Historically, Medicare has reimbursed drugs approved by the Food and Drug Administration (FDA) including drugs granted accelerated approval. In 2021, FDA granted accelerated approval to plaque-targeting treatments for Alzheimer’s disease (AD), but the Centers for Medicare and Medicaid Services (CMS) imposed a coverage paradigm for this entire class that requires patients to be enrolled in studies in order to receive coverage. This white paper uses the existing evidence base to calibrate the economic impact of such CMS coverage delays on this class of FDA approved new drugs for AD. Using historical data on such CMS delays show that the vast majority are ongoing and last as long as 17 years. We find that these data indicate expected losses from the imposed delay of the AD class ranging between $13.1 billion to $545.6 billion. We find that part of these losses stems from increased private and public healthcare spending ranging from $6.8 billion to $284.5 billion. These findings have important implications for how the Congressional Budget Office (CBO) should assess the budget impacts of these CMS delays as they likely raise, as opposed to lower, spending.

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