Figure 1. Estimated Medicare Spending on Accelerated Approval Drugs, 2015-2019.

Estimated annual Medicare spending on drugs with an accelerated approval indication reimbursed under Part B (blue) and Part D (orange) was stratified based on time when a drug was exclusively marketed for an accelerated approval indication vs time when a drug’s labeling additionally included one or more indications via the traditional approval pathway. All spending data were converted to 2020 US dollars using the Consumer Price Index for All Urban Consumers, and mid-year changes in accelerated approval status were prorated. Part D drug spending estimates are net of estimated class-specific rebates and discounts and include traditional Medicare and Medicare Advantage beneficiaries; Part B drug spending excludes Medicare Advantage beneficiaries and estimates were adjusted to account for missing data in the first years a drug is marketed.