Form CMS-10847 Negotiation Data Elements Form

Information Collection Request (ICR) Form for Negotiation Data Elements under Sections
11001 and 11002 of the Inflation Reduction Act (IRA) (CMS-10847, OMB 0938-NEW)
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 covered under Medicare Part B and Part D (“selected
drug”). 1 For the first year of the Negotiation Program, CMS will select 10 Part D high
expenditure, single source drugs for negotiation. The MFPs that are negotiated for these drugs
will apply beginning in initial price applicability year 2026. The negotiation period for initial
price applicability year 2026 begins October 1, 2023, or when the manufacturer of a selected
drug enters into a Medicare Drug Price Negotiation Program Agreement with CMS, whichever is
sooner. Section 1194(e) of the Act requires CMS to consider two sets of factors as the basis for
determining the offer and counteroffer throughout the negotiation process: (1) certain data that
must be submitted by the manufacturer of each drug selected for negotiation and (2) evidence
about alternative treatments, as available, with respect to each selected drug and therapeutic
alternative(s) for each selected drug.
In accordance with section 1193(a)(4) and section 1194(b)(2) of the Act, the manufacturer must
submit, in a form and manner specified by CMS, information on the non-Federal average
manufacturer price (“non-FAMP”) for the selected drug as defined in 38 U.S.C. § 8126(h)(5) 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 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).
For the purposes of this Information Collection Request (ICR), a selected drug for initial price
applicability year 2026 is defined as a drug included on the selected drug list published by CMS
by September 1, 2023. In section 1191(c)(1) of the Act, the statute adopts the definition of
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. 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 2026, 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”).
Likewise, for initial price applicability year 2026, 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
Hereinafter, “drug” includes drugs and biologics pursuant to the definition of a “qualifying single source drug” at
section 1192(e)(1) of the Act.

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the selected drug pursuant to an agreement with the Primary Manufacturer as a “Secondary
Manufacturer.” Secondary Manufacturers would include any manufacturer of any authorized
generics and any repackager or relabeler of the selected drug that meet these criteria.
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 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 per section 1194(e)(2) (see the supporting statement for further details).
Note: This ICR focuses on information required for selected drugs for initial price applicability
year 2026.
General Instructions
Overview
The Primary Manufacturer of each selected drug must complete Sections A through H for each
of its selected drug(s), which are specifically:
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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.

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 consumers, Part D plan sponsors and Medicare Advantage
organizations, Primary 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 (CMS HPMS). Instructions for Primary Manufacturers to gain access
to CMS HPMS to submit data related to Sections A through J will be available at:

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https://www.cms.gov/Research-Statistics-Data-and-Systems/Computer-Data-andSystems/HPMS/UserIDProcess.
All respondents who are not Primary Manufacturers will use a separate user-friendly 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 publicly accessible CMS HPMS landing page 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 forthcoming from CMS and made
available on CMS.gov. Submissions may not be saved for work completed in progress.
Technical assistance for Primary Manufacturers and other interested parties will also be made
available.
Additional Instructions
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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 the Medicare Drug Price Negotiation Program:
Revised Memorandum, Implementation of Sections 1191 – 1198 of the Social Security
Act for Initial Price Applicability Year 2026 (“the revised guidance”), the term’s
definition in this ICR is the same as in the revised guidance.
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 unless the
specific instructions for a question state otherwise. 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.
Respond “not applicable” to any question in Sections A to G and I that does not apply to
the selected drug (or therapeutic alternative, as applicable, in Section I).
Certification is required for submissions. Section H includes the Certification of
Submission of Sections A through G for Primary Manufacturers. Section J includes the
Certification of Submission of Section I for all respondents.
For Sections A through G of this form, CMS will pre-populate or 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.
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 I
(e.g., # to indicate a numerical response is required).
If the instruction for a particular response field indicates no explanation is necessary and
no voluntary explanation is being provided, please include “not applicable (N/A)” in the
free response field.
Primary Manufacturers must timely notify CMS if any of the information submitted
changes after the initial submission of data.
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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
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 an explanation of the standard used if it is inconsistent with GAAP.
• When calculating monetary values, assume at most an 8.1 percent annual cost of capital
for purposes of applying an adjustment. 2 If a Primary Manufacturer uses a cost of capital
adjustment below 8.1 percent, that amount must be used.
• Monetary amounts must be reported in United States dollars (USD) and include two
decimal places (i.e., dollars and cents).
• When converting another currency to USD, use the exchange rate applicable at the time
the costs were incurred. The Internal Revenue Service (IRS) website lists government
and external sources where historical exchange rates can be found to the day. 3 If the exact
date of a sale or conversion is not known, use the yearly average exchange rate for that
currency for the year the costs were incurred. 4 In the free response field, report the
amount, the currency, the exchange rate, and time period(s) used in this calculation.
• Do not count 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. As applicable,
in the free response field, specify the applicable time period for a specific question (e.g.,
calendar quarter, calendar year) and report the cost and revenue per each applicable time
period. CMS will make the relevant inflation adjustments, as necessary.
A. Selected Drug Information
Primary Manufacturer Response Required
In Section A, for each selected drug for initial price applicability year 2026, 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 revised guidance, meaning those NDC-11s of the selected drug that:
(1) had Part D PDE utilization in the 12-month period beginning June 1, 2022 and ending
May 31, 2023, or
(2) which CMS believes are likely to have Part D PDE utilization in the future (for
example, NDC-11s associated with recently approved NDAs / BLAs).

2
Most studies on research and development (R&D) costs apply a cost-of-capital adjustment to each company’s
R&D spending to reflect the lag between investment and return on investment. The use of 8.1 percent is consistent
with assumptions used by the Congressional Budget Office, see “Research and Development in the Pharmaceutical
Industry,” CBO (April 2021), available at https://www.cbo.gov/publication/57126.
3
See: https://www.irs.gov/individuals/international-taxpayers/foreign-currency-and-currency-exchange-rates.
4
See: https://www.irs.gov/individuals/international-taxpayers/yearly-average-currency-exchange-rates.

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CMS will populate the CMS HPMS with the Dosage Form, Strength, Unit, and Labeler Code for
each NDC-11 of the selected drug, including any NDC-11s that are marked as “discontinued”.
CMS will update this list as necessary (e.g., based on supplements from the Primary
Manufacturer or other updates).
Instructions for Section A:
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Please indicate whether:
(1) any NDC-11s associated with the NDA(s)/BLA(s) of the selected drug 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,
(2) any of the listed NDC-11s or additional NDC-11s are marketed or controlled solely
by a manufacturer that is not the Primary Manufacturer or Secondary Manufacturer,
and
(3) any of the listed NDC-11s or additional NDC-11s have been discontinued.

Product
Name

NDC-11 Marketed or Discontinued
Numbers Controlled
(Check box if
Solely by a
discontinued)
Manufacturer
that is not the
Primary or
Secondary
Manufacturer

Dosage Strength Unit
Form
(e.g.,
(e.g.,
mg)
tablet)

Labeler
Code

Text to be
prepopulated
by CMS

Numbers Yes/No
to be prepopulated
by CMS

Text

#

Check Box

#

Text

*Primary Manufacturer to add rows and identify any NDC-11s of the selected drug that are not
pre-populated by CMS
A Primary Manufacturer must report to CMS in writing any new NDC-11s of the selected drug
at least 30 days prior to their first marketed date for any Primary Manufacturer or any Secondary
Manufacturer(s) of such selected drug. The Primary Manufacturer also must report to CMS in
writing the delisting of any NDC-11 of the selected drug that is no longer marketed by the
Primary Manufacturer or any Secondary Manufacturer(s) within 30 days after its discontinuation.
B. Non-FAMP Data Collection
Primary Manufacturer Response Required
For Section B, the Primary Manufacturer is required to report the non-Federal average
manufacturer price (non-FAMP) for its selected drug(s) for calendar year 2021 (or, in the case
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that there is not an average non-FAMP available for such selected drug for calendar year 2021,
for the first full year following the market entry for such drug).
CMS plans to use the reported NDC-11s, quarterly non-FAMP, and total package unit volume in
the table below to calculate the average non-FAMP for calendar year 2021 for initial price
applicability year 2026.
Definitions for Section B:
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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. 5 For initial price
applicability year 2026, these are the quarters of 2021. 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 (or the first full year following
market entry of such drug, when applicable) for a given NDC-11 of such drug, the nonFAMP reported by the 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) 2023 Updated Guidance for Calculation of
Federal Ceiling Prices (FCPs) for New Drugs subject to Public Law 102-585. Any
restatements of the non-FAMP made in any manufacturer non-FAMP submissions to the
VA must be reflected in the non-FAMP submitted to CMS.
Non-FAMP unit: Non-FAMP unit is the package unit as described in 38 U.S.C. §
8126(h)(6).
Non-FAMP dosage form unit: The non-FAMP dosage form unit is the dosage form of the
NDC that is reported in the “Dose form” field of the Excel workbook used by the Office
of Pharmacy Benefits Management Services at the VA to collect non-FAMP information.

