
Clearance Officer, Mail Stop C4-26-05, Baltimore, Maryland 21244-1850.

****CMS Disclosure**** Please do not send applications, claims, payments, medical records
or any documents containing sensitive information to the PRA Reports Clearance Office.
Please note that any correspondence not pertaining to the information collection burden
approved under the associated OMB control number listed on this form will not be reviewed,
forwarded, or retained. If you have questions or concerns regarding where to submit your
documents, please contact Elisabeth Daniel ([email protected]).

101

PART 3: DRUG PRICE NEGOTIATION AND RENEGOTIATION PROCESS
COUNTEROFFER ICR FORM
Section 1193(a)(1) of the Social Security Act (“the Act”) establishes that CMS will negotiate an
MFP with “the manufacturer” of the selected drug. In section 1191(c)(1) of the Act, the
Negotiation Program statute adopts the definition of manufacturer established in section
1847A(c)(6)(A) of the Act. In accordance with section 40 of the final guidance42 CFR 429.20, to
the extent that more than one entity meets the statutory definition of manufacturer for a selected
drug for purposes of an initial price applicability year 2028, CMS will designate the entity that
holds the New Drug Application(s) (NDA(s))/)) / Biologics License Application(s) (BLA(s)) for
the selected drug to be “the manufacturer” of the selected drug (hereinafter “Primary
Manufacturer”).
In accordance with section 1191(b)(4) of the Act, for a drug selected for negotiation and with
respect to that specific selected drug, the negotiation period begins on the earlier of the date that
the Primary Manufacturer enters into a Medicare Drug Price Negotiation Program Agreement
(herein referred to as an “Agreement”),, or, February 28th of the calendar year of the selected drug
publication date for the initial price applicability year 2028,that the drug is selected for negotiation.
For a drug selected for renegotiation and with respect to that specific selected drug, the
renegotiation period for the initial price applicability year begins February 28, 2026 of the calendar
year of the selected drug publication date for such initial price applicability year. CMS intends to
implement the offer and counteroffer process consistent with the statutory goal of negotiating to
achieve agreement on “the lowest [MFP] for each selected drug,” established in section 1194(b)(1)
of the Act. In accordance with sections 1194(b)(2)(B) and 1194(f)(4)(B) of the Act and sections
60.442 CFR 429.520(a) and 130.4.3 of the final guidance,429.620(f), CMS will make a written
initial offer to the Primary Manufacturer with the proposal for the MFP for a drug selected drug or
the proposal for the renegotiated MFPnegotiation or renegotiation for a selected drug for an initial
price applicability year 2028 no later than June 1, 2026. of the calendar year of the selected drug
publication date for the initial price applicability year that the drug is selected for negotiation or
renegotiation. In accordance with sections 1194(b)(2)(C) and 1194(f)(4)(B) of the Act and sections
60.442 CFR 429.525(a) and 130.4.3 of the final guidance,429.620(g), the Primary Manufacturer
will respond to CMS’ written initial offer no later than 30 days after the date of receipt of the
written initial offer from CMS. If the Primary Manufacturer does not accept CMS’ written initial
offer, the Primary Manufacturer will submit a written counteroffer (referred to herein as the
“statutory written counteroffer” for the negotiation process and the “renegotiation written
counteroffer” for the renegotiation process, collectively referred to herein as the “Counteroffer),”),
including an Addendum to the Negotiation Program Agreement populated with the proposal for the
MFP. for the drug selected for negotiation or renegotiation. In accordance with sections
1194(b)(2)(D) and 1194(f)(4)(B) of the Act and sections 60.442 CFR 429.525(c) and 130.4.3 of the
final guidance,429.620(g), CMS will provide a written response to the statutory written
counteroffer and the renegotiation written counteroffer, respectively. CMS will provide this
response within 30 days of receipt or within 60 days of sharing the written initial offer, whichever
is later. If CMS rejects the Primary Manufacturer’s Counteroffer, CMS and Primary Manufacturers
can choose to initiate additional, written offers and counteroffers via the additional price exchange
102

