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pdfDrug Price Negotiation for Initial Price Applicability Year 2028
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: DraftFinal 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 DraftFinal Guidance” or
“draftfinal guidance”), for initial price applicability year 2028, CMS will select up to
15 high expenditure, single source drugs payable under Part B and/or covered under
Part D for negotiation. For 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 negotiated for these drugs will
apply beginning in initial price applicability year 2028. The negotiation period for
initial price applicability year 2028 begins February 28, 2026, or when the
manufacturer of a selected drug enters into a Medicare Drug Price Negotiation
Program Agreement with CMS, whichever is sooner.
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This ICR Form includes two parts: Part 1—Negotiation Data Elements ICR Form,
and Part 2—Counteroffer ICR Form.
PART 1: NEGOTIATION DATA ELEMENTS ICR FORM
Section 1194(e) of the Act and sections 50 and 130.4 of the draftfinal guidance
require CMS to consider 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 draftfinal guidance, which includes renegotiation of any
selected drug: (1) certain data that must be submitted by the manufacturer of each
drug selected (as described for negotiation (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
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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sections 50 and 130.3.2 of the draftfinal guidance, 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 draftfinal guidance, 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 on the selected drug list published by
CMS by February 1, 2026 and any selected drugs from initial price applicability
years 2026 or 2027 that are selected for renegotiation pursuant to section 1194(f)(3)
of the Act. 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 an MFP with “the manufacturer” of the
selected drug. In accordance with section 40 of the draftfinal guidance, 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 draftfinal guidance, CMS will refer to
any other entity that meets the statutory definition of manufacturer for a drug product
included on the selected drug list 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 an
agreement with the Primary Manufacturer as a “Secondary Manufacturer 2.”
1F
In accordance with sections 50 and 130.3.2 of the draftfinal guidance, CMS will
collect certain data from the Primary Manufacturer, including information on nonFAMP 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
As specified in section 40 of the draftfinal guidance, 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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section 1194(e)(2) of the Act from any interested party. 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 PSTPT on March 1, 2026.
Note: This ICR focuses on information required and optional for selected drugs for
negotiation and renegotiation for initial price applicability year 2028.
General Instructions
Overview
In accordance with sections 50 and 130.3.2 of the draftfinal guidance, 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.
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”
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PDF. 3 Instructions for gaining signatory access to the CMS HPMS are also included in this PDF.
Technical assistance will also be made available.
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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. In order to access the questions in Sections I and J through the web link, the
respondent must provide an email address. A confirmation email message from CMS will be sent
to the respondent-provided email address and the respondent must follow the steps contained in
the email message to obtain access to the questions in Sections I and J. 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 draftfinal guidance, the term’s definition in this ICR is
the same as in the draftfinal guidance. Questions about the draftfinal guidance, 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 respondentsAll 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, labeled, or
packaged by a Secondary Manufacturer.
https://www.cms.gov/files/document/instructions-requesting-drug-manufacturer-access-cms-health-planmanagement-system-cms-hpms-medicare.pdf.
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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 draftfinal guidance. 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 new
updates to 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, 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 20272028.
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 draftfinal guidance, 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 2426 regarding such applicable information provided in
response to Sections A through G, and any interested party is instructed to complete
Question 5657 regarding such applicable information provided in Section I. Sections
40.2.1, 60.4, and 60.6 of the draftfinal guidance discuss the situations in which CMS may
share submitted section 1194(e)(2) data submitted publicly, without sharing any personally
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Specifically, as described in section 40.2.1 of the draftfinal guidance, 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 non-proprietary. because CMS understands these data are
publicly available.
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See: https://www.justice.gov/oip/doj-guide-freedom-information-act-0.
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identifiable information 6 (PII) or protected health information 7 (PHI), proprietary
information, or information that is protected from disclosure under other applicable law.
Definitions included in this ICR are intended for purposes only related to this ICR and the
Medicare Drug Price Negotiation Program.
5F
•
6F
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
§ 400.200, unless the geographic area is specified in the authority for the data source (e.g.,
Federal Supply Schedule 8 (FSS) and “Big Four Agency” price 9 (“Big Four price”)).
• 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
7F
8F
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.
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Protected health information (PHI) 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.
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The price offered by the VA in its FSS program, by delegated authority of the General Services Administration.
See: https://department.va.gov/administrations-and-offices/acquisition-logistics-and-construction/freedom-ofinformation-act-requests/#toc_Historical_VA_Pharmaceutical_Prices.
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The Big Four price is described in section 8126 of title 38 of the U.S. Code.
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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.
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 2025 by using the annual
percentage increase of the consumer price index for all urban consumers (CPI-U) 10 for
2025.
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A. Selected Drug Information
Primary Manufacturer Response Required
In Section A, for each selected drug for negotiation and renegotiation for initial price applicability
year 2028, CMS will populate the CMS HPMS with the list of the 11-digit National Drug Codes
(NDC-11s) marketed by the Primary Manufacturer and any Secondary Manufacturer and
published in accordance with section 30.4 of the draftfinal guidance, meaning those NDC-11s of
the selected drug that:
(1) are associated with Healthcare Common Procedure Coding System
(HCPCS) codes that had Part B claims with utilization in the 12-month
period beginning November 1, 2024 and ending October 31, 2025, or
(2) had Part D PDE utilization in the 12-month period beginning November 1,
2024 and ending October 31, 2025, or
(3) any additional NDC-11s CMS identifies that are associated with
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 draftfinal 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., NDC11s 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.
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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).
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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]. 11
10F
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
draftfinal 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. § 447.504) and best
price (42 C.F.R. § 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
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).
• 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 are missing from the list 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 NDC-11s), 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
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 draftfinal guidance.
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and Total AMP Units Per Package.
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 neither
marketed nor controlled 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 discontinuation 12, 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.
• If an NDC-11 is neither marketed nor controlled by the Primary Manufacturer or a
Secondary Manufacturer, select “Yes” in response to the field labeled “Neither Marketed
nor Controlled 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 “Neither
Marketed nor Controlled by the Primary Manufacturer or a
Secondary Manufacturer,” the Primary Manufacturer should not
provide information about this NDC-11 in the remainder of the
data fields within Section A or within any other section in this ICR
Form.
•
11F
Product
Name
NDC-11
Numbers
Neither
Marketed nor
Controlled by
the Primary
or a
Secondary
Manufacturer
Discontinued
(Select if NDC11 has been
discontinued
and provide
date of
discontinuation)
Sample
Package
(Select
if NDC11 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,
MLmL,
GM)
Total
NCPDP
Units
per
Package
Text to
be prepopulate
d by
CMS
Numbers
to be prepopulated
by CMS
Yes/No
Text
Yes/No
TextYes/
No
TextYes/N
o
TextYes/N
o
TextYes
/No
TextEA,
mL, GM
#
AMP Unit
(Injectable
antihemophiliac
factor,
capsule,
suppository,
gram,
milliliter,
tablet,
transdermal
patch, EC,
millicurie,
microcurie)
Text
Total
AMP
Units
per
Pack
age
Labeler
Code
#
Numbers
to be
prepopulate
d 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
Please provide the date of discontinuation that was reported to FDA pursuant to 21 C.F.R. §§§ 314.81(b)(3)(iii) and
(iv).
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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).
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 calendar year 2025
for initial price applicability year 2028.
For Section B, for Primary Manufacturers of drugs selected for renegotiation: the Primary
Manufacturer is required to report the non-FAMP for NDC-11s payable under Part B, if
applicable, for its selected drug that are included in Section A.
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. 13
For initial price applicability year 2028, 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, 2026). 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
12F
13
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).
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the first full year following market entry of such drug, when applicable) or
2025, 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. 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 Drugs subject to Public
Law 102-585. 14 Any restatements of the non-FAMP made in any
manufacturer non-FAMP submissions to the VA must be reflected in the nonFAMP 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 cartonsingle dose vial containing
25 mg/mL in a single dose vial, the non-FAMP package would be the vial).