Instructions for Section B:
Please follow the instructions below when completing the following tables.
•

Please complete the table immediately below about the non-FAMP for each calendar
quarter of 2021 for the selected drug (or, in the case that there is not an average nonFAMP available for such drug for 2021, for calendar quarters for the first full year
following the market entry for such drug).

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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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Please report the non-FAMP and total package unit volume for each NDC-11 of the
selected drug. If an NDC-11 was not marketed, sold, or distributed in a particular
calendar quarter, enter the NDC-11 and quarter but enter “0” in the total package unit
volume field and leave the non-FAMP field blank.
Non-FAMP and total package unit volume information must be provided by the Primary
Manufacturer for its own NDC-11s and the NDC-11s 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) made in any
manufacturer non-FAMP submissions to the VA must be reflected in the table below.
Please indicate the total number of package units sold during the quarter and that are used
in the calculation of the non-FAMP in the total package unit volume field.
Please include the non-FAMP dosage form unit that will allow CMS to convert the
package unit to the National Council for Prescription Drug Programs (NCPDP) unit,
which is used for Part D prescription drug event (PDE) reporting, if the non-FAMP
dosage form unit is different from the NCPDP unit.

NDC-11
Text

Calendar
Quarter
QQYYYY

Total package
unit volume
#

Dosage form unit

Non-FAMP

Text

$

If the reported non-FAMP is for a calendar year other than 2021, the market entry date must be
provided in the free response field below. If necessary, describe assumptions, methodological
steps, and other information needed to interpret reported non-FAMP prices. If no explanation is
necessary, please include “not applicable (N/A)” in the free response field.
FIELD
Explanation of Non-FAMP Calculation

RESPONSE FORMAT
Text (1,000-word limit)

C. Research and Development (R&D) Costs and Recoupment
Primary Manufacturer Response Required
Section C contains five questions, related to different types of R&D costs incurred by the
Primary Manufacturer, including acquisition costs. Each of these questions requires the Primary
Manufacturer to report, as applicable: (1) dollar amounts for R&D costs, which must be reported
in the numerical response field and (2) explanations of how those costs were calculated in the
free response field. Section C also contains one question about the Primary Manufacturer’s
global and U.S. total lifetime net revenue for the selected drug. This question requires the
Primary Manufacturer to report, as applicable: (1) the dollar amount for global, total lifetime net
revenue, which must be reported in the numerical response field, (2) an explanation of how this
amount was calculated in the free response field, (3) the dollar amount for U.S. lifetime net
revenue, which must be reported in the numerical response field, and (4) an explanation of how
this amount was calculated in the free response field.
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Definitions for Section C:
R&D costs mean a combination of costs incurred by the Primary Manufacturer for all FDAapproved indications of a drug falling into the five categories below, and excluding the
following: (a) prior Federal financial support (see Question 9 in Section E), (b) costs associated
with applying for and receiving foreign approvals, and (c) costs associated with ongoing basic
pre-clinical research, clinical trials, and pending approvals:
1.
2.
3.
4.
5.

R&D: Acquisition Costs
R&D: Basic Pre-Clinical Research Costs
R&D: Post-Investigational New Drug (IND) Application Costs
R&D: Abandoned and Failed Drug Costs
R&D: All Other R&D Direct Costs

CMS is calculating recoupment of R&D costs using both the global and U.S. total lifetime net
revenue for the selected drug:
6. Recoupment: Global and U.S. Total Lifetime Net Revenue for the Selected Drug
The definitions and associated time periods for these terms are included below.
CMS is collecting costs only on FDA-approved indications of the drug up to the date the selected
drug appeared on the selected drug list for a price applicability year, unless otherwise specified.
Instructions for Section C:
Follow these instructions for Questions 1 through 6 when reporting R&D costs:
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For each dollar amount listed below, the Primary Manufacturer must report one dollar
amount in the numerical response field and a thorough explanation of the values,
including any calculations or conversions and any assumptions made.
All costs in this Section C are for FDA-approved indications of the selected drug, unless
otherwise specified. Do not report any costs for indications that are not labeled
indications.
All dollar figures submitted to CMS must be cash-outlay costs to the Primary
Manufacturer. They must exclude any costs to entities that are not the Primary
Manufacturer.
Reported costs for Questions 1 through 5 must be mutually exclusive for each question;
in other words, no costs must be counted in more than one section. Similarly, reported
costs for Questions 1 through 5 must be collectively exhaustive for all R&D costs; in
other words, all R&D costs that the Primary Manufacturer incurred for the selected drug
must be accounted for in Questions 1 through 5.
If the Primary Manufacturer received any prior Federal financial support, as defined in
Section E, for any of the costs listed in Questions 2 through 5 below (e.g., Basic
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 federal funding in
Questions 9, 10, and 11. Please reference Section E for instructions on reporting prior
Federal financial support.
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If the Primary Manufacturer shared the expenses described in Questions 1 through 5 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 must be included and reported in USD, costs associated
with applying for and receiving foreign approvals must not be included.

Question 1: Primary Manufacturer Acquisition Costs of the Selected Drug
Please provide the information below about acquisition costs incurred by the Primary
Manufacturer for the selected drug, as described in more detail below.
Definitions for Question 1:
For the sole purpose of data collection under section 1194(e)(1)(A) of the Act, acquisition costs
are defined as costs associated with the Primary Manufacturer’s purchase from another entity of
the rights to hold previously approved or future NDA(s) / BLA(s) of the selected drug.
Instructions for Question 1:
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First, report whether the Primary Manufacturer acquired the right to hold previously
approved or future NDA(s) / BLA(s) of the selected drug from another manufacturer.
If the response is No, please skip to Question 2.
If the response is Yes, please report the total costs of the acquisition(s) of the NDA(s) /
BLA(s) of the selected drug in the total acquisition costs for the selected drug field.
In situations where the total acquisition costs of the approved or future NDA(s) / BLA(s)
of the selected drug included costs other than for acquisition of the selected drug, please
(1) report those costs in the total acquisition costs field and (2) provide a proportional
allocation of the total acquisition costs for the selected drug in the total acquisition costs
for the selected drug field. In the free response field, please provide an explanation of the
allocation of total acquisition costs for the selected drug, as applicable. If this situation is
not relevant, please leave the total acquisition costs for the selected drug field blank.

RESPONSE FORMAT
Yes/No
FIELD
Total Acquisition Costs
Total Acquisition Costs for the Selected Drug
Explanation of Allocation of Total
Acquisition Costs for the Selected Drug

RESPONSE FORMAT
$
$
Text (1,000-word limit)
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Question 2: Basic Pre-Clinical Research for All Approved Indications of the Selected Drug
Provide the following information about total R&D costs incurred by the Primary Manufacturer
for all FDA-approved indications for the selected drug related to basic pre-clinical research, as
described in more detail below.
Definitions for Question 2:
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Basic pre-clinical research costs are defined as all discovery and pre-clinical
developmental costs incurred by the Primary Manufacturer with respect to the selected
drug during the basic pre-clinical research period and are the sum of (1) direct research
expenses and (2) the appropriate proportion of indirect research expenses (defined
below).
For each indication of the selected drug, the basic pre-clinical research period is defined
as the date of initial discovery or the date the Primary Manufacturer acquired the right to
hold the NDA(s) / BLA(s) of the selected drug (whichever is later) to the day before the
IND application for that indication of the selected drug went into effect. 6, 7 The basic preclinical research period may include both the initial research on the discovery of the
selected drug and basic pre-clinical research related to new applications of the selected
drug. If the length of the basic pre-clinical research period for the selected drug cannot be
calculated, use 52 months ending the day before the first IND application went into
effect. For example, if the selected drug had five IND applications that went into effect,
use the date of the first IND application that went into effect as the end date for the
52 month period. 8
Direct research costs are costs that can be specifically attributed to the discovery and preclinical development of the selected drug. Direct research expenses could include
personnel (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.
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

CMS acknowledges that the exact date of initial discovery might not be known, but manufacturers must use their
best estimate.
7
For the purposes of identifying the date the Primary Manufacturer acquired the right to hold the potential NDA(s) /
BLA(s) or NDA(s) / BLA(s) of the selected drug, use the earliest date of acquisition for any NDA / BLA of the
selected drug.
8
CMS believes that 52 months represents a solid average across studies. For example, one study reported that the
preclinical phase takes 52 months on average. See DiMasi, J, Hansen, R, Grabowski, H. The price of innovation:
new estimates of drug development costs. Journal of Health Economics. https://fds.duke.edu/db?attachment-25-1301-view-168. Another study estimated that the preclinical phase can take 31 months on average. See DiMasi, J,
Grabowski, H, Hansen, R. Innovation in the pharmaceutical industry: New estimates of R&D costs, Journal of
Health Economics, 2016, as cited by the Congressional Budget Office (CBO) in Research and Development in the
Pharmaceutical Industry, April 2021, https://www.cbo.gov/publication/57126. Other estimates have found that the
preclinical phase ranges from three to six years. See PhRMA, “Biopharmaceutical Research & Development: The
Process Behind New Medicines,” 2015, http://phrmadocs.phrma.org/sites/default/files/pdf/rd_brochure_022307.pdf.
6

