In June 2021, the Food and Drug Administration (FDA) granted accelerated approval to Aduhelm for the treatment of Alzheimer’s disease. This approval was granted against the recommendation of the FDA’s advisory committee and created significant concerns over safety, efficacy, and cost. Due to this concern, the Centers for Medicare & Medicaid Services (CMS) initiated a national coverage determination (NCD) for Medicare. In April 2022, CMS finalized a Medicare NCD to cover Aduhelm and other monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease under a coverage with evidence development (CED) policy. Coverage of these drugs is only allowed in an FDA-approved randomized controlled trial, CMS approved study, or study supported by the National Institutes of Health. Because of the requirements of the Medicaid Drug Rebate Program, state Medicaid programs must provide coverage of Aduhelm and any future drugs approved in the class to Medicaid beneficiaries.
In this session, staff presented on the potential implications of the Alzheimer’s disease treatments on Medicaid. The presentation provided an overview of coverage under the Medicaid and Medicare Part B, including Medicare’s CED policy. Next, staff summarized the approval of Aduhelm and the subsequent Medicare coverage decision. The presentation also included an analysis of the number of Medicaid beneficiaries with Alzheimer’s disease and the potential costs of treatment for non-dually eligible Medicaid beneficiaries and beneficiaries dually eligible for Medicare and Medicaid. Staff then discussed a potential policy option to allow states to implement coverage criteria based on a Medicare NCD, including any CED requirements.