module in the CMS HPMS. Sections 60.442 CFR 429.530, 429.535, 429.620(h), and 130.4.3 of the
final guidance429.620(i) describes the remainder of the negotiation process and renegotiation
process in greater detail, respectively.
Every written offer and counteroffer, including a Counteroffer, will include an Addendum to the
Negotiation Program Agreement populated with the proposal for the MFP. If an agreement on the
MFP is reached at any point during the negotiation process described at 42 CFR subpart F or the
renegotiation process in accordance with sections 60.4 and 130.4 of the final guidance,
respectivelydescribed at 42 CFR subpart G, the Addendum to the Negotiation Program Agreement,
as described in section 40.3 of the final guidance,set forth in 42 CFR 429.200(e), will be executed
by both parties and will constitute agreement on the MFP. The MFP included in the executed
Addendum to the Negotiation Program Agreement will apply for the selected drug for an initial
price applicability year 2028, subject to the conditions and timing described in section 70 of the
final guidance42 CFR 429.130 and 429.135 and will be updated according to section
1195(b)(1)(A) of the Act for subsequent years in the price applicability period, as applicable. Refer
to section 60.6 of the final guidance42 CFR 429.705 and 429.620(k) for information on how the
MFP will be updated for subsequent years in the price applicability period.
This document describes the ICR that may occur during the negotiation and renegotiation process
if the Primary Manufacturer chooses to develop and submit a Counteroffer to CMS’ written initial
offer during the negotiation or renegotiation process for an initial price applicability year 2028.
The estimated burden of the ICR for a Counteroffer submission from a Primary Manufacturer of a
selected drug and review of the Counteroffer submission by CMS staff is provided in the
accompanying Supporting Statement. More information on the negotiation process can be found in
42 CFR subpart F and more information on the renegotiation process can be found in the final
guidance42 CFR subpart G.
Note: This ICR focuses on information required for the submission of Counteroffers during the
negotiation and renegotiation process for initial price applicability year 202820XX.
Instructions for Completing the Counteroffer ICR Form
A Primary Manufacturer that seeks to submit a Counteroffer for its selected drug must complete
and submit the information requested in the Statutory Written Counteroffer ICR Form or the
Renegotiation Written Counteroffer ICR Form, as applicable, in the CMS Health Plan
Management System ((“the CMS HPMS)”) in order for CMS to consider the Primary
Manufacturer’s Counteroffer.
To complete the Counteroffer ICR Form, the Primary Manufacturer must provide the following:
•

The Primary Manufacturer’s Counteroffer proposal for the MFP per 30-day equivalent
supply of the selected drug (as described in section 60.1 of the final guidance);42 CFR
429.525(b));
103

•

•

Subject to the 30,000 character count limit, which is approximately 2,500 words, a
justification of the Counteroffer based on the factors listed in section 1194(e) of the Act.
The Primary Manufacturer’s Counteroffer justification should focus on the elements
described in section 1194(e) of the Act and indicate the reasons the Primary Manufacturer
believes that the information submitted by the Primary Manufacturer under section
1194(e)(1) or (e)(2) of the Act, or other available data related to the selected drug and its
therapeutic alternatives as described in section 1194(e)(2) of the Act, does not support the
written initial offer made by CMS and better supports the Primary Manufacturer’s
Counteroffer. TheseThe data related to the section 1194(e) datafactors may be information
already submitted to CMS by the Primary Manufacturer or other interested parties,
information submitted as part of the Counteroffer, or information that is otherwise available
and considered by CMS. A Primary Manufacturer may include in their Counteroffer
justification new information regarding the selected drug and its therapeutic alternative(s)
as described in section 1194(e)(2) of the Act that supports the Counteroffer proposal for the
MFP and additional information it deems relevant, such as a request to include certain
information from the Counteroffer justification in CMS’ public explanation of the MFP,
and;
A certification by: (1) the chief executive officer (CEO), (2) the chief financial officer
(CFO), (3) an individual other than a CEO or CFO, who has authority equivalent to a CEO
or a CFO, or (4) an individual with the directly delegated authority to perform the
certification on behalf of one of the individuals mentioned in (1) through (3).A certification
by an Authorized Representative of the Primary Manufacturer as defined in 42 CFR
429.20.