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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 biologics. 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. 9, 10 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, then indirect costs should be allocated
proportionally, 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.
Instructions for Question 2:
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The amount reported for basic pre-clinical research in the numerical response field for
Question 2 must be the sum of (1) direct research expenses and (2) a proportion of
indirect research expenses.
o If the Primary Manufacturer acquired the right to hold the most recent NDA /
BLA of the selected drug after the last IND application submitted to the FDA
went into effect, please include “$0” for Question 2.
o If there were basic pre-clinical research costs after the Primary Manufacturer
acquired the right to hold the NDA(s) / BLA(s) of the selected drug, the basic preclinical research costs must be reported in the numerical response field.
In the free response field, list the direct research expenses and the indirect research
expenses for the selected drug, the percentage of direct and indirect spending on the
selected drug out of the total direct and indirect basic pre-clinical research costs, an
explanation of the values used in the indirect cost calculation, and a list of the activities
the Primary Manufacturer included in the direct research expenses and the indirect
research expenses.
In the free response field, identify the length of the basic pre-clinical research period,
which runs from: the date of initial discovery or the date the Primary Manufacturer
acquired the right to hold the first NDA / BLA of the selected drug, whichever is later, to
the day before the last IND application for an FDA-approved indication of the selected
drug went into effect.

FIELD
Basic Pre-Clinical Research Costs for All FDA-Approved
Indications of the Selected Drug
Explanation of Basic Pre-Clinical Research for All-Approved
Indications of the Selected Drug, Including Allocation and
Apportionment Methods

RESPONSE FORMAT
$
Text (2,500-word limit)

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.
10
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-care-programmethird-edition(e43f24cd-099a-4d56-97e6-6524afaa37d1)/export.html.
9

11

Question 3: Post-IND Costs for All Approved Indications of the Selected Drug
Please provide the following information on the direct costs incurred by the Primary
Manufacturer beginning on the day the IND went into effect for the first FDA-approved
indication for the selected drug through the date when the last FDA-required post-marketing trial
was completed for the selected drug. The Primary Manufacturer must report the direct costs for
all completed post-marketing trials for all FDA-approved indications of the selected drug. Do not
report costs for indications that are not labeled indications.
Definitions for Question 3:
•

•

•

Post-IND costs are defined as all 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 FDA-approved indication. Post-IND costs also include all direct
costs associated with completed FDA-required, post-marketing trials that are conducted
after the FDA has approved a product. Post-IND costs exclude FDA-required, postmarketing trials that were not completed.
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, and facility costs that are directly related to conducting the
dosing and Phase I, Phase II, and Phase III clinical trials during the post-IND period.
Direct post-IND costs also include patient recruitment, per-patient costs, research and
data collection costs, personnel, and facility costs that are directly related to conducting
the completed FDA-required, post-marketing trial.
The post-IND period begins on the day the IND went into effect for the first FDAapproved indication for the selected drug through the date when the last FDA-required
post-marketing trial was completed for the selected drug.

Instructions for Question 3:
•

•

The amount reported in the numerical response field must include all 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 FDA-approved indication.
o If the Primary Manufacturer acquired the right to hold the NDA(s) / BLA(s) of the
selected drug after all NDA(s) / BLAs were approved by the FDA for a selected
drug, do not include any costs for these trials in the numerical response field.
o If the Primary Manufacturer acquired the right to hold the NDA(s) / BLA(s) of the
selected drug and there were additional post-IND costs that followed the
acquisition and were incurred before the FDA approved the most recent FDAapproved indication, those costs may be reported in the numerical response field.
For example, if a Primary Manufacturer acquired the right to hold the NDA(s) /
BLA(s) of the selected drug during the Phase I trial for the most recent FDAapproved indication, it may report the costs of the trials that followed the
acquisition in the numerical response field.
In the numerical response field, report the direct costs for all completed, FDA-required
post-marketing trials for all FDA-approved indications of the selected drug.
12

•

•
•
•

o If the Primary Manufacturer acquired the right to hold the NDA(s) / BLA(s) of the
selected drug after FDA-required post-marketing trials were completed or if no
such post-marketing trials were completed for the selected drug, do not include
any costs for these post-marketing trials in the numerical response field.
The free response field must note if the selected drug received early approval (e.g.,
through the accelerated approval pathway) and the type of approval pathway. If the
selected drug received accelerated approval, include the direct costs for any completed
post-approval confirmatory studies in the numerical response field. Direct costs for any
post-approval confirmatory studies that have not been completed should be reported in
Question 5.
The free response field must list the applicable direct costs included and any calculations
or conversions that were done.
The free response field must identify the length of the post-IND period used in the
calculations.
The free response field may include the post-IND cost associated with each FDAapproved indication and may break down those costs down further for each clinical trial
phase, as well as each completed, FDA-required post-marketing trial.

FIELD
Post-IND Costs for Approved Indications of the Selected Drug
Explanation of Post-IND Costs for Approved Indications of the
Selected Drug, Including the Allocation and Apportionment
Methods

RESPONSE FORMAT
$
Text (4,500-word limit)

Question 4: Costs of Failed or Abandoned Products Related to the Selected Drug
The Primary Manufacturer may allocate a portion of the direct costs spent on basic pre-clinical
research and clinical research for failed or abandoned products related to the selected drug.
Definitions for Question 4:
•

•

Failed or abandoned product costs include a sum of the portion of direct basic preclinical research costs on drugs with the same active moiety / active ingredient or
mechanism of action as the selected drug that did not make it to clinical trials and a
portion of direct post-IND costs for drugs in the same therapeutic class as the selected
drug that did not achieve FDA approval.
Failed or abandoned product costs include a portion of direct basic pre-clinical research
costs on drugs with the same active moiety / active ingredient or mechanism of action as
the selected drug that did not make it to clinical trials.
o Direct research expenses are costs that can specifically be attributed to the
discovery and pre-clinical development of the drug.
o Direct research expenses include personnel (compensation for investigators and
staff) researching the drug, materials for conducting basic pre-clinical research,
and in vivo and in vitro studies on the drug.

13

•

Failed or abandoned products costs include a portion of direct post-IND costs for drugs in
the same therapeutic class as the selected drug that did not achieve FDA approval.
o Direct post-IND costs are costs that can specifically be attributed to the dosing
and clinical trials for the drug.
o Direct post-IND costs include IRB review and amendment costs, user fees, patient
recruitment, per-patient costs, research and data collection costs, personnel, and
facility costs that are directly related to conducting dosing and clinical trials for
the drug.

Instructions for Question 4:
•

•

In the numerical response field, only include costs that can be directly attributed to failed
or abandoned product(s) with the same active moiety / active ingredient or mechanism of
action or drugs in the same therapeutic class as the selected drug that did not achieve
FDA approval.
In the free response field, detail how these costs were determined, what portion of direct
costs were included for basic pre-clinical research and clinical research costs, and how
the allocation was done.

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

RESPONSE FORMAT
$
Text (2,500-word limit)

Question 5: Direct Costs of Other R&D for the Selected Drug Not Accounted for Above
The Primary Manufacturer must report the dollar amount of direct costs it attributes to research
and development that were not accounted for in Questions 1 through 4.
Definition for Question 5:
•

Direct costs of other R&D for the selected drug are any other allowable costs that do not
align with R&D definitions 1-4. For example, other R&D direct costs may include direct
costs associated with conducting FDA-required post-marketing trials that were not
completed. No additional definitions adopted.

Instructions for Question 5:
•
•

In the numerical response field, report the direct costs of all other R&D for the selected
drug.
In the free response field, please individually report each “other R&D direct cost” for the
selected drug and define how each individual “other R&D direct cost” was calculated.

