Medicare Part D spending · FDA facts · help paying
Keytruda (pembrolizumab): what Medicare Part D spends and the dated federal facts we hold
CMS's Medicare Part D spending dataset reports gross spending on Keytruda of $140.06 million in 2024, across 11,882 claims and 1,906 beneficiaries. 4 assistance programs list pembrolizumab, each with its income ceiling and when we read it. 8 non-manufacturing label changes are dated in the last 12 months in the FDA's file.
Medicare Part D spending
CMS's Medicare Part D spending dataset reports gross spending on Keytruda of $140.06 million in 2024, across 11,882 claims and 1,906 beneficiaries. CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions. Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.
| Year | Gross spending | Claims | Beneficiaries | Average spending per claim |
|---|---|---|---|---|
| 2024 | $140.06 million | 11,882 | 1,906 | $11,787 |
| 2023 | $116.82 million | 9,668 | 1,523 | $12,083 |
| 2022 | $91.15 million | 7,915 | 1,335 | $11,516 |
| 2021 | $68.68 million | 6,392 | 1,050 | $10,745 |
| 2020 | $57.02 million | 5,573 | 959 | $10,232 |
Source: CMS Medicare Part D spending by drug (data-year-2024, modified 2026-06-25), read November 7, 2026. CMS dataset page. All manufacturers combined; the figures are a drug-level aggregate of claims and say nothing about a formulary or coverage.
Medicare Part B payment limit
CMS publishes a quarterly payment limit for the HCPCS code that its NDC crosswalk links to Keytruda. It is a ceiling for providers who bill Medicare Part B, not a price a patient pays, and a code's presence says nothing about whether Medicare covers a product.
| HCPCS code | Quarter | Payment limit | Per dosage descriptor | Effective | Read |
|---|---|---|---|---|---|
| J9271 | 2026 Q4 | $62.25 | 1 MG | October 1, 2026 through December 31, 2026 | November 7, 2026 |
Source: CMS ASP pricing files (october-2026-medicare-part-b-payment-limit-files-final.zip and the matching NDC-HCPCS crosswalk). CMS ASP pricing files page.
Biosimilar status
- Keytruda (pembrolizumab) is a reference product in the FDA Purple Book (BLA 125514, approved September 4, 2014). The Purple Book lists 0 biosimilars and 0 interchangeable products that name it as their reference product.
This is what the FDA Purple Book lists on the read date. It is a record, not a forecast of when any product will launch or be substituted.
Source: FDA Purple Book (purplebook-2026-10), read November 7, 2026. Purple Book data file.
Rare-disease (orphan) designations
The FDA's orphan drug database lists 22 designations for pembrolizumab, 17 with an approval recorded. The 6 most recent are shown. A designation is not an approval and not a statement that the drug treats the condition; the status column is the database's own.
| Designated | Designated use | Status | Sponsor |
|---|---|---|---|
| June 6, 2026 | treatment of neuroendocrine prostate cancer (NEPC) | Designated | Merck, Sharp & Dohme LLC. |
| January 3, 2025 | treatment of recurrent respiratory papillomatosis | Designated/Designation Withdrawn or Revoked | Massachusetts General Hospital |
| October 9, 2019 | Treatment of Biliary Tract Carcinoma | Designated/Approved | MSD International Business GmbH |
| October 3, 2017 | Treatment of Small Cell Lung Cancer | Designated/Approved | MSD International Business GmbH |
| June 15, 2017 | Treatment of esophageal carcinoma | Designated/Approved | MSD International Business GmbH |
| June 15, 2017 | Treatment of esophageal carcinoma | Designated/Approved | MSD International Business GmbH |
Source: FDA Orphan Drug Designations and Approvals database, read November 7, 2026. FDA orphan drug search.
Medicaid use by state
CMS's State Drug Utilization Data records, for 2025, how many prescriptions each state's Medicaid program paid for under this drug's packages and what it reimbursed. The 4 states with the largest reimbursement are shown. Reimbursement is before the rebates manufacturers pay states, so it is not a net cost and not a price a patient pays.
| State | Medicaid-paid prescriptions | Medicaid reimbursed | Covers |
|---|---|---|---|
| LA | 275 | $3,303,953 | Fee-for-service only |
| ND | 87 | $865,972 | Fee-for-service only |
| TN | 71 | $691,431 | All record types |
| CO | 66 | $368,518 | Fee-for-service only |
Where the publisher suppresses small managed-care cells, a state's figure covers fee-for-service claims only and understates use (3 state and package figures are marked that way here). A state missing from the table means its figures were suppressed or not reported, not zero use. 90 older-year figures are held and left out of the table.
Source: CMS State Drug Utilization Data (State Drug Utilization Data 2025, modified 2026-07-13T15:28:32Z), read November 7, 2026. CMS dataset page. State-reported data compiled by CMS; aggregate by state and package, no provider or patient data.
Medicaid spending
CMS's Medicaid spending dataset reports $829.45 million for Keytruda in 2024. CMS's dataset states spending includes Federal and State reimbursement and dispensing fees and is not reduced by Medicaid rebates paid to the states. Spending is what Medicaid paid, not what a patient pays.
| Year | Spending | Claims |
|---|---|---|
| 2024 | $829.45 million | 80,231 |
| 2023 | $818.67 million | 83,449 |
| 2022 | $776.89 million | 80,740 |
| 2021 | $613.98 million | 67,884 |
| 2020 | $529.28 million | 62,762 |
Source: CMS Medicaid spending by drug (data-year-2024, modified 2026-06-25), read November 7, 2026. CMS dataset page. A national drug-level aggregate; it says nothing about any state's coverage rules.