13F
•
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,
then please proceed to fill in the data for 2025 only.
o 2025: please fill in the information for non-FAMP for calendar year 2025.
• 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. As an example, if any NDC-11s of the selected drug have nonFAMP 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 there is no data). Additionally, all
NDC-11s for the four quarters of 2025, even if an NDC-11 was available in
2025 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
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.
14
11
•
•
•
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 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 2025 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.
2021 or First Other Full Year of Market Entry after 2021
NDC-11 Calendar
Calendar Total Non- NonQuarters
Year
FAMP
FAMP
of 2021 or
Package
First
Volume
Calendar
Year Post
Market
Entry
(e.g.,
Calendar
Quarters
in 2022,
2023, or
2024)
12345QQ
Select One: #
$
6789-01
2021, 2022,
2023, 2024
Explanation of why non-FAMP
was not Reported (if applicable)
Text (12,000 character count limit,
which is approximately 1,000 words)
Note: If the Primary Manufacturer indicates that 2025 is the “First Other Full Year of Market Entry
after 2021,” then the CMS HPMS will only display the data fields for 2025 for completion.
12
2025
NDC-11
123456789-01
Calendar
Quarter
for 2025
QQ
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)
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 for Indications 15 of the
Selected Drug, Post-Investigational New Drug (IND) Costs for Indications 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
clinical facilities and equipment) that are shared across multiple potential
drugs or biological products.
14F
•
For purposes of this ICR, CMS distinguishes between the use of the word “indication” and 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.
15
13
•
•
•
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 for each indication.. 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 for FDA-approved indications that were not
required by FDA, direct post-IND costs for indications that did not receive FDA
approval (following the definitions and instructions for calculating direct postIND 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
payments, coupons, goods in-kind, free or reduced-price services, grants, other
14
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 definitions and 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 incurred 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.
• 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.
• 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 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) 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 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 original full submission of section 1194(e)(1)
data starting from when initial research began, or when the drug was acquired by the
15
Primary Manufacturer, whichever is later. 16
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 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.
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
(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.
15F
•
•
•
•
•
•
Question 1: Costs Related to the Selected Drug, Including Basic Pre-Clinical
Research for Indications Costs of the Selected Drug, Post-IND Costs for Indications
of the Selected Drug, and Other Allowable Costs
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.
16
16
Provide the following information about R&D costs (for the time periods as specified
in the instructions above) incurred by the Primary Manufacturer for indications for
the selected drug related to basic pre-clinical research, post-IND costs for the selected
drug, and other allowable costs.
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 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. To calculate the proportion of preclinical 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. 17, 18 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.
• 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.
16F
17F
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.
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.
18
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.
17
17
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 original full submission of section 1194(e) 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).
Instructions for Question 2a:
• In the numerical response field for “Costs of Allowable Failed or Abandoned or
Failed 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 or Failed Products
Related to the Selected Drug Adjusted for Inflation,” report the cost included for
the “Costs of Allowable Failed or Abandoned or Failed Products Related to the
Selected Drug” data field adjusted for inflation.
Costs of Allowable Failed or Abandoned or
Failed Products Related to the Selected
Drug
$
Costs of Allowable Failed or Abandoned or
Failed Products Related to the Selected Drug
Adjusted for Inflation
$
Instructions for Question 2b:
18
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 or Failed
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).
Instructions for Question 3a:
• In the numerical response field for “Global Net Revenue for the Selected Drug” in
questionQuestion 3a, report the global net revenue.
• In the numerical response field for “Global Net Revenue for the Selected Drug
Adjusted for Inflation” in questionQuestion 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.
19
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 3c “U.S. Net Revenue for the Selected Drug” in
questionQuestion 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 3aQuestion 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)
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
or, furnished, or administered.
20
•
•
•
•
•
Units must be reported in one of the three NCPDP Billing Unit Standard (BUS). 19 The three
NCPDP BUS are: each (EA), milliliter (MLmL), 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:
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.
See: https://standards.ncpdp.org/BillingUnitRequest.aspx#:~:text=Billing%20Unit%20Requests,grams%22%20or%20%22milliliters.%22.
18F
19
21
•
•
“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 marketed 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
Please complete the following data fields using additional rows as necessary for the
following periods:
• 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.
22
NDC11
Average
Per Unit
Production
Cost
12345- $XX.XXX
678901
Average Per
NCPDP Unit
Unit Distribution (EA, MLmL,
Costs
GM)
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)
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 federal
government that support discovery, research, and/or development related to the selected drug.
23
•
•
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 federal financial support costs are costs that can be specifically attributed to the
discovery, pre-clinical development, and clinical trials of indications of the selected drug.
Instructions for Section E:
Follow the instructions below when answering Questions 6, 7, and 8. Do not make
adjustments for inflation.
•
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. federal agencies or
Federally-supported grants or contracts that contributed to any of the costs
described in response to Question 1 of this ICR Form for indications 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 issued 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.
o For Primary Manufacturers of drugs selected for renegotiation:
• Include all prior Federal financial support provided by U.S. federal agencies or
Federally-supported grants or contracts that contributed to any of the costs described
in response to Question 1 of this ICR Form for indications 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.
o For Primary Manufacturers of drugs selected for renegotiation:
• Include all prior Federal financial support provided by U.S. federal 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 issuedreceived during the time period from
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.
• If a new indication was added since the date of certification ofAs described in Section
C, 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 original
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
24
Manufacturer’s original full submission of section 1194(e)(1) data, include all
applicable prior Federal financial support for that new indication from when initial
research began or when the drug was acquired by the Primary Manufacturer,
whichever is later, through December 31, 2025. 20
• 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
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. 21, 22 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 received prior Federal financial support for a failed or
abandoned product with the same mechanism of action as the selected drug that did not
make it to clinical trials and/or drugs with the same mechanism of action as the selected
drug that did not receive FDA approval, including indications for the selected drug that did
not receive approval, the Primary Manufacturer should not include this amount in its
answer for Question 6. Instead, the Primary Manufacturer must include this amount as a
separate quantity when explaining prior Federal financial support in Question 7.
19F
20F
21F
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 prior Federal financial support related to the selected drug for initial price applicability year
2028. Therefore, this Section E also permits a Primary Manufacturer to report support 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 for the selected drug previously.
21
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.
22
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
25
•
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. Expenses 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
Complete
Instructions for Question 6:
• In the datanumerical response field below. Do not make adjustmentsfor “total Federal financial
support,” report the total Federal financial support.
• In the numerical response field for “total Federal financial support adjusted for inflation.,”
report the total Federal financial support reported adjusted for inflation.
Total Federal Financial SupportFIELD
$Total Federal Financial Support
RESPONSE FORMATTotal Federal
Financial Support Adjusted for
Inflation
$
Question 7: Explanation of Calculation of Federal Financial Support
DisaggregateInstructions 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
26
•
•
•
•
•
•
•
•
•
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
Federal financial support for failed or abandoned products related to the selected
drug (as described in the definitions for this section)
CRADA support
In-kind contributions not included elsewhere
Other Federal financial support not included elsewhere
FIELD
Explanation of Federal Financial
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.
• Report each total Federal financial support disaggregated amount adjusted for inflation, and
explain the methodology used to adjust for inflation.
FIELD
Federal Financial Support disaggregated
amount adjusted for inflation
Explanation of methodology used to adjust
for inflation
RESPONSE FORMAT
Text (36,000 character count limit, which is
approximately 3,000 words)
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 federal
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
27
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)
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:
• 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 federal
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; 23 patents that claim the drug product (e.g., the final product taken by
or administered to a patient), drug substance (active ingredient) or other chemicals related
to the active ingredient of a selected drug (e.g., crystalline forms, polymorphs, salts,
22F
FDA serves a ministerial role with regard to the listing of patent information in the Orange Book and
Purple Book.
