Redline CMS 10849 NDE Process ICR Forms

Negotiation Data Elements and Drug Price Negotiation Process for Initial Price
Applicability Year 2027 under Sections 11001 and 11002 of the Inflation Reduction Act
(IRA) Information Collection Request (ICR) Forms (CMS-10849, OMB 0938-1452)
Under the authority in sections 11001 and 11002 of the Inflation Reduction Act of 2022 (P.L.
117-169), the Centers for Medicare & Medicaid Services (CMS) is implementing the Medicare
Drug Price Negotiation Program (“the Negotiation Program”), codified in sections 1191 through
1198 of the Social Security Act (“the Act”). The Act establishes the Negotiation Program to
negotiate a maximum fair price (MFP), defined at section 1191(c)(3) of the Act, for certain high
expenditure, single source drugs covered under Medicare Part B and Part D (each a “selected
drug”). 1 As discussed in section 20 of the Medicare Drug Price Negotiation Program: Final
Guidance, Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price
Applicability Year 2027 and Manufacturer Effectuation of the Maximum Fair Price (MFP) in
2026 and 2027 (“the Medicare Drug Price Negotiation Program Final Guidance” or “final
guidance”), for initial price applicability year 2027, CMS will select up to 15 high expenditure,
single source drugs covered under Part D for negotiation. Any MFPs that are negotiated for these
drugs will apply beginning in initial price applicability year 2027. The negotiation period for
initial price applicability year 2027 begins February 28, 2025, or when the manufacturer of a
selected drug enters into a Medicare Drug Price Negotiation Program Agreement with CMS,
whichever is sooner.
This ICR Form includes two parts: Part 1—Negotiation Data Elements ICR Form, and Part 2—
Drug Price Negotiation Process ICR Form.
PART 1: NEGOTIATION DATA ELEMENTS ICR FORM
Section 1194(e) of the Act and section 50 of the final guidance require CMS to consider two sets
of factors as the basis for determining offer(s) and counteroffer(s) throughout the negotiation
process: (1) certain data that must be submitted by the manufacturer of each drug selected for
negotiation (in section 1194(e)(1)) of the Act), and (2) evidence about alternative treatments, as
available, with respect to each selected drug and therapeutic alternative(s) for each selected drug
(in section 1194(e)(2 of the Act)).
In accordance with section 1193(a)(4) and section 1194(b)(2)(A) of the Act and section 50 of the
final guidance, 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 determining 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 ICR, a selected drug for initial price applicability year 2027 is defined as
a drug included on the selected drug list published by CMS by February 1, 2025. In section
Hereinafter, “drug” includes drugs and biological products pursuant to the definition of a “qualifying single source
drug” at section 1192(e)(1) of the Act.

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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. In accordance with section 40 of the final
guidance, to the extent that more than one entity meets the statutory definition of manufacturer
for a selected drug for purposes of initial price applicability year 2027, CMS will designate the
entity that holds the New Drug Application(s) (NDA(s)) / Biologics License Application(s)
(BLA(s)) for the selected drug to be “the manufacturer” of the selected drug (hereinafter the
“Primary Manufacturer”).
Likewise, in accordance with section 40 of the final guidance, CMS will refer to any other entity
that meets the statutory definition of manufacturer for a drug product included on the selected
drug list and that either (1) is listed as a manufacturer in an NDA or BLA for the selected drug or
(2) markets the selected drug pursuant to an agreement with the Primary Manufacturer as a
“Secondary Manufacturer 2.”
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). Submission of the
information collected in this ICR Form is due by 11:59 PM PST on March 1, 2025.
Note: This ICR focuses on information required and optional for selected drugs for initial price
applicability year 2027.
General Instructions
Overview
In accordance with section 50 of the final guidance, the Primary Manufacturer of each selected
drug must complete Sections A through H for each of its selected drug(s), which are
specifically:
• A: Selected Drug Information,
• B: Non-FAMP Data Collection,
• C: Research and Development Costs and Recoupment,
• D: Current Unit Costs of Production and Distribution,
• E: Prior Federal Financial Support,
• F: Patents, Exclusivities, and Approvals,
• G: Market Data and Revenue and Sales Volume Data, and
• H: Certification of Submission of Sections A through G for Primary Manufacturers.
The Primary Manufacturer is responsible for aggregating and reporting all necessary data on its
As specified in section 40 of the final guidance, a manufacturer that is not listed as a manufacturer on the NDA / BLA and without
an agreement in place with the Primary Manufacturer would not be considered a Secondary Manufacturer. Examples of agreements
that could result in a Secondary Manufacturer relationship may include, but are not limited to, royalty agreements, licensing
agreements, revenue sharing agreements, marketing agreements, supply agreements, purchasing agreements, or parent / affiliate
agreements.
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selected drug(s) from other parties, as applicable.
Section I (“Evidence on Alternative Treatments”) collects available evidence on the selected
drug and its therapeutic alternative(s), as applicable. Any interested party, including but not
limited to patients and caregivers, Part D plan sponsors and Medicare Advantage
organizations, Primary Manufacturers, Secondary Manufacturers, manufacturers of
therapeutic alternative(s) for a selected drug, hospitals and health care providers,
wholesalers, pharmacies, researchers, and other members of the public, is permitted, but
not required, to submit information for Section I. Any interested party who submits evidence
in Section I must complete Section J (“Certification of Submission of Section I for All
Respondents”) as well.
Submission Method
Primary Manufacturers will submit the information for Sections A through J via the CMS Health
Plan Management System (“the CMS HPMS”), which can be accessed here:
https://hpms.cms.gov/. Manufacturers of high-expenditure, single source drugs may register for
access to the CMS HPMS, and are encouraged to do so before the questions for this ICR are
available to access in the CMS HPMS. Instructions for manufacturers to gain access to HPMS
can be found in the “Instructions for Requesting Drug Manufacturer Access in the Health Plan
Management System (HPMS)” PDF. 3 Instructions for gaining signatory access to the CMS
HPMS are also included in this PDF. Technical assistance will also be made available.
All respondents who are not Primary Manufacturers will use a separate web application to
access the questions in Sections I and J. This application will be accessible from an entry point
on CMS.gov, as well as on the CMS HPMS landing page, which is publicly accessible at
https://hpms.cms.gov. In order to access the questions in Sections I and J through the web link,
the respondent must provide an email address. A confirmation email message from CMS will be
sent to the respondent-provided email address and the respondent must follow the steps
contained in the email message to obtain access to the questions in Sections I and J. Additional
instructions to access this public web application will be available on CMS.gov.
Submissions may be saved while work is in progress. Primary Manufacturers and interested
parties may also wish to draft their submission outside of the web application and then copy
their submissions into the appropriate fields to complete the formal submission.
Questions about CMS HPMS user access should be sent to HPMS_Access@cms.hhs.gov. For
technical assistance related to the submission of information in HPMS, questions should be sent to
hpms@cms.hhs.gov. Technical assistance for Primary Manufacturers and other interested parties
will also be made available.
Additional Instructions
• The instructions in this section apply to all Sections A through J. If a term included in this
ICR is also included and defined in final guidance, the term’s definition in this ICR is the
same as in the final guidance. Questions about the final guidance, including questions
about terms defined in this ICR, should be sent to
3

https://www.cms.gov/about-cms/information-systems/hpms/user-id-process

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IRARebateandNegotiation@cms.hhs.gov.
For Sections A through G of this form, the Primary Manufacturer must provide data only
with regard to the selected drug as identified under section 1192 of the Act. If a
Primary Manufacturer has more than one selected drug, the Primary Manufacturer is
required to make a separate submission of the information required in Sections A
through G of this ICR for each selected drug.
All response fields are limited to a character count. The field and response format
sections provide a character count and an estimated word count.
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
Section I (e.g., # to indicate a numerical response is required).
Primary Manufacturers must timely notify CMS if any of the information submitted
changes after the initial submission of data, including as set forth in sections 40.2 and
50.1 of the final guidance. Please timely notify CMS via the IRA Mailbox at
IRARebateandNegotiation@cms.hhs.gov if any such changes are applicable to the
selected drug.
Section 1193(c) of the Act states that CMS must determine which information submitted
to CMS by a manufacturer of a selected drug is proprietary information of that
manufacturer. As described in section 40.2.1 of the final guidance, CMS will treat certain
data elements submitted by a Primary Manufacturer of a selected drug in accordance with
section 1194(e)(1) and section 1194(e)(2) of the Act as proprietary if the information
constitutes confidential commercial or financial information of the Primary Manufacturer
or a Secondary Manufacturer. 4 In order to identify information within a response that a
respondent believes should be withheld by CMS under FOIA Exemptions 3 and/or 4 (5
U.S.C. § 552(b)(3), (4)), 5 Primary Manufacturers are instructed to complete Question 27
regarding such applicable information provided in response to Sections A through G, and
any interested party is instructed to complete Question 62 regarding such applicable
information provided in Section I. Sections 40.2.1, 60.4 and 60.6 of the final guidance
discuss the situations in which CMS may share section 1194(e)(2) data submitted
publicly, without sharing any personally identifiable information 6 (PII) or protected

Specifically, as described in section 40.2.1 of the final guidance, CMS will treat research and development costs and
recoupment, unit costs of production and distribution, pending patent applications, market data, revenue, and sales
volume data as proprietary, unless the information that is provided to CMS is already publicly available, in which case
it would be considered non-proprietary. CMS will treat the data on prior Federal financial support and approved patent
applications, exclusivities, and approved applications under section 505(c) of the FD&C Act or section 351(a) of the
PHS Act as non-proprietary because CMS understands these data are publicly available.
5
See: https://www.justice.gov/oip/doj-guide-freedom-information-act-0.
6
Personally identifiable information (PII) is information that can be used to distinguish or trace an individual’s
identity, either alone or when combined with other information that is linked or linkable to a specific individual. PII
can include sensitive data, such as medical, financial, or legal information; “neutral” information such as name,
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health information 7 (PHI), proprietary information, or information that is protected from
disclosure under other applicable law.
Definitions included in this ICR are intended for purposes related to this ICR and the
Medicare Drug Negotiation Program only.

Instructions for Reporting Monetary Amounts
• When calculating and reporting monetary values, the information must be determined
using the methodologies described throughout the document and consistent with the
Generally Accepted Accounting Principles (GAAP), when applicable. Describe the
policies and methodologies used in the calculations in the free response field for the
relevant question, as well as the standard used if it is inconsistent with GAAP.
• When calculating monetary values, assume at most an 8.1 percent annual cost of capital
for purposes of applying an adjustment. 8 If a Primary Manufacturer uses a cost of capital
adjustment below 8.1 percent, that amount should be used.
• Monetary amounts must be reported in United States dollars (USD) and include two
decimal places (i.e., dollars and cents), unless otherwise specified in Section D or
Section G. Use the free response field of an applicable question, when it is
available, to clarify any rounding limitations or alternative rounding standard relied
on.
• The geographic area for data on U.S. Commercial markets, Medicare markets, and
Medicaid markets is based on the definition of the United States in 42 C.F.R §
400.200, unless the geographic area is specified in the authority for the data source
(e.g., FSS and Big Four prices).
• When converting another currency to USD, specify in the free response field of
applicable question which of the following options were used:
(1) 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. 9 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. 10 In the free response field, report the
amount, the currency, the exchange rate, and time period(s) used in this
calculation, or
facial photos, or work address; and, contextual information, such as a file for a specific health condition that
contains a list of treated patients. See: https://www.hhs.gov/web/policies-and-standards/hhs-webpolicies/privacy/index.html#what-is-pii.
7
Protected health information (PHI) is individually identifiable health information held or transmitted by a covered
entity or its business associate, in any form or media, whether electronic, paper, or oral. Individually identifiable
information is information, including demographic data, that relates to the individual’s past, present, or future
physical or mental health or condition; the provisions of health care to the individual; or the past, present, or future
payment for the provision of health care to the individual, and that identifies the individual or for which there is a
reasonable basis to believe it can be used to identify the individual. PII includes many common identifiers such as
name, address, birth date, Social Security Number, etc. See https://www.hhs.gov/hipaa/forprofessionals/privacy/laws-regulations/index.html.
8
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.
9
See: https://www.irs.gov/individuals/international-taxpayers/foreign-currency-and-currency-exchange-rates.
10
See: https://www.irs.gov/individuals/international-taxpayers/yearly-average-currency-exchange-rates.

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(2) the GAAP Accounting Standard Certification (ASC) 830 for translating foreign
currencies.
Do not report the same costs in multiple places unless the additional specific instructions
for that question instruct you to do so.
Do not include any costs that are unallowable under an applicable law or costs that are
otherwise expressly excluded from this ICR.
Do not make any adjustments for inflation to any dollar amounts reported unless the
additional specific instructions for that question instruct you to do so. 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.

A. Selected Drug Information
Primary Manufacturer Response Required
In Section A, for each selected drug for initial price applicability year 2027, 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 final guidance, meaning those NDC-11s of the selected drug that:
(1) had Part D PDE utilization in the 12-month period beginning November 1, 2023 and
ending October 31, 2024, or
(2) CMS believes are likely to have Part D PDE utilization in the future (for
example, NDC-11s associated with recently approved NDAs / BLAs).
For each of these NDC-11s of the selected drug, including any NDC-11s that are marked as
“discontinued,” CMS will also populate the CMS HPMS with the Product Name and the Labeler
Code. If a Primary Manufacturer believes that an NDC-11 that has been populated by CMS
within the CMS HPMS should not be populated, or an error has occurred, they can submit an
email to IRARebateandNegotiation@cms.hhs.gov.
Definitions for Section A:
• 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.
• Drug sample: A unit of a prescription drug that is not intended to be sold and is intended
to promote the sale of the drug (21 U.S.C. § 353(c)(1)).
• Labeler code: The first segment of the FDA-assigned NDC (21 C.F.R. § 207.33(b)(1)(i)).
Each entity who engages in manufacturing, repacking, relabeling, or private label
distribution of a drug subject to listing under 21 C.F.R. Part 207 must apply for an NDC
labeler code (21 C.F.R. § 207.33(c)(1)).
• Private label distributor: With respect to a particular drug, a person who did not
manufacture, repack, relabel, or salvage the drug but under whose label or trade name the
drug is commercially distributed (21 C.F.R. § 207.1).
• Total AMP Units per Package: The total number of AMP units per NDC-11 package size.
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Total National Council for Prescription Drug Programs (NCPDP) Units per Package: The
total number of NCPDP units per NDC-11 package size.

