Today, the U.S. Centers for Medicare & Medicaid Services (CMS) released its proposed National Coverage Determination decision memorandum on Medicare coverage of aducanumab/brand name Aduhelm™. The proposed decision would cover FDA-approved monoclonal antibodies that target amyloid for the treatment of Alzheimer’s disease through coverage with evidence development. This means that FDA-approved drugs in this class would be covered for people with Medicare only if they are enrolled in qualifying clinical trials. This proposed decision will enable researchers to collect crucial data to evaluate the clinical benefits of these drugs.
Aduhelm™ is the first and currently the only monoclonal antibody directed against beta-amyloid to receive accelerated approval by the FDA for the treatment of Alzheimer’s. Monoclonal antibodies are made by cloning a unique white blood cell, and beta-amyloid refers to a specific protein fragment that, in Alzheimer’s, is deposited in the brain.
This progress in understanding Alzheimer’s as well as related dementias reflect years of scientific discovery and momentum in this research more broadly. NIA thanks the many individuals who have participated in clinical trials that have helped bring us to this point. We continue to underscore the enormous importance of participating in clinical trials, today and in the future.
While NIH provided no direct support for the drug development of aducanumab, NIA supported basic science investigations behind the discovery of immunotherapies like aducanumab, as well as translational research for next-generation immunotherapies. Additionally, the selection of participants for the aducanumab clinical trials hinged on amyloid PET imaging, a technology that would not exist today without the publicly funded research supported by the NIA.
NIA will continue to advance its robust and diverse research portfolio in therapy development, building further on the significant achievements thus far to effectively prevent, detect, and treat Alzheimer’s and related dementias.
Richard J. Hodes, M.D., Director, National Institute on Aging, National Institutes of Health