The BTK inhibitor ibrutinib is one of the first 10 drugs covered under Medicare Part D eligible for price negotiation authorized through the Inflation Reduction Act, the U.S. Department of Health and Human Services (HHS) announced in August 2023. Together, the 10 drugs accounted for 20% of Medicare Part D prescription drug costs during the 12-month period used to identify the initial group of negotiable agents. Medicare enrollees taking the 10 drugs covered under Part D selected for negotiation paid a total of $3.4 billion in out-of-pocket costs for the drugs in 2022.

“For far too long, pharmaceutical companies have made record profits while American families were saddled with record prices and unable to afford life-saving prescription drugs. But thanks to the landmark Inflation Reduction Act, we are closer to reaching President Biden’s goal of increasing availability and lowering prescription drug costs for all Americans,” HHS Secretary Xavier Becerra said.

The list includes agents to manage heart disease, diabetes, autoimmune disease, and other chronic conditions. Ibrutinib is indicated for the treatment of various leukemias and lymphomas, Waldenstrom’s macroglobulinemia, and chronic graft-versus-host disease. Without any financial assistance, ibrutinib costs $567 per dose or about $17,000 per month as of January 2023.

The Centers for Medicare and Medicaid Services (CMS) is conducting the negotiations from 2023–2024 and publish the final negotiated prices for the 10 drugs by September 1, 2024. The prices will take effect on January 1, 2026. As outlined in the Inflation Reduction Act, CMS will select up to 15 more drugs covered under Part D for negotiation in 2027, up to 15 more drugs for 2028 (including drugs covered under Part B and Part D), and up to 20 more drugs for each year after.

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