Instructions for Section A:
• Review the list of NDC-11s populated by CMS, and if any NDC-11s associated with the
NDA(s) / BLA(s) of the selected drug are missing from the list (e.g., because they are
new NDC-11s, discontinued NDC-11s), including any missing NDC-11s of a Secondary
Manufacturer of the selected drug, provide the missing NDC-11 and corresponding
Product Name and Labeler Code.
• For each of the listed NDC-11s or any additional NDC-11s added by the Primary
Manufacturer, provide the NCPDP Unit, Total NCPDP Units Per Package, AMP Unit
and Total AMP Units Per Package.
• For each of the listed NDC-11s or any additional NDC-11s added by the Primary
Manufacturer, indicate whether:
(1) any of the listed NDC-11s or additional NDC-11s are marketed and controlled solely
by a manufacturer that is not the Primary Manufacturer or a Secondary Manufacturer,
(2) any of the listed NDC-11s or additional NDC-11s are distributed by a private label
distributor,
(3) any of the listed NDC-11s or additional NDC-11s have been discontinued and the
date of discontinuation 11, and
(4) any of the listed NDC-11s or additional NDC-11s are a sample package, outer package,
or inner package.
• If an NDC-11 is not controlled by a Primary or Secondary Manufacturer and the Primary
Manufacturer is not able to determine the information for the NDC, select “Unknown” in
response to whether the NDC-11 is “Marketed and Controlled Solely by a Manufacturer
that is not the Primary or Secondary Manufacturer.”
Product
Name

NDC-11
Numbers

Marketed and
Controlled
Solely by a
Manufacturer
that is not the
Primary or
Secondary
Manufacturer

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

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

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

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

Private
Label
(Select
if NDC11 is a
private
label)

NCPDP
Unit
(EA,
ML,
GM)

Total
NCPDP
Units
per
Package

Text to be
prepopulated
by CMS

Numbers
to be prepopulated
by CMS

Yes/No/Unknown

Text

Text

Text

Text

Text

Text

#

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

Total
AMP
Units
per
Package

Labeler
Code

#

Numbers
to be prepopulated
by CMS

Date if
Applicable

*Primary Manufacturer to add rows and identify any NDC-11s of the selected drug that are not
pre-populated by CMS
B. Non-FAMP Data Collection
Primary Manufacturer Response Required
11

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

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For Section B, the Primary Manufacturer is required to report the non-FAMP for its selected
drug(s) for the four quarters of calendar years 2021 (or, in the case that there is not an average
non-FAMP available for such selected drug for calendar year 2021, the Primary Manufacturer is
required to report average non-FAMP for the first full calendar year following the market entry
for such drug), as well as calendar year 2024 (i.e., the calendar year prior to the selected drug
publication date, February 1, 2025).
CMS plans to use the reported NDC-11s, quarterly non-FAMP, and total NDC-11 package
volume in the table below to calculate the average non-FAMP for calendar year 2021 (or for the
first full calendar year following the market entry of the selected drug) and calendar year 2024
for initial price applicability year 2027.
Definitions for Section B:
• Non-FAMP: Section 1194(c)(6) of the Act defines “average non-Federal average
manufacturer price” as the average of the non-FAMP (as defined in
38 U.S.C. § 8126(h)(5)) for the four calendar quarters of the year involved. 12 For initial
price applicability year 2027, these are the quarters of 2021 (or of the first full calendar
year following marketing entry of the drug) and 2024 (i.e., the calendar year prior to the
statutorily-defined selected drug publication date, February 1, 2025). When there are less
than 30 days of commercial sales data for all NDC-11s of the selected drug in calendar
year 2021, the applicable year will be the first full calendar year following market entry
of such drug. When there are at least 30 days of commercial sales data but less than a
calendar quarter of data to calculate the non-FAMP in calendar year 2021, the Primary
Manufacturer should submit 2021 data—to the extent that it exists—for all NDC-11s of
the selected drug. For a given NDC-11 of such drug, when there are at least 30 days of
commercial sales but less than a calendar quarter of data to calculate the non-FAMP in
calendar year 2021 (or the first full year following market entry of such drug, when
applicable) or 2024, the non-FAMP reported by the Primary Manufacturer to CMS
should reflect the temporary non-FAMP predicated upon the first 30 days of commercial
sales data. The temporary non-FAMP should be calculated following the same
methodology used to calculate the temporary non-FAMP amount used to determine the
Temporary Federal Ceiling Price, as described in the Department of Veterans Affairs
(VA) 2024 Updated Guidance for Calculation of Federal Ceiling Prices (FCPs) for New
Drugs subject to Public Law 102-585. 13 Any restatements of the non-FAMP made in any
manufacturer non-FAMP submissions to the VA must be reflected in the non-FAMP
submitted to CMS.
• Non-FAMP package: Non-FAMP package is the package unit as described in 38 U.S.C. §
8126(h)(6) and represents the NDC-11 package (e.g., for an NDC-11 that represents a
bottle of 30 tablets, the non-FAMP package would be the bottle).
Instructions for Section B:
Please follow the instructions below when completing the following tables.
12

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).
13
See: https://www.va.gov/opal/docs/nac/fss/pl102585-2024-pbm-fcp-guidance-for-new-covered-drugs.pdf.

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Please complete the two tables immediately below:
• Table 1: please fill in the information for non-FAMP for each calendar
quarter of 2021 for the selected drug (or, in the case that there is not an
average non-FAMP available for such drug for 2021, please fill in the
information for the applicable calendar quarters for the first full year
following the market entry for such drug). If the first full year following
the market entry happens to be 2024, then please proceed to fill in table 2
only.
• Table 2: please fill in the information for non-FAMP for calendar year
2024.
Please note that when filling out Table 1 and Table 2, there may be a different
number of NDC-11s with available data in Table 1 and in Table 2. As an example, if
a selected drug’s market entry was in the 3rd quarter of 2021, all associated NDC11s should be reported for the four quarters of 2022 in Table 1. Table 2 will consist
of all NDC-11s for the four quarters of 2024, even if an NDC-11 was available in
2024 but not available during any quarter of 2022 and therefore no data was
provided in Table 1.
Please report the non-FAMP and total non-FAMP package volume for each NDC-11
of the selected drug. Primary Manufacturers are responsible for reporting the
calendar year in Table 1 as either calendar year 2021 or the calendar year of first
year post market entry. If an NDC-11 was not marketed, sold, or distributed in a
particular calendar quarter, enter “0” in the total NDC-11 package volume field and
leave the non-FAMP field blank. In these situations, please provide an explanation in
the “Explanation of why non-FAMP was not reported (if applicable)” field of why the
NDC-11 had no non-FAMP for that calendar quarter (e.g., first marketed in a later
calendar quarter).
Non-FAMP and total non-FAMP package 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) and for 2024
made in any manufacturer non-FAMP submissions to the VA must be reflected in the
table below.
Please indicate the total number of NDC-11 packages sold during the quarter and that are
used in the calculation of the non-FAMP in the total non-FAMP package volume field.

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Table 1
NDC-11

123456789-01
Table 2
NDC-11

123456789-01

Calendar
Quarters
of 2021
or First
Calendar
Year
Post
Market
Entry
QQ

Calenda Total Nonr Year
FAMP
Package
Volume

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

YYYY

$

Calendar
Quarter
for 2024

Calenda Total Nonr Year
FAMP
Package
Volume
YYYY
#

QQ

#

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

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

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

C. Research and Development (R&D) Costs and Recoupment
Primary Manufacturer Response Required
Section C contains five questions, related to global R&D costs incurred by the Primary
Manufacturer, including acquisition costs, related to the selected drug. 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 global, total lifetime net revenue 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 U.S. lifetime net revenue was calculated in the
free response field.
Definitions for Section C:
R&D costs mean a combination of costs incurred by the Primary Manufacturer for all FDAapproved indications 14 of a drug falling into the five categories below, and excluding the
For purposes of this ICR, CMS distinguishes between the use of the word “indication” and the term “FDAapproved indication” such that “FDA-approved indication” refers to the information included in drug labeling per
21 C.F.R. § 201.57(c)(2) or other applicable FDA regulation(s), and “indication” refers to the condition or disease
state for which the selected drug is used. CMS will use “indication” for purposes of determining the initial offer, as
described in the final guidance.
14

10

following: (a) prior Federal financial support, (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. R&D: Acquisition Costs
2. R&D: Basic Pre-Clinical Research Costs
3. R&D: Post-Investigational New Drug Application (IND) Costs
4. R&D: Abandoned and Failed Drug Costs
5. 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.
Instructions for Section C:
Follow these instructions for Questions 1 through 6 when reporting R&D costs:
• For each dollar amount listed below, the Primary Manufacturer must report one dollar
amount in the numerical response field and an explanation of the values, including
any calculations or conversions and any assumptions made in the free response field.
• 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 FDA-approved
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 preclinical research, clinical trials, etc.), deduct such funding from the final calculated
numerical amount before answering the relevant question and note that deduction in the
applicable free response field. CMS will be collecting additional information on prior
Federal financial support in Questions 9, 10, and 11. Please reference Section E for
instructions on reporting prior Federal financial support.
• 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.
11

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:
• 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.
RESPONSE FORMAT
Yes/No
•

•

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; do not make adjustments for inflation or for the cost of capital.
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” numerical field.

FIELD
Total Acquisition Costs for the Selected Drug
Total Acquisition Costs

RESPONSE FORMAT
$
$

If the “Total Acquisition Costs for the Selected Drug” numeric field does not apply,
indicate N/A.
If the “Total Acquisition Costs for the Selected Drug” numeric field is populated, then please
provide an explanation of the allocation of “Total Acquisition Costs for the Selected Drug,” in
the free response field below. Additionally, report the following two values, separately,

and explain the methodology used for each:
o Value #1: the “Total Acquisition Costs for the Selected Drug” adjusted for
inflation (without making any other adjustments, e.g., an adjustment for the
cost of capital); this value is required.
o Value #2: the “Total Acquisition Cost for the Selected Drug” adjusted for
inflation AND adjusted for the cost of capital (without making any other
adjustments), if appropriate based on the Primary Manufacturer’s internal
accounting standards. If making an adjustment for the cost of capital, such an
adjustment must not be applied beyond the date that the first FDA-approved

12

indication was approved for the selected drug. If not making an adjustment
(e.g., because an adjustment is not appropriate based on the Primary
Manufacturer’s internal accounting standards), indicate that no adjustment for
cost of capital has been included and do not report a value separate from Value
#1.
FIELD
Explanation of Allocation of Total
Acquisition Costs for the Selected Drug

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

Question 2: Basic Pre-Clinical Research for All FDA-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:
• 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 FDA-approved 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 potential NDA(s) / BLA(s) or NDA(s) / BLA(s) of the
selected drug (whichever is later) to the day before the last IND application for that FDAapproved indication of the selected drug went into effect. 15,16 The basic pre-clinical
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 52month period. 17
CMS acknowledges that the exact date of initial discovery might not be known, but Primary Manufacturers should
use their best estimate.
16
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.
17
CMS believes that 52 months represents a solid average across studies. For example, one study reported that the
pre-clinical 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, 2003,
https://dukespace.lib.duke.edu/items/746bd624-1fbd-44ae-b348-73edc80b073f. Another study estimated that the
pre-clinical 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 pre-clinical phase ranges from three to
six years. See PhRMA, “Biopharmaceutical Research & Development: The Process Behind New Medicines,” 2015.
15

13

•

•

Direct basic pre-clinical research costs are costs that can be specifically attributed to the
discovery and pre-clinical development of the selected drug. Direct research expenses
could include personnel (monetary and non-monetary compensation for investigators and
staff) researching the selected drug, materials for conducting basic pre-clinical research,
and the costs of in vivo and in vitro studies on the selected drug before an IND
application went into effect.
Indirect basic pre-clinical research costs and relevant general and administrative
expenses are operating costs for basic pre-clinical research beyond the basic pre-clinical
research costs for the selected drug, including administrative personnel and overhead
costs (expenses for clinical facilities and equipment) that are shared across multiple
potential drugs or 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. 18, 19 For example, if the direct pre-clinical research costs
spent on the selected drug were approximately 10 percent of a Primary Manufacturer’s
total direct basic pre-clinical research costs for that period of time, then indirect costs
should be allocated proportionally. Thus, for the selected drug, they should be 10 percent
of the total spending on indirect pre-clinical research costs during that time period.

Instructions for Question 2a:
• In the numerical response field, report the basic pre-clinical research costs for the
selected drug; do not make adjustments for inflation or for the cost of capital.
• The amount reported for basic pre-clinical research costs in the numerical response
field for Question 2a must be the sum of (1) direct research expenses and (2) a
proportion of indirect research expenses. Any non-monetary compensation for
investigators and staff included in the total amount should reflect the fair market
value for such compensation at the time it was provided.
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, enter “$0” for Question 2a.
o If there were basic pre-clinical research costs incurred after the Primary
Manufacturer acquired the right to hold the NDA(s) / BLA(s) of the selected drug,
the basic pre-clinical research costs must be reported in the numerical response
field.
FIELD
Basic Pre-Clinical Research Costs for All FDA-Approved
Indications of the Selected Drug

RESPONSE FORMAT
$

Instructions for Question 2b:
• List the direct research expenses and the indirect research expenses for the selected
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.
19
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-programme-thirdedition(e43f24cd-099a-4d56-97e6-6524afaa37d1)/export.html.
18

14

•

drug.
Additionally, report the following two values, separately, and explain the methodology
used for each:
o Value #1: the basic pre-clinical research costs adjusted for inflation (without
making any other adjustments, e.g., an adjustment for the cost of capital); this
value is required.
o Value #2: the basic pre-clinical research costs adjusted for inflation AND
adjusted for the cost of capital (without making any other adjustments), if
appropriate based on the Primary Manufacturer’s internal accounting standards.
If making an adjustment for the cost of capital, such an adjustment must not be
applied beyond the date that the first FDA-approved indication was approved
for the selected drug. If not making an adjustment (e.g., because an adjustment
is not appropriate based on the Primary Manufacturer’s internal accounting
standards), indicate that no adjustment for cost of capital has been included and
do not report a value separate from Value #1.

FIELD
List of the direct research expenses and indirect research
expenses for the selected drug included in this section

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

Instructions for Question 2c:
•

Explain how the basic pre-clinical research costs were calculated, including the
allocation and apportionment methods. This explanation should include the percentage
of direct and indirect spending on the selected drug out of the total direct and indirect
basic pre-clinical research costs for the Primary Manufacturer and the length of the
basic pre-clinical research period used.

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

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

Question 3: Post-IND Costs for All FDA-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 FDA-approved indications for the selected drug.
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
15

•

•

costs associated with completed FDA-required, postmarketing 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 (compensation for investigators and staff) researching the
selected drug, and facility costs that are directly related to conducting the dosing and
Phase I, Phase II, and Phase III clinical trials during the post-IND period. Direct postIND 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, postmarketing trial. Personnel, patient recruitment, and perpatient costs include monetary and non-monetary compensation.
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
postmarketing trial was completed for the selected drug.

Instructions for Question 3a:
• 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,
as well as the direct costs for all completed, FDA-required post-marketing trials for all
FDA-approved indications of the selected drug. Any non-monetary compensation for
investigators and staff included in the total amount should reflect the fair market value
for such compensation at the time it was provided. Do not make adjustments for
inflation or for the cost of capital.
o If the Primary Manufacturer acquired the right to hold the NDA(s) / BLA(s) of the
selected drug after all NDA(s) / BLA(s) 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.
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.
o If the selected drug received accelerated approval for any FDA-approved
indication, 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.
FIELD
Post-IND Costs for Approved Indications of the Selected Drug

RESPONSE FORMAT
$
16

Instructions for Question 3b:
• Respond “Yes” or “No” in the “FDA Expedited Program” field if the selected drug
received fast track designation, breakthrough therapy designation, accelerated
approval, or priority review designation for any of its FDA-approved indications. If
“Yes,” indicate in the free response field the type of expedited program(s) and the
FDA-approved indication(s) for which the designation was granted.
FIELD
FDA Expedited Program
If yes, indicate the expedited program(s) and FDA-approved
indication(s)

RESPONSE FORMAT
Yes/No
Text (3,600 character
count limit, which is
approximately 300 words)

Instructions for Question 3c:
• List all the applicable direct costs included in the numerical value given in Question 3a.
FIELD
List of the direct costs included in this question

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

Instructions for Question 3d:
•

•

Explain how the post-IND costs for all FDA-approved indications numerical value were
calculated, including any conversions that were done. The Primary Manufacturer must
identify the length of the post-IND period used in the calculations. Additionally, the
Primary Manufacturer may include the post-IND cost associated with each FDAapproved indication or may break down those costs for each clinical trial phase.
Additionally, report the following two values, separately, and explain the methodology
used for each:
o Value #1: the post-IND costs for all FDA-approved indications adjusted for
inflation (without making any other adjustments, e.g., an adjustment for the
cost of capital); this value is required.
o Value #2: the post IND-costs for all FDA-approved indications adjusted for
inflation AND adjusted for the cost of capital (without making any other
adjustments), if appropriate based on the Primary Manufacturer’s internal
accounting standards. If making an adjustment for the cost of capital, such an
adjustment must not be applied beyond the date that the first FDA-approved
indication was approved for the selected drug. If not making an adjustment
(e.g., because an adjustment is not appropriate based on the Primary
Manufacturer’s internal accounting standards), indicate that no adjustment for
cost of capital has been included and do not report a value separate from Value
#1.

