Medicare Proposes To Limit Aduhelm Coverage To Randomized Clinical Trials

On January 14, 2022, Medicare issued a proposed national coverage decision (NCD) for Aduhelm™ (aducanumab), a new medication for treating Alzheimer’s disease, and will cover the medication only for beneficiaries taking place in a randomized clinical trial. The Food and Drug Administration (FDA) approved Aduhelm, a monoclonal antibody directed against amyloid beta, as a treatment for Alzheimer’s disease in July 2021. Immediately following the FDA approval, Medicare said it would consider whether to cover the medication, and if so, the criteria for coverage. Amyloid plaques in the brain are a characteristic of Alzheimer’s disease, and the progression . . .