Medicare Part D spending · FDA facts · help paying
Krystexxa (pegloticase): what Medicare Part D spends and the dated federal facts we hold
CMS's Medicare Part D spending dataset reports gross spending on Krystexxa of $212.35 million in 2024, across 4,801 claims and 662 beneficiaries. 1 non-manufacturing label change is 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 Krystexxa of $212.35 million in 2024, across 4,801 claims and 662 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 | $212.35 million | 4,801 | 662 | $44,230 |
| 2023 | $178.84 million | 3,892 | 603 | $45,950 |
| 2022 | $123.04 million | 2,906 | 496 | $42,340 |
| 2021 | $68.26 million | 1,781 | 301 | $38,329 |
| 2020 | $49.73 million | 1,266 | 242 | $39,279 |
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 Krystexxa. 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 |
|---|---|---|---|---|---|
| J2507 | 2026 Q4 | $4,001 | 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
- Krystexxa (pegloticase) is a reference product in the FDA Purple Book (BLA 125293, approved September 14, 2010). 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.
FDA safety program (REMS)
- Krystexxa (application BLA125293): listed as released, without Elements to Assure Safe Use. Program dated September 14, 2010, last modified April 11, 2016. 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 2 designations for pegloticase, 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 21, 2001 | To control the clinical consequences of hyperuricemia in patients with severe gout in whom conventional therapy is contraindicated or has been ineffective. | Designated/Approved | Horizon Therapeutics Ireland DAC |
| February 21, 2001 | To control the clinical consequences of hyperuricemia in patients with severe gout in whom conventional therapy is contraindicated or has been ineffective. | Designated/Approved | Horizon Therapeutics Ireland DAC |
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 7 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 |
|---|---|---|---|
| NC | 144 | $4,703,878 | Fee-for-service only |
| NJ | 113 | $3,310,883 | All record types |
| WI | 108 | $2,848,767 | All record types |
| IN | 69 | $2,181,411 | Fee-for-service only |
| NV | 74 | $1,855,998 | Fee-for-service only |
| KY | 73 | $1,700,453 | All record types |
| IL | 54 | $1,581,203 | 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 (4 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. 15 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 $87.13 million for Krystexxa 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 | $87.13 million | 3,214 |
| 2023 | $81.12 million | 3,117 |
| 2022 | $64.89 million | 2,720 |
| 2021 | $46.18 million | 1,960 |
| 2020 | $27.95 million | 1,418 |
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 pegloticase, which covers every maker's product with that ingredient, not only Krystexxa. Each row is a VA national drug file entry and its status.
| VA entry | Status | Active NDCs |
|---|---|---|
| PEGLOTICASE INJ,SOLN | Non-formulary | 2 |
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 Krystexxa dated since November 11, 2025, leaving out manufacturing (CMC) changes. 1 change in the window.
| Date | Class | Application | Submissions | FDA documents |
|---|---|---|---|---|
| August 7, 2026 | Labeling | BLA125293 | 116 | FDA letter posted August 18, 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.
Questions
Does Medicare have a negotiated price for Krystexxa?
The CMS negotiated-price file we read does not list Krystexxa, 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 Krystexxa?
No program in our finder lists this drug yet.
How much does Medicare Part D spend on Krystexxa?
CMS's Medicare Part D spending dataset reports gross spending on Krystexxa of $212.35 million in 2024, across 4,801 claims and 662 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/krystexxa.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.