17

FIELD
Explanation of Post-IND Costs for FDA-Approved Indications of
the Selected Drug

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

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 receive 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 (monetary and non-monetary
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.
• 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 receive 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
(compensation for investigators and staff) researching the drug, and facility costs
that are directly related to conducting dosing and clinical trials for the drug.
Personnel, patient recruitment, and per-patient costs include monetary and nonmonetary compensation.
Instructions for Question 4a:
• 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 receive
FDA approval. Any non-monetary compensation for investigators and staff, patient
recruitment, and per-patient costs included in the total amount should reflect the fair
market value for such compensation at the time it was provided.
• Do not make adjustments for inflation or for the cost of capital.
• Do not include acquisition costs for failed or abandoned products in the numerical
response field. Such costs should be reported in Question 5.
18

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

RESPONSE FORMAT
$

Instructions for Question 4b:
• List all the applicable direct costs included in the numerical value given in Question 4a.
FIELD
List of the direct costs included in this question

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

Instructions for Question 4c:
• In the free response field, detail how these costs were determined, what portion of direct
costs was included for basic pre-clinical research and post-IND costs, and how any
allocation was done.
• Additionally, report the following two values, separately, and explain the methodology
used for each:
o Value #1: the “Costs on Allowable Abandoned or Failed Products Related to
the Selected Drug” adjusted for inflation (without making any other
adjustments, e.g., an adjustment for the cost of capital); this value is required.
o Value #2: the “Costs on Allowable Abandoned or Failed Products Related to
the Selected Drug” adjusted for inflation AND adjusted for the cost of capital
(without making any other adjustments), if appropriate based on the Primary
Manufacturer’s internal accounting standards. If making an adjustment for the
cost of capital, such an adjustment must not be applied beyond the date that the
first FDA-approved indication was approved for the selected drug. If not
making an adjustment (e.g., because an adjustment is not appropriate based on
the Primary Manufacturer’s internal accounting standards), indicate that no
adjustment for cost of capital has been included and do not report a value
separate from Value #1.
FIELD
Explanation of Costs on Allowable Abandoned or Failed Products
Related to the Selected Drug, Including Allocation and
Apportionment Methods

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

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 R&D that
was not accounted for in Questions 1 through 4.
Definition for Question 5:
• All other R&D direct costs are any other allowable costs that do not align with R&D
definitions 1 through 4. For example, other R&D direct costs may include direct costs
associated with conducting FDA-required postmarketing trials and other FDA postmarketing requirements and commitments that were not completed, Phase IV
19

postmarketing studies for FDA-approved indications that were not required by FDA,
post-IND costs for indications that did not receive FDA approval, acquisition costs for
failed or abandoned products, and costs associated with generating real-world evidence
that was submitted to FDA to support the safety or effectiveness of a selected drug or to
support or satisfy a post-marketing requirement or commitment.
Instructions for Question 5a:
• In the numerical response field, report the sum of all other R&D direct costs for the
selected drug. Do not make adjustments for inflation or for the cost of capital.
FIELD
Costs of Other R&D for the Selected Drug Not Accounted for
Above

RESPONSE FORMAT
$

Instructions for Question 5b:
• List each “other R&D direct cost” for the selected drug included in the numerical value
in Question 5a.
FIELD
List of Other R&D Costs for the Selected Drug Not Accounted for
Above

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

Instructions for Question 5c:
• For each “other R&D direct cost” listed in Question 5b, explain how each was
calculated.
• Additionally, report the following two values, separately, and explain the methodology
used for each:
o Value #1: the “Costs of Other R&D for the Selected Drug Not Accounted for
Above” adjusted for inflation (without making any other adjustments, e.g., an
adjustment for the cost of capital); this value is required.
o Value #2: the “Costs of Other R&D for the Selected Drug Not Accounted for
Above” adjusted for inflation AND adjusted for the cost of capital (without
making any other adjustments), if appropriate based on the Primary
Manufacturer’s internal accounting standards. If making an adjustment for the
cost of capital, such an adjustment must not be applied beyond the date that the
first FDA-approved indication was approved for the selected drug. If not
making an adjustment (e.g., because an adjustment is not appropriate based on
the Primary Manufacturer’s internal accounting standards), indicate that no
adjustment for cost of capital has been included and do not report a value
separate from Value #1.

20

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

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

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 United States, 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
Primary Manufacturer must provide the revenue for each calendar year of the total lifetime net
revenue period. 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 biological
product 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.
• Global, total lifetime net revenue for the selected drug must be in nominal USD.
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; do not make
21

adjustments for inflation.
FIELD
Global, Total Lifetime Net Revenue for the Selected Drug
•

RESPONSE FORMAT
$

In the free response field, explain how the final global, total lifetime net revenue was
calculated, including any relevant currency conversions. Additionally, report the per
calendar year revenue for the global, total lifetime net revenue and specify the calendar
year date range(s) for the global, total lifetime net revenue period. Lastly, report the
global, total lifetime net revenue for the selected drug for the global, total lifetime net
revenue period after making adjustments for inflation and explain the methodology used
to make such adjustments for inflation.

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

RESPONSE FORMAT
Text (60,000 character count limit,
which is approximately 5,000 words)

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 biological product
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.
• U.S. lifetime net revenue for the selected drug must be in nominal USD.
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; do not make adjustments for inflation.
FIELD
U.S. Lifetime Net Revenue for the Selected Drug

RESPONSE FORMAT
$

In the free response field, explain how the final amount was calculated. Additionally, report
the per calendar year revenue for the U.S. lifetime net revenue and specify the calendar year
date range(s) for the U.S. lifetime net revenue period. Lastly, report the U.S. lifetime net
revenue for the selected drug for the U.S. lifetime net revenue period after making
adjustments for inflation and explain the methodology used to make such adjustments for
inflation.
22

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

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

D. Current Unit Costs of Production and Distribution
Primary Manufacturer Response Required
Section D contains two questions on current unit costs of production and distribution for the
selected drug. Question 7 is a table in which to report the average unit costs of production and
distribution for each NDC-11 of 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 Standard (BUS) 20: The
three NCPDP BUS are: each (EA), milliliter (ML), and gram (GM). For certain volume data
of the selected drug, CMS is requesting units be reported using the NCPDP BUS to facilitate
comparison with the amounts in the quantity dispensed field found in PDE data, which also
uses the NCPDP BUS.
• Costs of production are defined as all (direct and allocation of indirect) costs related to:
o Purchase of raw ingredients, including intermediates, active pharmaceutical
ingredients, excipients, and other bulk chemicals;
o Formulation and preparation of the finished drug product;
o Quality control and testing of the drug; and
o Operating costs for personnel, facilities, transportation, importation (if any), and
other expenses related to the preparation of the finished drug product for the
selected drug.
• Costs of distribution are defined as all (direct and allocation of indirect) costs related to:
o Packaging and packaging materials;
o Labeling (e.g., the mechanical aspects of printing and affixing the approved label);
o Shipping to any entity (e.g., distributor, wholesaler, retail or specialty pharmacy,
physician office or hospital, etc.) that acquires the drug from the Primary
Manufacturer or any Secondary Manufacturer; and
o Operating costs for facilities, transportation, and other expenses related to
packaging, labeling, and shipping to any entity that acquires the drug from the
Primary Manufacturer or any Secondary Manufacturer.
• Current unit costs of production and distribution of the selected drug are defined to
include:
o Units (and associated costs) marketed by the Primary Manufacturer and any
Secondary Manufacturer(s);
See: NCPDP BUS: https://standards.ncpdp.org/Billing-UnitRequest.aspx#:~:text=Billing%20Unit%20Requests,grams%22%20or%20%22milliliters.%22.
20

23

•

•

•

o Average unit costs during the 12-month period ending December 31, 2024;
o Only units (and associated costs) produced and distributed for U.S. sales; costs
incurred outside of the U.S. are included, provided that they are incurred for the
production or distribution of units produced and distributed for use in the U.S.;
o Only costs incurred by the Primary Manufacturer and any Secondary
Manufacturers; such costs may include payments to third-party vendors (e.g.,
contractors) performing activities that qualify as production or distribution, as
specified above; and
o Allocated shared operating and other indirect costs (such as capitalized production
facility costs, benefits, generalized and administrative costs, and overhead
expenses) specific to each NDC-11 based on unit volume.
Current unit costs of production and distribution of the selected drug are defined not to
include:
o R&D costs;
o Marketing costs; and
o Transfer prices.
“Marketing costs” are defined as expenditures incurred in the introduction or delivery for
introduction into interstate commerce of a drug product, specifically including media
advertisements, direct-to-consumer promotional incentives including patient assistance
programs, promotion of the drug to health professionals, and other paid promotion.
“Transfer prices” are defined as prices charged for goods, services, or other intangible
assets in transactions between two members of the same controlled group of the Primary
Manufacturer or any Secondary Manufacturer, including sales of a drug product,
provision of services (e.g., contract manufacturing), or transfer of intellectual property.
For the purposes of the definition of transfer prices, “controlled group” of the Primary
Manufacturer or any Secondary Manufacturer refers to all entities that were treated as a
single employer under subsection (a) or (b) of section 52 of the Internal Revenue Code
and the Department of the Treasury regulations thereunder.

Instructions for Section D:
Follow the instructions below when answering Questions 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.
• Costs may be reported up to three decimal places (USD).
Question 7: Per Unit Production and Distribution Costs
Please complete the following table using additional rows as necessary for the 12-month period
ending December 31, 2024.

24

NDC11

Average Per Average Per Unit NCPDP Unit
Unit
Distribution Costs (EA, ML, GM)
Production
Cost
12345- $XX.XXX
$XX.XXX
• Text
6789-01

Total Unit
Volume

Costs are
Not
Available

#

Select if
applicable

Explanation
of Why Costs
are Not
Available
Text (30,000
character count
limit, which is
approximately
2,500 words)

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

E. Prior Federal Financial Support
Primary Manufacturer Response Required
Section E focuses on capturing prior Federal financial support for novel therapeutic discovery
and development with respect to the selected drug.
Definitions for Section E:
• “Federal financial support for novel therapeutic discovery and development” refers to tax
credits, direct financial support, grants or contracts, in-kind contributions (e.g., support in
the form of office/laboratory space or equipment), and any other funds provided by the
federal government that support discovery, research, and/or development related to the
selected drug.
25

•

•

“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.
Prior Federal financial support includes the manufacturer’s reasonable estimate of the
dollar value of in-kind contributions and Cooperative Research and Development
Agreements (CRADAs) that do not have a readily ascertainable value.

Instructions for Section E:
Follow the instructions below when answering Questions 9, 10, and 11.
• When completing this section:






Include all prior Federal financial support provided by U.S. federal agencies or Federallysupported grants or contracts that 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.
Include prior Federal financial support received for indirect costs of developing the
selected drug. These indirect costs are operating costs such as administrative
personnel and overhead costs (expenses for clinical facilities and equipment) that
are shared across multiple potential drugs or biological products.
• To calculate the proportion of indirect costs, the Primary Manufacturer must
use proportional allocation, whereby the same proportion of spending
allocated for direct research on the selected drug is used to estimate the
proportional spending for indirect research. 21, 22 For example, if the direct
costs spent on the selected drug were approximately 10 percent of a Primary
Manufacturer’s total direct basic pre-clinical research costs, then indirect
costs must be allocated proportionally, thus for the selected drug they must
be 10 percent of the total spending on indirect costs during that time period.
• 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.
• For in-kind contributions and CRADAs, if the dollar value of the in-kind
contribution or CRADA is not readily ascertainable, the recipient should
provide a reasonable estimate.
If the Primary Manufacturer received prior Federal financial support for a failed or
abandoned product with the same active moiety / active ingredient or mechanism of

Wouters OJ, McKee M, Luyten J., Estimated Research and Development Investment Needed to Bring a New
Medicine to Market, 2009-2018. JAMA. 2020;323(9):844–853. doi:10.1001/jama.2020.1166.
22
Drummond MF, Sculpher MJ, Torrance GW, O’Brien BJ, Stoddart GL., Methods for the Economic Evaluation of
Health Care Programme. 3rd ed. Oxford, UK: Oxford University Press, 2005,
https://pure.york.ac.uk/portal/en/publications/methods-for-the-economic-evaluation-of-health-care-programme-thirdedition(e43f24cd-099a-4d56-97e6-6524afaa37d1)/export.html.
21

26



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 receive FDA approval,
including indications for the selected drug that did not receive approval, the Primary
Manufacturer should not include this amount in its answer for Question 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 support
received only for costs the Primary Manufacturer incurred. Expenses should be
allocated across entities based on each entity’s respective stake in the selected
drug’s discovery and development. The allocation to the Primary Manufacturer
should be reported as a dollar amount and the percentage of the total amount
allocated to the Primary Manufacturer should be included in the free response
field in Question 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 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. Do not make adjustments for inflation.
FIELD
Total Federal Financial Support

RESPONSE FORMAT
$

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 highest to lowest. In addition,
describe assumptions, methodological steps, and other information needed to calculate the
estimates provided in Question 9. If you report a value for “other Federal financial support not
otherwise included elsewhere” in your response to this question, please list the source(s) of that
Federal financial support. Please include the identification number for grants and comparable
awards. In addition to reporting the total Federal financial support disaggregated amounts
without making adjustments for inflation, also report each disaggregated amount adjusted for
inflation, specify the year(s) in which the amounts were received, and explain the methodology
used to adjust for inflation.
• Tax credits (General, R&D)
• Orphan Drug Act and other specific tax credits
• National Institutes of Health (NIH) funding
27

•
•
•
•
•
•
•
•

Department of Defense (DOD) Congressionally Directed Medical Research (CDMR)
funding
Biomedical Advanced Research and Development Authority (BARDA) funding
Defense Advanced Research Projects Agency (DARPA) funding
Federal financial support for failed or abandoned indications for the selected drug
Federal financial support for failed or abandoned products related to the selected drug (as
described in the definitions for this section)
CRADA support
In-kind contributions not included elsewhere
Other Federal financial support not included elsewhere

FIELD
Federal Financial Support

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

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.
•

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

Type of Agreement

Federal Agency(ies)
Participating in
Agreement
Select the agreement option:
Text (1,200 character count
licensing, pricing, purchasing, limit, which is approximately
other, none
100 words)

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

F. Patents, Exclusivities, and Approvals
Primary Manufacturer Response Required
Section F focuses on capturing data on the selected drug related to pending and approved patent
applications, exclusivities recognized by the FDA, and applications and approvals under section
28

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
14.
Definitions for Section F:
• Patents Exclusivities and Approvals. CMS considers relevant patents, both expired and
unexpired, and relevant patent applications to include:
o All patents issued by the United States Patent and Trademark Office (USPTO), as
of February 1, 2025, 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.
o 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).
o All patent applications related to the selected drug that are pending issuance by the
USPTO.
o 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
the FDA Orange Book or Purple Book; 23 patents that claim the drug product (e.g.,
the final product taken by or administered to a patient), drug substance (active
ingredient) or other chemicals related to the active ingredient of a selected drug
(e.g., crystalline forms, polymorphs, salts, metabolites or intermediates); patents
that claim a formulation of the drug; method-of-use patents (e.g., patents that claim
an indication or use of the drug for treating a particular disease); process patents
(e.g., patents that claim technologies and method(s) of manufacturing the drug);
device patents (e.g., patents that claim the device used to administer the selected
drug); and design patents (e.g., patents that claim a design on the packaging of the
selected drug).
• Relevant patents and patent applications do not include patent applications that were denied by the
USPTO.
• Exclusivity periods under the FD&C Act or the PHS Act refer to certain delays 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); 24
o New Chemical Entity Exclusivity (NCE); 25
o Generating Antibiotic Incentives Now (GAIN) Exclusivity for Qualified
Infectious Disease Products (QIDP); 26
o New Clinical Investigation Exclusivity (NCI); 27
FDA serves a ministerial role with regard to the listing of patent information in the Orange Book and Purple Book.
Section 527 of the FD&C Act.
25
Section 505(c)(3)(E)(ii) and Section 505(j)(5)(F)(ii) of the FD&C Act.
26
Section 505E(a) of the FD&C Act.
27
Section 505(c)(3)(E)(iii) & (iv) and Section 505(j)(5)(F)(iii) & (iv) of the FD&C Act.
23
24

29

•

o Pediatric Exclusivity (PED); 28 and
o Reference Product Exclusivity for Biological Products. 29
Active and pending FDA applications and approvals include all applications for approval
under section 505(c) of the FD&C Act or section 351(a) of the PHS Act, including those
not yet decided.

Instructions for Section F:
• For Questions 12 through 14, 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 14, include required data for the selected drug.
Question 12: Patents (Expired and Non-Expired) and Patent Applications
In the two tables below, please provide information about patents and patent applications
related to the selected drug. Question 12A provides a table for reporting information about
patents for the selected drug that have been granted by the USPTO. Question 12B provides a
table for reporting information about patent applications related to the selected drug that are
pending issuance by the USPTO.
Question 12A: Patents (Expired and Non-Expired)
In the table below, please list each patent that is related to the selected drug. For each patent
(expired or unexpired) listed in the table below, in the patent explanation field, please provide a
clear and concise written description of the patented invention and, if relevant, of the manner
and process of making and using the invention, as well as how a patent relates to any other
patents listed in the table. For example, if a listed patent is a parent or child of another patent,
include the patent number and how the two patents relate to each other. If the patent was
previously listed in the FDA Orange Book or Purple Book but is no longer listed, please explain
why. A PDF file of the USPTO patent application may be uploaded but is not required for this
question 12A. Add additional rows to your response to Question 12A as needed.

28
29

Section 505A(b) & (c) of the FD&C Act.
Section 351(k)(7) of the PHS Act.

30

Patent
Numb
er

Date
File
d

Patent
Expir
y Date

Patent Type

Is Patented
Product
Commerciall
y Available

#

MM/
DD/
YY
YY

MM/
DD/Y
YYY

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

Yes/No

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

Patent
Patent
Explanation Application

Text
(3,600
character
count
limit,
which is
approxima
tely 300
words

Optional.
Upload
correspon
ding
patent
applicatio
n

Question 12B: Patent Applications
In the table below, please list each patent application that is related to the selected drug. For
each patent application listed in the table below, in the patent explanation field, please provide a
clear and concise written description of the invention and, if relevant, of the manner and process
of making and using the invention, as well as how a patent application relates to any other
patents. Please upload a PDF file of the USPTO patent application. Do not include patent
applications that were denied. Add additional rows to your response to Question 12B as needed.