14

FIELD
Costs of Other R&D for the Selected Drug Not Accounted for
Above
Explanation of Costs of Other R&D for the Selected Drug Not
Accounted for Above, Including the Allocation and Apportionment
Methods

RESPONSE FORMAT
$
Text (4,000-word limit)

Question 6: Global and U.S. Total Lifetime Net Revenue for the Selected Drug
In order for CMS to consider the extent to which the Primary Manufacturer has recouped its
research and development costs, the Primary Manufacturer must report the global, total lifetime
net revenue for the selected drug from all countries, including the U.S., in which the selected
drug was sold on or after the date of approval as determined by each country’s drug regulatory
agency. The Primary Manufacturer must also report the subset of U.S. lifetime net revenue for
the selected drug sold to all U.S. entities following initial FDA approval. The definitions and
instructions for this section are separated into two categories: (1) definitions and instructions for
reporting global, including U.S. total lifetime net revenue for the selected drug and (2)
definitions and instructions for reporting U.S. lifetime net revenue for the selected drug.
Definitions for Question 6: Global and U.S. Total Lifetime Net Revenue for the Selected Drug
CMS will use both the Primary Manufacturer’s global and U.S. total lifetime net revenue for the
selected drug to determine the extent to which the Primary Manufacturer has recouped R&D
costs for the selected drug.
Definitions for Question 6a: Global, including U.S., Total Lifetime Net Revenue for the Selected
Drug:
•

•

•

Global, total lifetime 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 price concessions or similar
benefits offered to any purchasers or any royalty payments or percentage payments in
purchase contracts.
Global, total lifetime net revenue period is defined as the date the drug or biologic was
first sold anywhere globally through the date of the publication of the selected drug list
that includes the drug as a selected drug for an initial price applicability year.
If global, total lifetime net revenue for the selected drug is not available through the date
of the publication of the selected drug list that includes the drug as a selected drug for an
initial price applicability year, calculate net revenue through the most recent quarter for
which such data are available.

15

Instructions for Question 6a: Global, including U.S., Total Lifetime Net Revenue for the
Selected Drug:
•
•

•

In the numerical response field, report the global, total lifetime net revenue for the
selected drug for the global, total lifetime net revenue period.
Global, total lifetime net revenue for the selected drug must be in nominal USD and
reported from the date the drug or biologic was first sold anywhere globally to the date of
the publication of the selected drug list that includes the drug as a selected drug for an
initial price applicability year.
In the free response field, include any relevant currency conversions, report the date
ranges for the global, total lifetime net revenue period, and explain how the final amount
was calculated.

FIELD
Global, Total Lifetime Net Revenue for the Selected Drug
Explanation of Global, Total Lifetime Net Revenue for the Selected
Drug

RESPONSE FORMAT
$
Text (2,500-word limit)

Definitions for Question 6b: U.S. Lifetime Net Revenue for the Selected Drug:
•

•

•

U.S. lifetime 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.
U.S. lifetime net revenue period is defined as the date the drug or biologic was first sold
in the U.S. through the date of the publication of the selected drug list that includes the
drug as a selected drug for an initial price applicability year.
If U.S. lifetime net revenue for the selected drug is not available through the date of the
publication of the selected drug list that includes the drug as a selected drug for an initial
price applicability year, calculate net revenue through the most recent quarter for which
such data are available.

Instructions for Question 6b: U.S. Lifetime Net Revenue for the Selected Drug:
•
•

•

In the numerical response field, report the U.S. lifetime net revenue for the selected drug
for the U.S. lifetime net revenue period.
U.S. lifetime net revenue for the selected drug must be in nominal USD and reported
from the date the drug or biologic was first sold in the U.S. to the date of the publication
of the selected drug list that includes the drug as a selected drug for an initial price
applicability year.
In the free response field, report the date ranges for the U.S. lifetime net revenue period,
and explain how the final amount was calculated.

16

FIELD
U.S. Lifetime Net Revenue for the Selected Drug
Explanation of U.S. Lifetime Net Revenue for the Selected Drug

RESPONSE FORMAT
$
Text (2,500-word limit)

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. Question 7 is a table in which to report the average unit costs of production and
distribution for all of the NDC-11s included in the selected drug. Question 8 provides a free
response field for explaining the methodology for calculating the amount reported in Question 7.
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 (such as a capsule or tablet,
milligram of molecules, or grams) of the drug or biological product that is dispensed or
furnished.
Units must be reported in one of the three NCPDP Billing Unit Standards (BUS) 11: each
(EA), milliliter (ML), or gram (GM). The unit reported must be specified for each of the
NDC-11s of the selected drug. Selections of EA, ML, or GM must be made as follows:
o “EA” is used when the product is dispensed in discrete units. These products are
not measured by volume or weight. The Billing Unit of “EA” is also used to
address exceptions where “GM” and “ML” are not applicable. Examples of
products defined as “EA” include, but are not limited to:
 Tablets;
 Capsules;
 Suppositories;
 Transdermal patches;
 Non-filled syringes;
 Tapes;
 Devices/Digital Therapies;
 Blister packs;
 Oral powder packets;
 Powder filled vials for injection;
 Kits; 12 and
 Unit-of-use packages of products other than injectables with a quantity
less than one milliliter or gram should be billed as “one each,” for

See: https://standards.ncpdp.org/Billing-UnitRequest.aspx#:~:text=Billing%20Unit%20Requests,grams%22%20or%20%22milliliters.%22.
12
Kits are defined as products that contain one of the following: (1) at least two distinct items with different billing
units; (2) one product packaged with medicated or unmedicated swabs, wipes and/or cotton swabs/balls; or (3)
meters packaged with test strips.
11

17

•

•

•

example, ointment in packets of less than 1 gram or eye drops in
dropperettes that contain less than 1 ML.
o “ML” is used when a product is measured by its liquid volume. Examples of
products defined as “ML” include, but are not limited to:
 Liquid non-injectable products of 1 ML or greater;
 Liquid injectable products in vials/ampules/syringes;
 Reconstitutable non-injectable products at the final volume after
reconstitution except when they are in powder packets; and
 Inhalers (when labeled as milliliters on the product).
o “GM” is used when a product is measured by its weight. Examples of products
defined as “GM” include, but are not limited to:
 Creams (of 1 GM or greater);
 Ointments (of 1 GM or greater); and
 Inhalers (when labeled as GM on the product). 13
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 Average unit costs during the 12-month period ending May 31, 2023 (for selected
drugs for initial price applicability year);

https://standards.ncpdp.org/Standards/media/pdf/BUS_fact_sheet.pdf. Permission is hereby granted to any
organization to copy and distribute this material as long as this copyright statement is included, the contents are not
changed, and the copies are not sold.
13

18

•

•

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 parties (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 are defined not to
include:
o R&D costs; and
o Marketing costs.
For the purposes of this form, “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, and
other paid promotion.

Instructions for Section D:
Follow the instructions below when answering Questions 7 and 8:
•

•

•

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 8 to explain any shared operating and other indirect
costs that were included in the response to Question 7.

Question 7: Per Unit Production and Distribution Costs
Please complete the following table using additional rows as necessary for the 12-month period
ending May 31, 2023.
NDC-11 Average Per Unit
Production Cost
12345$XX.XX
6789-01

Average Per Unit
Distribution Costs
$XX.XX

Indicate Unit Used
Select one:
• Gram (GM)
• Milliliter (ML)
• Each (EA)

Total Unit
Volume
#

19

Question 8: 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 7, 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 assumptions about costs 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 (2,500-word limit)

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, and any other funds provided by the
federal government that support discovery, research, and/or development related to the
selected drug.
“Prior Federal financial support” refers to Federal financial support for novel therapeutic
discovery and development (as defined above) issued during the time period from when
initial research began (as defined above in the R&D Costs subsection), or when the drug
was acquired by the Primary Manufacturer, whichever is later, to the day through the date
the most recent NDA / BLA was approved for the selected drug.

Instructions for Section E:
Follow the instructions below when answering Questions 9, 10, and 11.
•

When completing this section:
20









Include all prior Federal financial support provided by federal agencies or Federally
supported grants or contracts contributed to direct costs for the basic pre-clinical
research and clinical trials phase of research and development for FDA-approved
indications of the selected drug to the Primary Manufacturer only (do not include
Federal financial support provided to applicable Secondary Manufacturers of a
selected drug). These direct costs are costs that can be specifically attributed to the
discovery, pre-clinical development, and clinical trials of FDA-approved
indications of the selected drug. Please include prior Federal financial support that
contributed to pre-IND and post-IND direct costs.
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 biologics.
• 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. 14, 15 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.
• 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.
If the Primary Manufacturer received prior Federal financial support for a failed or
abandoned product with the same active moiety / active ingredient or mechanism of
action as the selected drug that did not make it to clinical trials and/or drugs in the
same therapeutic class as the selected drug that did not achieve 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 9. Instead,
the Primary Manufacturer must include this amount as a separate quantity when
explaining prior Federal financial support in Question 10.
If the Primary Manufacturer shared the prior Federal financial support described in
Questions 9 through 11 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. Expenses should be allocated across entities
based on each entity’s respective stake in the selected drug’s discovery and

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.
15
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-care-programmethird-edition(e43f24cd-099a-4d56-97e6-6524afaa37d1)/export.html.
14

