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Medicare Part D spending · FDA facts · help paying

Benlysta (belimumab): what Medicare Part D spends and the dated federal facts we hold

CMS's Medicare Part D spending dataset reports gross spending on Benlysta of $216.81 million in 2024, across 44,771 claims and 5,831 beneficiaries. 4 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 1 recall entry.

Assistance programs: 0CMS Part D spending, data year 2024Drugs@FDA, read November 7, 2026openFDA recalls, read November 7, 2026
0programs in our finder list this drug
$216.81 millionMedicare Part D gross spending in 2024, before manufacturer rebates; not a patient price
6federal data layers besides Part D spending hold facts for this drug: FDA application facts, recalls, biosimilar status, Part B payment limit, Medicaid spending, federal formularies

Medicare Part D spending

CMS's Medicare Part D spending dataset reports gross spending on Benlysta of $216.81 million in 2024, across 44,771 claims and 5,831 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.

$96.76 million2020$121.89 million2021$149.76 million2022$187.01 million2023$216.81 million2024Gross spending before rebates, not a patient price
Source: CMS Medicare Part D spending by drug, reported under Benlysta*; gross spending before manufacturer rebates.
YearGross spendingClaimsBeneficiariesAverage spending per claim
2024$216.81 million44,7715,831$4,843
2023$187.01 million38,6134,938$4,843
2022$149.76 million33,8054,402$4,430
2021$121.89 million29,2883,812$4,162
2020$96.76 million24,3263,104$3,978

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 Benlysta. 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 codeQuarterPayment limitPer dosage descriptorEffectiveRead
J04902026 Q4$58.3310 MGOctober 1, 2026 through December 31, 2026November 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

  • Benlysta (belimumab) is a reference product in the FDA Purple Book (BLA 125370, approved March 9, 2011). The Purple Book lists 0 biosimilars and 0 interchangeable products that name it as their reference product.
  • Benlysta (belimumab) is a reference product in the FDA Purple Book (BLA 761043, approved July 20, 2017). 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 1 designation for belimumab. A designation is not an approval and not a statement that the drug treats the condition; the status column is the database's own.

DesignatedDesignated useStatusSponsor
January 24, 2023Treatment of systemic sclerosisDesignatedGSK LLC

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. Reimbursement is before the rebates manufacturers pay states, so it is not a net cost and not a price a patient pays.

StateMedicaid-paid prescriptionsMedicaid reimbursedCovers
UT167$849,162Fee-for-service only
NE103$530,768All record types
MN241$483,129Fee-for-service only
OR79$302,662Fee-for-service only
NM66$287,321Fee-for-service only
MI53$276,570Fee-for-service only
KY83$236,608Fee-for-service only
TN70$209,210All record types
IA81$157,789Fee-for-service only
AK97$140,007Fee-for-service only

Explore every state, both years and the per-prescription figures for this drug in the Medicaid by state explorer.

Where the publisher suppresses small managed-care cells, a state's figure covers fee-for-service claims only and understates use (8 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. 131 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 $229.27 million for Benlysta 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.

YearSpendingClaims
2024$229.27 million57,400
2023$212.56 million56,339
2022$171.05 million48,594
2021$128.91 million38,596
2020$87.75 million28,166

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 belimumab, which covers every maker's product with that ingredient, not only Benlysta. Each row is a VA national drug file entry and its status.

VA entryStatusActive NDCs
BELIMUMAB INJ,LYPHLNational Formulary2
BELIMUMAB INJ,SOLNNational Formulary5

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 Benlysta dated since November 11, 2025, leaving out manufacturing (CMC) changes. 4 changes in the window.

Labeling: 4
DateClassApplicationSubmissionsFDA documents
October 30, 2026LabelingBLA12537089Label (PDF) posted November 3, 2026FDA letter posted November 4, 2026
October 30, 2026LabelingBLA76104338Label (PDF) posted November 3, 2026FDA letter posted November 4, 2026
August 21, 2026LabelingBLA12537090Label (PDF) posted August 25, 2026FDA letter posted August 25, 2026
August 21, 2026LabelingBLA76104339Label (PDF) posted August 25, 2026FDA letter posted August 25, 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 Benlysta by its NDC: 1 entry, 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.

ReportedClassStatusRecalling firmReason (shortened)Packages named
July 30, 2025D-0540-2025Class IIOngoingMckesson Medical-Surgical Inc. Corporate OfficeCGMP Deviations; potential temperature excursions due to transit delays7

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 Benlysta?

The CMS negotiated-price file we read does not list Benlysta, 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 Benlysta?

No program in our finder lists this drug yet.

How much does Medicare Part D spend on Benlysta?

CMS's Medicare Part D spending dataset reports gross spending on Benlysta of $216.81 million in 2024, across 44,771 claims and 5,831 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/benlysta.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.