31

Patent
Number

Date
Filed

Patent Type

Patent Explanation

Patent Application

#

MM/
DD/ YY
YY

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

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

Upload
corresponding
patent
application.

Question 13: Exclusivity Periods
As applicable, please report all exclusivity periods under the FD&C Act or the PHS Act that are
listed or were listed in the Orange Book or the Purple Book and are in effect or have expired
for the selected drug. Complete table for Question 13 by adding rows as needed.
Type of Exclusivity

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

Exclusi
vity
Expira
tion
Date
MM/DD/YY
YY

Application
(NDA /
BLA)
Number
#

NDC-9s
Covered
by
Exclusivi
ty
Text

Comments

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

Question 14: All Active and Pending FDA Applications and Approvals
List all active and pending FDA applications and approvals for the selected drug under section
505(c) of the FD&C Act or section 351(a) of the PHS Act.
• 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
32

•

those applications not yet approved. [Complete table for Question 14 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.

Applica
tion
(NDA /
BLA)
Number

Applica
tion
Type
(NDA;
BLA)

Classification Code 30

Appr
oval
Date

Indic
ation

Dosage
Form
and
Strength

Spon
sor

Applicatio
n Status

Comments

#

Select the
applicatio
n type:
NDA,
BLA

Select one or more of
the following options:
Options: Type 1 — New
Molecular Entity, Type
2
— New Active
Ingredient, Type 3 —
New Dosage Form,
Type 4
— New Combination,
Type 5 — New
Formulation or Other
Differences (e.g., new
indication, new
applicant, new
manufacturer)
, Type 6 — New
Indication or Claim,
Same Applicant, Type 7
— Previously Marketed
But Without an Approved
NDA, Type 8
— Rx to OTC, Type 9
New Indication or
Claim, Drug Not to be
Marketed Under Type 9
NDA After Approval,
Type 10 — New
Indication or Claim,
Drug to be Marketed
Under Type 10 NDA
After Approval

MM
DD,
YYY
Y

Text

Text

Text

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

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

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

30

33

G. Market Data and Revenue and Sales Volume Data
Primary Manufacturer Response Required
The purpose of Questions 15 through 26 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.
• The three NCPDP BUS 31 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 for all but Medicaid best price to facilitate comparison with the amounts in the
quantity dispensed field found in PDE data, which also uses the NCPDP BUS.
• Medicaid best price: The Medicaid best price is defined in 42 C.F.R. § 447.505. The
Medicaid best price is reported at the NDC-9 level.
• AMP unit: The unit type used by the manufacturer to calculate AMP (42 C.F.R. §
447.504) and best price (42 C.F.R. § 447.505) for purposes of the Medicaid Drug Rebate
Program (MDRP): injectable anti-hemophilic factor, capsule, suppository, gram,
milliliter, tablet, transdermal patch, each, millicurie, microcurie. Such units are reported
by the manufacturer on a monthly basis at the NDC-9 level.
• Federal supply schedule (FSS) price: The price offered by the VA in its FSS program, by
delegated authority of the General Services Administration. 32 The FSS price is reported
at the NDC-11 level.
• Big Four price: The Big Four price is described in 38 U.S.C. § 8126. The Big Four price
is reported at the NDC-11 level. 33
• Manufacturer U.S. commercial average net unit price: For the sole purpose of data
collection under section 1194(e)(1)(E) of the Act, the average net unit price of the
selected drug for group or individual commercial plans on- and off-Exchange, excluding
Medicare fee-for-service (Parts A and B), Medicare Advantage, Medicare Part D,
Medicaid fee-for-service, and Medicaid managed care. The U.S. commercial average net
unit price includes discounts, chargebacks or rebates, cash discounts, free goods
contingent on a purchase agreement, up-front payments, goods in kind, free or reducedprice 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 excludes manufacturer-run patient assistance programs
that provide financial assistance such as coupons, co-payment assistance or free drug
31

See: https://standards.ncpdp.org/Billing-UnitRequest.aspx#:~:text=Billing%20Unit%20Requests,grams%22%20or%20%22milliliters.%22.
32
See: https://www.fss.va.gov/index.asp.
33
The Big Four price is the maximum price a drug manufacturer is allowed to charge the Big Four federal agencies,
which are the Department of Veterans Affairs, the Department of Defense, the Public Health Services, and the Coast
Guard. See: https://www.cbo.gov/publication/57007.

34

•

•

•

•

products to patients offered by the Primary Manufacturer and any Secondary
Manufacturer(s). The U.S. commercial average net unit price is reported at the NDC-11
level.
Manufacturer U.S. commercial average net unit price─ net of patient assistance program:
For the sole purpose of data collection under section 1194(e)(1)(E) of the Act, the U.S.
commercial average net unit price includes manufacturer-run patient assistance programs
that provide financial assistance such as coupons, co-payment assistance, or free drug
products to patients offered by the Primary Manufacturer and any Secondary
Manufacturer(s). The U.S. commercial average net unit price—net of patient assistance
includes discounts, chargebacks or rebates, cash discounts, free goods contingent on a
purchase agreement, up-front payments, goods in kind, free or reduced-price services,
grants, or other price concessions or similar benefits offered by the Primary
Manufacturer and any Secondary Manufacturer(s) to any purchasers. The U.S.
commercial average net unit price─ net of patient assistance program is reported at the
NDC-11 level.
Manufacturer U.S. commercial average net unit price─ best: For the sole purpose of data
collection under section 1194(e)(1)(E) of the Act, the lowest U.S. commercial average net
unit price offered by the Primary Manufacturer and any Secondary Manufacturer(s) to any
commercial payer in the U.S. The U.S. commercial average net unit price – best includes
discounts, chargebacks or rebates, cash discounts, free goods contingent on a purchase
agreement, up-front payments, goods in-kind, free or reduced- price services, grants, or
other price concessions or similar benefits offered by the Primary Manufacturer or any
Secondary Manufacturer(s) to any purchasers. The U.S. commercial average net unit price
– best excludes manufacturer-run patient assistance programs that provide financial
assistance such as coupons, co-payment assistance or free drug products to patients offered
by the Primary Manufacturer and any Secondary Manufacturer(s). The U.S. commercial
average net unit price – best is reported at the NDC-11 level.
Manufacturer net Medicare Part D average unit price: For the sole purpose of data
collection under section 1194(e)(1)(E) of the Act, the manufacturer net Medicare Part D
average unit price as calculated by the Primary Manufacturer. This manufacturer net
Medicare Part D average unit price would include specific data, including coverage gap
discounts and other supply chain concessions (e.g., wholesale discounts) of the Primary
Manufacturer or any Secondary Manufacturer(s) not reflected in the sum of the planspecific enrollment weighted amounts calculation and utilization, that may differ from
the PDE data. The manufacturer net Medicare Part D average unit price is reported at the
NDC-11 level.
Manufacturer net Medicare Part D average unit price – best: For the sole purpose of data
collection under section 1194(e)(1)(E) of the Act, the lowest manufacturer net Medicare
Part D average unit price offered by the Primary Manufacturer or any Secondary
Manufacturer(s) to any Part D plan sponsors in the U.S. This manufacturer net Medicare
Part D average unit price – best would include specific data, including coverage gap
discounts and other supply chain concessions (e.g. wholesale discounts) of the Primary
Manufacturer or any Secondary Manufacturer(s) not reflected in the sum of the planspecific enrollment weighted amounts calculation and utilization, that may differ from
the PDE data. The manufacturer net Medicare Part D average unit price – best is reported
35

at the NDC-11 level.
Instructions for Section G:
• For Question 15 through 26, information for the Primary Manufacturer and any
Secondary Manufacturer(s) must be reported.
• For questions 15 through 26, for the sole purpose of data collection under section
1194(e)(1)(E) of the Act, as applicable, the total unit volume must be reported at the
NDC-9 or NDC-11 level and reflect the NCPDP BUS or AMP unit. The total unit
volume must include the total unit volume sold by the Primary Manufacturer and any
Secondary Manufacturer(s) in the U.S. for the data reported.
Question 15: 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:
• If the NDC-11 had multiple WACs for a given quarter, please calculate an average
WAC per unit for the quarter using the following methodology. For each WAC per unit
available in the quarter, please multiply the WAC per unit by the proportion of the total
units sold in that quarter at that WAC out of total unit volume sold in the quarter. Then
sum these values across all WACs available in the quarter to calculate the average
WAC per unit for the quarter.
• Any deviation from the reported WAC unit price in the 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 16 so that CMS can understand the reasons for
these differences.
• Units must be reported in one of the three NCPDP BUS: each (EA), milliliter (ML), or
gram (GM). Total unit volume must be the total number of units sold to wholesalers and
direct purchasers during the quarter. Please do not include units associated with free
samples in the calculated prices or reported total unit volume.
• Report all quarters for the three calendar years in 2022, 2023, and 2024. If the NDC-11
was marketed, sold, or distributed at any time during the quarter, please complete all
requested fields. If the NDC-11 was not marketed, sold, or distributed to any wholesaler
or direct purchaser in a particular calendar quarter, please enter “0” in the total unit
volume field and leave the WAC field blank and provide an explanation in the
“Explanation of why WAC was not reported (if applicable)” field of why the NDC-11
had no WAC for that calendar quarter (e.g., the NDC-11 was first marketed in a later
calendar quarter).
NDC-11

Quarter

WA NCPDP Unit
C
(EA, ML,
GM)

12345-6789-01

QQ/YYYY $

Text

Total
Unit
Volume

Explanation of why WAC was not
Reported (if applicable)

#

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

36

Question 16: Explanation of Information Reported in Question 15: 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 15 and those
found in available drug databases (e.g., Medi-Span, First Databank, RED BOOK). Please
indicate not applicable (N/A) in the free response field if no explanation is necessary.
FIELD
Explanation of WAC unit price data

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

Question 17: Medicaid Best Price
Was a Medicaid best price determination ever made for a calendar quarter for the selected drug
during the most recent three years?
RESPONSE FORMAT
Yes/No
(If response is Yes, please fill out the following tables. If response is No, please skip to
Question 19) 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.
• Total unit volume for the quarter is the sum of monthly AMP units reported to the
MDRP for the quarter.
• If a Medicaid best price determination was made during the calendar quarter for that
NDC-9, please complete all requested fields. If the NDC-9 did not have a Medicaid best
price determination in a particular calendar quarter, please enter “0” in the total unit
volume field and leave the Medicaid best price field blank and provide an explanation in
the “Explanation of why Medicaid best price was not reported (if applicable)” field of
why the NDC-9 had no Medicaid best price determination for that calendar quarter (e.g.,
the NDC-9 was first marketed in a later quarter).

37

NDC-9

Quart Medicaid
er
Best Price

123456789

QQYY $ (up to 6
YY
decimal
places)

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

Total Explanation of why Medicaid Best
Unit
Price was not Reported (if
Volum applicable)
e

#

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

Question 18: Explanation of Information Reported in Question 17: Medicaid Best Price
If applicable, describe other information you feel is necessary to interpret reported information in
response to Question 17. Please indicate not applicable (N/A) in the free response field if no
explanation is necessary.
FIELD
Explanation of Medicaid Best Price data

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

Question 19: Federal Supply Schedule (FSS) Price
Was a FSS price for the selected drug ever available during the most recent three years, ending
with the calendar year ending December 31, 2024?
RESPONSE FORMAT
Yes/No
(If response is Yes, please fill out the following tables. If response is No, please skip to
Question 21) 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. 34 We note that the FSS
price information should be for the NDC-11 package (e.g., for a bottle of 30 tablets,
please report the FSS price for the bottle).
• Units must be reported in one of the three NCPDP BUS: each (EA), milliliter (ML), or
gram (GM). Total unit volume is the total number of NCPDP units (i.e., EA, ML, or
GM) for each NDC-11 sold indirectly (e.g., through a wholesaler) or directly to federal
purchasers. Please do not include units associated with free samples in the reported total
unit volume.
34

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

38

•

For each NDC-11, please include a row for each price period that occurred during the
three years ending with the calendar year ending December 31, 2024, and fill out the
requested information. If the NDC-11 did not have a FSS price during the three years
ending with the calendar year ending December 31, 2024, please enter “0” in the total
unit volume field and leave the “Federal Supply Schedule Price” field blank and provide
an explanation in the “Explanation of why FSS price was not reported (if applicable)”
field of why the NDC-11 had no FSS price for the three years ending with the calendar
year ending December 31, 2024 (e.g., the NDC-11 was discontinued before the three year
period began).

NDC-11

Price Start Federal
Date to
Supply
End Date Schedule
Price

NCPDP
Unit (EA,
ML, GM)

12345-6789-01

MMDDYYY $
YMMDDYYY
Y

Text

Tota
l
Unit
Volu
me
#

Explanation of why
FSS price was not
Reported (if
applicable)
Text (3,600 character count
limit, which is
approximately 300 words)

Question 20: Explanation of Information Reported in Question 19: Federal Supply Schedule Price
If applicable, describe other information you feel is necessary to interpret reported information in
response to Question 19. Please indicate not applicable (N/A) in the free response field if no
explanation is necessary.
FIELD
Explanation of Federal Supply Schedule price data

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

Question 21: Big Four Price
Was a Big Four price ever available for the selected drug during the most recent three years
ending with the calendar year ending December 31, 2024?
RESPONSE FORMAT
Yes/No
(If response is Yes, please fill out the following tables. If response is No, please skip to
Question 23) 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. 35
We note that the Big Four price information should be for the NDC-11 package (e.g.,
35

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

39

•

•

•

for a bottle of 30 tablets, please report the FSS price for the bottle).
Units must be reported in one of the three NCPDP BUS: each (EA), milliliter (ML), or
gram (GM). Total unit volume is the total number of units (i.e., EA, ML, or GM) for
each NDC-11 indirectly (e.g., through a wholesaler) or directly sold to the Big Four
federal agencies (Department of Veterans Affairs, Department of Defense, the Public
Health Service, and the Coast Guard). Please do not include units associated with free
samples in the reported total unit volume.
For each NDC-11, please include a row for each price period that occurred during the
three years ending with the calendar year ending December 31, 2024, and fill out the
requested information. If the NDC-11 did not have a Big Four price during the three
years ending with the calendar year ending December 31, 2024, please enter “0” in the
total unit volume field and leave the “Big Four Price” field blank and provide an
explanation in the “Explanation of why Big Four price was not reported (if applicable)”
field of why the NDC-11 had no Big Four price for the three years ending with the
calendar year ending December 31, 2024 (e.g., the NDC-11 was discontinued before the
three year period began).
Please complete Questions 19 and 20 for the FFS price of the selected drug and
Questions 21 and 22 for the Big Four price of the selected drug even if the Primary
Manufacturer or the Secondary Manufacturer is considered a “single pricer.”

NDC-11

Price Start Date to Price Big
End Date
Four
Price

NCPDP Unit
(EA, ML,
GM)

Total Unit
Volume

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

123456789-01

MMDDYYYYMMDDYYYY

Text

#

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

$

Question 22: Explanation of Information Reported in Question 21: Big Four Price
If applicable, describe other information you feel is necessary to interpret reported information in
response to Question 21. Please indicate not applicable (N/A) in the free response field if no
explanation is necessary.
FIELD
Explanation of Big Four price data

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

Question 23: Manufacturer U.S. Commercial Average Net Unit Price
Follow the instructions below when providing responses in the following table about the
Manufacturer U.S. commercial average net unit price, including group and individual
commercial plans on- and off-Exchange of the selected drug:
• 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
40

•

•

•

•
•
•

Medicaid managed care.
For each NDC-11, please include a row for each quarter for the three years ending with
the calendar year ending December 31, 2024, based on the Primary Manufacturer’s
responses in Section A. If the NDC-11 was ever marketed, sold, or distributed at any
time during the quarter, please complete all requested fields. If the NDC-11 was not
marketed, sold, or distributed in a particular quarter, please enter “0” in the total unit
volume field and leave the three price fields blank and provide an explanation in the
“Explanation of why Manufacturer U.S. Commercial prices were not reported (if
applicable)” field of why the NDC-11 had no Manufacturer U.S. commercial prices for
that calendar quarter (e.g., the NDC-11 was first marketed in a later quarter).
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, 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, co-payment assistance, or free drug products to
patients, separately report the price net of such financial assistance to patients in the
“U.S. commercial average net unit price─ net of patient assistance programs” field. If the
Primary Manufacturer and Secondary Manufacturer(s) did not provide financial
assistance to patients, please leave the “U.S. commercial average net unit price─ net of
patient assistance programs” field blank.
Provide the lowest price that the Primary Manufacturer or any Secondary
Manufacturer(s) made available to any commercial payer during the quarter in the
“Manufacturer U.S. commercial average net unit price─ best” field.
Units must be reported in one of the three NCPDP BUS: each (EA), milliliter (ML), or
gram (GM). Please do not include units associated with free samples in the calculated
prices or reported total unit volume.
Provide the total unit volume of the lowest price that the Primary Manufacturer and
any Secondary Manufacturer(s) sold to any commercial payer during the quarter in the
“Total unit volume for U.S. commercial average net unit price – best” field.