Additional instructions for submitting the Counteroffer ICR Form are as follows:
•

•

•

If the Primary Manufacturer chooses to submit the Counteroffer ICR Form, this form must
be completed and submitted within the CMS HPMS within 30 days of receiving the written
initial offer from CMS.
Question 1 asks the Primary Manufacturer to enter its Counteroffer proposal for the MFP
for a 30-day equivalent supply of the selected drug. CMS will interpret this proposal as a
single price per 30-day equivalent supply (rather than per unit – such as tablet, capsule,
injection – or per volume or weight-based metric), and weighted across dosage forms and
strengths, if applicable. The Primary Manufacturer may reference information provided by
CMS during the negotiation or renegotiation process regarding the application of a single
MFP across dosage forms and strengths of the selected drug to understand how the 30-day
equivalent supply Counteroffer proposal for the MFP will convert into prices for each
dosage form and strength of the selected drug.
The Primary Manufacturer should answer Question 2 in narrative (text) form. Responses
will be limited to the 30,000 character count limit, which is approximately 2,500 words, 10
visual representations of data, and a maximum of 50 citations. All response fields are
limited to a character count. Response fields provide a maximum character count and
104

•

•

•

•

•

corresponding estimated word count. Total character counts include all characters within
the response, including spaces between words.
Submissions may include but are not limited to published or unpublished material such as
peer-reviewed articles, whitepapers, case studies, and government reports.
o CMS prefers publicly available, peer reviewed literature rather than poster abstracts
and non-peer reviewed literature. When providing non-peer reviewed literature,
CMS must be provided sufficient information on these studies in order to assess
their applicability to the Negotiation Program. Information should, at a minimum,
include methods, data sources, and limitations for unpublished evidence.
o Please note that CMS reserves the right to review submitted materials for relevance
and in accordance with the standards outlined in section 50.2 of the final
guidance.42 CFR 429.505(e).
o The Primary Manufacturer should provide citations to published material rather than
copies of articles. The Primary Manufacturer is responsible for ensuring that its
submission complies with applicable law, including but not limited to copyright
law. If data are unpublished, clearly indicate this in the citation. For unpublished
data without a citation, the Primary Manufacturer should summarize key findings as
appropriate in your response and upload any relevant visual representations as
additional materials as described below.
The Primary Manufacturer should provide citations in the National Library of Medicine
(NLM) style format appropriate for the source of information (e.g., a journal article).
Information on how to format citations is available for free through the NLM at:
https://www.ncbi.nlm.nih.gov/books/NBK7256/.
When information in Question 2 is supported by a citation, the Primary Manufacturer
should label the end of the sentence in the free text response with a number (e.g., [1], [2])
that corresponds to the number assigned to the provided citations.and submit the citations in
the same order in response to Question 3. In response to Question 3, respondents are
requested to provide the list of all citations. Additional instructions are included with
Question 3 to link and format citations.
CMS will review submitted studies that use cost-effectiveness measures or methods to
determine if the study is relevant to the selected drug and/or its therapeutic alternative(s)
and to determine if the cost-effectiveness measure used does not value extending the life of
an individual who is elderly, disabled, or terminally ill as of lower value than an individual
who is younger, nondisabled, or not terminally ill.
As described in 42 CFR 429.505(e), CMS will not use comparative clinical effectiveness
research in a manner that treats extending the life of an elderly, disabled, or terminally ill
individual as of lower value than extending the life of an individual who is younger,
nondisabled, or not terminally ill. Information submitted that treats extending the life of
individuals in the listed populations as of lower value will not be used in the Negotiation
Program. Moreover, in accordance with section 1182(e) of Title XI of the Social Security
Act and other applicable law, including section 504 of the Rehabilitation Act, CMS will not
use QALYs. In instances where a study includes a measure that treats extending the life of
105

•

•

•

individuals who are elderly, disabled, or terminally ill as of lower value but separates such
a measure from other evidence in the report (e.g., clinical effectiveness, risks, harms, etc.)
that is relevant to the factors listed in section 1194(e)(2) of the Act, CMS may consider
such separate evidence.
In addition to the Counteroffer justification, the Primary Manufacturer may upload up to 10
visual representations of information, including charts, tables, and/or graphs, as part of the
ICR to support the justification. The information submitted in the space for visual
representations in Question 4 should only include the table, chart, or graph, with no
additional text. CMS will not review any additional text included beyond the titles, labels,
legends, and footnotes in the visual representation. If the Primary Manufacturer provides
additional text, such as extensive narrative descriptions embedded within a visual
representation, CMS will not review such additional text. PDF files will be accepted within
specified file size limits for visual representations. PDF files must be uploaded together in a
Zip file. The free text response should include clear numbers/references to the charts,
tables, or graphs submitted. When information in Question 2 is supported by a chart, table,
or graph, the Primary Manufacturer should label the end of the sentence in the free text
response with a letter (e.g., [A], [B]) that corresponds to the letter assigned to the provided
document.
CMS will only review submitted visual representations that use cost-effectiveness
measures or methods to determine if the data are relevant tomaximum number of citations
or upload files permitted in the selected drug and/or its therapeutic alternative(s) and to
ensure any cost-effectiveness measure used does not value extending the life of an
individual who is elderly, disabled, or terminally ill as of lower value than extending the
life of an individual who is younger, nondisabled, or not terminally ill.instructions.
If a Primary Manufacturer is the holder of the NDA(s)/) / BLA(s) for multiple selected
drugs for an initial price applicability year, a separate form must be submitted for each
selected drug for which the Primary Manufacturer chooses to submit a Counteroffer.

