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.

摘要

在美国食品和药物管理局 (FDA) 有争议地批准 aducanumab 用于治疗阿尔茨海默病后，医疗保险和医疗补助服务中心 (CMS) 使用其国家覆盖范围确定流程来确定其对医疗保险受益人的覆盖范围。公众评议期为 2021 年 7 月 12 日至 2021 年 8 月 11 日，为期 30 天。本研究分析了第一个公众评议期提交的 132 条意见。这些评论是从 CMS 的公开网站下载的，并进行分析以确定利益相关者的关键主题。确定了三个主要主题。那些支持 CMS 批准 aducanumab 的人认为 FDA 的批准是适当的，治疗的最终决定应该留给患者及其医生。那些反对或不确定 CMS 批准 aducanumab 的人表示对其临床获益、风险、负担和成本的担忧；许多利益相关者反而主张 CMS 应该通过证据开发来覆盖范围。最后，无论观点如何，利益相关者都鼓励 CMS 涵盖诊断工具以支持阿尔茨海默病的研究和治疗。我们的分析确定了 CMS 决策的关键主题和政策影响，包括意见确认和 CMS 决策的后续变更，强调了公众意见作为了解利益相关者对政策决策观点的资源的价值。