Biosimilars Prescribing Survey

Data to Support Drug Product Communications

Biosimilars Survey Questionaire

Biosimilars Prescribing Survey

OMB: 0910-0695

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OMB Control # 0910-0695

Expiration Date: 02-28-2021

Programmer Notes Revised 11-1-2020


Paperwork Reduction Act Statement:  According to the Paperwork Reduction Act of 1995, an agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a valid OMB control number.  The time required to complete this information collection from eligibility to completion of the survey is estimated to average 23 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.


Send comments regarding this burden estimate or any other aspects of this collection of information, including suggestions for reducing burden, to [email protected].


Department of Health and Human Services (HHS)/ Food and Drug Administration (FDA) Biosimilars Survey


SURVEY QUESTIONS


SECTION I: Current prescribing practice


PROGRAMMER NOTE: For Q2 – Q4, please display blue text in blue on screen.


Q1. In your practice, how do you most often prescribe medicines that are not controlled substances? [Single punch]


Value

Label

01

Written prescriptions or orders

02

Electronic prescriptions or orders

03

Preprinted forms, prescriptions or orders

04

Verbal prescriptions or orders

-99

Refused



Q2. In your practice, what terminology do you most often use in prescribing medicine for your patients? [Single punch]


Value

Label

01

The brand name of the product (e.g., Zofran)

02

The nonproprietary name of the product (e.g., ondansetron )

03

The brand name together with the nonproprietary name (e.g., Zofran (ondansetron)

04

The nonproprietary name along with the name of the drug maker (e.g., ondansetron by Novartis)

05

Other (specify)

-99

Refused


Q3. In your practice, how do you most often identify the medicines you are prescribing to patients? [Single punch]


Value

Label

01

The brand name of the product (e.g., I am treating you with Zofran)

02

The nonproprietary (generic) name of the product (e.g., I am treating you with ondansetron)

03

The brand name of the reference product regardless of whether a generic drug is prescribed (e.g., I am treating you with a generic version of Zofran)

04

The brand name together with the nonproprietary name (e.g., I am treating you with Zofran, also known as ondansetron)

05

The nonproprietary name along with the name of the drug maker (e.g., I am treating you with ondansetron by Novartis)

06

Terms related to the mechanism of action or indication of use (e.g., I am treating you with a medicine that helps prevent nausea)

-99

Refused


Q4. In your experience how do patients most often refer to the medicines they are taking? [Single punch]


Value

Label

01

The brand name of the medicine (e.g., I need a refill for Zofran)

02

The nonproprietary (generic) name of the medicine (e.g., I need a refill for ondansetron)

03

The brand name and nonproprietary name together (e.g., I need a refill for Zofran, or ondansetron)

04

The nonproprietary name along with the name of the drug maker (e.g., I need a refill for Novartis’ ondansetron)

05

Terms related to the mechanism of action or indication of use (e.g., I need a refill for my medicine for nausea)

06

Terms related to the physical characteristics of the medication or packaging (e.g., I need a refill for my blue and yellow pills)

-99

Refused


Q5. For biological medicines, please indicate how biological medicines are obtained and administered to your patients. Please choose all that apply. [Multi punch]


Value

Label

01

I prescribe the biological medicine to patients; they pick the medicine up from a specialty pharmacy and return to a clinic for the medicine to be administered.

02

I prescribe the biological medicine to patients; they pick the medicine up from a specialty pharmacy, and administer the medicine at home.

03

I (or my staff) order biological medicines into my clinic and then administer to the patients during clinic visits.

04

I prescribe the biological medicine to patients; they pick the medicine up from a pharmacy and return to a clinic for the initial doses of the medicine to be administered. Patients may administer subsequent doses at home.

05

I prescribe the biological medicine to patients; they obtain and administer the biological medicines through other means.

06

I prescribe the biological medicine to patients; a specialty pharmacy sends it to an infusion center to be administered to patients.