21

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 10. 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 9. Then, it would note the source of the shared
prior Federal financial support and that that it received 80 percent of that support in
Question 10. 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
11.
Question 9: Federal Funding Support Amount
Complete the table below.
Total Federal Financial Support

$

Question 10: Explanation of Calculation of Federal Financial Support
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 magnitude. In addition, describe
assumptions, methodological steps, and other information needed to calculate the estimates
provided in Question 9. If you report a value in “Other Federal Financial Support Not Otherwise
Included Elsewhere” in your response to this question, please list the source(s) of that Federal
financial support. Please include the identification number for grants and comparable awards.
•
•
•
•
•
•
•
•

Tax credits (General, R&D)
Orphan Drug Act and Other Specific Tax Credits
National Institutes of Health (NIH) Funding
Department of Defense (DOD) Congressionally Directed Medical Research (CDMR)
Funding
Biomedical Advanced Research and Development Authority (BARDA) Funding
Defense Advanced Research Projects Agency (DARPA) Funding
Other Federal Financial Support Not Included Elsewhere
Federal Financial Support for failed products related to the selected drug

Federal Financial Support

RESPONSE FORMAT Text (5,000-word limit)

Question 11: 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 11 as needed.
22

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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,
timelines to delivering goods/services, conditions on the agreement (exclusivity, sole
supplier, etc.) and effective dates and expiration dates, if applicable. For example, this
field could detail an agreement between the Primary Manufacturer and Federal
Government where the Primary Manufacturer agrees to produce a certain quantity of a
drug that is being developed and has not yet been approved or licensed, deliver it to the
Federal Government within a specified timeline, and not contract with other state or local
governmental entities or insurers while this agreement is in place.

Type of Agreement
Drop down menu of agreement options:
licensing, pricing, purchasing, other

Federal Agency(ies)
Participating in
Agreement
Text (100-word limit)

Nature of
Agreement
Text (1,000-word
limit)

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 12 through
15.
Definitions for Section F:
•

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), as
of September 1, 2023, 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 related 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 related 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
23

•

•

the FDA Orange Book or Purple Book; 16 utility patents that claim the drug product
(formulation or composition), drug substance (active ingredient), metabolites or
intermediaries of a selected drug, method(s) of using the drug, or method(s) of
manufacturing the drug; and design patents that, for example, claim a design on the
packaging of the selected drug
Exclusivity periods under the FD&C Act or the PHS Act refer to certain delays and
prohibitions on the approval of competitor drug products. An NDA or BLA holder is
eligible for exclusivity if statutory requirements are met. Exclusivities include:
o Orphan Drug Exclusivity (ODE); 17
o New Chemical Entity Exclusivity (NCE); 18
o Generating Antibiotic Incentives Now (GAIN) Exclusivity for Qualified
Infectious Disease Products (QIDP); 19
o New Clinical Investigation Exclusivity (NCI); 20
o Pediatric Exclusivity (PED); 21 and
o Reference Product Exclusivity for Biological Products. 22
Active and pending FDA applications and approvals includes:
o all applications for approval under section 505(c) of the FD&C Act or sections
351(a) of the PHS Act, including those not yet decided.

Instructions for Section F:
•

•

For Questions 12 through 15, the relevant time period for reporting 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 the date the most recent NDA
/ BLA was approved for the selected drug.
For Questions 12 through 15, include required data for the selected drug.

Question 12: Patents (Expired and Non-Expired) and Patent Applications
In the table below, please list each patent that is related to the selected drug, as well as each
application for a patent related to the selected drug that is pending with the USPTO. Patents and
patent applications related to the selected drug that should be listed below include, but are not
limited to, utility patents that claim the drug product (formulation or composition), drug
substance (active ingredient), metabolites or intermediaries of a selected drug, method(s) of
using the drug, or method(s) of manufacturing the drug, as well as any design patents that, for
example, claim a design on the packaging of the selected drug. Any patents or patent
applications related to the selected drug 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
FDA serves a ministerial role with regard to the listing of patent information in the Orange Book and Purple
Book.
17
Section 527 of the FD&C Act.
18
Section 505(c)(3)(E)(ii) and Section 505(j)(5)(F)(ii) of the FD&C Act.
19
Section 505E(a) of the FD&C Act.
20
Section 505(c)(3)(E)(iii) & (iv) and Section 505(j)(5)(F)(iii) & (iv) of the FD&C Act.
21
Section 505A(b) & (c) of the FD&C Act.
22
Section 351(k)(7) of the PHS Act.
16

24

selected drug are held by a federal agency) must be listed below. Any patents that are or have
been listed for the selected drug in the FDA Orange Book or Purple Book must be included in
the table below. For each entry, indicate whether the patent claims the drug product, drug
substance, and/or a method of use of the selected drug. For each patent (expired or unexpired)
and pending patent application listed in the table below, please upload a PDF file of the USPTO
patent application. Do not include patent applications which were denied. Add additional rows to
your response to Question 12 as needed.
Patent
Date
Number File
d

Paten
t
Expir
y
Date
MM/ MM/
DD/ DD/Y
YY
YYY
YY

Drug
Produc
t
Patent

Drug
Substa
nce
Patent

Drug
Method
of Use
Patent

#

Yes/No
Flag

Yes/No Yes/No
Flag
Flag

Patent
Patent
Applicati Type
on
Pending
Yes/No
Flag

Drop
down
menu of
patent
types.
Options:
Utility,
Design

Listed in
FDA
Orange
Book/Pur
ple Book
Yes/No
Flag

Patent
Applicati
on
Upload
correspon
ding
patent
applicatio
n.

Question 13: Explanation of Patents (Expired and Non-Expired) and Patent Applications
If applicable, please provide additional information about the patent applications reported in the
table above and describe how they relate to the selected drug. This information can include
further information on the purpose of the patent, for example, if the patent claims a specific
indication(s) of the selected drug or a device used to administer the selected drug, or other
information that will be helpful to understand how the patent contributes to the selected drug. As
applicable, please also use this free response field to indicate which patents related to the
selected drug are held by a federal agency and describe how they relate to the selected drug.
FIELD
Explanation of patents

RESPONSE FORMAT
Text (1,000-word limit)

Question 14: Regulatory Exclusivity Periods
As applicable, please report all regulatory exclusivity periods under the FD&C Act or the PHS
Act that are listed in the Orange Book or the Purple Book and in effect or have expired for the
selected drug. 23 Complete table for Question 14 by adding rows as needed.

With respect to biological products, CMS understands that FDA has not made a determination of first licensure
for each 351(a) biological product included in the Purple Book. The absence of a date of first licensure in the Purple
Book does not mean that a biological product on the list is not, or was not, eligible for reference product exclusivity.
23

25

Type of
Exclusivity
Drop down
menu of
exclusivity
types.
Options:
Orphan
Drug
Exclusivity,
New
Chemical
Entity
Exclusivity,
GAIN
Exclusivity
for Qualified
Infectious
Disease
Products,
New Clinical
Investigation
Exclusivity,
Pediatric
Exclusivity,
Reference
Product
Exclusivity
for
Biological
Products

Exclusivity
Application (NDA /
Expiration
BLA) Number
Date
MM/DD/YYYY #

NDC-9s
Comments
Covered by
Exclusivity
Text
Text (300-word
limit)

Question 15: 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 and 351(a) of the PHS Act.
•

•

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 decided. [Complete table for Question 15 by adding rows as
needed using the indicated format]
Please submit any efficacy supplements that have been approved or are pending FDA
approval but exclude manufacturing supplements.

26

Application
(NDA /
BLA)
Number

Application Classification Approval
Type
Code 24
Date
(NDA;
BLA)

#

Drop down
menu of
application
types.
Options:
NDA, BLA

Select one or
MM DD,
more of the
YYYY
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

Indicat
ion

Text

Dos Sponso
age r
For
m
and
Str
eng
th
Text Text

Applic
ation
Status

Comm
ents

Select
one of
the
followi
ng
options
:
approv
ed,
tentativ
ely
approv
ed,
pending
,
withdra
wn, or
other

Text
(300word
limit)

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.
24

27

Application
(NDA /
BLA)
Number

Application Classification Approval
Type
Code 24
Date
(NDA;
BLA)

Indicat
ion

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

Dos
age
For
m
and
Str
eng
th

Sponso
r

Applic
ation
Status

Comm
ents

G. Market Data and Revenue and Sales Volume Data
Primary Manufacturer Response Required
The purpose of Questions 16 through 25 in this section 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.

