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August 1, 2022

Unfairness to Patients With Alzheimer Disease in Medicare’s Coverage of Antiamyloid Immunotherapy

Author Affiliations
  • 1Ann Romney Center for Neurologic Diseases, Division of Cognitive and Behavioral Neurology, Department of Neurology, Brigham and Women’s Hospital, Harvard Medical School, Boston, Massachusetts
JAMA Neurol. 2022;79(10):962-963. doi:10.1001/jamaneurol.2022.2131

On April 7, 2022, the US Center for Medicare and Medicaid Services (CMS) finalized its national coverage determination (NCD) for antiamyloid antibodies, a drug class that includes aducanumab (Aduhelm). CMS has chosen a coverage with evidence development (CED) mechanism because it identified a gap in evidence of efficacy that CMS seeks to fill before broadening to full coverage. As a result, antiamyloid antibodies will only be covered for research participants.1 Aduhelm is controversial because of mixed clinical trial results and the US Food and Drug Administration’s (FDA) use of the accelerated approval pathway based on biomarker efficacy rather than traditional approval based on clinical efficacy, leading CMS to choose a CED in its preliminary proposal in January 2022 instead of full coverage. However, the final April 2022 NCD details the CMS plan to also restrict coverage for even future antiamyloid antibodies that have typical success with fully positive trial results and traditional FDA approval—a step it has never taken for any other medication for any other disease. This decision, therefore, discriminates against patients with Alzheimer disease.

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