Medicare Part D Coverage for Humira Biosimilars Has Inspector General’s Attention

The HHS Office of Inspector General will evaluate the extent and quality of Medicare Part D plan coverage for biosimilars to AbbVie Inc.’s Humira (adalimumab) and expects to issue a report on the study in 2025, according to a recent update to the OIG’s work plan.

The study could provide fodder for reforms to pharmacy benefit manager rebating practices and for changes in Part D coverage policy that could help boost the uptake of biosimilars. Stakeholders and policy makers have viewed adalimumab biosimilars as a test case for the viability of the biosimilar model.

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Cathy Kelly

Cathy Kelly

Cathy is a senior writer with Pink Sheet and has covered U.S. regulation and reimbursement policy for the biopharma industry since 2004, starting with the establishment of the Medicare Part D program. Since then, she has written extensively about developments in all major sectors of the U.S. insurance market (Medicare, Medicaid and commercial plans). She has covered key legislation affecting biopharma, including the Medicare Prescription Drug, Improvement, and Modernization Act which created Part D, health care reform under President Obama, and the Inflation Reduction Act. She has closely followed the increasing influence of pharmacy benefit managers and their use of formulary negotiations and rebates to control pricing. Cathy also has covered developments in health technology assessments and has monitored industry progress on novel drug contracting that reflects value-based pricing.

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