106

Appendix: Counteroffer ICR Form
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Statutory Written Counteroffer
ICR Form
Under the authority in sections 11001 and 11002 of the Inflation Reduction Act of 2022 (P.L. 117169), the Centers for Medicare & Medicaid Services (CMS) is implementing the Medicare Drug Price
Negotiation Program, codified in sections 1191 through 1198 of the Social Security Act (the Act), for
initial price applicability year 2028.). In accordance with section 1194(b)(2)(B) of the Act, CMS has
provided the Primary Manufacturer of the selected drug named above with a written initial offer that
contains CMS’ proposal for the selected drug’s maximum fair price (MFP), as defined in section
1191(c)(3),) of the Act, and a concise justification based on the factors described in section 1194(e).) of
the Act. Submission of this form indicates that the Primary Manufacturer has not accepted CMS’
written initial offer and is submitting a statutory written counteroffer in accordance with section
1194(b)(2)(C) of the Act and 42 CFR 429.525(a).
In order for CMS to consider the Primary Manufacturer’s statutory written counteroffer, this form must
be certified by (1) the chief executive officer (CEO) of the Primary Manufacturer, (2) the chief
financial officer (CFO) of the Primary Manufacturer, (3) an individual other than a CEO or CFO of the
Primary Manufacturer, who has authority equivalent to a CEO or a CFO, or (4) an individual with the
directly delegated authority to perform the certification on behalf of one of the individuals mentioned
in (1) through (3). an Authorized Representative of the Primary Manufacturer as defined in 42 CFR
429.20.
Question 1: Proposal for the MFP per 30-day equivalent supply
Please provide the Primary Manufacturer's statutory written counteroffer proposal for the MFP for the
selected drug in the table below. CMS will interpret this proposal as a single price per 30-day
equivalent supply (rather than per unit – such as tablet, capsule, injection – or per volume or weightbased metric), and weighted across all dosage forms and strengths of the selected drug, if applicable.
The Primary Manufacturer may use information previously shared by CMS on the application of a
single MFP across dosage forms and strengths of the selected drug to understand how this statutory
written counteroffer proposal for the MFP price will apply to the dosage forms and strengths as
identified on the list of National Drug Codes (NDCs) of the selected drug maintained by CMS.
Proposal for the MFP per 30-day equivalent supply
$

107

Question 2: Statutory Written Counteroffer Justification
Please provide a justification of the statutory written counteroffer proposal for the MFP based on the
factors listed in section 1194(e) of the Act. This statutory written counteroffer justification should also
respond to the justification provided in CMS’ written initial offer and provide the reasons the Primary
Manufacturer believes that the information submitted by the Primary Manufacturer on the factors listed
in section 1194(e)(1) or (e)(2) of the Act, or other available data related to the selected drug and its
therapeutic alternatives as described in section 1194(e)(2) of the Act, does not support the written
initial offer made by CMS and better supports the Primary Manufacturer’s statutory written
counteroffer.
FIELD
RESPONSE FORMAT
Statutory Written Counteroffer Justification
Text (30,000 character count limit, which is
approximately 2,500 words)
FIELD
RESPONSE FORMAT
Statutory Written Counteroffer Justification
Text (30,000 character count limit, which is
approximately 2,500 words)
Additional Materials to Support the Justification
Text (Up to 50 citations)
[file upload] (Up to 10 tables/charts/graphs)
Question 3: Citations to Support the Justification
Provide up to 50 citations that support the justification provided in response to Question 2. Citations
should be labeled with a number corresponding to the number used by the respondent to reference the
source in-text throughout the response to Question 2. Citations should be listed in the order the citation
is first used within the response to Question 2. For example, the citation #1 included on the citation list,
can be referenced in-text as such [1].
Provide each citation in the National Library of Medicine (NLM) style format appropriate for the
source of information (e.g., a journal article). Information on how to format citations is available for
free through the NLM at: https://www.ncbi.nlm.nih.gov/books/NBK7256/. When available, please
include a Pub Med ID (https://pubmed.ncbi.nlm.nih.gov/) or, if the Pub Med ID is not available,
include the Digital Object Identifier (DOI) (https://www.doi.org/). Additionally, please provide a
hyperlink to the source, if possible.
Respondents must upload a single PDF document of the list of citations in a Zip file. To create the PDF
document, respondents may use an Excel file that includes the information specified in the data fields
below for each citation listed by the respondent.
FIELDS
• Numbered List
• Full Citation
• PubMed ID, if available
• If the PubMed ID is not available, the
Digital Object Identifier (DOI), if available
• Hyperlink, if available