-99

Refused


Q6. If you (or your staff) procure, store, and administer biological medicines in your clinic or office, how do you generally procure the biological medicines? Please choose all that apply. [Multi punch]


Value

Label

01

For individual patients as the need arises

02

In bulk, to have ready for patients who are likely to present with a need for these medicines

03

A combination of bulk ordering and individual-specific ordering depending on the medicine

04

Not applicable to my practice

-99

Refused



Q7. If you (or your staff) procure, store, and administer medicines in your clinic or office, how do you order specific biological medicines for use in your clinic? Please choose all that apply. [Multi punch]


Value

Label

01

National Drug Code (NDC)

02

Brand name

03

Nonproprietary name

04

Other (please specify)

05

Not sure

06

Not applicable to my practice

-99

Refused



SECTION II: Impressions of biosimilar naming: unaided and aided questions


PROGRAMMER NOTE: For Q8 – Q15, pipe in appropriate information based on provider specialty. Note that the nonproprietary names should appear in parentheses after the brand names. Half of the respondents within each specialty will be randomized to receive the survey with the nonproprietary name for Junexant piped from A1 and other half the nonproprietary name for Junexant will be piped from A2.


Specialty

A1

Junexant

(with suffix)

A2

Junexant

(without suffix)

B

Nexsymeo


C

Indication

Rheumatology


denliximab-ghvb

denliximab

denliximab-kbcn

rheumatoid arthritis


Dermatology

denliximab-ghvb

denliximab

denliximab-kbcn

plaque psoriasis


Gastroenterology


denliximab-ghvb

denliximab

denliximab-kbcn

adult Crohn’s Disease


Oncology


alodripsim-ghvb

alodripsim

alodripsim-kbcn

treatment of neutropenia

Hematology


alodripsim-ghvb

alodripsim

alodripsim-kbcn

treatment of neutropenia

Nephrology

esalamin-ghvb

alodripsim

esalamin-kbcn

treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and patients not on dialysis


Q8. Suppose Junexant ([A1 or A2: pipe in based on specialty and randomization]) is a biological product that is approved for [C: pipe in based on specialty]. Recently, a new biological product Nexsymeo ([B: pipe in based on specialty]) was introduced into the market after receiving FDA approval.


Based only on the information presented above, how certain are you that the new Nexsymeo ([B: pipe in based on specialty]) product and Junexant ([A1 or A2: pipe in based on specialty and randomization]) will …? [Grid]


PROGRAMMER NOTE: Randomize A through F, same order for Q8 and Q9.


Q8A. Have the same active ingredient

Q8B. Have one or more of the same FDA-approved indications in common

Q8C. Have common route(s) of administration

Q8D. Have the same expected clinical performance (i.e., safety and efficacy)

Q8E. Have the same mechanism of action

Q8F. Have the same dosing


Value

Label

01

Completely certain

02

Very certain

03

Somewhat certain

04

Not certain at all

-99

Refused


Q9. Assume you prescribe Junexant ([A1 or A2: pipe in based on specialty and randomization]) frequently in your practice. You research the new Nexsymeo ([B: pipe in based on specialty]) product, which is approved by the FDA as a biosimilar to Junexant for ([C: pipe in based on specialty]) . “Biosimilar” means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. A biosimilar product must also have the same strength, route of administration, and dosage form as the reference product, and its conditions of use (e.g., indications) must have been previously approved for the reference product.


In order for your patients to receive the biosimilar product, you must expressly prescribe “[B: pipe in based on specialty]” or Nexsymeo.

Considering the information above, how certain are you that the new Nexsymeo ([B: pipe in based on specialty]) product and Junexant ([A1 or A2: pipe in based on specialty and randomization]) will…? [Grid]


PROGRAMMER NOTE: Randomize A through F, same order for Q8 and Q9.


Q9A. Have the same active ingredient

Q9B. Have one or more of the same FDA-approved indications in common

Q9C. Have common route(s) of administration

Q9D. Have the same expected clinical performance (i.e., safety and efficacy)

Q9E. Have the same mechanism of action

Q9F. Have the same dosing


Value

Label

01

Completely certain

02

Very certain

03

Somewhat certain

04

Not certain at all

-99

Refused




//NEW SCREEN//


For the following set of questions, you will be presented with a set of treatment scenarios. For each, we ask that you consider the information presented as you make your decision about which drug therapy you would prescribe. When choosing your answers, we urge you to respond as if you were actually selecting a drug for a patient.


PROGRAMMER NOTE: For Q10-Q15, piped values should be labeled as A1: Junexant with suffix, A2: Junexant without suffix, and B: Nexsymeo


Use table below for Q10–Q11.