28

•

•
•

•

•
•

•

•

National Council of Prescription Drug Programs Billing Unit Standards (NCPDP): The
three NCPDP Billing Unit Standards (BUS) 25 are: each (EA), milliliter (ML), and gram
(GM). For certain volume data of the selected drug, CMS is requesting units be reported
using the NCPDP BUS to facilitate comparison with the amounts in the quantity
dispensed field found in PDE data, which also uses the NCPDP BUS.
Medicaid best price: The Medicaid best price is defined in 42 C.F.R. § 447.505(a). The
Medicaid best price is reported at the NDC-9 level.
Average manufacturer price (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. 26 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. The Big Four
Price is reported at the NDC-11 level. 27
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 group
or individual commercial plans on- and off-Exchange, excluding Medicare fee-forservice (Parts A and B), Medicare Advantage, Medicare Part D, Medicaid fee-for-service,
and Medicaid managed care. The average net unit price must be net of discounts,
chargebacks or rebates, cash discounts, free goods contingent on a purchase agreement,
up-front payments, coupons, 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 is reported at the NDC-11 level.
U.S. commercial average net unit price─ without 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 manufacturer-run patient assistance programs that provide
financial assistance such as coupons and 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─ without patient assistance program is reported at
the NDC-11 level.
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 lowest U.S. commercial average net unit price

See: https://standards.ncpdp.org/Billing-UnitRequest.aspx#:~:text=Billing%20Unit%20Requests,grams%22%20or%20%22milliliters.%22.
26
See: https://www.fss.va.gov/index.asp.
27
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.
25

29

offered by the Primary Manufacturer and any Secondary Manufacturer(s) to any
commercial payer in the U.S. The average net unit price must be net of discounts,
chargebacks or rebates, cash discounts, free goods contingent on a purchase agreement,
up-front payments, coupons, 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 U.S. commercial average net unit
price─ best is reported at the NDC-11 level.
Instructions for Section G:
•
•
•
•

For the purpose of answering Questions 16 through 25, please also follow the instructions
specific to each question.
Use the list of definitions in the “Definitions for Section G. Market Data and Revenue
and Volume Data” section to answer the questions.
For Question 16 through 25, information for the Primary Manufacturer and any
Secondary Manufacturer(s) must be reported.
For Questions 17, 19, 21, 23, and 25, please include not applicable (N/A) in the free
response field if no explanation is necessary.

Question 16: Wholesale Acquisition Cost Unit Price
Follow the instructions below when providing responses in the following table about the WAC
unit price of the selected drug:
•

•

•

Any deviation from the reported WAC unit price in the table 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 17 so that CMS can understand the reasons for
these differences.
Units must be reported in one of the three NCPDP BUS: each (EA), milliliter (ML), or
gram (GM). The unit type reported must be specified for each of the NDC-11s associated
with the selected drug. 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.
Include a row for each NDC-11 and each quarter during the most recent five years if the
NDC-11 was marketed, sold, or distributed at any time during the most recent five years
and complete all fields. If the NDC-11 was not marketed, sold, or distributed to any
wholesaler or direct purchaser in a particular quarter, please still include a row for this
particular quarter, and enter the NDC-11, quarter, and unit type information, but enter “0”
in the total unit volume field and leave the WAC field blank.

NDC-11

Quarter

WAC

Unit type (each, ML,
GM)

Total Unit Volume

12345-678901

QQ/YYYY

$

Drop down (each, ML,
GM)

#

30

Question 17: Explanation of Information Reported in Question 16: 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 16 and those
found in available drug databases (e.g., Medi-Span, First Databank, RED BOOK).
FIELD
Explanation of WAC unit price data

RESPONSE FORMAT
Text (1,000-word limit)

Question 18: Medicaid Best Price
Was a Medicaid best price determination ever made for a calendar quarter for the selected drug
during the most recent five years?
RESPONSE FORMAT
Yes/No
(If response is Yes, please fill out the following tables. If response is No, please skip to
Question 20) Follow the instructions below when providing responses in the following table
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 section 42 C.F.R. § 447.505 – Determination of best price. The reported
Medicaid best price in the table below must reflect any restatements that have been
certified under the MDRP.
• Please report Medicaid best price information using the same unit type used to report
AMP and Medicaid (i.e., injectable anti-hemophilic factor, capsule, suppository, gram,
milliliter, tablet, transdermal patch, each, millicurie, microcurie). Total unit volume for
the quarter is the sum of monthly AMP units reported to the MDRP for the quarter.
• Include a row for each NDC-9 and each quarter during the most recent five years if a
Medicaid best price determination was made at any time during the most recent five years
for that NDC-9 and complete all fields. If the NDC-9 did not have a Medicaid best price
determination in a particular quarter, please still include a row for this particular quarter
and enter NDC-9, quarter, and unit type information, but enter “0” in the total unit
volume field and leave the Medicaid best price field blank.
NDC-9

Quarter

Medicaid
Best Price

Unit Type

Total Unit Volume

12345-6789

QQYYYY

$

Text

#

31

Question 19: Explanation of Information Reported in Question 18: Medicaid Best Price
If applicable, describe other information you feel is necessary to interpret reported information in
response to Question 18.
FIELD
Explanation of Medicaid Best Price data

RESPONSE FORMAT
Text (1,000-word limit)

Question 20: Federal Supply Schedule Price
Was a Federal supply schedule (FSS) price for the selected drug ever available during the most
recent five years?
RESPONSE FORMAT
Yes/No
(If response is Yes, please fill out the following tables. If response is No, please skip to
Question 22) Follow the instructions below when providing responses in the following table
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. 28
Units must be reported in one of the three NCPDP BUS: each (EA), milliliter (ML), or
gram (GM). The unit type reported must be specified for each of the NDC-11s associated
with the selected drug. Total unit volume is the total number of units (i.e., EA, ML, or
GM) for each NDC-11 sold to direct federal purchasers. Please do not include units
associated with free samples in the reported total unit volume.
Include a row for each NDC-11 and price period that occurred during the most recent five
years.

NDC-11

Price Start Date
to End Date

Federal Supply
Schedule Service
Price

Unit Type (EA, Total Unit
ML, GM)
Volume

12345-678901

MMDDYYYYMMDDYYYY

$

Drop down (EA, #
ML, GM)

Question 21: Explanation of Information Reported in Question 20: Federal Supply
Schedule Price
If applicable, describe other information you feel is necessary to interpret reported information in
response to Question 20.
FIELD
Explanation of federal supply schedule price data
28

RESPONSE FORMAT
Text (1,000-word limit)

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

32

Question 22: Big Four Price
Was a Big Four price ever available for the selected drug during the most recent five years?
RESPONSE FORMAT
Yes/No
(If response is Yes, please fill out the following tables. If response is No, please skip to
Question 24) Follow the instructions below when providing responses in the following table
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. 29
• Units must be reported in one of the three NCPDP BUS: each (EA), milliliter (ML), or
gram (GM). The unit type reported must be specified for each of the NDC-11s associated
with the selected drug. Total unit volume is the total number of units (i.e., EA, ML, or
GM) for each NDC-11 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.
• Include a row for each NDC-11 and price period that occurred during the most recent five
years.
NDC-11

Price Start Date to
Price End Date

Big
Four
Price

Unit Type EA,
ML, GM)

Total Unit Volume

123456789-01

MMDDYYYYMMDDYYYY

$

Drop down (EA,
ML, GM)

#

Question 23: Explanation of Information Reported in Question 22: Big Four Price
If applicable, describe other information you feel is necessary to interpret reported information in
response to Question 22.
FIELD
Explanation of Big Four price data

RESPONSE FORMAT
Text (1,000-word limit)

Question 24: U.S. Commercial Average Net Unit Price
Follow the instructions below when providing responses in the following table about the U.S.
commercial average net unit price, including group and individual commercial plans on- and offExchange of the selected drug:

29

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

33

•

•

•

•

•

•

Exclude price and volume information for the selected drug for Medicare fee-for-service
(Parts A and B), Medicare Advantage, Medicare Part D, Medicaid fee-for-service, and
Medicaid managed care.
Include a row for each NDC-11 and each quarter during the most recent five years if the
NDC-11 was ever marketed, sold, or distributed at any time during the most recent five
years and complete all fields. If the NDC-11 was not marketed, sold, or distributed in a
particular quarter, please still add include a row for this particular quarter, and enter the
NDC-11, quarter, and unit type information, but enter “0” in the total unit volume field
and leave the three price fields blank.
Units must be reported in one of the three NCPDP BUS: each (EA), milliliter (ML), or
gram (GM). The unit type reported must be specified for each of the NDC-11s associated
with the selected drug. Please do not include units associated with free samples in the
calculated prices or reported total unit volume.
The NDC-11 price reported in the U.S. commercial average net unit price field must be
net of discounts, chargebacks or rebates, cash discounts, free goods contingent on a
purchase agreement, up-front payments, coupons, goods in kind, free or reduced-price
services, grants, or other price concessions or similar benefits offered by Primary
Manufacturer or any Secondary Manufacturer(s) to any purchasers.
If the Primary Manufacturer or Secondary Manufacturer(s) provided manufacturer-run
financial assistance such as coupons and co-payment assistance or free drug products to
patients, separately report the price net of coupons and co-payment assistance to patients
in the U.S. commercial average net unit price─ without patient assistance programs field.
If the Primary Manufacturer and Secondary Manufacturer(s) did not provide coupons or
co-payments assistance to patients, please leave the U.S. commercial average net unit
price─ without patient assistance programs field blank.
Provide the lowest price that the Primary Manufacturer or any Secondary
Manufacturer(s) made available to any commercial payer during the quarter in the U.S.
commercial average net unit price─ best field.