RESPONSE FORMAT
Text (Up to 50 citations within a PDF file in one
Zip file)

An example of how a respondent may format the response fields within an Excel file is also included
below for reference.
108

Numbered Full Citation
List
1

Surname First-and-Middle-Initials,
Surname First-and-Middle Initials.
Article Title. Journal Title. Date of
Publication; Volume (Issue):
Pagination.

PubMed ID, if
available
[if no PubMed,
provide DOI]
123456789

Hyperlink, if available

www.pubmed.com/example

Question 4: Visual Representations to Support the Justification
Provide up to 10 visual representations such as tables, charts, and/or graphs that support the
justification provided in response to Question 2. Regardless of the number of PDF files uploaded in the
single Zip file, respondents may not submit more than 10 total visuals (e.g., tables, charts, and/or
graphs).
FIELD
RESPONSE
Visual Representations to Support the
Text (Up to 10 PDF files in a single Zip file)
Justification
Certification
I hereby certify, to the best of my knowledge, that the information being sent to CMS in this
submission is complete and accurate, and the submission was prepared in good faith and after
reasonable efforts. I reviewed the submission and made a reasonable inquiry regarding its content. I
understand the information contained in this submission is being provided to and will be relied upon
by CMS for Medicare reimbursement purposes, including determination of an MFP, as defined in
section 1191(c)(3) of the Act. I understand further that the proposed price submitted in this Statutory
Written Counteroffer ICR Form, if accepted by CMS, is intended to be the MFP as defined in section
1191(c)(3) of the Act for the selected drug for purposes of section 1193(a)(1) of the Act. I certify that I
will timely notify CMS if I become aware that any of the information submitted in this form has
changed. I also understand that any misrepresentations may give rise to liability, including under the
False Claims Act. and/or in the form of civil monetary penalties pursuant to section 1197(c) of the Act.
Yes [ ] No [ ]
PRA Disclosure Statement
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid
OMB control number. The valid OMB control number for this information collection is 0938-1452 (Expires XX/XX/XXXX). This
information collection includes the form a Primary Manufacturer must submit in order to submit a statutory written counteroffer for a selected
drug, and this information will be used to implement Sections 11001 and 11002 of the Inflation Reduction Act. The time required to complete
this information collection is estimated to average 204.25 hours per response, including the time to review instructions, search existing data
resources, gather the data needed, and to review and complete the information collection. This information collection is required to retain or
obtain a benefit (section 1194(b)(2)(C) of the Social Security Act) and will be carried out consistent with the confidentiality requirements
specified at section 1193(c) of the Social Security Act and section 40.2.1 of the Medicare Drug Price Negotiation Program: Final Guidance,
Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2028 and Manufacturer Effectuation of
the Maximum Fair Price (MFP) in 2026, 2027, and 2028.in 42 C.F.R. 429.300. If you have comments concerning the accuracy of the time
estimate(s) or suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer,
Mail Stop C4-26-05, Baltimore, Maryland 21244-1850

