Medicare Alzheimer's Drug Study Criteria Would Be Out Of Reach In Many States – Analysis

The Centers for Medicare and Medicaid Services’ proposed eligibility criteria for the research sites capable of conducting clinical trials for monoclonal antibody drugs for Alzheimer’s disease could be met in just 28 states, leaving a large swath of the country without access to the drugs, according to an analysis by the advocacy group UsAgainstAlzheimer's and clinical trial facilitator the Global Alzheimer’s Platform Foundation.

In a draft national coverage determination released in January, CMS proposed to allow Medicare coverage for Biogen, Inc.’s Aduhelm (aducanumab) and similar drugs, such as those being developed by Eli Lilly and Company, Eisai Co., Ltd. and Roche Holding AG, only when patients are enrolled in a agency-approved randomized clinical trial. The NCD also includes specifications around the studies, including that they should be conducted in a hospital outpatient clinic