23
28
•
•
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); 24
o New Chemical Entity Exclusivity (NCE); 25
o Generating Antibiotic Incentives Now (GAIN) Exclusivity for
Qualified Infectious Disease Products (QIDP); 26
o New Clinical Investigation Exclusivity (NCI); 27
o Pediatric Exclusivity (PED); 28 and
o Reference Product Exclusivity for Biological Products. 29
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.
23F
24F
25F
26F
27F
28F
•
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.
o For Primary Manufacturers of drugs selected for renegotiation:
for a drug selected that was originally selected for negotiation for initial price
applicability year 2026, include (1) patents, approvals and exclusivities issued or filed
(and related items) after September 1, 2023 through December 31, 2025; and 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 September 1, 2023 through December 31,
2025, if requested below; and
for a drug selected 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
Section 527 of the FD&C Act.
Section 505(c)(3)(E)(ii) and Section 505(j)(5)(F)(ii) of the FD&C Act.
26
Section 505E(a) of the FD&C Act.
27
Section 505(c)(3)(E)(iii) & (iv) and Section 505(j)(5)(F)(iii) & (iv) of the FD&C Act.
28
Section 505A(b) & (c) of the FD&C Act.
29
Section 351(k)(7) of the PHS Act.
24
25
29
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 period specified in the instructions. 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. 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. Clearly identify which patent or patents is the composition of
matter patent(s) in the free response. 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 original full submission of section 1194(e)(1) data where no change has occurred.
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 original 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 original 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.
30
Paten
t
Expir
y
Date
Patent
Numb
er
Date
Filed
#
MM/
MM/
DD/ YY DD/Y
YY
YYY
(not
applica
ble it
patent
expired
)
Patent Type
Is Patented
Product
Available to
Purchase in
the
Applicable
Market?
Select patent
type (allow more
than one to be
selected): drug
product patent;
drug substance
patent;
formulation
patent; process
patent; methodof-use patent;
device patent;
other (e.g.,
patent that
claims other
chemicals
related to the
active
ingredient,
design patent)
Yes/No
Never,
Previously,
or
Currently
Listed in
FDA
Orange
Book/Purple
Book
Never/
Previously
/
Currently
Patent
Patent Deleted Cells
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
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 original full submission of section 1194(e)(1) data where no change has
occurred. 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 original full submission of section 1194(e)(1) data for the negotiation
31
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.
Patent
Number
Date
Filed
Patent Type
Patent Explanation, Patent Application
or Explanation of
What Changed Since
Last Submission
#
MM/
DD/ YY
YY
(not
applica
ble if
patent
pending
)
Select patent type (allow
more than one to be
selected): drug product
patent; drug substance
patent; formulation patent;
process patent; method-ofuse 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.
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 original full submission of section 1194(e)(1) data where no change has occurred.
Information may include, for example, a new exclusivity since 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.
Complete the data fields for Question 10 by adding rows as needed.
32
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
vity
Expira
tion
Date
MM/DD/YY
YY
Application
(NDA /
BLA)
Number
NDC-9s
Comments
Covered
by
Exclusivity
#
Text
Text
(3,600
character
count
limit,
which is
approxim
ately 300
words)
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 original full submission of section 1194(e)(1) data where no change has
occurred. 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 original full submission of section 1194(e)(1) data for the negotiation
period in which the selected drug’s MFP was negotiated.
33
Applica
tion
(NDA /
BLA)
Number
Applica
tion
Type
(NDA;
BLA)
Classification Code 30
Appr
oval
Date
Indic
ation
Dosage
Form
and
Strength
Spon
sor
Applicatio
n Status
Comments
#
Select the
applicatio
n type:
NDA,
BLA
Select one or more of
the following options:
Options: Type 1 — New
Molecular Entity, Type
2
— New Active
Ingredient, Type 3 —
New Dosage Form,
Type 4
— New Combination,
Type 5 — New
Formulation or Other
Differences (e.g., new
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
MM
DD,
YYY
Y
Text
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)
29F
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.
30
34
G. Market Data and Revenue and Sales Volume Data
Primary Manufacturer Response Required
The purpose of Questions 12 through 23 in this sectionSection 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:
• 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
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). The WAC unit price is reported at the NDC-11 level.
• The three NCPDP BUS 31 are: each (EA), milliliter (MLmL), and gram (GM). For certain
volume data of the selected drug, CMS will requestrequests 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.
§ 414.902.
• ASP Unit: The unit type used by the manufacturer to report ASP as specified in 42 C.F.R. §
414.802.Medicaid best price: The Medicaid best price is defined in 42 C.F.R. § 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. § 447.504)
and best price (42 C.F.R. § 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 price offered by the VA in its FSS program, by
delegated authority of the General Services Administration. 32 The FSS price is reported at
the NDC-11 level.
• Big Four price: The Big Four price is described in 38 U.S.C. § 8126. 33 The Big Four price
is reported at the NDC-11 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 private health insurance plans, including small group or and individual commercial
plans on- and off-Exchange and large group plans, excluding Medicare fee-for-service
(Parts A and B), Medicare Advantage, Medicare Part D, Medicaid fee-for-service, and
30F
31F
32F
31
See: https://standards.ncpdp.org/Billing-UnitRequest.aspx#:~:text=Billing%20Unit%20Requests,grams%22%20or%20%22milliliters.%22.
32
See: https://department.va.gov/administrations-and-offices/acquisition-logistics-andconstruction/freedom-ofinformation-act-requests/#toc_Historical_VA_Pharmaceutical_Prices.
33
The Big Four price is the maximum price a drug manufacturer is allowed to charge the Big Four federal 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.
35
•
•
•
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 Secondary Manufacturer(s) to any purchasers. The following items should not be
deducted from gross revenue in your calculation: 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.
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 U.S.
commercial average net unit price─ net of patient assistance program, the following items
should be deducted from thecommercial payer in the U.S. The following items should not
be deducted from gross revenue in your calculations: 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 following items should be not be deducted from gross revenue in
your calculations: 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 Secondary Manufacturer(s) to any purchasers. The U.S. commercial average net
unit price─ net of patient assistance programThe U.S. commercial average net unit price is
reported at the NDC-11 level.
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.
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, up-front 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. The following items should not be deducted from the
gross revenue in your calculations: 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.
36
•
•
commercial average net unit price – best is reported at the NDC-11 level.
Manufacturer net Medicare Part D average unit price: For the sole purpose of data
collection under section 1194(e)(1)(E) of the Act, the manufacturer net Medicare Part D
average unit price as calculated by the Primary Manufacturer. 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 the Primary Manufacturer or any Secondary
Manufacturer(s) not reflected in the sum of the plan-specific enrollment weighted amounts
calculation and utilization, that may differ from the PDE data. The manufacturer net
Medicare Part D average unit price is reported at the NDC-11 level.
Manufacturer net Medicare Part D average 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 unit price – best is the lowest manufacturer net Medicare Part D average unit price
offered by the Primary Manufacturer or any Secondary Manufacturer(s) to any 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 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 the Primary
Manufacturer or any Secondary Manufacturer(s) not reflected in the sum of the planspecific enrollment weighted amounts calculation and utilization, that may differ from the
PDE data. The manufacturer net Medicare Part D average unit price – best is reported at the
NDC-11 level.
Instructions for Section G:
• For Question 12 through 2325, information for the Primary Manufacturer and any Secondary
Manufacturer(s) must be reported.
• For questionsQuestions 12 through 2325, 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.
• Include NDC-11s that were marked in Section A as sample packages, inner packages, outer
packages and NDC-11s that are discontinued.
Follow the specific instructions for each question below. The applicable reporting time periods are
as follows (except unless otherwise instructed for a specific question):
37
•
•
•
for drugs selected for negotiation for initial price applicability year 2028, the calendar
years 2023, 2024, and 2025 through the calendar quarter ending with December 31, 2025,
for a drug that was selected for negotiation for 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, and
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.
