Aduhelm was the first FDA-approved disease-modifying treatment for Alzheimer’s, sparking debate among providers, regulators, and patients. Aduhelm received a controversial accelerated approval from the FDA in June 2021, a decision that balanced the lack of consensuses among the scientific community regarding the efficacy of Aduhelm with the significant unmet need in Alzheimer’s. Following this approval, the Centers for Medicare and Medicaid Services (CMS) issued an unprecedented blanket National Coverage Determination (NCD) that applied to all monoclonal antibodies receiving accelerated approval based on beta-amyloid plaques in Alzheimer’s disease.
CRA’s Lev Gerlovin and Kira Gordon investigated whether this decision by CMS was an outlier event due to the unique situation with Aduhlem or an indicator of a potential new CMS modus operandi.
Click here to read more about CMS’ Alzheimer’s NCD.