Federal formulary status
VA national formulary
The VA's national formulary files list the ingredient pembrolizumab, which covers every maker's product with that ingredient, not only Keytruda. Each row is a VA national drug file entry and its status.
| VA entry | Status | Active NDCs |
|---|---|---|
| PEMBROLIZUMAB INJ,SOLN | National Formulary | 3 |
Source: VA Pharmacy Benefits Management national formulary (va-formulary-2026-09), read November 7, 2026. VA formulary page.
Where help paying exists
Programs in our finder that list pembrolizumab. Each shows its income ceiling, when we read it and whether we checked it against the program's own document. Eligibility is decided by the program, not by us.
- Merck Helps (Merck Patient Assistance Program) manufacturer
Income at or below $79,800 for one person for KEYTRUDA, or $63,840 for JANUVIA and JANUMET - Keytruda Patient Assistance (Merck) manufacturer
Income at or below $79,800 for one person, $108,200 for a couple (500% FPL) - HealthWell Foundation nonprofit
Up to 300% to 500% FPL depending on the disease fund; many funds close to new patients
Ceiling matched against the program's page text, November 6, 2026.Status. The HealthWell Foundation homepage lists disease funds as Open or Closed when read. Closed funds include Type 2 Diabetes, Migraine and Multiple Sclerosis - Medicare Access; open funds include Multiple Myeloma - Medicare Access, which the page says offers up to $8,000 in prescription drug copayment or Medicare Part B premium assistance. The page carries no fund-level date; the status is as of the read. (read November 7, 2026)
- Good Days (formerly Chronic Disease Fund) nonprofit
Income at or below 500% of the poverty level
Figure not yet re-read on the program's own page.
Check where your income sits against each ceiling: open the assistance finder. See what has changed and when we last verified each program on the program status board.
Label changes
FDA actions on the applications behind Keytruda dated since November 11, 2025, leaving out manufacturing (CMC) changes. 8 changes in the window.
| Date | Class | Application | Submissions | FDA documents |
|---|---|---|---|---|
| October 16, 2026 | Efficacy | BLA125514 | 191 | Label (PDF) posted October 27, 2026FDA letter posted October 27, 2026 |
| July 10, 2026 | Efficacy | BLA125514 | 194 | Label (PDF) posted July 15, 2026FDA letter posted July 13, 2026 |
| June 24, 2026 | Efficacy | BLA125514 | 187 | Label (PDF) posted June 29, 2026FDA letter posted June 26, 2026 |
| June 12, 2026 | Efficacy | BLA125514 | 192 | Label (PDF) posted June 16, 2026FDA letter posted June 26, 2026 |
| May 12, 2026 | Labeling | BLA125514 | 190 | Label (PDF) posted May 18, 2026FDA letter posted May 13, 2026 |
| April 6, 2026 | Labeling | BLA125514 | 195 | Label (PDF) posted April 8, 2026FDA letter posted April 7, 2026 |
| February 10, 2026 | Efficacy | BLA125514 | 186 | Label (PDF) posted February 12, 2026FDA letter posted February 12, 2026 |
| November 21, 2025 | Efficacy | BLA125514 | 188 | Label (PDF) posted November 25, 2025FDA letter posted November 24, 2025 |
Source: FDA Drugs@FDA data file, read November 7, 2026. Dates are the FDA action dates; the documents are on FDA's own site. FDA data file. All recent changes across these drugs: label changes feed.
Questions
Does Medicare have a negotiated price for Keytruda?
The CMS negotiated-price file we read does not list Keytruda, so this page shows no negotiated price. A drug appears in that file only when CMS selects it for negotiation, and not being listed says nothing about what it costs a patient.
Is there help paying for Keytruda?
4 assistance programs list it in our finder. Eligibility depends on income, coverage and the program's current rules; each program's own page decides.
How much does Medicare Part D spend on Keytruda?
CMS's Medicare Part D spending dataset reports gross spending on Keytruda of $140.06 million in 2024, across 11,882 claims and 1,906 beneficiaries. CMS's dataset states spending is gross drug cost and does not reflect manufacturers' rebates or other price concessions. Spending is the total paid by Medicare, plans and beneficiaries for the drug's claims, not what a patient pays.
For developers: this drug as data
One call returns the generic-entry upper bound, label history, recalls, trials, assistance and Part D spending, and where facts exist the FDA safety program (REMS), DEA schedule, orphan designations, safety notices and Medicaid use by state, each with receipts.
Example file: https://omnirx.org/api/v1/dossier/keytruda.json
The licence page sets out what a data licence covers, and the API page documents these files.
Evaluation files with receipts; contract may change; not clinical advice.
Sources and terms. This drug is not in the CMS negotiated-price file, so no price source is used. Program details read from each program's own pages; CMS Medicare Part D spending by drug; CMS Medicaid spending by drug; TRICARE and VA formulary files; CMS ASP pricing files; FDA Purple Book; FDA Drugs@FDA and Orange Book data files. Figures are stored with their sources in the OmniRx library (edition 2026-11). Free to cite with attribution. Not medical, legal or financial advice. Report an error through the contact page. Licence the data.