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 12: 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:
• 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 13 so that CMS can understand the reasons for these
differences.
• Units must be reported in one of the three NCPDP BUS: each (EA), milliliter (MLmL), 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 leave the
WAC field blank and provide an explanation in the “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).
38
NDC-11
Quarter
WA NCPDP Unit
C
(EA, MLmL,
GM)
12345-6789-01
QQ/YYYY $
Text
Total
Unit
Volume
Explanation of why WAC was not
Reported (if applicable)
#
Text (3,600 character count limit, which
is approximately 300 words)
Question 13: Explanation of Information Reported in Question 12: 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 12 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, 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 14: Average Sales Price (ASP)
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, 2025.
• The information provided in the data fields must reflect the same data that was
submitted to CMS consistent with 42 C.F.R. § 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 § 414.802.
• ASP Unit refers to the ASP Unit type used by the manufacturer to report ASP as specified
in 42 C.F.R. § 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
39
•
that calendar quarter (e.g., the NDC-11 was first marketed in a later calendar
quarter).
If an ASP reported is negative, provide an explanation in the “Explanation of
why ASP was not reported (if applicable)” field of why the ASP is negative.
NDC-11
12345-6789-01
Sales
Quarter
ASP ASP Unit (the
same ASP unit
as reported in
the ASP Data
Collection
System)
QQ/YYYY $
Text
Total
Units
Sold
Explanation of why ASP was not
Reported (if applicable)
#
Text (3,600 character count limit, which
is approximately 300 words)
Question 15: Explanation of Information Reported in Question 14: ASP
If applicable, describe other information you feel is necessary to interpret reported information in
response to Question 14. Please indicate not applicable (N/A) in the free response field if no
explanation is necessary.
Question 16: 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?
RESPONSE FORMAT
Yes/No
(If response is Yes, please fill out the following data fields. If response is No, please skip to
Question 1618) 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. § 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 leave the
Medicaid best price field blank 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
40
•
Medicaid best price determination for that calendar quarter (e.g., the NDC-9 was first
marketed in a later quarter).
If a Medicaid best price is reported and “0” is entered for Total Unit Volume, explain why
“0” units are reported.
NDC-9
Quart Medicaid
er
Best Price
123456789
QQYY $ (up to 6
YY
decimal
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 1517: Explanation of Information Reported in Question 1416: Medicaid Best Price
If applicable, describe other information you feel is necessary to interpret reported
information in response to Question 16. Please indicate not applicable (N/A) in the
free response field if no explanation is necessary.
If applicable, describe other information you feel is necessary to interpret reported information in
response to Question 14. 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
1,000 words)
Question 1618: 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 1820) Follow the instructions below when providing responses in the following data fields
41
about FSS prices of the selected drug:
• The FSS price information must reflect what can be found online in the pharmaceutical
pricing data for all VA National Acquisition Center programs. 34 We note that the FSS price
information should be for the NDC-11 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 (MLmL), 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 and leave the
“Federal Supply Schedule Price” field blank.. Also provide an explanation in the
“Explanation of why FSS price was not reported (if applicable)” field of why the NDC11 had no FSS price during an applicable calendar quarter specified in the instructions
above (e.g., the NDC-11 was discontinued before the three-year 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. The and provide the FSS in the “Explanation of
why FSS price should bewas not reported. (if applicable)” field.
• Please complete Questions 1618 and 1719 for the FSS price of the selected drug and
Questions 1820 and 1921 for the Big Four price of the selected drug even if the Primary
Manufacturer or the Secondary Manufacturer is considered a “single pricer.”
33F
NDC-11
Price Start Federal
Date to
Supply
End Date Schedule
Price
NCPDP
Unit (EA,
MLmL,
GM)
12345-6789-01
MMDDYYY $
YMMDDYYY
Y
Text
Tota
l
Unit
Volu
me
#
Explanation of why
FSS price was not
Reported (if
applicable)
Text (3,600 character count
limit, which is
approximately 300 words)
Question 1719: Explanation of Information Reported in Question 1618: Federal Supply
Schedule Price
If applicable, describe other information you feel is necessary to interpret reported information in
response to Question 18. Please indicate not applicable (N/A) in the free response field if no
34
See: https://www.va.gov/opal/nac/fss/pharmprices.asp.
42
explanation is necessary.
FIELD
RESPONSE FORMAT
If applicable, describe other information you feel is necessary to interpret reported information in
response to Question 16. 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 1820: 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 2022) 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. 35 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
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 leave the “Big Four Price” field
blank 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 three year period for the requested data began).
34F
35
See: https://www.va.gov/opal/nac/fss/pharmprices.asp.
43
•
Please complete Questions 1618 and 1719 for the FFS FSS price of the selected drug and
Questions 1820 and 1921 for the Big Four price of the selected drug even if the Primary
Manufacturer or the Secondary Manufacturer is considered a “single pricer.”
NDC-11
Price Start Date to Price Big
End Date
Four
Price
NCPDP Unit
(EA, MLmL,
GM)
Total Unit
Volume
Explanation of why Big
Four price was not
Reported (if applicable)
123456789-01
MMDDYYYYMMDDYYYY
Text
#
Text (3,600 character
count limit, which is
approximately 300 words)
$
Question 1921: Explanation of Information Reported in Question 1820: Big Four Price
If applicable, describe other information you feel is necessary to interpret reported information in
response to Question 20. Please indicate not applicable (N/A) in the free response field if no
explanation is necessary.
FIELD
RESPONSE FORMAT
If applicable, describe other information you feel is necessary to interpret reported information in
response to Question 18. 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 2022: 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, including group and individual commercial
plans on- and off-Exchange of the selected drug:
• 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 leave the three price fields blank and 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.
44
•
•
•
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-service (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 (MLmL), or
gram (GM). Please do not include units associated with free samples in the calculated
prices or reported total unit volume.
NDC Quarte Manufactu
-11
r
rer U.S.
Commerc
ial
Average
Unit Net
Price
Manufactu
rer U.S.
Commerci
al Average
Net Unit
Price- Net
of Patient
Assistance
Programs
Manufactu
rer U.S.
Commerci
al
Average
Net Unit
PriceBest
1234 QQY
5YY Y
678901
$
$
$
NCP
DP
Unit
(EA,
MLm
L,
GM)
Text
Total
Unit
Volu
me
#
Total
Unit
Volume
for U.S.
Commer
cial
Average
Net Unit
Price Best
#
Explanatio
n of why
Manufactu
rer U.S.
Commerci
al prices
were not
Reported
(if
applicable)
Text (3,600
character
count limit,
which is
approximately
300 words)
Question 2123: Explanation of Information Reported in Response to Question
2022: Manufacturer U.S. Commercial Average Net Unit Price
Describe assumptions, methodological steps, and other information for the following topics related
to Question 22:
Describe assumptions, methodological steps, and other information for the following topics related
to Question 20:
• How sales to enrollees of private health insurance plans, including small group and
individual commercial 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 purchaserscommercial payer were
allocated across NDC-11s and calendar quarters.
45
•
•
•
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 2224: Manufacturer Net Medicare Part D Average Unit Price
Follow the instructions below when providing responses in the following data fields about the
manufacturer net Medicare Part D price of the selected drug.
• 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 leave the three price fields blank and provide an
explanation in the “Explanation of why manufacturer net Medicare Part D Price was not
reported (if applicable)” field of why the NDC-11 had no manufacturer net Medicare
Part D 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
(MLmL), or gram (GM). Please do not include units associated with free
samples in the calculated prices or reported total unit volume.