Specialty

A1

Junexant)

(with suffix)

A2

Junexant

(without suffix)

B

Nexsymeo

D

New Patient Scenario

Rheumatology


denliximab-ghvb

denliximab

denliximab-kbcn

Your new patient with rheumatoid arthritis:

  • Is symptomatic with moderately active disease

  • Would benefit from treatment with a TNF inhibitor

Dermatology


denliximab-ghvb

denliximab

denliximab-kbcn

Your new patient has:

  • Chronic and severe plaque psoriasis

  • Is a good candidate for systemic therapy with a TNF inhibitor

Gastroenterology


denliximab-ghvb

denliximab

denliximab-kbcn

Your new adult patient with moderately active Crohn’s disease:

  • Has had an inadequate response to conventional therapy

  • Would benefit from a TNF inhibitor

Oncology


alodripsim-ghvb

alodripsim

alodripsim-kbcn

Your new patient with cancer:

  • Is neutropenic following treatment with chemotherapy

  • She needs treatment in order to continue chemotherapy 

Hematology


alodripsim-ghvb

alodripsim

alodripsim-kbcn

Your new patient with cancer:

  • Is neutropenic following treatment with chemotherapy

  • She needs treatment in order to continue chemotherapy

Nephrology


esalamin-ghvb

esalamin

esalamin-kbcn

Your adult patient with end-stage renal disease requiring hemodialysis:

  • Has a hemoglobin level that would be appropriate for treatment with an erythropoiesis stimulating agent



//NEW SCREEN//


Q10. [D: pipe in based on specialty] Consider the circumstances below, and select the therapy you are more likely to prescribe. [Single punch]


Biologic:

Junexant ([A1 or A2: pipe in based on specialty and randomization])

Nexsymeo ([B: pipe in based on specialty])

Prescription history:

You have prescribed it before

Recently introduced; you have not prescribed it before

Formulary status:

On formulary

On formulary

Method of Delivery:

Same

Indications:

Same


In this situation I would prescribe:


Value

Label

01

Junexant ([A1 or A2: pipe in based on specialty and randomization])

02

Nexsymeo ([B: pipe in based on specialty])

-99

Refused



Q11. Now, again consider the same new patient and products, except now the formulary lists Nexsymeo ([B: pipe in based on specialty]), not Junexant ([A1 or A2: pipe in based on specialty and randomization]). Consider the circumstances below, and select the therapy you are more likely to prescribe. [Single punch]


Biologic:

Junexant ([A1 or A2: pipe in based on specialty and randomization])

Nexsymeo ([B: pipe in based on specialty])

Prescription history:

You have prescribed it before

Recently introduced; you have not prescribed it before

Formulary status:

NOT on formulary; higher out-of-pocket for patient

On formulary; lower out-of-pocket for patient

Method of Delivery:

Same

Indications:

Same


In this situation, I would prescribe:


Value

Label

01

Junexant ([A1 or A2: pipe in based on specialty and randomization])

02

Nexsymeo ([B: pipe in based on specialty])

-99

Refused


PROGRAMMER NOTE: Use table below for Q12-Q13.


Specialty

A1

Junexant

(with suffix)

A2

Junexant

(without suffix)

B

Nexsymeo

E

Existing Patient Scenario

Rheumatology


denliximab-ghvb

denliximab

denliximab-kbcn

  • Has rheumatoid arthritis

  • Is symptomatic with moderately active disease

  • Has been treated with Junexant (denliximab-ghvb) previously and tolerated it well

  • This patient would benefit from an anti-TNF inhibitor

Dermatology


denliximab-ghvb

denliximab

denl.iximab-kbcn

  • Has chronic and severe plaque psoriasis

  • Has been treated with Junexant (denliximab-ghvb) previously and tolerated it well

  • This patient would benefit from an anti-TNF inhibitor

Gastroenterology


denliximab-ghvb

denliximab

denliximab-kbcn

  • Has moderately active Crohn’s disease

  • Has been treated with Junexant (denliximab-ghvb) previously and tolerated it well

  • This patient would benefit from an anti-TNF inhibitor

Oncology


alodripsim-ghvb

alodripsim

alodripsim-kbcn

  • Is neutropenic following treatment with chemotherapy

  • The patient was treated with Junexant (alodripstim-ghvb) during a previous cycle of chemotherapy, and tolerated the therapy well

  • The patient needs treatment in order to continue chemotherapy

Hematology


alodripsim-ghvb

alodripsim

alodripsim-kbcn

  • Is neutropenic following treatment with chemotherapy

  • The patient was treated with Junexant (alodripstim-ghvb) during a previous cycle of chemotherapy, and tolerated the therapy well