109

Department of Health and Human Services
Centers for Medicare & Medicaid Services
Renegotiation Written
Counteroffer ICR Form
Under the authority in sections 11001 and 11002 of the Inflation Reduction Act of 2022 (P.L. 117169), the Centers for Medicare & Medicaid Services (CMS) is implementing the Medicare Drug Price
Negotiation Program, codified in sections 1191 through 1198 of the Social Security Act (the Act), for
initial price applicability year 2028. In accordance with section 1194(f)(4)(B) of the Act and section
130.4.3 of the final guidance, CMS has provided the Primary Manufacturer of the selected drug named
above with a written initial offer that contains CMS’ proposal for the selected drug’s maximum fair
price (MFP), as defined in section 1191(c)(3), and a concise justification based on the factors described
in section 1194(e). Submission of this form indicates that the Primary Manufacturer has not accepted
CMS’ written initial offer and is submitting a renegotiation written counteroffer.
In order for CMS to consider the Primary Manufacturer’s renegotiation written counteroffer, this form
must be certified by (1) the chief executive officer (CEO) of the Primary Manufacturer, (2) the chief
financial officer (CFO) of the Primary Manufacturer, (3) an individual other than a CEO or CFO of the
Primary Manufacturer, who has authority equivalent to a CEO or a CFO, or (4) an individual with the
directly delegated authority to perform the certification on behalf of one of the individuals mentioned
in (1) through (3).
Question 1: Please provide the Primary Manufacturer's renegotiation written counteroffer proposal for
the MFP for the selected drug in the table below. CMS will interpret this proposal as a single price per
30-day equivalent supply (rather than per unit – such as tablet, capsule, injection – or per volume or
weight metric), and weighted across dosage forms and strengths, if applicable. The Primary
Manufacturer may use information previously shared by CMS on the application of a single MFP
across dosage forms and strengths of the selected drug to understand how this renegotiation written
counteroffer proposal for the MFP price will apply to the dosage forms and strengths as identified on
the list of National Drug Codes (NDCs) of the selected drug maintained by CMS.

110

Department of Health and Human Services
Centers for Medicare & Medicaid Services
Renegotiation Written
Counteroffer ICR Form
Under the authority in sections 11001 and 11002 of the Inflation Reduction Act of 2022 (P.L. 117169), the Centers for Medicare & Medicaid Services (CMS) is implementing the Medicare Drug Price
Negotiation Program, codified in sections 1191 through 1198 of the Social Security Act (the Act). In
accordance with section 1194(f)(4)(B) of the Act and 42 CFR 429.620(f), CMS has provided the
Primary Manufacturer of the selected drug named above with a written initial offer that contains CMS’
proposal for the selected drug’s maximum fair price (MFP), as defined in section 1191(c)(3) of the Act,
and a concise justification based on the factors described in section 1194(e). Submission of this form
indicates that the Primary Manufacturer has not accepted CMS’ written initial offer and is submitting a
renegotiation written counteroffer.
In order for CMS to consider the Primary Manufacturer’s renegotiation written counteroffer, this form
must be certified by an Authorized Representative of the Primary Manufacturer as defined in 42 CFR
429.20.
Question 1: Proposal for the MFP per 30-day equivalent supply
Please provide the Primary Manufacturer's renegotiation written counteroffer proposal for the MFP for
the selected drug in the table below. CMS will interpret this proposal as a single price per 30-day
equivalent supply (rather than per unit – such as tablet, capsule, injection – or per volume or weightbased metric), weighted across all dosage forms and strengths of the selected drug, if applicable. The
Primary Manufacturer may use information previously shared by CMS on the application of a single
MFP across dosage forms and strengths of the selected drug to understand how this renegotiation
written counteroffer proposal for the MFP will apply to the dosage forms and strengths as identified on
the list of National Drug Codes (NDCs) of the selected drug maintained by CMS.
Proposal for the MFP per 30-day equivalent supply
$
Question 2: Renegotiation Written Counteroffer Justification
Please provide a justification of the renegotiation written counteroffer proposal for the MFP based on
the factors listed in section 1194(e) of the Act. This renegotiation written counteroffer justification
should also respond to the justification provided in CMS’ written initial offer and provide the reasons
the Primary Manufacturer believes that the information submitted by the Primary Manufacturer on the
factors listed in section 1194(e)(1) or (e)(2) of the Act, or other available data related to the selected
drug and its therapeutic alternatives as described in section 1194(e)(2) of the Act, does not support the
written initial offer made by CMS and better supports the Primary Manufacturer’s renegotiation written
counteroffer.
FIELD
Renegotiation Written Counteroffer Justification
FIELD

RESPONSE FORMAT
Text (30,000 character count limit, which is
approximately 2,500 words)
RESPONSE FORMAT
111

Renegotiation Written Counteroffer Justification
Additional Materials to Support the Justification