46
NDC- Calenda Manufactur
11
r
er Net
Quarter Medicare
Part D
Average
Unit Price
Manufactur
er Net
Medicare
Part D
Average
Unit Price Best
Medica
re
Discoun
t
Progra
m
Amount
Paid
(Per
NCPDP
Unit)
NCPD
P Unit
(EA,
MLm
L,
GM)
Total
Unit
Volu
me
Total
Unit
Volume
for Net
Medica
re Part
D
Averag
e Unit
Price Best
Explanation
of why
manufactur
er net
Medicare
Part D price
was not
Reported (if
applicable)
12345 QQYY
YY
678901
$
$
Text
#
#
Text (3,600
character count
limit, which is
approximately
300 words)
$
Question 2325: Explanation of Information Reported in Response to Question
2224: Manufacturer net Medicare Part D price
Describe assumptions, methodological steps, and other information for the following topics related to
Question 22:Describe assumptions, methodological steps, and other information for the following
topics related to Question 24:
• 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 Medicare
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 purchasers were
allocated across NDC-11s and calendar quarters.
• If applicable, how financial assistance to patientscommercial 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 Unit
Price” and the “Manufacturer Net Medicare Part D Average Unit Price – best.”
• Please indicate not applicable (N/A) in the free response field if no explanation is
necessary.
FIELD
Explanation of “manufacturer Net
Medicare Part D price” data
RESPONSE FORMAT
Text (12,000 character count limit, which is
approximately 1,000 words)
47
Question 2426: Primary Manufacturer Identification of Information Submitted in Sections A
through G that the Primary Manufacturer Believes Should be Withheld as Proprietary
Information
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 draftfinal guidance, 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. 36 For each
In addition to the information CMS already designates as proprietary consistent with section
and/or question40.2.1 of the final guidance: For information submitted that athe Primary
Manufacturer believes contains information that 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)), 37 first list each
applicablefollow 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 letter and question60.6.1 of the final
guidance.
• 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 and thenin
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 26 as the reason the manufacturer believes the
information should be withheld (e.g., {1}, {2}). To differentiate references
in response to Question 26 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
35F
36F
Specifically, as described in section 40.2.1 of the draftfinal guidance, 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.
37
See: https://www.justice.gov/oip/doj-guide-freedom-information-act-0.
36
48
•
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.
Include the question number that the explanation corresponds to in the free text response.
This submission will be used during CMS’ process to determine which information
submitted by a manufacturer is proprietary.
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
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.
FIELDLOCATION (List the Bracket Number (E.g. {1},
{2}) or Question/Section/Data Entry Field/Line Number))
List of Section Letter(s) and Question Number(s) the
Primary Manufacturer Believes Includes Information That
Should Be Withheld As Proprietary InformationList of
Bracket Locations, in Order of First Appearance (E.g. {1},
{2}); Add a row for each additional item
Explanation for EachList of Non-Bracketed Locations,
Identified by the Section Letter/, Question, Data Entry
Field and/or Line Number Listed; Add a row for each
additional item
RESPONSEJUSTIFICATION
TextText (each item 2,400
character count limit, which is
approximately 200 words)
Text (60,000each item 2,400
character count limit, which is
approximately 5,000200 words)
H. Certification of Submission of Sections A through G for Primary Manufacturers
Required for Primary
Manufacturers Instruction for
Section H:
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).
49
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)(7) of the Act.
Checkbox for certification [ ]
Contact Information to be entered:
Field
Name of the Person Responsible for the
Submission
Signature
Date
Response
Text
Text (Electronic Dated Signature)
MMDDYYYY
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 therapeutic alternative(s), respondents are not required to include
personally identifiable information 38 (PII), protected health information 39 (PHI) or proprietary
information that includes confidential or trade-secret information. CMS seeks to collect only the
37F
38F
38
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.
39
Protected health information (PHI) 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/for-professionals/privacy/lawsregulations/index.html.https://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/index.html.
50
minimum necessary information related to the selected drug and its 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 original full
submission of section 1194(e)(2) data to CMS for the negotiation period in which the selected drug’s
MFP was negotiated through December 31, 2025.
Question 2527: Respondent Information
Required: Individuals or organizations, including manufacturers, that wish to provide
information in this Section I must provide the following information. 40
39F
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)
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.
40
51
[ ] 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
alternative(s)? 41
40F
General Instructions for Section I
• All questions are optional.
• Any interested party may answer Questions 2627 through 5557. Each interested party will be
able to answer each of Questions 2627 through 5557 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 respondent that answers any of Questions 2627 through 5556 should also review
Question 5657 and respond as applicable.
• CMS has grouped Questions 2628 through 5354 in five categories of topics that are
addressed by the set of questions. Specifically, these categories by question number are:
o Questions 26-3128-33: Patient- or Caregiver-Focused Input
o Questions 32-3734-39: Manufacturer-Focused Input
o Questions 38-4340-45: Clinical-Focused Input
o Questions 44-5046-51: Health Research-Focused Input
o Questions 51-5352-54: 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
2628 through 5556. 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
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.
41
52
•
•
•
•
•
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
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.
o 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 draftfinal
guidance.
53
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 5456. Use the number originally
assigned to for the same source citation each time the citation is used throughout
Section I.
o In response to Question 5456, respondents are requested to provide the list of all
citations. Additional instructions are included with Question 5456 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 draftfinal guidance, 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. 42 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 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
5455 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.
o
•
•
•
41F
•
42
Section 1194(e)(2) of the Social Security Act.
54
•
CMS will only review the maximum number of citations or upload files permitted in the
instructions.
Definitions for Section I:
• Therapeutic Advance: CMS intends to examine improvements in outcomes to determine
the extent to which 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) 43 when determining the extent to which a selected drug represents a
therapeutic advance. For purposes of the Negotiation Program, anytime CMS considers
therapeutic advance, CMS will 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 be 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.
• 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.
• 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
42F
For purposes of the final guidance and this ICR, CMS distinguishes between the use of the word “indication” and
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.
43
55
interest by providers and/or caregivers when patients cannot report for themselves. 44
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: A circumstance in which the relevant disease or condition is one for
which no other treatment options exist, or existing treatments do not adequately address the
disease or condition. 45 For purposes of the Negotiation Program, anytime CMS considers
an unmet medical need, CMS will consider the extent to which the drug represents 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. § 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(s) are is a
medically-accepted indication covered under Part D and/or payable under Part B, taking
into consideration the major drug compendia, authoritative medical literature, and/or
accepted standards of medical practice. 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: Off-label use means a use of a selected drug or therapeutic alternative that is
not approved by the FDA but is included in evidence-based clinical practice guidelines and
the off-label use is a medically-accepted use covered under Part D or payable under Part B,
taking into consideration the major drug compendia, authoritative medical literature and/or
accepted standards of medical practice.
43F
•
44F
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 FDA-approved 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]
44
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).
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.
45
56
Questions 2628 through 5557: Optional for All Respondents
Questions 2628 through 3133: Patient-Focused Experience
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 2628: Background
Question 26a28a: Have you or someone you provide care for ever taken [the selected drug]?
Field
Response
Response to Question 26a28a Check box: YES or NO
If you answer yes, review Questions 28a1 and 28a2. If you answer no, skip to Questions 28a3 and
28a4.
Question 26a128a1: [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
26a128a1
Response
Text (6,000 character count limit, which is approximately
500 words)
Question 26a228a2: [If YES] When were you or someone you provide care for
given a diagnosis related to this condition or conditions? You may write an
approximate date, or if you never received a diagnosis write “N/A.”
Field
Response to Question
26a228a2
Response
Text (6,000 character count limit, which is approximately
500 words)
Question 26a328a3 [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
26a328a3
Response
Text (366,000 character count limit, which is approximately
3,000500 words)
Question 26a428a4: [If NO] What is your experience with this condition or conditions?
57
Field
Response
Response to Question 36a42a4 Text (36,000 character count limit, which is approximately
3,000 words)
Question 2729: Information on Your Condition(s) or Condition(s) of Someone You Care For
Question 27a29a: How do the condition(s) you listed in Question 26a128a1 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 27a29a
Response
Text (36,000 character count limit, which is approximately
3,000 words)
Question 27b29b: How has the condition(s) you listed in Question 2628 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?