41

NDC- Quarter Manufacture
11
r U.S.
Commercia
l Average
Unit Net
Price

12345 QQYY
YY
678901

$

Manufactur
er U.S.
Commercial
Average Net
Unit PriceNet of
Patient
Assistance
Programs
$

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

$

NCPD
P Unit
(EA,
ML,
GM)

Text

Total
Unit
Volum
e

Total Unit
Volume
for U.S.
Commerci
al Average
Net Unit
Price Best

#

#

Explanation
of why
Manufactur
er U.S.
Commercial
prices were
not
Reported (if
applicable)
Text (3,600
character count
limit, which is
approximately
300 words)

Question 24: Explanation of Information Reported in Response to Question 23:
Manufacturer U.S. Commercial Average Net Unit Price
Describe assumptions, methodological steps, and other information for the following topics
related to Question 23:
• 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, goods in-kind, free or reduced-price services,
grants, or other price concessions or similar benefits offered to any purchasers were
allocated across NDC-11s and calendar quarters.
• If applicable, how financial assistance, such as coupons or co-payment assistance, to
patients was allocated across NDC-11s and calendar quarters.
• How information was used to calculate the “U.S. commercial average net unit price” ,
the “U.S. commercial average net unit price─ net of patient assistance programs, ” and
the “U.S. commercial average net unit price─ best”.
• Please indicate not applicable (N/A) in the free response field if no explanation is
necessary.
FIELD
Explanation of manufacturer U.S. commercial
average net unit price data

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

Question 25: Manufacturer Net Medicare Part D Average Unit Price
Follow the instructions below when providing responses in the following table about the
manufacturer net Medicare Part D price of the selected drug.
•
•

Only include price and volume information of the selected drug for Part D plan sponsors.
For each NDC-11, please include a row for each quarter for the three years ending with
42

•

•
•
•
•

the calendar year ending December 31, 2024, based on the Primary Manufacturer’s
responses in Section A. If the NDC-11 was ever marketed, sold, or distributed at any
time during the quarter, please complete all requested fields. If the NDC-11 was not
marketed, sold, or distributed in a particular quarter, please enter “0” in the total unit
volume field and leave the three price fields blank and provide an explanation in the
“Explanation of why manufacturer net Medicare Part D Price was not reported (if
applicable)” field of why the NDC-11 had no manufacturer net Medicare Part D price
for that calendar quarter (e.g., the NDC-11 was first marketed in a later quarter).
The NDC-11 price reported in the manufacturer net Medicare Part D price must be net
of discounts, including the applicable discount amount provided under the Medicare
Coverage Gap Discount Program, chargebacks or rebates, cash discounts, free goods
contingent on a purchase agreement, up-front payments, goods in-kind, free or
reduced-price services, grants, or other price concessions or similar benefits offered by
Primary Manufacturer or any Secondary Manufacturer(s) to any purchasers.
Provide the Medicare Coverage Gap Discount Program applicable discount amount
paid by the Primary Manufacturer or any Secondary Manufacturer(s) during the
quarter in the “Medicare Coverage Gap Discount Program” field.
Provide the lowest price that the Primary Manufacturer or any Secondary
Manufacturer(s) made available to any Part D plan sponsor during the quarter in the
“manufacturer net Medicare Part D average unit price ─ best” field.
Units must be reported in one of the three NCPDP BUS: each (EA), milliliter (ML), or
gram (GM). Please do not include units associated with free samples in the calculated
prices or reported total unit volume.
Provide the total unit volume of the lowest price that the Primary Manufacturer and
any Secondary Manufacturer(s) sold to any Part D plan sponsor during the quarter in
the “Total unit volume for net Medicare Part D average unit price – best” field.

NDC- Calendar Manufacturer
11
Quarter Net Medicare
Part D
Average Unit
Price

Manufacturer
Net Medicare
Part D
Average Unit
Price - Best

Medicare
Coverage
Gap
Discount
Program
Discount
Amount
Paid

NCPDP
Unit
(EA,
ML,
GM)

Total
Unit
Volume

Total
Unit
Volume
for Net
Medicare
Part D
Average
Unit
Price Best

Explanation
of why
manufacturer
net Medicare
Part D price
was not
Reported (if
applicable)

12345- QQYYY
6789- Y
01

$

$

Text

#

#

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

$

43

Question 26: Explanation of Information Reported in Response to Question 25:
Manufacturer net Medicare Part D price
Describe assumptions, methodological steps, and other information for the following topics
related to Question 25:
•
•

•
•

How sales to Medicare Part D enrollees of Part D plan sponsors sales were determined.
How discounts, including the applicable discount amount provided under the Medicare
Coverage Gap Discount Program, chargebacks or rebates, cash discounts, free goods
contingent on a purchase agreement, up-front payments, goods in-kind, free or reducedprice services, grants, or other price concessions or similar benefits offered to any
purchasers were allocated across NDC-11s and calendar quarters.
If applicable, how financial assistance to patients were allocated across NDC-11s and
calendar quarters.
Please indicate not applicable (N/A) in the free response field if no explanation is
necessary.

FIELD
Explanation of “manufacturer Net
Medicare Part D price” data

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

Question 27: Primary Manufacturer Identification of Information Submitted in Sections A
through G that the Primary Manufacturer Believes Should be Withheld as Proprietary
Information
Section 1193(c) of the Act states that CMS must determine which information submitted to
CMS by a manufacturer of a selected drug is proprietary information of that manufacturer. As
described in section 40.2.1 of the final guidance, CMS will treat certain data elements submitted
by a Primary Manufacturer of a selected drug in accordance with section 1194(e)(1) and section
1194(e)(2) of the Act as proprietary if the information constitutes confidential commercial or
financial information of the Primary Manufacturer or a Secondary Manufacturer. 36 For each
section and/or question that a Primary Manufacturer believes contains information that should
be withheld by CMS consistent with existing federal requirements for protecting proprietary
information, including Exemption 3 and/or 4 of the FOIA(5 U.S.C. § 552(b)(3), (4)), 37 first list
each applicable section letter and question number and then provide a brief explanation
regarding why the Primary Manufacturer believes the information should be withheld as
proprietary information. Include the question number that the explanation corresponds to in the
free text response.

Specifically, as described in section 40.2.1 of the final guidance, CMS will treat research and development costs and
recoupment, unit costs of production and distribution, pending patent applications, market data, revenue, and sales
volume data as proprietary, unless the information that is provided to CMS is already publicly available, in which case
it would be considered non-proprietary. CMS will treat the data on prior Federal financial support and approved patent
applications, exclusivities, and approved applications under section 505(c) of the FD&C Act or section 351(a) of the
PHS Act as non-proprietary because CMS understands these data are publicly available.
37
See: https://www.justice.gov/oip/doj-guide-freedom-information-act-0.
36

44

Section Letter and Question Number
Text

Explanation
Text (60,000 character count limit, which is
approximately 5,000 words)

H. Certification of Submission of Sections A through G for Primary Manufacturers
Required for Primary Manufacturers
Instruction for Section H:
An individual eligible to certify this submission on behalf of the Primary Manufacturer must be
one of the following: (1) the chief executive officer (CEO) of the Primary Manufacturer, (2) the
chief financial officer (CFO) of the Primary Manufacturer, (3) an individual other than a CEO or
CFO, who has authority equivalent to a CEO or a CFO of the Primary Manufacturer, or (4) an
individual with the directly delegated authority to perform the certification on behalf of one of
the individuals mentioned in (1) through (3).
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:
Field
Name of the Person Responsible for the
Submission
Signature
Date

Response
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), respondents are not

45

required to include personally identifiable information 38 (PII) or protected health information 39
(PHI). CMS seeks to collect only the minimum necessary information related to the selected
drug and its therapeutic alternatives for the purpose of implementing and operating the
Negotiation Program. CMS will not retrieve evidence for manufacturer negotiations by personal
identifier (PII or PHI). CMS will not, through this collection, create or maintain a system of
records as understood by the Privacy Act of 1974 and accompanying Office of Management
and Budget guidance.
Question 28: Respondent Information
Required: Individuals or organizations, including manufacturers, that wish to provide
information in this Section I must provide the following information. 40
FIELD
Selected Drug
Respondent Name
Organization Name (if applicable)
Respondent Email

RESPONSE FORMAT
TEXT [Select from list]
TEXT
TEXT
TEXT

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

[ ] Representative of a manufacturer of the selected drug [this category is pre-selected
for a Primary Manufacturer when submitting information about its selected drug]
[ ] Representative of a manufacturer of a potential therapeutic alternative(s) to the
selected drug
[ ] Representative of a manufacturer that does not manufacture the selected drug or a potential
therapeutic alternative(s)
[ ] Representative of a trade association
[ ] Representative of a patient advocacy organization
[ ] A health care provider who has experience prescribing, dispensing, or administering the
Personally identifiable information (PII) is information that can be used to distinguish or trace an individual’s
identity, either alone or when combined with other information that is linked or linkable to a specific individual. PII
can include sensitive data, such as medical, financial, or legal information; “neutral” information such as name,
facial photos, or work address; and, contextual information, such as a file for a specific health condition that
contains a list of treated patients. See: https://www.hhs.gov/web/policies-and-standards/hhs-webpolicies/privacy/index.html#what-is-pii.
39
Protected health information (PHI) is individually identifiable health information held or transmitted by a covered
entity or its business associate, in any form or media, whether electronic, paper, or oral. Individually identifiable
information is information, including demographic data, that relates to the individual’s past, present, or future
physical or mental health or condition; the provisions of health care to the individual; or the past, present, or future
payment for the provision of health care to the individual, and that identifies the individual or for which there is a
reasonable basis to believe it can be used to identify the individual. PII includes many common identifiers such as
name, address, birth date, Social Security Number, etc. See https://www.hhs.gov/hipaa/forprofessionals/privacy/laws-regulations/index.html.
40
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.
38

46

selected drug or its therapeutic alternative(s) or treating conditions pertinent to the selected drug
or its therapeutic alternative(s).
[ ] A patient who has experience taking the selected drug or a potential therapeutic alternative(s)
[ ] A caregiver for an individual who has experience taking the selected drug or a potential
therapeutic alternative(s)
[ ] Academic researcher or other subject matter expert on topics including but not limited to
pharmaceutical policy, comparative effectiveness research, and/or clinical value assessment
[ ] Other
If “Other” is selected, provide a brief description of the person completing this form: [Text (960 character
count limit, which is approximately 80 words)]
•

[For all options except this question does not populate for a Primary Manufacturer when submitting about
its selected drug] Are you or your organization affiliated with the manufacturer of the selected drug or its
therapeutic alternative(s)? 41

General Instructions for Section I
• All questions are optional.
• Any interested party may answer Questions 29 through 60. Each interested party will be
able to answer each of Questions 29 through 60 in Section I one time for each selected
drug. You may answer some or all of the questions. If you do not wish to respond to a
given question you may skip the question or enter “no response.”
• Any respondent that answers any of Questions 29 through 60 should also review Questions
61 and 62 and respond as applicable.
• CMS has grouped Questions 29 through 60 in five categories of topics that are addressed
by the set of questions. Specifically, these categories by question number are:
• Questions 29-35: Manufacturer-Focused Input
• Questions 36-42: Patient- or Caregiver-Focused Input
• Questions 43-49: Clinical-Focused Input
• Questions 50-56: Health Research-Focused Input
• Questions 57-60: Other Public Input
• CMS provides the following examples of individuals and organizations that may choose to
address a category of questions based on personal and/or professional insight and
expertise. ANY AND ALL INTERESTED PARTIES may respond to ANY AND ALL
QUESTIONS 29 through 60. These examples are intended as illustrative; a respondent is
not limited to any category of questions based on the individual’s or organization’s insight
and/or experience.
• Manufacturer-Focused Input—for example, a Primary Manufacturer of a selected
drug.
• Patient or Caregiver-Focused Input—for example, an individual with experience
taking the selected drug or a different medicine that may be used to treat the same
For the purpose of this ICR, an individual or organization is “affiliated with the manufacturer” if the individual or
organization receives or has received funding from the manufacturer for research, speaking, or other engagements,
and/or any other purpose related to the drug or its potential therapeutic alternative(s) or if the individual or
organization has been asked by the manufacturer to respond to this ICR or to advise the manufacturer on the
Negotiation Program, regardless of compensation.
41

47

•

•

•

•

•

condition or disease state (which is also called a potential therapeutic alternative(s)
to the selected drug), a caregiver’s experience caring for someone taking such
drugs, patient organizations with insight into patients’ lived experience of taking
such drugs or living with a condition the drugs treat.
• Clinical-Focused Input—for example, clinicians, pharmacists, hospitals, or other
entities with clinical experience related to the selected drug, its therapeutic
alternatives, or the condition(s) the drugs treat.
• Health Research-Focused Input—for example, researchers, academic centers,
patient groups, or other entities with evidence-based input regarding the selected
drug or its therapeutic alternative(s).
• Other Public Input—any other interested party that wishes to respond to the
questions in section I.
All declarative statements should be supported by evidence with a citation, unless you are
sharing a personal experience with prescribing or taking the selected drug and/or its
therapeutic alternative(s) or you are a caregiver describing the experience of the person
taking the selected drug and/or its therapeutic alternative(s).
The Additional Instructions and the Instructions for Reporting Monetary Amounts
included in this ICR apply to Section I. These instructions are for respondents providing
original data but are not applicable when a respondent provides citations for existing
published data.
Please answer each question in narrative (text) form. Your responses will be limited to
the character and citation maximums provided for each question.
• Information provided in response to an individual question does not need to
be duplicated across additional responses. CMS will review submissions
holistically across the entire submission.
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.
• CMS prefers publicly available, peer reviewed literature rather than poster
abstracts and non-peer reviewed literature. When providing non-peer
reviewed literature, CMS must be provided sufficient information on these
studies in order to assess their applicability to the Negotiation Program.
• Please note that CMS reserves the right to review submitted materials for
relevance and in accordance with the standards outlined in section 50.2 of
the final guidance.
• Please provide citations to published material rather than copies of articles.
The respondent is responsible for ensuring that their submission complies with
applicable law, including but not limited to copyright law. If data are
unpublished, clearly indicate this in the citation. For unpublished data without
a citation, please summarize key findings as appropriate in your response.
When citing studies to support responses, briefly summarize the study context and
relevant comparator or therapeutic alternative drug(s) studied, as applicable.
• When information in the free text response is supported by a citation provided
in response to that question, please label the end of the sentence in the free text
response with a number (e.g., [1], [2]) that corresponds to the number assigned
to the citations provided for that same question.
48

Respondents are requested to provide citations in the National Library of
Medicine (NLM) style format appropriate for the source of information (e.g.,
a journal article). Information on how to format citations is available for free
through the NLM at: https://www.ncbi.nlm.nih.gov/books/NBK7256/.
CMS will review submitted studies that use cost-effectiveness measures or methods to
determine if the study is relevant to the selected drug and/or its therapeutic alternative(s)
and to determine if the cost-effectiveness measure used does not value extending the life
of an individual who is elderly, disabled, or terminally ill as of lower value than an
individual who is younger, nondisabled, or not terminally ill. Respondents must indicate
if their submission includes any cost-effectiveness measures or methods. Examples of
cost-effectiveness measures or methods include but are not limited to quality-adjusted
life-years (QALYs), Equal Value of Life-Years Gained (evLYG), Equal Value Life-Year
(evLY), Health Years in Total (HYT), and Generalized Risk-Adjusted CostEffectiveness (GRACE). CMS also requests that respondents provide a short description
of any cost-effectiveness measures or methods 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.
As described in section 50.2 of the final guidance, CMS will not use comparative clinical
effectiveness research in a manner that treats extending the life of an elderly, disabled, or
terminally ill individual as of lower value than extending the life of an individual who is
younger, nondisabled, or not terminally ill.42 Information submitted that treats extending
the life of individuals in the listed populations as of lower value will not be used in the
Negotiation Program. Moreover, in accordance with section 1182(e) of Title XI of the
Social Security Act and other applicable law, including section 504 of the Rehabilitation
Act, CMS will not use QALYs. In instances where a study includes a measure that treats
extending the life of individuals who are elderly, disabled, or terminally ill as of lower
value but separates such a measure from other evidence in the report (e.g., clinical
effectiveness, risks, harms, etc.) that is relevant to the factors listed in section 1194(e)(2)
of the Act, CMS 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.
Submissions may include visual representations of the information, including tables,
charts, and/or graphs. 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 beyond the titles, labels, legends, and footnotes in the visual
representation. PDF files will be accepted within specified file size limits for visual
representations. List the question number that a submitted table/chart/graph corresponds
to in the free text response provided with the question to submit tables/charts/graphs.
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).
CMS will only review the maximum number of citations or upload files permitted in
•