Text (30,000 character count limit, which is
approximately 2,500 words)
Text (Up to 50 citations)
[file upload] (Up to 10 tables/charts/graphs)

Question 3: Additional Materials to Support the Justification
Provide up to 50 citations that support the justification provided in response to Question 2. Citations
should be labeled with a number corresponding to the number used by the respondent to reference the
source in-text throughout the response to Question 2. Citations should be listed in the order the citation
is first used within the response to Question 2. For example, the citation #1 included on the citation list,
can be referenced in-text as such [1].
Provide each citation in the National Library of Medicine (NLM) style format appropriate for the
source of information (e.g., a journal article). Information on how to format citations is available for
free through the NLM at: https://www.ncbi.nlm.nih.gov/books/NBK7256/. When available, please
include a Pub Med ID (https://pubmed.ncbi.nlm.nih.gov/) or, if the Pub Med ID is not available,
include the Digital Object Identifier (DOI) (https://www.doi.org/). Additionally, please provide a
hyperlink to the source, if possible.
Respondents must upload a single PDF document of the list of citations in a Zip file. To create the PDF
document, respondents may use an Excel file that includes the information specified in the data fields
below for each citation listed by the respondent.
FIELDS
• Numbered List
• Full Citation
• PubMed ID, if available
• If the PubMed ID is not available, the
Digital Object Identifier (DOI), if available
• Hyperlink, if available

RESPONSE FORMAT
Text (Up to 50 citations within a PDF file in one
Zip file)

An example of how a respondent may format the response fields within an Excel file is also included
below for reference.
Numbered Full Citation
List
1

Surname First-and-Middle-Initials,
Surname First-and-Middle Initials.
Article Title. Journal Title. Date of
Publication; Volume (Issue):
Pagination.

PubMed ID, if
available
[if no PubMed,
provide DOI]
123456789

Hyperlink, if available

www.pubmed.com/example

Question 4: Visual Representations to Support the Justification
Provide up to 10 visual representations such as tables, charts, and/or graphs that support the
justification provided in response to Question 2. Regardless of the number of PDF files uploaded in the
single Zip file, respondents may not submit more than 10 total visuals (e.g., tables, charts, and/or
112

graphs).
FIELD
Visual Representations to Support the
Justification

RESPONSE
Text (Up to 10 PDF files in a single Zip file)

Certification
I hereby certify, to the best of my knowledge, that the information being sent to CMS in this
submission is complete and accurate, and the submission was prepared in good faith and after
reasonable efforts. I reviewed the submission and made a reasonable inquiry regarding its content. I
understand the information contained in this submission is being provided to and will be relied upon
by CMS for Medicare reimbursement purposes, including determination of an MFP, as defined in
section 1191(c)(3) of the Act. I understand further that the proposed price submitted in this
Renegotiation Written Counteroffer ICR Form, if accepted by CMS, is intended to be the MFP as
defined in section 1191(c)(3) of the Act for the selected drug for purposes of section 1193(a)(12) of
the Act. I certify that I will timely notify CMS if I become aware that any of the information submitted
in this form has changed. I also understand that any misrepresentations may give rise to liability,
including under the False Claims Act. and/or in the form of civil monetary penalties pursuant to
section 1197(c) of the Act.
Yes [ ] No [ ]
PRA Disclosure Statement
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid
OMB control number. The valid OMB control number for this information collection is 0938-1452 (Expires XX/XX/XXXX). This
information collection includes the form a Primary Manufacturer must submit in order to submit a renegotiation written counteroffer for a
selected drug, and this information will be used to implement Sections 11001 and 11002 of the Inflation Reduction Act. The time required to
complete this information collection is estimated to average 204.25 hours per response, including the time to review instructions, search
existing data resources, gather the data needed, and to review and complete the information collection. This information collection is required
to retain or obtain a benefit (section 1194(b)(2)(C) of the Social Security Act) and will be carried out consistent with the confidentiality
requirements specified at section 1193(c) of the Social Security Act and section 40.2.1 of the Medicare Drug Price Negotiation Program:
Final Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2028 and
Manufacturer Effectuation of the Maximum Fair Price (MFP) in 2026, 2027, and 2028.in 42 C.F.R. 429.300. If you have comments
concerning the accuracy of the time estimate(s) or suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn:
PRA Reports Clearance Officer, Mail Stop C4-26-05, Baltimore, Maryland 21244-1850

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