Field
Response to Question 27b29b
Response
Text (36,000 character count limit, which is approximately
3,000 words)
Question 27c29c: What is important to you or those you provide care for in
managing the condition(s) you listed in Question 2628?
• 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).
• 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 27c29c
Response
Text (36,000 character count limit, which is approximately
3,000 words)
58
Question 27d29d: What challenges do you, or someone you care for, face in managing this
condition(s)?
Field
Response to Question 27d29d
Response
Text (36,000 character count limit, which is approximately
3,000 words)
Question 2830: Information on the Current Medication to Treat Your Condition
Question 28a30a: Are you, or someone you care for, currently taking medication(s)
to manage the condition(s) you listed in Question 2628?
Field
Response
Response to Question 28a30a YES or NO
If you answer yes, review Questions 30a2 through 30a4. If you answer no, skip to Question 31.
Question
Question 28a130a1: [If YES] What medication(s) are you, or someone you provide
care for, currently taking to manage the condition(s) you listed in Question 2628?
• If more than one medication is currently taken, please list medications in the
order you started them.
Field
Response to Question
28a130a1
Response
Text (366,000 character count limit, which is approximately
3,000500 words)
Question 28a230a2: [If YES] How did you or someone you care for decide to start
taking the medication(s) currently used to manage the condition(s) you listed in
Question 2628?
• What factors, if any, affected the choice of medication(s) currently used to manage the
condition(s) you have selected?
• 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
28a230a2
Response
Text (36,000 character count limit, which is approximately
3,000 words)
Question 28a330a3: [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 2628?
59
•
•
•
•
•
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
28a330a3
Response
Text (36,000 character count limit, which is approximately
3,000 words)
Question 28a430a4: [If YES] How satisfied are you, or someone you care for, with
the medication(s) you take now to manage your condition(s)?
Field
Response to Question
28a430a4
Response
Text (36,000 character count limit, which is approximately
3,000 words)
Question 2931: Information on the Medication(s) Used in the Past to Treat Your Condition
Question 29a31a: Have you, or someone you care for, taken other medication(s) in
the past to manage the condition(s) you listed in Question 2628?
Field
Response to Question 29a31a
Response
YES or NO
Question 29b1If you answer yes, review Question 31b1 through 31b4. If you answer no, skip to
Question 32.
Question 31b1: [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 2628?
• If possible, please indicate when past medication(s) were started and stopped to
the best of your knowledge.
Field
Response to Question
29b131b1
Response
Text (366,000 character count limit, which is approximately
3,000500 words)
Question 29b231b2: [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 2628?
• What other factors, if any, affected the choice of medication(s) used in the past to manage the
condition(s) you listed in Question 2628?
60
• 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
29b231b2
Response
Text (36,000 character count limit, which is approximately
3,000 words)
Question 29b331b3: [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 2628?
• 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
29b331b3
Response
Text (36,000 character count limit, which is approximately
3,000 words)
Question 29b431b4: [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 2628?
Field
Response to Question
29b431b4
Response
Text (36,000 character count limit, which is approximately
3,000 words)
Question 3032: 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 3032
Response
Text (36,000 character count limit, which is approximately
3,000 words)
61
Question 3133: Demographic Questions [Only when a respondent selects the “patient” or
“caregiver” option in response to Question 2527.]
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
Medicare Beneficiary
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
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 3234 through 3739: 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.
62
Instructions for Questions 3234 through 3739
Manufacturers are permitted to submit a dossier in Question 3739. Dossier submission is optional.
Such dossiers may be used to supplement responses provided in Questions 3234 through 3638.
CMS requests that manufacturers submitting a dossier also submit an outline of the location of
information related to Questions 3234 through 3638, to the extent applicable.
Question 3234: 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 (612,000 character count limit, which
selected drug, along with which indication(s) of is approximately 5001,000 words)
the selected drug the respondent would like
CMS to consider for each of the potential
therapeutic alternatives listed
Question 3335: Use in treatment and clinical comparative effectiveness evidence
Question 33a35a: Describe the selected drug’s use in the course of care for its
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 3234) in the course of care for the indication(s) relative to the selected
drug.
Field
Response to Question 33a35a
Response
Text (36,000 character count limit, which is approximately
3,000 words)
Question 33b35b: For the indication(s) identified in the instructions and Question
3034, identify relevant clinical outcome measures CMS should consider in its
evaluation of clinical comparative effectiveness (e.g., clinical efficacy, real-world
effectiveness, or safety). ProvideInclude references to any supporting citations listed
in Question 56 for identified clinical outcome measures.
Field
Response to Question 33b35b
Response
Text (3618,000 character count limit, which is
approximately 3,0001,500 words)
Question 33c35c: For the indication(s) of the selected drug, identify any relevant
63
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. ProvideInclude references
to any supporting citations listed in Question 56 for relevant comparative evidence.
Field
Response to Question 33c35c
Response
Text (36,000 character count limit, which is approximately
3,000 words)
Question 3436: Prevalence, utilization, and cost estimates
Question 34a36a: For the indication(s) of the selected drug, provide an estimate of
its prevalence among the Medicare population. ProvideInclude references to any
citations listed in Question 56 and/or brief methodology to support the estimate(s).
Field
Response to Question 364a
Response
Text (36,000 character count limit, which is approximately
3,000 words)
Question 34b36b: For the indication(s) of the selected drug, provide an estimate of
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. ProvideInclude references to any citations listed in Question 56
and/or brief methodology to support the estimate(s).
Field
Response to Question 346b
Response
Text (36,000 character count limit, which is approximately
3,000 words)
Question 34c36c: 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: disease burden or cost-of-illness analyses, costeffectiveness or cost-utility analyses, and/or other analyses of health care resource
utilization relevant to the selected drug and any potential therapeutic alternatives.
ProvideInclude references to any citations listed in Question 56 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,
64
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 34c36c
Response
Text (36,000 character count limit, which is approximately
3,000 words)
Question 3537: Therapeutic advance and unmet medical need
Question 37a: 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) and/or the extent to which the selected drug and
therapeutic alternatives address an unmet medical need.).
Field
Response to Question 3537a
Response
Text (36,000 character count limit, which is approximately
3,000 words)
Question 37b: For the indication(s) of the selected drug, describe the extent the
selected drug and its potential therapeutic alternative(s) address an unmet medical
need.
Field
Response to Question 37b
Response
Text (36,000 character count limit, which is approximately
3,000 words)
Question 38: Specific populations and patient experience
Question 36a38a: For the indication(s) of the selected drug, identify any specific
populations that are impacted by the selected drug and/or its potential therapeutic
alternatives,alternative(s), and describe how they are impacted. ProvideInclude any
supporting citations listed in Question 56.
Field
Response to Question 36a
Response to Question 38a
Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (18,000 character count limit, which is approximately
1,500 words)
Question 36b38b: 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 alternatives.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. ProvideReference any supporting citations listed in Question 56.
65
Field
Response to Question 36b
Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (18,000 character count limit, which is approximately
1,500 words)
Response to Question 38b
Question 3739: Dossier Submission
Manufacturers are permitted to submit a dossier in Question 3739. Such dossiers may be
used to supplement responses provided in questions 3234 through 3638, preferably
formatted using an industry standard such as the most current AMCP Format (version 5.0)
for Formulary Submissions. CMS requests that manufacturers submitting a dossier also
submit an outline of the location of information within the drug dossier that the
manufacturer suggests is related to Questions 3234 through 3638, 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.
Response
Text (Up to 2 PDF files in a Zip file, one of these files should include an outline of the
location of the information in the drug dossier related to Questions 34 through 38, as
applicable)
Questions 3840 through 4345: 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 3840: Background Questions
Question 38a40a: Are you a health care provider (i.e., a person who is trained and
licensed to give health care 46)?
