Medicare Part D spending · FDA facts · help paying
Prolia (denosumab): what Medicare Part D spends and the dated federal facts we hold
CMS's Medicare Part D spending dataset reports gross spending on Prolia of $771.84 million in 2024, across 450,858 claims and 284,965 beneficiaries. 2 non-manufacturing label changes are dated in the last 12 months in the FDA's file. The FDA's enforcement reports name this drug's packages in 3 recall entries.
Medicare Part D spending
CMS's Medicare Part D spending dataset reports gross spending on Prolia of $771.84 million in 2024, across 450,858 claims and 284,965 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 | $771.84 million | 450,858 | 284,965 | $1,712 |
| 2023 | $673.29 million | 403,592 | 255,565 | $1,668 |
| 2022 | $546.63 million | 362,308 | 229,044 | $1,509 |
| 2021 | $439.59 million | 316,281 | 202,494 | $1,390 |
| 2020 | $369.12 million | 286,629 | 185,170 | $1,288 |
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 Prolia. 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 |
|---|---|---|---|---|---|
| J0897 | 2026 Q4 | $29.86 | 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
- Prolia; Xgeva (denosumab) is a reference product in the FDA Purple Book (BLA 125320, approved June 1, 2010). The Purple Book lists 0 biosimilars and 12 interchangeable products that name it as their reference product.
Interchangeable: Jubbonti; Wyost, interchangeable since March 5, 2024; Ponlimsi, interchangeable since March 27, 2026; Ospomyv; Xbryk, interchangeable since October 29, 2025; Bomyntra; Conexxence, interchangeable since October 29, 2025; Osenvelt; Stoboclo, interchangeable since October 29, 2025; Jubereq; Osvyrti, interchangeable since October 29, 2025; Aukelso; Bosaya, interchangeable since October 29, 2025; Enoby; Xtrenbo, interchangeable since October 29, 2025; Bildyos; Bilprevda, interchangeable since October 29, 2025; Boncresa, interchangeable since December 19, 2025; Oziltus, interchangeable since December 19, 2025; Degevma, interchangeable since September 25, 2026
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.
FDA safety program (REMS)
- Prolia (application BLA125320): listed as in force, without Elements to Assure Safe Use. Program dated June 1, 2010, last modified June 9, 2025. 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.
Rare-disease (orphan) designations
The FDA's orphan drug database lists 3 designations for denosumab, 2 with an approval recorded. 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 |
|---|---|---|---|
| February 2, 2021 | Treatment of osteogenesis imperfecta | Designated/Designation Withdrawn or Revoked | Amgen Inc. |
| September 11, 2013 | Treatment of hypercalcemia in malignancy | Designated/Approved | Amgen, Inc. |
| December 20, 2010 | Treatment of patients with giant cell tumor of bone | Designated/Approved | Amgen, Inc. |
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 10 states with the largest reimbursement are shown of 44 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 |
|---|---|---|---|
| CA | 5,098 | $7,178,548 | All record types |
| SD | 569 | $2,124,004 | All record types |
| NY | 2,313 | $1,997,468 | All record types |
| NJ | 1,388 | $1,931,930 | Fee-for-service only |
| IL | 1,673 | $1,640,413 | All record types |
| AZ | 1,985 | $1,624,032 | Fee-for-service only |
| MN | 863 | $1,330,364 | Fee-for-service only |
| IN | 1,614 | $1,111,883 | All record types |
| OH | 1,222 | $1,014,980 | All record types |
| PA | 1,139 | $938,095 | 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 (18 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. 96 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.
FDA drug safety communication
The most recent FDA Drug Safety Communication that names denosumab is dated January 19, 2024: FDA adds Boxed Warning for increased risk of severe hypocalcemia in patients with advanced chronic kidney disease taking osteoporosis medicine Prolia (denosumab). It is the FDA's own dated notice, listed as published. OmniRx does not interpret it or say whether it applies to your treatment.
Source: FDA Drug Safety Communications, read November 7, 2026.
Medicaid spending
CMS's Medicaid spending dataset reports $62.74 million for Prolia 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 | $62.74 million | 54,219 |
| 2023 | $64.04 million | 60,005 |
| 2022 | $57.60 million | 55,700 |
| 2021 | $51.00 million | 52,453 |
| 2020 | $43.58 million | 46,923 |
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 denosumab, which covers every maker's product with that ingredient, not only Prolia. Each row is a VA national drug file entry and its status.
| VA entry | Status | Active NDCs |
|---|---|---|
| DENOSUMAB INJ,SOLN | National Formulary | 4 |
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 Prolia dated since November 11, 2025, leaving out manufacturing (CMC) changes. 2 changes in the window.
| Date | Class | Application | Submissions | FDA documents |
|---|---|---|---|---|
| June 23, 2026 | Labeling | BLA125320 | 225 | Label (PDF) posted June 29, 2026FDA letter posted June 24, 2026 |
| June 23, 2026 | Labeling | BLA125320 | 224 | Label (PDF) posted June 29, 2026Label (PDF) posted June 18, 2026FDA letter posted June 24, 2026 |
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.
Safety notices
FDA enforcement report entries that name a package of Prolia by its NDC: 3 entries, newest first. FDA assigns each a class by health risk: Class I is the most serious and Class III the least. An entry records what the recalling firm reported and FDA classified; it is not advice about any package you hold.
| Reported | Class | Status | Recalling firm | Reason (shortened) | Packages named |
|---|---|---|---|---|---|
| July 30, 2025D-0538-2025 | Class II | Ongoing | Mckesson Medical-Surgical Inc. Corporate Office | CGMP Deviations; potential temperature excursions due to transit delays | 2 |
| May 16, 2018D-0748-2018 | Class II | Terminated | Kroger Specialty Pharmacy, Inc. | Lack of Processing Controls. | 1 |
| November 13, 2013D-66318-001 | Class II | Terminated | Amgen, Inc. | Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination. | 2 |
Source: openFDA drug enforcement reports, file read November 7, 2026. openFDA data file. All recent recalls across these drugs: drug recalls feed.
Questions
Does Medicare have a negotiated price for Prolia?
The CMS negotiated-price file we read does not list Prolia, 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 Prolia?
No program in our finder lists this drug yet.
How much does Medicare Part D spend on Prolia?
CMS's Medicare Part D spending dataset reports gross spending on Prolia of $771.84 million in 2024, across 450,858 claims and 284,965 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/prolia.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; openFDA drug enforcement reports. 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.