  • The patient needs treatment in order to continue chemotherapy

Nephrology


esalamin-ghvb

esalamin

esalamin-kbcn

  • Has end-stage renal disease requiring hemodialysis

  • Has a hemoglobin level that would be appropriate for treatment with an erythropoiesis stimulating agent

  • The patient has been treated with Junexant (alodripsim-ghvb) previously and tolerated it well


Q12. Next, please consider an existing patient who: [E: pipe in based on specialty] Consider the circumstances below, and select the therapy you are more likely to prescribe. [Single punch]


Biologic:

Junexant ([A1 or A2: pipe in based on specialty and randomization])

Nexsymeo ([B: pipe in based on specialty])

Prescription history:

You have prescribed it before to this patient.

Recently introduced; you have not prescribed it before to this patient

Formulary status:

On formulary

On formulary

Method of Delivery:

Same

Indications:

Same


In this situation I would prescribe:

Value

Label

01

Junexant ([A1 or A2: pipe in based on specialty and randomization])

02

Nexsymeo ([B: pipe in based on specialty])

-99

Refused



Q13. Now, consider the same existing patient and products, except now the formulary lists Nexsymeo ([B: pipe in based on specialty]), not Junexant ([A1 or A2: pipe in based on specialty and randomization]). Consider the circumstances below, and select the therapy you are more likely to prescribe. [Single punch]


Biologic:

Junexant ([A1 or A2: pipe in based on specialty and randomization])

Nexsymeo ([B: pipe in based on specialty])

Prescription history:

You have prescribed it before to this patient

Recently introduced; you have not prescribed it before to this patient

Formulary status:

NOT on formulary; higher out-of-pocket for patient

On formulary; lower out-of-pocket for patient

Method of Delivery:

Same

Indications:

Same


In this situation I would prescribe:


Value

Label

01

Junexant ([A1 or A2: pipe in based on specialty and randomization])

02

Nexsymeo ([B: pipe in based on specialty])

-99

Refused



PROGRAMMER NOTE: Use table below for Q14.


Specialty

A1

Junexant

(with suffix)

A2

Junexant

(without suffix)

B

Nexsymeo

F

Junexant Presentations

G

Nexsymeo Presentation

Rheumatology


denliximab-ghvb

denliximab

denliximab-kbcn

  • IV infusion: Single-dose vial

  • Subcutaneous injection: prefilled syringe or auto-injector

  • IV infusion: Single-dose vial

  • Subcutaneous injection: prefilled syringe


Dermatology


denliximab-ghvb

denliximab

denliximab-kbcn

  • IV infusion: Single-dose vial

  • Subcutaneous injection: prefilled syringe or auto-injector

  • IV infusion: Single-dose vial

  • Subcutaneous injection: prefilled syringe

Gastroenterology


denliximab-ghvb

denliximab

denliximab-kbcn

  • IV infusion: Single-dose vial

  • Subcutaneous injection: prefilled syringe or auto-injector

  • IV infusion: Single-dose vial

  • Subcutaneous injection: prefilled syringe

Oncology


alodripsim-ghvb

alodripsim

alodripsim-kbcn

  • IV infusion : Single-dose vial

  • Subcutaneous injection: prefilled syringe or single-dose vial

  • IV infusion : Single-dose vial

  • Subcutaneous injection: Single-dose vial


Hematology


alodripsim-ghvb

alodripsim

alodripsim-kbcn

  • IV infusion : Single-dose vial

  • Subcutaneous injection: prefilled syringe

  • IV infusion : Single-dose vial

  • Subcutaneous injection: Single-dose vial


Nephrology


esalamin-ghvb

esalamin

esalamin-kbcn

  • IV infusion : Single-dose vial

  • Subcutaneous: prefilled syringe or single-dose vial

  • IV infusion : Single-dose vial

  • Subcutaneous injection: Single-dose vial



Q14. Now, consider the same existing patient and products, except that one product has fewer approved presentations (i.e. method of delivery). Both medications are approved for the same indications and approved for the same routes of administration. Consider the circumstances below, and select the therapy you are more likely to prescribe. [Single punch]


Biologic:

Junexant ([A1 or A2: pipe in based on specialty and randomization])

Nexsymeo ([B: pipe in based on specialty])

Prescription history:

You have prescribed it before

Recently introduced; you have not prescribed it before

Formulary status:

On formulary

On formulary

Method of Delivery:

[F: pipe in based on specialty]

[G: pipe in based on specialty]

Indications:

Same


In this situation I would prescribe:


Value

Label

01

Junexant ([A1 or A2: pipe in based on specialty and randomization])

02

Nexsymeo ([B: pipe in based on specialty])

-99

Refused



PROGRAMMER NOTE: Use table below for Q15.


