Analysis of the First Round of Public Comments for the National Coverage Determination for Monoclonal Antibodies in the Treatment of Alzheimer's Disease.

Abstract

Following the Food and Drug Administration's (FDA) controversial approval of aducanumab for the treatment of Alzheimer's disease, the Centers of Medicare & Medicaid Services (CMS) used its National Coverage Determination process to determine its coverage for Medicare beneficiaries. A public comment period was available for 30 days between July 12, 2021 and August 11, 2021. This study analyzed the 132 comments submitted in the first public comment period. The comments were downloaded from CMS' publicly-available website and analyzed to identify key themes across stakeholders. Three major themes were identified. Those supporting CMS approving aducanumab argued FDA's approval was appropriate and the final decision for treatment should be left to patients and their doctors. Those against or uncertain of CMS approving aducanumab stated concerns about its clinical benefits, risks, burdens, and costs; many of these stakeholders instead argued CMS institute Coverage with Evidence Development. Lastly, regardless of perspective, stakeholders encouraged CMS to cover diagnostic tools to support Alzheimer's disease research and treatments. Our analysis identifies key themes and policy implications of CMS' decision, including acknowledgment of comments and subsequent changes to CMS' determination, highlighting the value of public comments as a resource to understand stakeholder perspectives on policy decisions.