45F
Field
Response
Response to Question 40a
YES or NO
If you answer yes, review Questions 40a1. If you answer no, skip to Question 40.
46
Refer to the CMS Glossary for the term of “health care provider” available at: https://www.cms.gov/glossary.
66
Question 40a1
Question 38a1: [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.
Field
Response to Question
38a140a1
Response
Text (6,000 character count limit, which is approximately
500 words)
Question 38b40b: Do you have experience prescribing or managing the use of [the selected drug]?
Field
Response
Response to Question 40b
YES or NO
If you answer yes, review Question 40b1. If you answer no, skip to Question 40b2.
Question 40b1
Question 38b1: [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 40b1
Response
Text (6,000 character count limit, which is approximately
500 words)
Question 38b240b2: [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 38b2
Response to Question 40b2
Response
Text (6,000 character count limit, which is approximately
500 words)
Text (6,000 character count limit, which is approximately
500 words)
Question 3941: Treatment-related Questions
Question 39a41a: 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 39a41a
Response
TextText (18,000 character count limit, which is
approximately 1,500 words)
Question 39b41b: What outcomes do you use to assess improvement or treatment
response for this indication(s)?
67
•
Please provide specific clinical, functional, or patient-reported outcomes.
Field
Response to Question 39b41b
Response
Text (3618,000 character count limit, which is
approximately 3,0001,500 words)
Question 39b141b1: What would you consider to be a meaningful improvement or
treatment response for the outcomes listed in question 39bQuestion 41b?
Field
Response to Question
39b141b1
Response
Text (12,000 character count limit, which is approximately
1,000 words)
Question 39b241b2: Would you assess improvement or treatment response
differently in certain patient subpopulations? If so, which subpopulations and why?
Field
Response to Question
39b241b2
Response
Text (36,000 character count limit, which is approximately
3,000 words)
Question 39c41c: 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
includereference any citations listed in Question 56 for major drug compendia,
authoritative medical literature, and/or accepted standards of medical practice.
Field
Response to Question 4139c
Response
Text (36,000 character count limit, which is approximately
3,000 words)
Question 4042: Additional Treatment-related Questions
Question 40a42a: 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 40a42a
Response
Text (3618,000 character count limit, which is
approximately 3,0001,500 words)
Question 40b42b: 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
drug]? What other treatments might be considered before [the selected drug] is
considered a clinically appropriate treatment option, if any?
68
Field
Response to Question
40b42b
Response
Text (3618,000 character count limit, which is
approximately 3,0001,500 words)
Question 40c42c: 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 56 where applicable.
Response to Question 40c
Field
Response to Question 42c
Text (36,000 character count limit, which is approximately
3,000 words)
Response
Text (12,500 character count limit, which is approximately
1,000 words)
Question 40d42d: What considerations drive treatment selection among [the selected
drug] and its potential therapeutic alternativesalternative(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 40d42d
Response
Text (3618,000 character count limit, which is approximately
3,0001,500 words)
Question 40e42e: Are there notable differences between how [the selected drug] or
the potential therapeutic alternativesalternative(s) identified in Question 45c42c 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 40e42e
Response
Text (3618,000 character count limit, which is approximately
3,0001,500 words)
Question 40f42f: How would you characterize the benefits and risks associated with
[the selected drug]?
Field
Response to Question 40f42f
Response
Text (3618,000 character count limit, which is approximately
3,0001,500 words)
69
Question 40f142f1: What side effects or risks, common or serious, or other safety
concerns would you take into consideration when selecting a treatment option from
among [the selected drug] or its potential therapeutic alternativesalternative(s) for the
condition(s) treated with [the selected drug]?
Field
Response to Question
40f142f1
Response
Text (3618,000 character count limit, which is approximately
3,0001,500 words)
Question 40f242f2: 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 alternativesalternative(s) for the indication(s)?
Field
Response
Field
Response to Question 40f2
Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (18,000 character count limit, which is approximately
1,500 words)
Response to Question 42f2
Question 40f342f3: 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 alternativesalternative(s) for the indication(s)?
Response to Question 42f3
Text (18,000 character count limit, which is approximately
1,500 words)
Response to Question 40f3
Text (36,000 character count limit, which is approximately
3,000 words)
Question 40g42g: How would you assess whether a patient is tolerating and/or
responding to [the selected drug] or any of its potential therapeutic
alternativesalternative(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?
Field
Response to Question 40g42g
Response
Text (3618,000 character count limit, which is approximately
3,0001,500 words)
70
Question 4143: 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 alternativesalternative(s) for
the condition(s) treated by [the selected drug]?
Response to Question 41
Text (36,000 character count limit, which is approximately
3,000 words)
Question 44
Question 42: Therapeutic Advance and Unmet Medical Need
Question 42a44a: 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).
Field
Response to Question 42a
Response to Question 44a
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 42b44b: For the condition(s) treated by [the selected drug], describe the
extent to which [the selected drug] currently addresses (or does not address) an
unmet medical need.
Field
Response to Question 42b44b
Response
Text (36,000 character count limit, which is approximately
3,000 words)
Question 42c44c: 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
42c44c
Response
Text (36,000 character count limit, which is approximately
3,000 words)
Question 4345: 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]? ProvideReference any citations
listed in Question 56 when applicable.
Field
Response to Question 453
Response
Text (36,000 character count limit, which is approximately
3,000 words)
71
Questions 4446 through 5051: 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 4546: 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 to Question 4546
Response
YES or NO for each item 1-3 (listed above in question)
Question 45a46a: 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 45a46a
Response
Text (6,000 character count limit, which is approximately
500 words)
Question 4647: Potential Therapeutic Alternatives
What medications would you consider to be potential therapeutic alternatives for [the
selected drug] for each indication(s)? Provide supporting rationaleFor 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). Reference any citations listed in Question 56 where applicable.
Field
Response to Question 4647
Response
Text (3612,000 character count limit, which is
approximately 31,000 words)
72
Question 4748: Comparative Clinical Evidence
Question 47a48a: 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 to Question 487a
Response
Text (36,000 character count limit, which is approximately
3,000 words)
Question 47b48b: 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
alternativesalternative(s) for the indication(s)? ProvideReference any supporting citations
listed in Question 56 where applicable.
Field
Response to Question 487b
Response
Text (3618,000 character count limit, which is
approximately 1,53,000 words)
Question 47c48c: 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.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. ProvideReference any supporting citations
listed in Question 56.
Field
Response
Response to Question
Text (36,000 character count limit, which is approximately
47c48c
3,000 words)
Question 4849: Specific Populations and Patient Experience
Question 48a49a: What evidence are you aware of regarding patient experiences related to
use of [the selected drug], its potential therapeutic alternatives,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. ProvideReference
any supporting citations listed in Question 56.
73
Field
Response to Question 49a
Response
Text (36,000 character count limit, which is approximately
3,000 words)
Question 48b49b: What specific populations or patient subgroups are impacted by [the
selected drug] and/or its potential therapeutic alternativesalternative(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
alternativesalternative(s) on the specific populations. ProvideReference 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 48c49c: What considerations related to health insurance coverage or access to
[the selected drug], its potential therapeutic alternatives,alternative(s), and/or or this
condition(s) treated by [the selected drug]? ProvideReference any supporting citations
listed in Question 56 where applicable.
Field
Response to Question 48c
Response to Question 49c
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 4950: Prevalence, Utilization, and Cost Estimates
Question 49a50a: For each indication(s), provide an estimate of prevalence among the
Medicare population. ProvideReference any citations listed in Question 56 and/or provide a
brief methodology to support the estimate.
Field
Response to Question 49a
Response to Question 50a
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 49b50b: For each indication(s), provide an estimate for Medicare utilization of
[the selected drug] and/or its potential therapeutic alternatives.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. ProvideReference any citations listed in Question 56
and/or provide a brief methodology to support the estimate.