Specialty

A1

Junexant

(with suffix

A2

Junexant

(without suffix)

B

Nexsymeo

H

Junexant Indication

J

Nexsymeo Indication

Rheumatology


denliximab-ghvb

denliximab

denliximab-kbcn

  • Rheumatoid Arthritis

  • Juvenile Idiopathic Arthritis

  • Psoriatic Arthritis

  • Rheumatoid Arthritis


Dermatology


denliximab-ghvb

denliximab

denliximab-kbcn

  • Plaque Psoriasis

  • Hidradenitis Suppurativa

  • Uveitis

  • Plaque Psoriasis


Gastroenterology


denliximab-ghvb

denliximab

denliximab-kbcn

  • Adult Crohn’s Disease

  • Pediatric Crohn’s Disease

  • Ulcerative Colitis

  • Adult Crohn’s Disease


Oncology


alodripsim-ghvb

alodripsim

alodripsim-kbcn

  • Treatment of neutropenia

  • Mobilization of stem cells

  • Treatment of neutropenia

Hematology


alodripsim-ghvb

alodripsim

alodripsim-kbcn

  • Treatment of neutropenia

  • Mobilization of stem cells

  • Treatment of neutropenia

Nephrology


esalamin-ghvb

esalamin

esalamin-kbcn

  • Treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and patients not on dialysis

  • Reduction of allogeneic blood transfusion in surgery patients


  • Treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and patients not on dialysis



Q15. Now, consider the same existing patient and products, except that one product has fewer approved indications. Both medications are approved for the indication your patient presents with and have the same routes of administration. Consider the circumstances below, and select the therapy you are more likely to prescribe. [Single punch]


Biologic:

Junexant ([A1 or A2: pipe in based on specialty and randomization])

Nexsymeo ([B: pipe in based on specialty])

Prescription history:

You have prescribed it before

Recently introduced; you have not prescribed it before

Formulary status:

On formulary

On formulary

Method of Delivery:

Same

Indications:

[H: pipe in based on specialty]

[J: pipe in based on specialty]


In this situation I would prescribe:


Value

Label

01

Junexant ([A1 or A2: pipe in based on specialty and randomization])

02

Nexsymeo ([B: pipe in based on specialty])

-99

Refused



PROGRAMMER NOTE: Use table below for Q16.


Specialty

A1

Junexant

(with suffix)

A2

Junexant

(without suffix)

B

Nexsymeo

K

Therapy type

Rheumatology


denliximab-ghvb

denliximab

denliximab-kbcn

denliximab

Dermatology


denliximab-ghvb

denliximab

denliximab-kbcn

denliximab

Gastroenterology


denliximab-ghvb

denliximab

denliximab-kbcn

denliximab

Oncology


alodripsim-ghvb

alodripsim

alodripsim-kbcn

alodripsim

Hematology


alodripsim-ghvb

alodripsim

alodripsim-kbcn

alodripsim

Nephrology


esalamin-ghvb

esalamin

esalamin-kbcn

esalamin


Q16. Imagine your institution or patient’s formulary recently added the biosimilar Nexsymeo ([B: pipe in based on specialty]) as a preferred product on formulary instead of Junexant ([A1 or A2: pipe in based on specialty and randomization]). For each of the following patients, indicate how likely you would be to pursue a prior authorization or formulary exception for treatment with Junexant ([A1 or A2: pipe in based on specialty and randomization]) instead of Nexsymeo ([B: pipe in based on specialty]). [Grid]


Q16A. Patients new to [A1 or A2: pipe in based on specialty and randomization].

Q16B. Patients currently treated with Junexant ([A1 or A2: pipe in based on specialty and randomization]) successfully with no tolerability issues.

Q16C. Patients currently treated with Junexant ([A1 or A2: pipe in based on specialty and randomization]) successfully with minor tolerability issues.