•

•

•

•
•
42

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

49

the instructions for a particular question per each such question.
Definitions for Section I:
• Therapeutic Advance: CMS will determine the extent to which a selected drug
represents a therapeutic advance as compared to its therapeutic alternative(s) by
examining improvements in outcomes compared to its therapeutic alternative(s) and may
consider the extent to which a selected drug represents a therapeutic advance by
examining the extent to which the selected drug provides a substantial improvement in
outcomes for an indication(s). CMS will consider the extent to which a selected drug
represents a therapeutic advance at the time of submission of evidence related to 1194(e)
factors through the Negotiation Data Elements and Drug Price Negotiation ICR.
• Therapeutic Alternative: A therapeutic alternative must be a pharmaceutical product or
group of pharmaceutical products that is clinically comparable to the selected drug (in
other words, a medicine other than the selected drug that may be used to treat the same
condition or disease state). CMS 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 off-label to treat a
given indication. CMS will identify therapeutic alternatives within the same
pharmacologic class as the selected drug based on properties such as chemical class,
therapeutic class, or mechanism of action and then also consider therapeutic alternatives
in different pharmacologic classes. In cases where there are many potential therapeutic
alternatives for a given indication of the selected drug, CMS may focus on a subset of
therapeutic alternatives that are clinically comparable to the selected drug.
• Outcomes: Outcomes may be clinical or related to the functioning, symptoms, quality of
life, or other aspects of a patient’s life. Outcomes 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 may also be identified
and considered in determining clinical benefit, if available. Additional outcomes such as
changes to productivity, independence, and quality of life will also be considered to the
extent that these outcomes correspond with a direct impact on individuals taking the
drug, including patient-centered outcomes when available. The caregiver perspective
will be considered to the extent it reflects directly upon the experience or relevant
outcomes of the patient taking the selected drug.
• Patient-centered outcome: An outcome that is important to patients’ survival, functioning,
or feelings as identified or affirmed by patients themselves, or judged to be in patients’
best interest by providers and/or caregivers when patients cannot report for themselves. 43
• 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,
A patient-centered outcome is defined as: An outcome that is important to patients’ survival, functioning, or feelings as
identified or affirmed by patients themselves, or judged to be in patients’ best interest by providers and/or caregivers when
patients cannot report for themselves. (Source: https://www.fda.gov/drugs/development-approval-process-drugs/patientfocused-drug-development-glossary).
43

50

ethnicity, disability, sexual orientation, gender identity, socioeconomic status, geography,
preferred language, or other factors that affect access to care and health outcomes. 44
• Unmet medical need: A circumstance in which the relevant disease or condition is
one for which no other treatment options exist, or existing treatments do not
adequately address the disease or condition. 45 Unmet medical need is determined at
the time of submission of this information. Under section 1194(e)(2) of the Act,
CMS will consider the extent to which a selected drug and its therapeutic alternatives
address an unmet medical need.
• Indication: Indication refers to the condition or disease state that the selected drug
treats. An indication may include any FDA-approved indication included in drug
labeling per 21 C.F.R. § 201.57(c)(2) or other applicable FDA regulation(s) and offlabel use(s) that are included in nationally recognized, evidence-based guidelines and
listed in CMS-recognized Part D compendia. For the purpose of an ICR submission,
a respondent may combine FDA-approved indications (e.g., identical adult and
pediatric indications) and off-label use(s). The respondent, if appropriate, may also
choose not to report on certain FDA-approved indications or off-label uses.
• Off-label Use: Off-label use means a use of a selected drug or therapeutic alternative
that is not approved by the FDA but is included in nationally recognized, evidencebased guidelines and listed in CMS-recognized Part D compendia.
FDA-Approved Indications and Off-label Uses for [the selected drug]
For reference by respondents to Section I, CMS is providing the FDA-approved indications for
[the selected drug]. CMS notes that individuals may be prescribed [the selected drug] for
conditions not listed as an FDA-approved indication (i.e., an off-label use). When responding to
questions, please note which indications (including an FDA-approved indication or an off-label
use) are relevant to your response or experience. If you are responding about more than one
indication, please clearly note which indication your response refers to.
The selected drug is approved by the FDA for the following indications:
• [List all FDA-approved indications (populated by CMS)]
Questions 29 through 61: Optional for All Respondents
Questions 29 through 35: Manufacturer-Focused Questions
CMS is collecting information to support its evaluation of [the selected drug (all bracketed text is
intended to be populated by CMS)] for the indication(s) it is used to treat relative to its therapeutic
alternative(s) for those indication(s). CMS is interested in obtaining input and evidence from
manufacturers of selected drugs related to [the selected drug] and its potential therapeutic
alternative(s), methodological approaches to evaluation of [the selected drug] consistent with
statutory requirements, and publicly available evidence CMS should consider related to [selected
drug] and the indication(s) it treats.
Instructions for Questions 29 through 35
See: https://www.cms.gov/pillar/health-equity.
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.
44
45

51

Manufacturers are permitted to submit a dossier in Question 34. Dossier submission is optional.
Such dossiers may be used to supplement responses provided in Questions 29 through 33 and
35. CMS requests that manufacturers submitting a dossier also submit an outline of the location
of information related to Questions 29 through 33 and 35, to the extent applicable.
Question 29: Potential therapeutic alternatives
Provide a list of therapeutic alternatives CMS should consider for the indication(s) of [the
selected drug].
Indication
List therapeutic alternatives for the indications

Therapeutic Alternative(s)
Text (6,000 character count limit, which is
approximately 500 words)

Question 30: Use in treatment and clinical comparative effectiveness evidence
Question 30a: Describe the selected drug’s use in the course of care for its indication(s) based on
current clinical use, clinical practice guidelines, or other relevant clinical practice standards and
provide all supporting citations. When relevant, please describe the use of each potential
therapeutic alternative (identified in Question 29) in the course of care for the indication(s) relative
to the selected drug.
Field
Response to Question 30a
Additional Materials for
Question 30a

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 30b: For the indication(s) identified in the instructions and Question 29, identify
relevant clinical outcome measures CMS should consider in its evaluation of clinical
comparative effectiveness (e.g., clinical efficacy, real-world effectiveness, or safety). Provide
supporting citations for identified clinical outcome measures.
Field
Response to Question 30b
Additional Materials for
Question 30b

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 30c: For the indication(s) of the selected drug, identify any relevant evidence
evaluating the clinical comparative effectiveness (e.g., clinical efficacy, real-world effectiveness,
or safety) of the selected drug and potential therapeutic alternatives. Relevant comparative
evidence may include but is not limited to: head-to-head randomized controlled trials, pragmatic
clinical trials, network meta-analyses, observational studies, and real-world evidence. Provide
supporting citations for relevant comparative evidence.

52

Field
Response to Question 30c
Additional Materials for
Question 30c

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 31: Prevalence, utilization, and cost estimates
Question 31a: For the indication(s) of the selected drug, provide an estimate of its prevalence
among the Medicare population. Provide citations and/or brief methodology to support the
estimate(s).
Field
Response to Question 31a
Additional Materials for
Question 31a

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 31b: For the indication(s) of the selected drug, provide an estimate of Medicare
utilization of the selected drug for that indication. Estimates of Medicare utilization can include
estimates of total number of patients treated, estimates of share of selected drug prescriptions
dispensed to patients with that indication, or similar measures. Provide citations and/or brief
methodology to support the estimate(s).
Field
Response to Question 31b
Additional Materials for
Question 31b

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 31c: For the indication(s) of the selected drug, identify or provide evidence relevant to
Medicare regarding relative health care resource utilization associated with patients who take the
selected drug and its potential therapeutic alternatives. Relevant evidence of relative health care
resource utilization may include but is not limited to: disease burden or cost-of-illness analyses,
cost-effectiveness or cost-utility analyses, and/or other analyses of health care resource
utilization relevant to the selected drug and any therapeutic alternatives. Provide citations and/or
brief methodology to support analyses.
Note, CMS will not use QALYs or any evidence from comparative effectiveness research in a
manner that treats extending the life of an individual who is elderly, disabled, or terminally ill as
of lower value than extending the life of an individual who is younger, non-disabled, or not
terminally ill.

53

Field
Response to Question 31c
Additional Materials for
Question 31c

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 32: Therapeutic advance and unmet medical need
Question 32a: For the indication(s) of the selected drug, describe the extent to which the
selected drug currently represents a therapeutic advance as compared to its therapeutic
alternative(s). Provide supporting citations.
Field
Response to Question 32a
Additional Materials for
Question 32a

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 32b: For the indication(s) of the selected drug, describe the extent to which the
selected drug addresses an unmet medical need. Provide supporting citations.
Field
Response to Question 32b
Additional Materials for
Question 32b

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 33: Specific populations and patient experience
Question 33a: For the indication(s) of the selected drug, identify any specific populations
that are impacted by the selected drug and/or its therapeutic alternatives, and describe how they
are impacted. Provide supporting citations.
Field
Response to Question 33a
Additional Materials for
Question 33a

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 33b: For the indication(s) of the selected drug, identify evidence regarding patient
experiences related to the indication(s), selected drug, and/or its therapeutic alternatives. This
may include but is not limited to evidence regarding patient priorities and preferences related to
treatment of the indication, treatment burden, burden of disease, or other patient experience
data. Provide supporting citations.

54

Field
Response to Question 33b
Additional Materials for
Question 33b

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 33c: For the indication(s) of the selected drug, identify any considerations related to
access, social drivers of health and health-related social needs, health equity, and/or health
disparities that are relevant to the indication, selected drug, and/or its therapeutic alternatives.
Provide supporting citations.
Field
Response to Question 33c
Additional Materials for
Question 33c

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 34: Dossier Submission
Manufacturers are permitted to submit a dossier in Question 34. Such dossiers may be used to
supplement responses provided in questions 29 through 33, preferably formatted using an
industry standard such as the most current AMCP Format (version 5.0) for Formulary
Submissions. CMS requests that manufacturers submitting a dossier also submit an outline of
the location of information related to Questions 29 through 33, to the extent applicable.
While submitted dossiers may include a variety of economic information, CMS will not use
QALYs or any evidence from comparative effectiveness research in a manner that treats
extending the life of an individual who is elderly, disabled, or terminally ill as of lower value
than extending the life of an individual who is younger, non-disabled, or not terminally ill.
Response
Text (Up to 2 PDF files)
Question 35: Visual Representations to Support Responses to Questions 29 through 33
Provide up to 10 visual representations, if any, such as tables, charts, and/or graphs that
support the responses to Questions 29 through 33. Indicate which question each file
corresponds to. Regardless of the number of PDF files uploaded, respondents may not
submit more than 10 total visuals (e.g., tables, charts, and/or graphs).
Response
Text (Up to 10 PDF files)

Indicate Question Each File Corresponds To
Text

Questions 36 through 42: Patient-Focused Experience
CMS would like your input to better understand patients’ and caregivers’ experiences with [the
55

selected drug]. In this section, CMS is interested in your experience with [the selected drug], the
health condition(s) that [the selected drug] may be used to treat, and other medications that may
be used to manage those condition(s). Individual patients and caregivers, and organizations
representing patients and/or caregivers are encouraged to answer the following.
Question 36: Background
Question 36a: Have you or someone you provide care for ever taken [the selected drug]?
Field
Response to Question 36a

Response
Check box: YES or NO

Question 36a1: [If YES] For which condition(s) (including FDA-approved indication(s) or offlabel use as defined in the instructions) was [the selected drug] taken?
Field
Response to Question 36a1

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

Question 36a2: [If YES] When were you or someone you provide care for given a diagnosis
related to this condition or conditions? You may write an approximate date, or if you never
received a diagnosis write “N/A.”
Field
Response to Question 36a2

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

Question 36a3 [If NO] What condition(s) (including FDA-approved indication(s) or off-label
use as defined in the instructions) treated by [the selected drug] would you like to provide input
on?
Field
Response to Question 36a3

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

Question 36a4: [If NO] What is your experience with this condition or conditions?
Field
Response to Question 36a4

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

Question 37: Information on Your Condition(s) or Condition(s) of Someone You Care For
Question 37a: How do the condition(s) you listed in Question 36a1 impact your daily life and
well-being or the daily life and well-being of someone you provide care for?
•

For example,
56

o What are your symptoms related to the condition(s) on a “good” or “bad” day?
o How do these symptoms impact daily routines, work, family, and/or hobbies?
o What other activities are impacted by your symptoms?
Field
Response to Question 37a

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

Question 37b: How has the condition(s) you listed in Question 36 changed or progressed over
time?
•

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

Field
Response to Question 37b

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

Question 37c: What is important to you or those you provide care for in managing the
condition(s) you listed in Question 36?
•
•

This may be how you feel or function in your daily life, how long you live, or other goals
you have related to your medication(s) or condition(s).
For example, this could mean fewer symptoms, better ability to complete daily tasks such as
chores, fewer visits to your doctor or hospital, fewer side effects, lower health care costs,
worrying less about your health, or other things.

Field
Response to Question 37c

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

Question 37d: What challenges do you, or someone you care for, face in managing this condition(s)?
Field
Response to Question 38d

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

Question 38: Information on the Current Medication to Treat Your Condition
Question 38a: Are you, or someone you care for, currently taking medication(s) to manage the
condition(s) you listed in Question 37?
Field
Response to Question 38a

Response
YES or NO
57

Question 38a1: [If YES] What medication(s) are you, or someone you provide care for,
currently taking to manage the condition(s) you listed in Question 36?
•

If more than one medication is currently taken, please list medications in the order you
started them.

Field
Response to Question 38a1

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

Question 38a2: [If YES] How did you or someone you care for decide to start taking the
medication(s) currently used to manage the condition(s) you listed in Question 36?
•
•

What factors, if any, affected the choice of medication(s) currently used to manage the
condition(s) you have selected?
For example, this could mean side effects, cost, interactions with other medication, whether
your local pharmacy or mail-order pharmacy could provide it, family influence, interference
with your work or life, other health condition(s), whether the medication was covered by
your insurance, whether your medical provider recommended the medication based on
clinical guidelines or clinical experience, or other things that influenced your choice.

Field
Response to Question 38a2

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

Question 38a3: [If YES] What has been your experience, or the experience of someone you
provide care for, with the medication(s) currently used to manage the condition(s) you listed in
Question 36?
•
•
•
•
•

What are benefits of the medication(s)? What do you like about it?
What are drawbacks of the medication(s)? What do you wish was different?
How do the medication(s) impact daily life? Does the medication(s) make you feel better in
your daily life?
How easy or difficult is it to take the medication(s)? What is difficult about taking your
medication(s)?
Has taking this medication impacted your emotional or mental well-being? How?

Field
Response to Question 38a3

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

Question 38a4: [If YES] How satisfied are you, or someone you care for, with the medication(s)
you take now to manage your condition(s)?

58

Field
Response to Question 38a4

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

Question 39: Information on the Medication(s) Used in the Past to Treat Your Condition
Question 39a: Have you, or someone you care for, taken other medication(s) in the past to
manage the condition(s) you listed in Question 38?
Field
Response to Question 39a

Response
YES or NO

Question 39b1: [If YES] What medication(s) have you, or someone you care for, taken in the
past to manage the condition(s) you listed in Question 36?
•

If possible, please indicate when past medication(s) were started and stopped to the best of
your knowledge.

Field
Response to Question 39b1

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

Question 39b2: [If YES] How did you, or someone you care for, decide to start taking the
medication(s) used in the past to manage the condition(s) you listed in Question 36?
What other factors, if any, affected the choice of medication(s) used in the past to manage the
condition(s) you listed in Question 36?
For example, factors could include side effects, cost, interactions with other medication,
whether your local pharmacy or mail order pharmacy could provide it, family influence,
interference with your work or life, other health condition(s), whether the medication was
covered by your insurance, whether your medical provider recommended the medication
based on clinical guidelines or clinical experience, or other things that influenced your choice.

