Over 6 million older Americans are believed to have Alzheimer’s Disease, and this prevalence is expected to rise to 14 million by 2060 barring effective interventions. Effective treatments are needed, and because of the early but promising evidence and the immense burden of this devastating disease on the Medicare population, CMS is finalizing Medicare coverage under CED to support rigorous studies approved by the FDA and NIH to help answer whether this class of drugs improves health outcomes for patients.

The FDA has an important role in making sure that what is on the market is safe and effective for all individuals. Currently, Aduhelm™ (aducanumab) is the only monoclonal antibody directed against amyloid that has been granted approval by the FDA through its accelerated program for the treatment of Alzheimer’s disease based on evidence that it may reduce plaque on the brain. FDA and the NIH have approved clinical trials for Aduhelm, which are ongoing, to continue studying the drug and determine whether there is a reasonable assurance of a clinical benefit. Under this NCD, CMS will support the FDA and NIH by covering the drug and any related services (including PET scans in some cases if required by trial protocol) for people with Medicare who are participating in these randomized controlled trials.


Importantly, if the FDA determines a clinical benefit for drugs within this class through its traditional approval program, CMS, as a part of this decision, will provide enhanced access and coverage for people with Medicare participating in CMS-approved studies, such as a study where an intervention is tested in a real care setting. Any new drugs in this class that receive FDA traditional approval will be available in a variety of care settings.

While drugs in this class that receive FDA traditional approval will have broader coverage in the Medicare program, CMS believes important questions still need to be answered to support people with Medicare, caregivers, and their referring and treating physicians to make informed, appropriate decisions about use of any drug in this particular class. People with Medicare, if they are enrolled in an CMS-approved study, will have access to the drug with a multidisciplinary team of dementia experts that have the expertise to provide optimal medical management. Under CED for drugs in this class that receive FDA traditional approval, CMS-approved studies could include a large registry-based study with a comparator, such as the results of the randomized control trials (RCTs) used for FDA approval. CED is the appropriate Medicare coverage pathway until CMS knows that specific monoclonal antibodies for the treatment of Alzheimer’s Disease demonstrate health outcomes while minimizing harm to individuals.

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