74
Field
Response to Question 49b50b
Response
Text (36,000 character count limit, which is approximately
3,000 words)
Question 49c50c: For each indication(s), identify or provide evidence relevant to Medicare
regarding relative health care resource utilization of patients who take [the selected drug]
and its potential therapeutic alternatives.alternative(s). Relevant evidence of relative health
care resource utilization may include but is not limited to: 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. Providealternative(s). Reference any citations listed in Question 56 and/or
provide a brief methodology to support the assessments.
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 49c
Response
Text (36,000 character count limit, which is approximately
3,000 words)
Response to Question 50c
Text (36,000 character count limit, which is approximately
3,000 words)
Question 5051: What other information or evidence do you think CMS should
consider in the evaluation of [the selected drug]? ProvideReference any citations
listed in Question 56 when applicable.
Field
Response to Question 510
Response
Text (36,000 character count limit, which is approximately
3,000 words)
Questions 5152 through 5354: Other Public Input
CMS is collecting information to support its evaluation of [selected drug] relative to potential
therapeutic alternatives.alternative(s). CMS is interested in obtaining any additional input that
CMS should consider when evaluating [the selected drug].
Question 5152: 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 521
Response
Text (6,000 character count limit, which is approximately
75
Field
Response
500 words)
Question 5253: What is your experience with [the selected drug] or the condition(s) it treats?
Field
Response to Question 5253
Response
Text (36,000 character count limit, which is approximately
3,000 words)
Question 5354: What information or evidence do you think CMS should be aware
of as it evaluates [the selected drug] for each indication(s)? ProvideReference any
citations listed in Question 56 when applicable.
Field
Response to Question 5354
Response
Text (36,000 character count limit, which is approximately
3,000 words)
Questions 5455 and 55: Citations and 56: Visual Information and Citations
Consistent with the General Instructions for Section I, a respondent may include visual
representations and/or citations to support responses included in this section.
Question 5455: 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 5556: 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).
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
76
available, include the Digital Object Identifier (DOI).) (https://www.doi.org/). Additionally,
please provide a hyperlink to the source, if possible.
Respondents may either enter citations individually ormust 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.
RESPONSE
FIELDS
Text (Up to 250 citations entered • Numbered List
individual or within a PDF file in • Citation
one Zip file)
• PubMed ID or, if available
•
•
If the Pub Med ID is not available, the Digital Object
Identifier, if available
Hyperlink, if available
For Any Respondent that Responded to One or More Questions in Section I
Question 5657: Identification of Information Submitted in Section I that the
Respondent Believes Should be Withheld as Proprietary Information
In addition to the information CMS already designates as proprietary consistent with section
40.2.1 of the final guidance: 47 For each question that a Respondentrespondent to Section I
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, first list each applicable question number and then provide a brief explanation regarding
whyfollow the Respondent believes theinstructions to below to identify this information should be
withheld as proprietary for CMS. This identification of information. List the question number that
the explanation corresponds to in the free text response. The Respondent should not include by a
respondent to Section I will be used during CMS’ process to determine which information that
CMS specifies assubmitted is proprietary and which information may be disclosed in the public
explanation of the MFP consistent with section 40.260.6.1 of the draftfinal guidance. 48
• 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]
46F
47F
Specifically, as described in section 40.2.1 of the final guidance, 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 is publicly available as non-proprietary.
48
Specifically, as described in section 40.2.1 of the draft guidance, 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 is publicly available as non-proprietary.
47
77
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 57 as the reason the
respondent believes the information should be withheld (e.g., {1}, {2}). To
differentiate references in response to Question 57 from citations, use different
symbols for numbering (for example, a {curly brace} for Question 57 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 57, 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.
FIELDLOCATION (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 Section Letter(s) andNon-Bracketed Locations,
Identified by the, Question, Data Entry Field and/or Line
Number(s) the respondent believes includes information
that should be withheld as proprietary information; Add a
row for each additional item
RESPONSEJUSTIFICATION
Text (20,400 character count limit,
which is approximately 200
words)
Text (60,000each item 2,400
character count limit, which is
approximately 5,000200 words)
J. Certification of Submission of Section I for All Respondents
78
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
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: DraftFinal
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. 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]).
79
80
PART 2: 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 draftfinal guidance, 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 “Primary Manufacturer”).
In accordance with section 1191(b)(4) of the Act, 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, for initial price applicability year 2028,
February 28, 2026. 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 60.4 and 130.4.3 of the draftfinal guidance, CMS will make a
written initial offer to the Primary Manufacturer with the proposal for the MFP for a selected drug
or the proposal for the renegotiated MFP for a selected drug for initial price applicability year 2028
no later than June 1, 2026. In accordance with sections 1194(b)(2)(C) and 1194(f)(4)(B) of the Act
and sections 60.4 and 130.4.3 of the draftfinal guidance, 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 populated with the proposal for the MFP. In accordance with sections 1194(b)(2)(D)
and 1194(f)(4)(B) of the Act and sections 60.4 and 130.4.3 of the draftfinal guidance, CMS will
provide a written response to the statutory written counteroffer and the renegotiation written
counteroffer, respectively. 49 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 module in the CMS HPMS.
Sections 60.4 and 130.4.3 of the draftfinal guidance describes the remainder of the negotiation
process and renegotiation process in greater detail, respectively.
48F
Every written offer and counteroffer, including a Counteroffer, will include an Addendum
populated with the proposal for the MFP. If an agreement on the MFP is reached at any point
during the negotiation process or the renegotiation process in accordance with sections 60.4 and
130.4 of the draftfinal guidance, respectively, the Addendum to the Agreement, as described in
The statutory written counteroffer and renegotiation written counteroffer are hereinafter collectively referred to as
the “Counteroffer.”
49
81
section 40.3 of the draftfinal guidance, will be executed by both parties and will constitute
agreement on the MFP. The MFP included in the executed Addendum will apply for the selected
drug for initial price applicability year 2028, subject to the conditions and timing described in
section 70 of the draftfinal guidance 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
draftfinal guidance 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 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 and renegotiation
process can be found in the draftfinal guidance.
Note: This ICR focuses on information required for the submission of Counteroffers during the
negotiation and renegotiation process for initial price applicability year 2028.
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 (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 draftfinal guidance);
Subject to the 30,000 character count limit, which is approximately 2,500 words, a
justification of the Counteroffer based on the factors 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.
These section 1194(e) data 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
82
•
and its therapeutic alternative(s) as described in section 1194(e)(2) 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).
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 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
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. CMS reserves
the right to review submitted materials for relevance and in accordance with the standards
outlined in section 50.2 of the draftfinal guidance.
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 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).
83
•
•
•
•
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.
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 should only include the table, chart, or graph, with no additional text
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 review submitted visual representations that use cost-effectiveness measures or
methods to determine if the data are relevant to 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.
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.
84
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), 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 statutory written counteroffer in accordance with section 1194(b)(2)(C).
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).
Question 1: 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 30day 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 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
$
Question 2: Please provide a justification of the statutory written counteroffer proposal for the MFP
based on the factors in section 1194(e) of the Act. This statutory written counteroffer justification
85
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 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
Statutory Written Counteroffer Justification
Additional Materials to Support the Justification
RESPONSE FORMAT
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)
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.
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: DraftFinal
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. 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
86
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 draftfinal 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.
Proposal for the MFP per 30-day equivalent
supply
$
Question 2: Please provide a justification of the renegotiation written counteroffer proposal for the
MFP based on the factors 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 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.
87
FIELD
Renegotiation Written Counteroffer Justification
Additional Materials to Support the Justification
RESPONSE FORMAT
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)
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)(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.
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:
DraftFinal 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. 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
88
| File Type | application/pdf |
| Author | Wojcicki, Michelle (CMS/CM) |
| File Modified | 2025-11-24 |
| File Created | 2025-11-24 |