•
•

Field
Response to Question 39b2

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

Question 39b3: [If YES] What was your experience, or the experience of someone you provide
care for, with the medication(s) used in the past to manage the condition(s) you listed in
Question 36?
•
•
•
•
•

What are benefits of the medication(s)? What do you like about it?
What are drawbacks of the medication(s)? What do you wish was different?
How do the medication(s) impact daily life? Does the medication(s) make you feel better in
your daily life?
How easy or difficult is it to take the medication(s)? What is difficult about taking your
medication(s)?
Has taking this medication impacted your emotional or mental well-being? How?
59

Field
Response to Question 39b3

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

Question 39b4: [If YES] Why did you, or someone you provide care for, stop taking the
medication(s) used in the past to manage the condition(s) you listed in Question 36?
Field
Response to Question 39b4

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

Question 40: What other information about the condition(s) you have identified or the
medication(s) used to manage these condition(s) do you think CMS should consider while
evaluating [the selected drug]?
Field
Response to Question 40
Citations

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Citations (50 limit)

Question 41: Visual Representations to Support Responses to Questions 36 through 40
Provide up to 10 visual representations, if any, such as tables, charts, and/or graphs that
support the responses to Questions 36 through 40. Indicate which question each file
corresponds to. Regardless of the number of PDF files uploaded, respondents may not
submit more than 10 total visuals (e.g., tables, charts, and/or graphs).
Response
Text (Up to 10 PDF files)

Indicate Question Each File Corresponds To
Text

Question 42: Demographic Questions [Only when a respondent selects the “patient” or
“caregiver” option in response to Question 28.]
To put the above responses into context, CMS is interested in understanding the demographic
information of the individual who has used the selected drug:

60

Field
Age

Response Options
Select one:
18-24 years
25-34 years
35-44 years
45-64 years
65-84 years
85-99 years

Race/Ethnicity
What is your race and/or
ethnicity?

100 years or older
Select all that apply:
American Indian or Alaska Native
Asian
Black or African American
Hispanic or Latino
Middle Eastern or North African
Native Hawaiian or Pacific Islander
White

Regional Location

Other not listed
Select one:
New England: CT, ME, MA, NH, RI, VT
Middle Atlantic: NJ, NY, PA
Midwest-East North Central: IN, IL, MI, OH, WI
Midwest-West North Central: IA, KS, MN, MO,
NE, ND, SD
South-South Atlantic: DE, DC, FL, GA, MD, NC,
SC, VA, WV
61

Field

Response Options
South-East South Central: AL, KY, MS, TN
South-West South Central: AR, LA, OK, TX
West-Mountain: AZ, CO, ID, NM, MT, UT, NV,
WY
West-Pacific: AK, CA, HI, OR, WA
U.S. Territory: American Samoa, Guam, Northern
Mariana Islands, Puerto Rico, U.S. Virgin Islands

Medicare Beneficiary

Other
Select one:
Yes
No

Questions 43 through 49: Clinical-Focused Experience
CMS is collecting information to support its evaluation of [the selected drug] for the
indication(s) it is used to treat relative to its therapeutic alternative(s) for those indication(s).
CMS is interested in obtaining the perspectives of health care providers who have clinical
experience with prescribing or managing use of [the selected drug] and/or its therapeutic
alternative(s) for these indication(s).
Question 43: Background Questions
Question 43a: Are you a health care provider (i.e., a person who is trained and licensed to give
health care 46)?
Field
Response to Question 43a

Response
YES or NO

Question 43a1: [If YES] What is your area of specialization? If you are currently practicing,
provide a brief description of the type of practice and your practice site.
Field
Response to Question 43a1

46

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

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

62

Question 43b: Do you have experience prescribing or managing the use of [the selected drug]?
Field
Response to Question 43b

Response
YES or NO

Question 43b1: [If YES] For which indication(s) (which includes off-label use(s) per the
definition provided in the instructions) have you prescribed or managed use of [the selected
drug] that you would like to provide CMS information on? Check all that apply.
Field
Response to Question 43b1

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

Question 43b2: [If NO] On which indication(s) (which includes off-label use(s) per the
definition provided in the instructions) would you like to provide input?
Field
Response to Question 43b2

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

Question 44: Treatment-related Questions
Question 44a: What are goals of treatment for the condition(s) treated by [the selected drug]?


Examples of treatment goals may include but are not limited to disease remission, symptom
management, quality of life improvement, or cure.

Field
Response to Question 44a

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

Question 44b: What outcomes do you use to assess improvement or treatment response for this
indication(s)?
 Please provide specific clinical, functional, or patient-reported outcomes.
Field
Response to Question 44b
Additional Materials for
Question 44b

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

63

Question 44b1: What would you consider to be a meaningful improvement or treatment
response for the outcomes listed in question 44b?
Field
Response to Question 44b1
Additional Materials for
Question 44b1

Response
Text (12,000 character count limit, which is approximately
1,000 words)
Text (Up to 50 citations)

Question 44b2: Would you assess improvement or treatment response differently in certain
patient subpopulations? If so, which subpopulations and why?
Field
Response to Question 44b2
Additional Materials for
Question 44b2

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 44c: Are there widely used evidence-based clinical practice guidelines for the
condition(s) treated by [the selected drug]? If so, please cite these guidelines and explain how
they are used to support clinical decision-making. For off-label use, please include citations for
nationally-recognized, evidence-based guidelines listed in CMS-recognized Part D compendia.
Field
Response to Question 44c
Additional Materials for
Question 44c

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 45: Additional Treatment-related Questions
Question 45a: How does [the selected drug] fit into the current treatment paradigm for patients
with the conditions(s) treated by [the selected drug]?
Field
Response to Question 45a

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

Additional Materials for

Text (Up to 50 citations)

Question 45a

words)

Question 45b: At what point in treatment might [the selected drug] be considered as a treatment
option for patients with the condition(s) treated with [the selected drug]? What other treatments
64

might be considered before [the selected drug] is considered a clinically appropriate treatment
option, if any?
Field
Response to Question 45b
Additional Materials for
Question 45b

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 45c: What medications would you consider to be therapeutic alternatives for [the
selected drug] for treatment of the condition(s) treated with [the selected drug]?
Field
Response to Question 45c
Additional Materials for
Question 45c

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 45d: What considerations drive treatment selection among [the selected drug] and its
therapeutic alternatives for the indication(s)?
•

For example, relative efficacy, safety profile, route of administration, patient characteristics,
patient preferences, cost, formulary placement, etc.

Field
Response to Question 45d
Additional Materials for
Question 45d

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 45e: Are there notable differences between how [the selected drug] or the therapeutic
alternatives identified in Question 45c are prescribed or managed in your practice setting and
how these drugs are used in broader clinical practice and/or treatment recommendations in
current clinical guidelines for the condition(s) treated with [the selected drug]?
•

For example, are there general debates or uncertainties related to selection or use of these
drugs for the indication(s)?

Field
Response to Question 45e
Additional Materials for
Question 45e

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

65

Question 45f: How would you characterize the benefits and risks associated with [the selected
drug]?
Field
Response to Question 45f
Additional Materials for
Question 45f

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 45f1: What side effects or risks, common or serious, or other safety concerns would
you take into consideration when selecting a treatment option from among [the selected drug] or
its therapeutic alternatives for the condition(s) treated with [the selected drug]?
Field
Response to Question 45f1
Additional Materials for
Question 45f1

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 45f2: In your opinion, how do the benefits and risks associated with [the selected drug]
differ from the benefits and risks associated with its therapeutic alternatives for the
indication(s)?
Field
Response to Question 45f2
Additional Materials for
Question 45f2

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 45f3: What specific populations or patient subgroups may derive greater benefits or be
at risk for greater harms by using [the selected drug] or any of its therapeutic alternatives for the
indication(s)?
Field
Response to Question 45f3
Additional Materials for
Question 45f3

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 20 citations)

Question 45g: How would you assess whether a patient is tolerating and/or responding to [the
selected drug] or any of its therapeutic alternatives when used for each indication(s)?
•
•
•

When might you consider discontinuing a medication?
When might you consider switching to a different medication?
When might you consider adding another medication to the regimen?
66

Field
Response to Question 45g
Additional Materials for
Question 45g

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 20 citations)

Question 46: Health Equity and Patient Experience
What health equity or access issues would you consider relevant to an evaluation of [the selected
drug] and its therapeutic alternatives for the condition(s) treated by [the selected drug]?
Field
Response to Question 46
Additional Materials for
Question 46

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 47: Therapeutic Advance and Unmet Medical Need
Question 47a: For the condition(s) treated by [the selected drug], describe the extent to which
[the selected drug] currently represents (or does not represent) a therapeutic advance as
compared to its therapeutic alternative(s).
Field
Response to Question 47a
Additional Materials for
Question 47a

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 47b: For the condition(s) treated by [the selected drug], describe the extent to which
[the selected drug] currently addresses (or does not address) an unmet medical need.
Field
Response to Question 47b
Additional Materials for
Question 47b

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 47c: What unmet medical needs do you believe persist among patients with the
condition(s) treated by [the selected drug], if any?
Field

Response
67

Response to Question 47c
Additional Materials for
Question 47c

Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 48: What other information about [the selected drug], its therapeutic
alternative(s), or the indication(s) do you think CMS should consider in its evaluation of
[the selected drug]? Provide citations when applicable.
Field
Response to Question 48
Citations

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Citations (20 limit)

Question 49: Visual Representations to Support Responses to Questions 43 through 48
Provide up to 10 visual representations, if any, such as tables, charts, and/or graphs that
support the responses to Questions 43 through 48. Indicate which question each file
corresponds to. Regardless of the number of PDF files uploaded, respondents may not
submit more than 10 total visuals (e.g., tables, charts, and/or graphs).
Response
Text (Up to 10 PDF files)

Indicate Question Each File Corresponds To
Text

Questions 50 through 56: Research-Focused Experience
CMS is collecting information to support its evaluation of [the selected drug] in the indication(s)
it is used to treat relative to its therapeutic alternative(s). CMS is interested in obtaining input
and evidence from individual researchers and research or advocacy organizations related to [the
selected drug] and its potential therapeutic alternative(s), methodological approaches to
evaluation of [the selected drug] consistent with statutory requirements, and publicly available
evidence CMS should consider related to [selected drug] and the indication(s) it treats.
Question 50: Background
Are you:
(1) An individual or representative of an entity that has conducted research (including clinical
trials or data analyses) related to use of [the selected drug] or its potential therapeutic
alternative(s)?
(2) Familiar with methods used to evaluate use of [the selected drug] or its potential therapeutic
alternatives?
(3) Aware of research-based evidence CMS should consider regarding [the selected drug], its
potential therapeutic alternatives and/or the indication(s) it treats?
68

Field
Response to Question 50

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

Question 50a: On which indication(s) (which includes off-label use(s) per the definition
provided in the instructions) of [the selected drug] would you like to provide input?
Field
Response to Question 50a

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

Question 51: Potential Therapeutic Alternatives
What medications would you consider to be therapeutic alternatives for [the selected drug] for
each indication(s)? Provide supporting rationale and citations where applicable.
Field
Response to Question 51
Additional Materials for
Question 51

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 52: Comparative Clinical Evidence
Question 52a: What methodology, framework, or other analytic approach would you
recommend CMS consider for use in its evaluation of the clinical comparative effectiveness
(e.g., clinical efficacy, real-world effectiveness, or safety) of [the selected drug] and its potential
therapeutic alternatives for the indication(s)? Provide supporting rationale and citations where
applicable.
Field
Response to Question 52a
Additional Materials for
Question 52a

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 52b: What relevant clinical outcome measures should CMS consider in its evaluation
of clinical comparative effectiveness (e.g., clinical efficacy, real-world effectiveness, or safety)
of [the selected drug] and its potential therapeutic alternatives for the indication(s)? Provide
supporting citations where applicable.

69

Field
Response to Question 52b
Additional Materials for
Question 52b

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 52c: For the indication(s) of the selected drug, identify any relevant evidence
evaluating the clinical comparative effectiveness (e.g., clinical efficacy, real-world effectiveness,
or safety) of the selected drug and potential therapeutic alternatives. Relevant comparative
evidence may include but is not limited to: head-to-head randomized controlled trials, pragmatic
clinical trials, network meta-analyses, observational studies, and real-world evidence. Provide
supporting citations.
Field
Response to Question 52c
Additional Materials for
Question 52c

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 53: Specific Populations and Patient Experience
Question 53a: What evidence are you aware of regarding patient experiences related to use of
[the selected drug], its potential therapeutic alternatives, and/or condition(s) treated by [the
selected drug]? This may include but is not limited to evidence regarding patient priorities and
preferences related to treatment of the condition(s), treatment burden, burden of disease, or other
patient experience data. Provide supporting citations.
Field
Response to Question 53a
Additional Materials for
Question 53a

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 53b: What specific populations or patient subgroups are impacted by [the selected
drug] and/or its potential therapeutic alternatives for the condition(s) treated by [the selected
drug]? How are these populations or subgroups impacted? Identify studies focused on the impact
of [the selected drug] and its therapeutic alternatives on the specific populations. Provide
supporting citations where applicable.

70

Field
Response to Question 53b
Additional Materials for
Question 53b

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 53c: What considerations related to access, health equity, and/or health disparities are
relevant to [the selected drug], its potential therapeutic alternatives, and/or or this condition(s)
treated by [the selected drug]? Provide supporting citations where applicable.
Field
Response to Question 53c
Additional Materials for
Question 53c

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 54: Prevalence, Utilization, and Cost Estimates
Question 54a: For each indication(s), provide an estimate of prevalence among the Medicare
population. Provide citations and/or brief methodology to support the estimate.
Field
Response to Question 54a
Additional Materials for
Question 54a

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 54b: For each indication(s), provide an estimate for Medicare utilization of [the
selected drug] and/or its potential therapeutic alternatives. Estimates of Medicare utilization can
include estimates of total number of patients treated, estimated share of [selected drug]
prescriptions dispensed to patients for a given indication, or similar measures. Provide citations
and/or a brief methodology to support the estimate.
Field
Response to Question 54b
Additional Materials for
Question 54b

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

71

Question 54c: For each indication(s), identify or provide evidence relevant to Medicare
regarding relative health care resource utilization of patients who take [the selected drug] and its
potential therapeutic alternatives. Relevant evidence of relative health care resource utilization
may include but is not limited to: disease burden or cost-of-illness analyses, cost-effectiveness
or cost-utility analyses, and/or other analyses of health care resource utilization relevant to [the
selected drug] and any therapeutic alternatives. Provide citations and/or a brief methodology to
support the assessments.
Note, CMS will not use QALYs or any evidence from comparative effectiveness research in a
manner that treats extending the life of an individual who is elderly, disabled, or terminally ill as
of lower value than extending the life of an individual who is younger, non-disabled, or not
terminally ill.
Field
Response to Question 54c
Additional Materials for
Question 54c

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 55: What other information or evidence do you think CMS should consider in the
evaluation of [the selected drug]? Provide citations when applicable.
Field
Response to Question 55
Additional Materials for
Question 55

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Text (Up to 50 citations)

Question 56: Visual Representations to Support Responses to Question 49 through 55
Provide up to 10 visual representations, if any, such as tables, charts, and/or graphs that
support the responses to Questions 51 through 57. Indicate which question each file
corresponds to. Regardless of the number of PDF files uploaded, respondents may not
submit more than 10 total visuals (e.g., tables, charts, and/or graphs).
Response
Text (Up to 10 PDF files)

Indicate Question Each File Corresponds To
Text

Questions 57 through 60: Other Public Input
CMS is collecting information to support its evaluation of [selected drug] relative to potential
therapeutic alternatives. CMS is interested in obtaining any additional input that CMS should
consider when evaluating [the selected drug].

