Statement from the Alzheimer’s Drug Discovery Foundation on Medicare Coverage Decision for Aduhelm

The Centers for Medicare and Medicaid Services (CMS), the government agency tasked with determining Medicare drug coverage, announced plans yesterday for Medicare to pay for the recently approved drug Aduhelm (aducanumab) only for patients who enroll in qualifying clinical trials.

“Medicare made a difficult, but ultimately reasonable decision by proposing coverage for Aduhelm under Coverage with Evidence Development (CED), which is consistent with the FDA’s decision to grant Accelerated Approval to Aduhelm,” says Dr. Howard Fillit, Co-Founder and Chief Science Officer of the Alzheimer’s Drug Discovery Foundation (ADDF). “This decision supports conducting additional clinical trials, which are needed to obtain further insights into the clinical efficacy and safety of this drug in real world populations.”

Currently in addition to Biogen, Eli Lilly, Eisai and Roche all have monoclonal amyloid antibody drugs in late-stage development that are expected to be reviewed by the FDA later this year. According to Dr. Fillit, if these trials demonstrate more robust clinical efficacy and better safety profiles, then it is likely the FDA will award them full approval, providing a path for Medicare to grant unrestricted coverage. New drugs only have value if they are available to the patients who may benefit from them, which is why the ADDF favors efforts to increase access to approved treatments.

While drugs like Aduhelm that reduce amyloid plaques in the brain are one piece of the puzzle, the ADDF has long believed the real answer lies in the biology of aging. This approach focuses on having multiple treatments available to address the many underlying biological causes of this disease. The ADDF supports nearly 20% of the current Alzheimer’s clinical trials in the United States. We seek out innovative, rigorously designed trials that are developing drugs targeting not just one—but seven biological processes that can go wrong with aging and lead to Alzheimer’s. In fact, three in four drugs in today’s diverse research pipeline take a non-amyloid approach to Alzheimer’s treatment.

“Today’s Medicare decision is a partial win for the Alzheimer’s field because it will generate additional data from clinical trials that will allow us to properly evaluate the real word benefit and safety of Aduhelm,” says Dr. Fillit. “Aduhelm is the first of many new therapeutics for Alzheimer’s in the pipeline that will ultimately give us the options we need to develop combination therapy approaches that can be used to individualize treatment based on each patient’s biological profile.”