Q16D. Patients currently treated with Junexant ([A1 or A2: pipe in based on specialty and randomization]) successfully with moderate to major tolerability issues.


Value

Label

01

Very likely

02

Likely

03

Neither likely nor unlikely

04

Unlikely

05

Very unlikely

-99

Refused




Q17. Please indicate how strongly each consideration would influence your willingness to try the new biosimilar Nexsymeo ([B: pipe in based on specialty]) for your patients. [Grid]


[Randomize A through L; “Other” appears last]


Q17A. Recommendations of colleagues in your field.

Q17B. Education on the type of information and analysis the FDA uses to conclude products are highly similar, including the availability of summaries that describe the analytic and clinical evidence used in the approval of this particular product.

Q17C. Confidence in specific, timely and accurate pharmacovigilance to monitor the safety of these products.

Q17D. Clarity of the labeling and package insert.

Q17E. Differences between the nonproprietary names of the biosimilar and reference products.

Q17F. The ability to identify which product is dispensed to the patient.

Q17G. Financial savings to the patient.

Q17H. Financial implications to me/my practice related to insurance reimbursement rates.

Q17I. Prior authorization (e.g. paperwork required for the patient to receive therapy).

Q17J. The patient experience with Junexant ([A1 or A2: pipe in based on specialty and randomization]).

Q17K. Patients’ interest in trying a biosimilar similar to Junexant ([A1 or A2: pipe in based on specialty and randomization).

Q17L. Institutional preference.

Q17M. Varying clinical situations.


Other; please describe what other factors would influence your decision making:

Q17M1. Factor 1:________________________________

Q17M2. Factor 2:­­­­­­­­­­­­­­­­­­­________________________________

Q17M3. Factor 3:­­­­­­­­­­­­­­­­­­­________________________________


[Participants should be able to rate influence level for any “other” entries.]


Value

Label

01

1 - No influence at all

02

2

03

3

04

4

05

5 – Strong influence

-99

Refused


Q17BIO. Please indicate how strongly you agree or disagree with the following statement:


I would never prescribe a biosimilar. [Single Punch]


Value

Label

01

Strongly agree

02

Agree

03

Neither agree nor disagree

04

Disagree

05

Strongly disagree

-99

Refused


Q18. Please indicate how strongly you agree or disagree with the following items: [Grid]


[Randomize A through G]


Q18A. I answered the questions as if I were actually prescribing these biologics.

Q18B. I prefer to prescribe products I have experience prescribing, rather than new products.

Q18C. I am less likely to prescribe biosimilar products than reference biologics.

Q18D. I anticipate biosimilar products will be less expensive for my patients.

Q18E. I am waiting until biosimilar products have been on the market longer before I prescribe them.

Q18F. I am more likely to prescribe biosimilar products than reference biologics.

Q18G. In general, for my patients, I specify “Dispense as Written” to ensure dispensing of the intended biological product.


Value

Label

01

Strongly agree

02

Agree

03

Neither agree nor disagree

04

Disagree

05

Strongly disagree

-99

Refused




SECTION III: Overall Impressions of Naming Scheme


[Randomize order of Q19, 20]


Q19. How often is it reported to you that a patient received a different medicine than the one you had intended? [Single punch]


Value

Label

01

Always

02

Frequently

03

Occasionally

04

Seldom

05

Never

06

Don’t know

-99

Refused



Q20. Suffixes incorporated in nonproprietary names of biological products… [Grid]


Q20A. Allow me to ensure my patient gets the product I intended.

Q20B. Facilitate tracking any adverse events to a specific product.

Q20C. Make prescribing burdensome.

Q20D. Make prescribing confusing.


Value

Label

01

Strongly agree

02

Agree

03

Neither agree nor disagree

04

Disagree

05

Strongly disagree

06

Don’t know

-99

Refused


SECTION IV: Impact of Biological Naming on Communication


PROGRAMMER NOTE: Use table below for Q21–Q23.


