Health Affairs November 1, 2024
Katherine A. Clifford, A. Alex Levine, Daniel E. Enright, Peter J. Neumann, James D. Chambers

Abstract

The Inflation Reduction Act of 2022 requires that Medicare negotiate a Maximum Fair Price for selected small-molecule drugs nine years after their Food and Drug Administration (FDA) approval and thirteen years postapproval for selected biologics. The discrepancy between these time frames raises questions about the relative value of small-molecule drugs versus biologics. We compared the incremental quality-adjusted life-year (QALY) gains, incremental costs, and incremental cost-effectiveness ratios (ICERs) of small-molecule drugs and biologics approved by...

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Topics: Biotechnology, FDA, Govt Agencies, Insurance, Medicare, Pharma / Biotech
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