Medicare’s Aducanumab decision highlights needed reforms to FDA and CMS regulatory pathways

Date: January 25, 2022
Journal: Health Affairs Forefront
Citation: Medicare’s Aducanumab Decision Highlights Needed Reforms To FDA And CMS Regulatory Pathways, Health Affairs Forefront, January 25, 2022. DOI: 10.1377/forefront.20220121.566837


Much ink has already been spilled to parse the Centers for Medicare and Medicaid Services’ (CMS’s) January 11 draft national coverage determination (NCD) on monoclonal antibody (mAb) therapies for mild cognitive impairment and early Alzheimer’s disease (AD). In this Forefront article, we examine a critical and underappreciated concern that the decision highlights: the Food and Drug Administration (FDA’s) and CMS’s different decision-making authorities and the issues that arise when the two agencies make different judgments about the same evidence. We also explore what the Alzheimer’s decision may mean for future Medicare drug coverage policy, especially for drugs that treat serious diseases for which existing therapies are inadequate.

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