Medicare Part D spending · FDA facts · help paying
Fentanyl: what Medicare Part D spends and the dated federal facts we hold
CMS's Medicare Part D spending dataset reports gross spending on Fentanyl of $92.39 million in 2024, across 821,141 claims and 116,822 beneficiaries. 4 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 Fentanyl of $92.39 million in 2024, across 821,141 claims and 116,822 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 | $92.39 million | 821,141 | 116,822 | $113 |
| 2023 | $98.43 million | 895,886 | 124,042 | $110 |
| 2022 | $110.75 million | 1,021,975 | 137,451 | $108 |
| 2021 | $120.03 million | 1,185,979 | 156,332 | $101 |
| 2020 | $129.01 million | 1,378,763 | 175,917 | $93.57 |
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.
FDA safety program (REMS)
- Opioid Analgesic REMS (application ANDA076258): listed as in force, with Elements to Assure Safe Use. Program dated July 9, 2012, last modified June 18, 2026. REMS@FDA program page.
- Opioid Analgesic REMS (application ANDA077449): listed as in force, with Elements to Assure Safe Use. Program dated July 9, 2012, last modified June 18, 2026. REMS@FDA program page.
A REMS is a safety program the FDA can require for a drug. Some restrict how it is prescribed or dispensed, for example through certified prescribers or pharmacies. This lists what the FDA's REMS@FDA files tie to the application; it does not say which prescribers or pharmacies take part, or whether a given patient needs the program.
Source: FDA REMS@FDA data files (rems-fda-files-2026-11-07-products-20a9945448dd), read November 7, 2026. REMS@FDA product file.
Controlled-substance schedule
Fentanyl appears in the DEA schedules at Schedule II (21 CFR 1308.12(c)). This is a federal classification under 21 CFR Part 1308. It is not a statement about whether a patient can get the drug.
Source: eCFR, Title 21 Part 1308, version 2026-11-05, read November 7, 2026. eCFR section.
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 10 states with the largest reimbursement are shown of 22 with data. 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 |
|---|---|---|---|
| PA | 610 | $73,816 | Fee-for-service only |
| OH | 391 | $39,663 | Fee-for-service only |
| NC | 350 | $29,907 | Fee-for-service only |
| MN | 326 | $25,714 | Fee-for-service only |
| CO | 306 | $22,032 | Fee-for-service only |
| WI | 204 | $17,056 | All record types |
| IN | 256 | $14,568 | Fee-for-service only |
| MI | 313 | $12,837 | All record types |
| UT | 148 | $10,979 | Fee-for-service only |
| KY | 110 | $10,648 | 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 (21 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. 150 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 $9.22 million for Fentanyl 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 | $9.22 million | 90,369 |
| 2023 | $9.79 million | 107,422 |
| 2022 | $9.14 million | 119,749 |
| 2021 | $10.62 million | 140,272 |
| 2020 | $11.44 million | 159,193 |
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 fentanyl, which covers every maker's product with that ingredient, not only Fentanyl. Each row is a VA national drug file entry and its status.
| VA entry | Status | Active NDCs |
|---|---|---|
| FENTANYL INJ,SOLN | National Formulary | 74 |
| FENTANYL PATCH | National Formulary | 55 |
| FENTANYL POWDER | Non-formulary | 33 |
Source: VA Pharmacy Benefits Management national formulary (va-formulary-2026-09), read November 7, 2026. VA formulary page.
Where help paying exists
No program in our finder currently lists this drug as open to new patients.
Label changes
FDA actions on the applications behind Fentanyl dated since November 11, 2025, leaving out manufacturing (CMC) changes. 4 changes in the window.
| Date | Class | Application | Submissions | FDA documents |
|---|---|---|---|---|
| June 18, 2026 | REMS | ANDA076258 | 53 | No document linked in the FDA file |
| June 18, 2026 | REMS | ANDA077449 | 45 | No document linked in the FDA file |
| December 22, 2025 | Labeling | ANDA076258 | 48, 51, 52 | No document linked in the FDA file |
| December 22, 2025 | Labeling | ANDA077449 | 42, 44 | No document linked in the FDA file |
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 Fentanyl?
The CMS negotiated-price file we read does not list Fentanyl, 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 Fentanyl?
No program in our finder lists this drug yet.
How much does Medicare Part D spend on Fentanyl?
CMS's Medicare Part D spending dataset reports gross spending on Fentanyl of $92.39 million in 2024, across 821,141 claims and 116,822 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/fentanyl.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; 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.