NDC-11

Quarter

U.S.
Commerci
al Average
Unit Net
Price

U.S. Commercial
Average Net Unit
Price- Without
Patient Assistance
Programs

U.S.
Commercia
l Average
Net Unit
Price- Best

Unit type
(EA, ML,
GM)

Total
Unit
Volume

123456789-01

QQYYY
Y

$

$

$

Drop
down (EA,
ML, GM)

#

Question 25: Explanation of Information Reported in Response to Question 24: U.S.
Commercial Average Net Unit Price
Describe assumptions, methodological steps, and other information for the following topics
related to Question 24:
34

•
•

•
•

How sales to enrollees of group and individual commercial plans on- and off-Exchange
were determined.
How discounts, chargebacks or rebates, cash discounts, free goods contingent on a
purchase agreement, up-front payments, coupons, 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 quarters.
If applicable, how coupons and co-payment assistance to patients were allocated across
NDC-11s and quarters.
How all of this information was used to calculate the U.S. commercial average net unit
price and U.S. commercial average net unit price─ without patient assistance programs
and determine the U.S. commercial average net unit price─ best.

FIELD
Explanation of U.S. commercial average net unit price data

RESPONSE FORMAT
Text (1,000-word limit)

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, 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).
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. I also understand that any misrepresentations may also give rise to liability, including
under the False Claims Act.
Yes [ ]
No [ ]
Contact Information to be entered:

35

Field
Name of the Person Responsible for the
Submission
Title
Telephone
Email
Signature
Date

Response
Text
Text
Text
Text
Text
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 pharmaceutical therapeutic alternative(s), please limit your response
and do not include personally identifiable information 30 (PII) or protected health information 31
(PHI). CMS will collect only the minimum necessary information related to the selected drug
and its therapeutic alternative(s) for the purpose of implementing and operating the Negotiation
Program and 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.
Each interested party will be able to answer each of the questions in Section I one-time for each
selected drug.
Question 26: Respondent Information
Required: Individuals or organizations, including manufacturers, that wish to provide
information in this Section I must provide the following information. 32
FIELD
Selected Drug
Respondent Name
Organization Name (if applicable)
Respondent Email

RESPONSE FORMAT
TEXT
TEXT
TEXT
TEXT

Personally identifiable information (PII) 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/laws-regulations/index.html.
31
Protected health information 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. See
https://www.hhs.gov/hipaa/for-professionals/privacy/laws-regulations/index.html.
32
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.
30

36

Optional: Check the relevant box: Which of the following best describes the person completing
this form?
[ ] Representative of a manufacturer that does not manufacture the selected drug or its
therapeutic alternative(s)
[ ] Representative of a manufacturer of the selected drug or its 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 therapeutic alternative(s)
[ ] A patient who has experience taking the selected drug or its therapeutic alternative(s)
[ ] A caregiver for an individual who has experience taking the selected drug or its therapeutic
alternative(s)
[ ] Academic researcher or other subject matter expert not affiliated with a manufacturer of the
selected drug or its therapeutic alternative(s)
[ ] Academic researcher or other subject matter expert affiliated with a manufacturer of the
selected drug or its therapeutic alternative(s) 33
[ ] Other
Instructions for Questions 27 through 31:
Please follow the instructions below when answering these questions.
•
•
•

•

The following questions are optional. You may answer some or all of the questions. Enter
“No response” if you do not wish to respond to a given question.
Please answer each question in narrative (text) form. Your responses will be limited to
the word and citation maximums provided for each question.
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. 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 revised
guidance.
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

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

33

37

•

•

•

•

•

34

appropriate in your response to Questions 28 through 30 and upload any relevant visual
representations as additional materials as described below.
Respondents are requested to provide citations in response to Questions 28 through 30 in
the MLA 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 National Library
of Medicine at: https://www.ncbi.nlm.nih.gov/books/NBK7256/.
When information in the free text response for Questions 28 through 30 is supported by a
citation reported in response to that question, please 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 citations provided for that same question.
CMS will review submitted studies that use cost-effectiveness measures to determine if
the study is relevant to the selected drug and/or its therapeutic alternative(s) and to ensure
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. Respondents must indicate if their submission
includes any cost-effectiveness measures. Respondents are also requested to provide a
short description of any cost-effectiveness measures included in the research submitted
and the utility they believe the data provides in reviewing the selected drug without
treating 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. Cost-effectiveness measures include but are not limited to quality-adjusted
life-years (QALYs), Equal Value of Life-Years Gained (evLYG), Equal Value Life-Year
(evLY), and Health Years in Total (HYT).
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. 34 Information submitted that treats extending the life of individuals in these
populations as of lower value, for example, QALYs will not be used. In instances where a
study includes a measure such as QALYs but has clearly separated QALYs or other
measures that treat extending the life of individuals who are elderly, disabled, or
terminally ill as of lower value 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 will consider such separate evidence. In these cases, indicate clearly in
the in-text citation if the evidence provided 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 and clearly indicate what
separate evidence CMS might consider.
All declarative statements must 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).

Section 1194(e)(2) of the Social Security Act.

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•

•
•

Submissions may include visual representations of the information, including tables,
charts, and/or graphs in Questions 28 through 30. The information submitted in the space
for visual representations should only include the table/chart/graph, and no additional
text. CMS will not review any additional text included. PDF files will be accepted within
specified file size limits for visual representations. The main text response for Questions
28 through 30 should include clear numbers/references to the tables/charts/graphs
submitted.
When citing studies to support responses, briefly summarize the study context and
relevant comparator or therapeutic alternative drug(s) studied, as applicable.
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).

Question 27: Prescribing Information
Definitions:
•

Therapeutic Alternative: A therapeutic alternative must be a pharmaceutical product that
is clinically comparable to the selected drug. CMS will 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 offlabel to treat a given indication. CMS will begin by identifying therapeutic alternatives
within the same drug class as the selected drug based on properties such as chemical
class, therapeutic class, or mechanism of action before considering therapeutic
alternatives in other drug 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 most clinically comparable to the selected drug.

Additional information regarding identification of indications for a selected drug and its
pharmaceutical therapeutic alternative(s) is described in section 60.3.1 of the revised guidance.
Instructions for Question 27:
•

Specify whether you are referencing the selected drug or a pharmaceutical therapeutic
alternative(s) for each indication(s) you are referencing when discussing FDA prescribing
information.

Questions on Prescribing Information:
•
•

What prescribing information has been approved by the FDA for the selected drug and
for therapeutic alternative(s) to the selected drug?
Please provide information about how the selected drug and its therapeutic alternative(s)
are used in the course of care for the condition or disease treated by each indication.

39

•

If the selected drug is used off-label to treat a certain disease or condition, please indicate
this and provide evidence from nationally recognized, evidence-based guidelines and
recognized by CMS-approved Part D compendia, as applicable. 35

FIELD
Response to Question 27

RESPONSE FORMAT
Text (3,000-word limit)

Does the evidence submitted include a cost-effectiveness measure:
[ ] Yes
[ ] No
[ ] Don’t know
If yes to the question above, please select the applicable statement.
[ ] The evidence submitted includes QALYs or other cost-effectiveness measures that treat
extending the life 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.
[ ] The evidence submitted includes cost-effectiveness measures that DO NOT treat extending
the life 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.
Question 28: Therapeutic Impact and Comparative Effectiveness
Definitions:
•

•

Therapeutic Alternative: A therapeutic alternative must be a pharmaceutical product that
is clinically comparable to the selected drug. CMS will 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 offlabel to treat a given indication. CMS will begin by identifying therapeutic alternatives
within the same drug class as the selected drug based on properties such as chemical
class, therapeutic class, or mechanism of action before considering therapeutic
alternatives in other drug 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 most 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 such as cure, survival, progression-free
survival, or improved morbidity could be considered when comparing the selected drug
to its therapeutic alternative(s). Outcomes such as changes in symptoms or other factors
that are of importance to patients, and patient-reported outcomes will also be identified
and considered in determining clinical benefit, if available. Additional outcomes such as

CMS-approved Part D compendia are listed in Chapter 6 of the Prescription Drug Benefit Manual as described in
1927(g)(1)(B)(i) of the Act.
35

40

•

changes to productivity, independence, and quality of life will also be considered,
including patient-centered outcomes when available, to the extent that these outcomes
correspond with a direct impact on individuals taking the drug. The caregiver perspective
will be considered when there is a direct impact on the individuals taking the selected
drug or therapeutic alternatives.
Patient-centered outcome: An outcome that is important to patients’ survival, functioning,
or feelings as identified or affirmed by patients themselves, or judged to be in patients’
best interest by providers and/or caregivers when patients cannot report for themselves. 36

Additional information regarding identification of indications for a selected drug and its
pharmaceutical therapeutic alternative(s) is described in section 60.3.1 of the revised guidance.
Instructions for Question 28:
•
•

Specify the therapeutic alternative and indication of the selected drug that you are
discussing.
When discussing the therapeutic impact of the selected drug, indicate outcome(s) used,
the indication(s) to which the evidence applies, and the therapeutic alternative(s) to which
the evidence applies.