72

Question 57: For which indication(s) (which includes off-label use(s) per the definition
provided in the instructions) would you like to provide input?
Field
Response to Question 57

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

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

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

Question 59: What information or evidence do you think CMS should be aware of as it
evaluates [the selected drug] for each indication(s)? Provide citations when applicable.
Field
Response to Question 59
Additional Materials for
Question 59

Response
Text (36,000 character count limit, which is approximately
3,000 words)
Citations (50 limit)

Question 60: Visual Representations to Support Responses to Question 57 through 59
Provide up to 10 visual representations such as tables, charts, and/or graphs that support the
responses to Questions 56 through 58. Indicate which question each file corresponds to.
Regardless of the number of PDF files uploaded, respondents may not submit more than 10
total visuals (e.g., tables, charts, and/or graphs).
Response
Text (Up to 10 PDF files)

Indicate Question Each File Corresponds To
Text

For Any Respondent that Responded to One or More Questions in Section I
Question 61: Does any evidence submitted include a cost-effectiveness measure:
[ ] Yes
[ ] No
[ ] Don’t know
If yes, select which Questions included a cost-effectiveness measure in the evidence submitted.
All question numbers listed in a drop down list to select.
For each question number selected, please select the applicable statement.
[ ] The evidence submitted includes QALYs or cost-effectiveness measures that treat extending
the life an individual who is elderly, disabled, or terminally ill as of lower value than extending
73

the life of an individual who is younger, nondisabled, or not terminally ill.
[ ] The evidence submitted DOES NOT include 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.
Checkboxes will populate for each question selected.
Question 62: Identification of Information Submitted in Section I that the Respondent
Believes Should be Withheld as Proprietary Information
For each question that a Respondent believes contains information that should be withheld by
CMS consistent with existing federal requirements for protecting proprietary information,
including Exemptions 3 and/or 4 of the FOIA, first list each applicable question number and
then provide a brief explanation regarding why the Respondent believes the information should
be withheld as proprietary information. List the question number that the explanation
corresponds to in the free text response. The Respondent should not include information that
CMS specifies as proprietary in the section 40.2.1 of the final guidance. 47
Section Letter and Question Number
Text

Explanation
Text (60,000 character count limit, which is
approximately 5,000 words)

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 [ ]
Contact Information for respondent:

Specifically, as described in section 40.2.1 of the final guidance, CMS will treat research and development costs
and recoupment, unit costs of production and distribution, pending patent applications, market data, revenue, and
sales volume data as proprietary, unless the information that is provided to CMS is already publicly available, in
which case it would be considered non-proprietary. CMS will treat the data on prior Federal financial support and
approved patent applications, exclusivities, and approved applications under section 505(c) of the FD&C Act or
section 351(a) of the PHS Act as non-proprietary because CMS understands these data are publicly available.
47

74

Field
Name of the Person Responsible for the
Submission
Signature
Date

Response
Text
Text
MMDDYYYY

75

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 0938-1452 (Expires XX/XX/XXXX). This information
collection is both a mandatory and voluntary information collection and this information will be
used to implement Sections 11001 and 11002 of the Inflation Reduction Act. The time required
to complete this information collection is estimated to average 3 hours for individuals and 30
hours for organizations per response for the general public and 1,000 total hours per response for
the manufacturers of selected drugs, including the time to review instructions, search existing
data resources, gather the data needed, and complete and review the information collection. This
information collection is both mandatory and voluntary (sections 1193(a)(4) and 1194(e)(1) and
(2) of the Social Security Act) and will be carried out consistent with the confidentiality
requirements specified at section 1193(c) of the Social Security Act and section 40.2.1 of the
Medicare Drug Price Negotiation Program: Final Guidance, Implementation of Sections 1191 –
1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer
Effectuation of the Maximum Fair Price (MFP) in 2026 and 2027. 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 Elisabeth Daniel (elisabeth.daniel@cms.hhs.gov).

76

PART 2: DRUG PRICE NEGOTIATION PROCESS STATUTORY WRITTEN
COUNTEROFFER ICR FORM
Section 1193(a)(1) of the Act establishes that CMS will negotiate an MFP with “the
manufacturer” of the selected drug. In section 1191(c)(1) of the Act, the Negotiation Program
statute adopts the definition of manufacturer established in section 1847A(c)(6)(A) of the Act. In
accordance with section 40 of the final guidance, to the extent that more than one entity meets
the statutory definition of manufacturer for a selected drug for purposes of initial price
applicability year 2027, CMS will designate the entity that holds the New Drug Application(s)
(NDA(s))/Biologics License Application(s) (BLA(s)) for the selected drug to be “the
manufacturer” of the selected drug (hereinafter “Primary Manufacturer”).
In accordance with section 1191(b)(4) of the Act, the negotiation period begins on the earlier of
the date that the Primary Manufacturer enters into a Medicare Drug Price Negotiation Program
Agreement (herein referred to as an “Agreement”), or, for initial price applicability year 2027,
February 28, 2025. CMS intends to implement the offer and counteroffer process consistent with
the statutory goal of negotiating to achieve agreement on “the lowest [MFP] for each selected
drug,” established in section 1194(b)(1) of the Act. In accordance with sections 1191(d)(5)(B)
and 1194(b)(2)(B) of the Act, CMS will make a written initial offer to the Primary Manufacturer
with the proposal for the MFP for a selected drug for initial price applicability year 2027 no later
than June 1, 2025. In accordance with section 1194(b)(2)(C) of the Act, the Primary
Manufacturer will respond to CMS’ written initial offer no later than 30 days after the date of
receipt of the written initial offer from CMS. If the Primary Manufacturer does not accept CMS’
written initial offer, the Primary Manufacturer will submit a written counteroffer (referred to
herein as the “statutory written counteroffer”), including an Addendum populated with the
proposal for the MFP. In accordance with section 1194(b)(2)(D) of the Act, CMS will provide a
written response to the statutory written counteroffer. CMS will provide this response within 30
days of receipt or within 60 days of sharing the written initial offer, whichever is later. Section
60.4 of the final guidance describes the remainder of the negotiation process in detail.
Every written offer and counteroffer will include an Addendum populated with the proposal for
the MFP. If an agreement on the MFP is reached at any point during the negotiation process as
described in section 60.4 of the final guidance, the Addendum to the Agreement, as described in
section 40.3 of the final guidance, will be executed by both parties and will constitute agreement
on the MFP. The MFP included in the executed Addendum will apply for the selected drug for
initial price applicability year 2027, subject to the conditions and timing described in section 70
of the final guidance and will be updated according to section 1195(b)(1)(A) of the Act for
subsequent years in the price applicability period, as applicable. Refer to section 60.6 of the
final guidance for information on how the MFP will be updated for subsequent years in the price
applicability period.
This document describes the ICR that may occur during the negotiation process if the Primary
Manufacturer chooses to develop and submit a statutory written counteroffer to CMS’ written
initial offer during the drug price negotiation process for initial price applicability year 2027.
77

The estimated burden of the ICR for a statutory written counteroffer submission from a Primary
Manufacturer of a selected drug and review of the statutory written counteroffer submission by
CMS staff is provided in the accompanying Supporting Statement. More information on the
negotiation process can be found in the final guidance.
Note: This ICR focuses on information required for the submission of statutory written
counteroffers during the drug price negotiation process for initial price applicability year 2027.
Instructions for Completing the Statutory Written Counteroffer Form
A Primary Manufacturer that seeks to submit a statutory written counteroffer for its selected drug
must complete and submit the information requested in the Statutory Written Counteroffer Form
in the CMS Health Plan Management System (CMS HPMS) in order for CMS to consider the
Primary Manufacturer’s statutory written counteroffer.
To complete the Statutory Written Counteroffer Form, the Primary Manufacturer must provide
the following:
•
•

•

The Primary Manufacturer’s statutory written counteroffer proposal for the MFP per 30day equivalent supply of the selected drug (as described in section 60.1 of the final
guidance);
Subject to the 30,000 character count limit, which is approximately 2,500 words, a
justification of the counteroffer based on the factors in section 1194(e) of the Act. The
Primary Manufacturer’s counteroffer justification should focus on the elements described
in section 1194(e) of the Act and indicate the reasons the Primary Manufacturer believes
that the information submitted by the Primary Manufacturer under section 1194(e)(1) or
(e)(2) of the Act, or other available data related to the selected drug and its therapeutic
alternatives as described in section 1194(e)(2) of the Act, does not support the written
initial offer made by CMS and better supports the Primary Manufacturer’s statutory
written counteroffer. These section 1194(e) data may be information already submitted to
CMS by the Primary Manufacturer or other interested parties, information submitted as
part of the statutory written counteroffer, or information that is otherwise available and
considered by CMS. A Primary Manufacturer may also include in their statutory written
counteroffer justification new information regarding the selected drug and its therapeutic
alternative(s) as described in section 1194(e)(2) that supports the statutory written
counteroffer proposal for the MFP and additional information it deems relevant, such as a
request to include certain information from the statutory written counteroffer justification
in CMS’ public explanation of the MFP, and;
A certification, including an attestation on the use of cost-effectiveness measures, by: (1)
the chief executive officer (CEO), (2) the chief financial officer (CFO), (3) an individual
other than a CEO or CFO, who has authority equivalent to a CEO or a CFO, or (4) an
individual with the directly delegated authority to perform the certification on behalf of
one of the individuals mentioned in (1) through (3).

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

•

•

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•
•

If the Primary Manufacturer chooses to submit the Statutory Written Counteroffer Form,
this form must be completed and submitted within the CMS HPMS within 30 days of
receiving the written initial offer from CMS.
Question 1 asks the Primary Manufacturer to input its statutory written counteroffer
proposal for the MFP for a 30-day equivalent supply of the selected drug. CMS will
interpret this proposal as a single price per 30-day equivalent supply (rather than per unit
– such as tablet, capsule, injection – or per volume or weight metric), and weighted
across dosage forms and strengths, if applicable. The Primary Manufacturer may
reference information provided by CMS during the negotiation process regarding the
application of a single MFP across dosage forms and strengths of the selected drug to
understand how the 30-day equivalent supply statutory written counteroffer proposal for
the MFP will convert into prices for each dosage form and strength of the selected drug.
The Primary Manufacturer should answer Question 2 in narrative (text) form. Responses
will be limited to the 30,000 character count limit, which is approximately 2,500 words,
10 visual representations of data, and a maximum of 50 citations. All response fields are
limited to a character count. Response fields provide a maximum character count and
corresponding estimated word count.
Submissions may include but are not limited to published or unpublished material such as
peer-reviewed articles, whitepapers, case studies, and government reports. CMS reserves
the right to review submitted materials for relevance and in accordance with the
standards outlined in section 50.2 of the final guidance.
The Primary Manufacturer should provide citations to published material rather than
copies of articles. The Primary Manufacturer is responsible for ensuring that its
submission complies with applicable law, including but not limited to copyright law. If
data are unpublished, clearly indicate this in the citation. For unpublished data without a
citation, the Primary Manufacturer should summarize key findings as appropriate and
upload any relevant visual representations as additional materials as described below.
The Primary Manufacturer should provide citations in the National Library of Medicine
(NLM) style format appropriate for the source of information (e.g., a journal article).
Information on how to format citations is available for free through the NLM at:
https://www.ncbi.nlm.nih.gov/books/NBK7256/
When information in Question 2 is supported by a citation, the Primary Manufacturer
should label the end of the sentence in the free text response with a number (e.g., [1], [2])
that corresponds to the number assigned to the provided citations.
In addition to the statutory written counteroffer justification, the Primary Manufacturer
may upload up to 10 visual representations of information, including charts, tables,
and/or graphs, as part of the ICR to support the justification. The information submitted
in the space for visual representations should only include the table, chart, or graph, with
no additional text beyond the titles, labels, legends, and footnotes in the visual
representation. If the Primary Manufacturer provides additional text, such as extensive
narrative descriptions embedded within a visual representation, CMS will not review
such additional text. PDF files will be accepted within specified file size limits for visual
representations. The free text response should include clear numbers/references to the
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charts, tables, or graphs submitted. When information in Question 2 is supported by a
chart, table, or graph, the Primary Manufacturer should label the end of the sentence in
the free text response with a letter (e.g., [A], [B]) that corresponds to the letter assigned
to the provided document.
CMS will review submitted visual representations that use cost-effectiveness measures or
methods to determine if the data are relevant to the selected drug and/or its therapeutic
alternative(s) and to ensure any cost-effectiveness measure used does not value extending
the life of an individual who is elderly, disabled, or terminally ill as of lower value than
extending the life of an individual who is younger, nondisabled, or not terminally ill.
Respondents must indicate via the checkboxes in the form if their submission includes
any cost-effectiveness measures or methods. Examples of cost-effectiveness measures or
methods include but are not limited to Quality-Adjusted Life Years (QALYs), Equal
Value of Life-Years Gained (evLYG), Equal Value Life-Year (evLY), Health Years in
Total (HYT), and Generalized Risk-Adjusted Cost-Effectiveness (GRACE).
If a Primary Manufacturer is the holder of the NDA(s)/BLA(s) for multiple selected
drugs for an initial price applicability year, a separate form must be submitted for each
selected drug for which the Primary Manufacturer chooses to submit a statutory written
counteroffer.

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Appendix. Statutory Written Counteroffer ICR Form
Department of Health and Human Services
Centers for Medicare & Medicaid Services
Statutory Written Counteroffer
ICR Form
Under the authority in sections 11001 and 11002 of the Inflation Reduction Act of 2022 (P.L. 117169), the Centers for Medicare & Medicaid Services (CMS) is implementing the Medicare Drug Price
Negotiation Program, codified in sections 1191 through 1198 of the Social Security Act (the Act), for
initial price applicability year 2027. In accordance with section 1194(b)(2)(B) of the Act, CMS has
provided the Primary Manufacturer of the selected drug named below with a written initial offer that
contains CMS’ proposal for the selected drug’s maximum fair price (MFP), as defined in section
1191(c)(3), and a concise justification based on the factors described in section 1194(e). Submission of
this form indicates that the Primary Manufacturer has not accepted CMS’ written initial offer and is
submitting a statutory written counteroffer in accordance with section 1194(b)(2)(C).
In order for CMS to consider the Primary Manufacturer’s statutory written counteroffer, this form must
be certified by (1) the chief executive officer (CEO) of the Primary Manufacturer, (2) the chief
financial officer (CFO) of the Primary Manufacturer, (3) an individual other than a CEO or CFO of the
Primary Manufacturer, who has authority equivalent to a CEO or a CFO, or (4) an individual with the
directly delegated authority to perform the certification on behalf of one of the individuals mentioned
in (1) through (3).
Question 1: Please provide the Primary Manufacturer's statutory written counteroffer proposal for the
MFP for the selected drug in the table below. CMS will interpret this proposal as a single price per 30day equivalent supply (rather than per unit – such as tablet, capsule, injection – or per volume or
weight metric), and weighted across dosage forms and strengths, if applicable. The Primary
Manufacturer may use information previously shared by CMS on the application of a single MFP
across dosage forms and strengths of the selected drug to understand how this statutory written
counteroffer proposal for the MFP price will apply to the dosage forms and strengths as identified on
the list of National Drug Codes (NDCs) of the selected drug maintained by CMS.
Proposal for the MFP per 30-day equivalent
supply of [selected drug name]
$
Question 2: Please provide a justification of the statutory written counteroffer proposal for the MFP
based on the factors in section 1194(e) of the Act. This statutory written counteroffer justification
should also respond to the justification provided in CMS’ written initial offer and provide the reasons
the Primary Manufacturer believes that the information submitted by the Primary Manufacturer on the

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factors in section 1194(e)(1) or (e)(2) of the Act, or other available data related to the selected drug and
its therapeutic alternatives as described in section 1194(e)(2) of the Act, does not support the written
initial offer made by CMS and better supports the Primary Manufacturer’s statutory written
counteroffer.
FIELD
Statutory Written Counteroffer Justification

RESPONSE FORMAT
Text (30,000 character count limit, which is
approximately 2,500 words)
Additional Materials to Support the Justification
Text (Up to 50 citations)
[file upload] (Up to 10 tables/charts/graphs)
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 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 DOES NOT include 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.
Certification
I hereby certify, to the best of my knowledge, that the information being sent to CMS in this
submission is complete and accurate, and the submission was prepared in good faith and after
reasonable efforts. I reviewed the submission and made a reasonable inquiry regarding its content. I
understand the information contained in this submission is being provided to and will be relied upon
by CMS for Medicare reimbursement purposes, including determination of an MFP, as defined in
section 1191(c)(3) of the Act. I understand further that the proposed price submitted in this Statutory
Written Counteroffer Form, if accepted by CMS, is intended to be the MFP as defined in section
1191(c)(3) of the Act for the selected drug for purposes of section 1193(a)(1) of the Act. I certify that I
will timely notify CMS if I become aware that any of the information submitted in this form has
changed. I also understand that any misrepresentations may give rise to liability, including under the
False Claims Act.
Yes [ ] No [ ]
PRA Disclosure Statement
According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid
OMB control number. The valid OMB control number for this information collection is 0938-1452 (Expires XX/XX/XXXX). This
information collection includes the form a Primary Manufacturer must submit in order to submit a statutory written counteroffer for a selected
drug, and this information will be used to implement Sections 11001 and 11002 of the Inflation Reduction Act. The time required to complete
this information collection is estimated to average 204.25 hours per response, including the time to review instructions, search existing data
resources, gather the data needed, to review and complete the information collection. This information collection is required to retain or obtain
a benefit (section 1194(b)(2)(C) of the Social Security Act) and will be carried out consistent with the confidentiality requirements specified
at section 1193(c) of the Social Security Act and section 40.2.1 of the Medicare Drug Price Negotiation Program: Final Guidance,
Implementation of Sections 1191 – 1198 of the Social Security Act for Initial Price Applicability Year 2027 and Manufacturer Effectuation of
the Maximum Fair Price (MFP) in 2026 and 2027. If you have comments concerning the accuracy of the time estimate(s) or suggestions for
improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail Stop C4-26-05, Baltimore,
Maryland 21244-1850

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