Subcutaneous Ustekinumab Cost Rose 84% Under Medicare Part D, Set to Drop Under Negotiated Price Reduction

The Office of the Inspector General (OIG) of the Department of Health and Human Services reported that Medicare expenditures for the cost of subcutaneous ustekinumab increased almost 10-fold from 2016 to 2023, from $300 million almost $3 billion, due to coverage changes that affected whether the injections were covered under Medicare Part B or Part D.

The report was issued shortly before the Centers for Medicare and Medicaid Services announced that the price of ustekinumab, approved for the treatment of moderate to severe Crohn’s disease and ulcerative colitis, will decrease in 2026 by 66%, from $13,836 to the new negotiated price of $4695 for a 30-day supply. 

“Our findings illustrate how differences in the methods used to set drug payment amounts under Part B (i.e., manufacturers’ sales prices) versus under Part D (i.e., negotiations between plan sponsors, manufacturers, pharmacy benefit managers, and pharmacies) result in widely different payment amounts for the same drugs,” the OIG stated in its report.

Subcutaneous ustekinumab is typically self-injected and covered under Medicare Part D. Prior to 2023, Part B covered subcutaneous ustekinumab when a physician administered the injection. However, the OIG report stated, “Medicare Administrative Contractors (MACs) now exclude Stelara injections under a policy designed to omit self-administered drugs from Part B coverage.  The period during which Stelara was covered under Parts B and D provides a unique opportunity to examine how coverage determinations affect payments made by the Medicare program and costs for its enrollees.” 

Medicare and some enrollees paid substantially more when ustekinumab injections were self-administered and covered under Part D versus under physician-administered injections, covered under Part B. Recent changes in Medicare coverage require enrollees who once opted to receive physician-administered injections to now obtain their subcutaneous ustekinumab through a pharmacy (Part D), “where they will potentially face much higher out-of-pocket costs,” the report noted.

The average cost for a 90-mg injection of ustekinumab actually dropped from $14,500 in 2016 to $12,912 in 2023 when covered under Part B, while the cost per injection under Part D increased from $17,717 to $32,559 under Part D. Crohn’s disease and ulcerative colitis require six 90-mg doses annually of subcutaneous ustekinumab annually.

 “As such, Part B and Part D programmatic features—such as payment amounts and available payment supports (e.g., Medigap or LIS)—can have a major effect on expenditures for Medicare and out-of-pocket costs for enrollees, and can also impact where patients choose to obtain the drug,” the report concluded.

Reference:

Medicare and some enrollees paid substantially more when Stelara was covered under Part D versus Part B. Report in Brief. US Department of Health and Human Services Office of the Inspector General. August 2024. Accessed August 15, 2024. https://oig.hhs.gov/reports-and-publications/all-reports-and-publications/medicare-and-some-enrollees-paid-substantially-more-when-stelara-was-covered-under-part-d-versus-part-b/

Medicare drug price negotiation program: negotiated prices for initial price applicability year 2026. Centers for Medicare and Medicaid Services. August 2024. Accessed August 15, 2024. https://www.cms.gov/files/document/fact-sheet-negotiated-prices-initial-price-applicability-year-2026.pdf