Questions on Therapeutic Impact and Comparative Effectiveness:
•

•
•
•

•

Please provide information on the therapeutic impact of the selected drug compared to
existing therapeutic alternatives. What is known about the comparative effectiveness of
the selected drug and its therapeutic alternative(s)? Please discuss for each indication of
the selected drug, as applicable. Consider discussing outcomes (including patientreported outcomes) and patient experience for each indication, as applicable.
Please provide key outcomes for each indication of the selected drug, as applicable, and
explain why each outcome was chosen.
To what extent does the selected drug represent a therapeutic advance as compared to
existing therapeutic alternatives? Please discuss for each indication of the selected drug,
as applicable.
Please provide information on the risks, harms, or side effects, and any unique scenarios
or considerations related to clinical benefit, safety, and patient experience related to the
selected drug and its therapeutic alternative(s) for each indication, as applicable. Please
describe any differences in the safety profile of the selected drug and its therapeutic
alternative(s) for each indication, as applicable.
Please provide current costs of such existing therapeutic alternatives (if known).

FIELD
Response to Question 28
Additional Materials for Question 28

RESPONSE FORMAT
Text (3,000-word limit)
Text (Up to 50 citations; up to 10
tables/charts/graphs)

ISPOR Plenary, Patrick (2013) via FDA’s “Patient-Focused Drug Development: Collecting Comprehensive and
Representative Input – Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders,” June
2020. See: https://www.fda.gov/media/139088/download.

36

41

Does the evidence submitted include a cost-effectiveness measure:
[ ] Yes
[ ] No
[ ] Don’t know
If yes to the question above, please select the applicable statement.
[ ] The evidence submitted includes QALYs or other cost-effectiveness measures that treat
extending the life 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.
[ ] The evidence submitted includes cost-effectiveness measures that DO NOT treat extending
the life 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.
Question 29: Comparative Effectiveness on Specific Populations
Definitions:
•

•

Specific populations: Specific populations include individuals with disabilities, the
elderly, individuals who are terminally ill, children, and other patient populations among
Medicare beneficiaries including those that may experience disparities in access to care,
health outcomes, or other factors when taking the selected drug that impact health equity.
Health equity: The attainment of the highest level of health for all people, where
everyone has a fair and just opportunity to attain their optimal health regardless of race,
ethnicity, disability, sexual orientation, gender identity, socioeconomic status, geography,
preferred language, or other factors that affect access to care and health outcomes. 37

Instructions for Question 29:
•

Specify which specific population and which indication of the selected drug you are
discussing.

Questions on Comparative Effectiveness on Specific Populations:
•

•
•
•

37

What is known about the comparative effectiveness of the selected drug and therapeutic
alternatives to the selected drug with respect to specific populations, such as individuals
with disabilities, the elderly, individuals who are terminally ill, and children?
Are there other specific populations not noted in the question above that use the selected
drug that could be considered? If so, please explain.
As applicable, for other specific populations that use the selected drug, what is known
about comparative effectiveness of the selected drug and its therapeutic alternative(s)?
What health equity considerations should CMS consider related to specific populations
taking the selected drugs? This may include, but is not limited to, challenges or

See: https://www.cms.gov/pillar/health-equity.

42

•

advantages accessing the drug compared to therapeutic alternatives, differences in
clinical or other outcomes, or differences in disease or condition symptoms for a specific
population that the drug does or does not adequately address.
In addition to comparative effectiveness, please discuss any differences in the safety
profile of the selected drug compared to its therapeutic alternative(s) for each applicable
specific population.

Field
Response to Question 29
Additional Materials for
Question 29

Response
Text (3,000-word limit)
Text (Up to 50 citations; up to 10 tables/charts/graphs)

Does the evidence submitted include a cost-effectiveness measure:
[ ] Yes
[ ] No
[ ] Don’t know
If yes to the question above, please select the applicable statement.
[ ] The evidence submitted includes QALYs or other cost-effectiveness measures that treat
extending the life 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.
[ ] The evidence submitted includes cost-effectiveness measures that DO NOT treat extending
the life 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.
Question 30: Addressing Unmet Medical Needs
Definitions for Question 30:
•

Unmet medical need: A drug or biological product may be considered to meet an unmet
medical need if the drug or biological product treats a disease or condition in cases where
no other treatment options exist or existing treatments do not adequately address the
disease or condition. 38 Unmet medical need is determined at the time of submission of
this information.

Instructions for Question 30:
•

Specify the therapeutic alternative and indication of the selected drug that you are
discussing, if applicable.

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.
38

43

•

When discussing the therapeutic impact of the selected drug, indicate outcome(s) used,
the indication(s) to which the evidence applies, and the therapeutic alternative(s) to which
the evidence applies.

Questions on Addressing Unmet Medical Needs:
•
•
•

Does the selected drug address an unmet medical need for any indications; and if so,
which indications?
To what extent do the selected drug and therapeutic alternative(s) to the selected drug
address an unmet medical need for an indication, as applicable?
If unmet medical need is determined based on inadequate therapeutic alternative(s),
please explain why therapeutic alternative(s) do not meet the medical need of individuals
with the disease or condition for an indication, as applicable.

FIELD
Response to Question 30
Additional Materials for Question 30

RESPONSE FORMAT
Text (1,000-word limit)
Text (Up to 50 citations; up to 10
tables/charts/graphs)

Does the evidence submitted include a cost-effectiveness measure:
[ ] Yes
[ ] No
[ ] Don’t know
If yes to the question above, please select the applicable statement.
[ ] The evidence submitted includes QALYs or other cost-effectiveness measures that treat
extending the life 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.
[ ] The evidence submitted includes cost-effectiveness measures that DO NOT treat extending
the life 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.
Question 31: Patient and Caregiver Experience
Note: This question will be available only for respondents who indicate in Question 26 that they
are a patient or caregiver.
Instructions for Question 31:
•
•

For patients: Please describe your experience taking the selected drug and/or its
therapeutic alternative(s).
For caregivers: Please describe your experience and the experience of the person you care
for that has taken the selected drug and/or its therapeutic alternative(s). When describing
your experience as a caregiver, please focus on experiences that directly impact the health
and wellbeing on the person you care for.
44

Questions on Patient and Caregiver Experience:
•
•
•
•
•

What is your experience taking the selected drug and/or its therapeutic alternative(s)?
How long have you been taking the selected drug and/or its therapeutic alternative(s)?
How did treatment with the selected drug and/or its therapeutic alternative(s) impact your
health, including your symptoms?
Please describe any side effects that you have experienced, and the impact of these side
effects have had on you.
How did treatment with the selected drug and/or its therapeutic alternative(s) impact your
quality of life and wellbeing?
Have you had challenges accessing or taking the drug? For example, challenges affording
the drug, gaining coverage through your health insurance, or taking the drug as
prescribed.

FIELD
Response to Question 31

RESPONSE FORMAT
Text (2,000-word limit)

Question 32: Executive Summary
Note: This question is available to all respondents except individuals who indicate in Question
26 that they are a patient or caregiver.
Instructions for Question 32:
•
•

Please provide an executive summary of the information submitted for Section I
Questions 27-30.
Citations and study summaries do not need to be included in this question.

FIELD
Response to Question 32

RESPONSE FORMAT
Text (1,000-word limit)

J. Certification of Submission of Section I for All Respondents
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.
Yes [ ]
No [ ]
45

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

Response
Text
Text
MMDDYYYY

46

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 0938-XXXX (Expires XX/XX/XXXX). This contains
both a mandatory and voluntary information collection. The time required to complete this
information collection is estimated to average 2 hours for individuals and 20 hours for
organizations per response for the general public and 500 total hours for the manufacturers of
selected drugs, including the time to review instructions, search existing data resources, gather
the data needed, and complete and review the information collection. If you have comments
concerning the accuracy of the time estimate(s) or suggestions for improving this form, please
write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop C426-05, 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 Lara Strawbridge (lara.strawbridge@cms.hhs.gov).

47