Specialty

A1

Junexant

(with suffix)

A2

Junexant

(without suffix)

B

Nexsymeo

K

Therapy type

Rheumatology


denliximab-ghvb

denliximab

denliximab-kbcn

denliximab

Dermatology


denliximab-ghvb

denliximab

denliximab-kbcn

denliximab

Gastroenterology


denliximab-ghvb

denliximab

denliximab-kbcn

denliximab

Oncology


alodripsim-ghvb

alodripsim

alodripsim-kbcn

alodripsim

Hematology


alodripsim-ghvb

alodripsim

alodripsim-kbcn

alodripsim

Nephrology


esalamin-ghvb

esalamin

esalamin-kbcn

esalamin



Q21. In your practice, what terminology would you anticipate using most often to prescribe biosimilar biological products? Select one. [Single punch]


[Randomize A through F; G (“Other”) appears last]


Text in blue should appear in blue on screen. Blue text can be omitted from variable labels in data set so that we have standard labels across specialties.


Value

Label

01

The brand name of the product you want your patient to receive if the product has one (e.g., Junexant, Nexsymeo).

02

The nonproprietary name of the product including the suffix (e.g., [A1 or A2: pipe in based on specialty and randomization] or [B: pipe in based on specialty]).

03

The nonproprietary name of the product excluding the suffix (e.g., [K: pipe in based on specialty]).

04

Both the brand name, if the product has a brand name, and nonproprietary name, including suffix (e.g., Junexant ([A1 or A2: pipe in based on specialty and randomization]) or Nexsymeo ([B: pipe in based on specialty]).)

05

The drug substance name along with the name of the drug maker (e.g., “Ghyra’s [K: pipe in based on specialty] product”).

06

The brand name of the reference product (e.g., Junexant or “a biosimilar to Junexant”).

07

Other (please describe)

-99

Refused



Q22. As more biosimilar biological products are introduced, how do you anticipate that you or your staff will record the name of the prescribed medicine in the patient health record? [Single punch]


[Randomize A through E; F (“Other”) appears last]


Text in blue should appear in blue on screen. Blue text can be omitted from variable labels in data set so that we have standard labels across specialties.


Value

Label

01

The brand name of the product you prescribed, if the product has one (e.g., Junexant or Nexsymeo).

02

The nonproprietary name of the product including any suffix (e.g., [A1 or A2: pipe in based on specialty and randomization] or [B: pipe in based on specialty]).

03

The nonproprietary name of the product excluding any suffix (e.g., [K: pipe in based on specialty]).

04

Both the brand name, if the product has a brand name, and nonproprietary name (e.g., Junexant ([A1 or A2: pipe in based on specialty and randomization]) or Nexsymeo ([B: pipe in based on specialty])).

05

The nonproprietary name along with the name of the drug maker (e.g., “Ghyra’s [K: pipe in based on specialty] product”).

06

Other

-99

Refused



Q23. As more biosimilar biological products are introduced, how do you anticipate that you or your staff will record the names of biological medicines administered at your office or clinic in the patient health record? [Single punch]


[Randomize A through E; F (“Other”) and G (“Not applicable”) appear last]


Text in blue should appear in blue on screen. Blue text can be omitted from variable labels in data set so that we have standard labels across specialties.


Value

Label

01

The brand name of the product you prescribed, if the product has one (e.g., Junexant or Nexsymeo).

02

The nonproprietary name of the product including any suffix (e.g., [A1 or A2: pipe in based on specialty and randomization] or [B: pipe in based on specialty]).

03

The nonproprietary name of the product excluding any suffix (e.g., [K: pipe in based on specialty]).

04

Both the brand name, if the product has a brand name, and nonproprietary name (e.g., Junexant ([A1 or A2: pipe in based on specialty and randomization]) or Nexsymeo ([B: pipe in based on specialty])).

05

The nonproprietary name along with the name of the drug maker (e.g., “Ghyra’s [K: pipe in based on specialty] product”).

06

Other

07

Not applicable (Neither my staff nor I administer medicines)

-99

Refused



Q24. Have you ever prescribed a biosimilar? Examples of FDA-approved biosimilars currently on the market are Renflexis (infliximab-abda), Inflectra (infliximab-dyyb), Zarxio (filgrastim-sndz), Retacrit (epoetin alfa-epbx), and Fulphila (pegfilgrastim-jmdb). [Single punch]


Value

Label

01

Yes

02

No

03

Unsure

-99

Refused



Closing/Debrief


Thank you for your participation in this study; we appreciate your time and effort. Your participation helps the U.S. Department of Health and Human Services and FDA learn more about how health care providers think and communicate about biosimilar drug products.


The drug names that you saw today were created for the purposes of this study and are not for real prescription drugs.


File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorTaylor, Kellie
File Modified0000-00-00
File Created2021-01-15

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