The Center for Medicare and Medicaid Services (CMS) has decided to limit Medicare coverage of Aduhelm to those receiving it as participants in a clinical trial. The final decision was announced on April 7, as the drug approaches the one-year anniversary of its historic and controversial FDA approval in June 2021.
Aduhelm made headlines as a potential first-of-its-kind treatment for Alzheimer’s patients. While evidence has suggested that the drug can reduce amyloid-beta plaques in the brain, little has been shown about its ability to stop or slow a person’s cognitive decline.
The ruling is not specific to Aduhelm. The FDA’s Center for Medicare and Medicaid Services (CMS), has a national policy on future monoclonal antibodies meant to treat Alzheimer’s. The CMS states that accelerated-approved drugs can only be tested on participants who have already been diagnosed with Alzheimer’s, limiting the trial population.
“There is the potential for promise with this treatment; however, there is not currently enough evidence of demonstrating improved health outcomes to say that it is reasonable and necessary for people with Medicare, which is a key consideration for CMS when making national coverage determinations,” Lee Fleisher, M.D., CMS chief medical officer and director of the Center for Clinical Standards and Quality, said in a statement. He added that the agency “weighed the potential for patient benefit against the significance of serious unknown factors that could lead to harm.” Side effects of the drug include headache, confusion, dizziness, falls and vision changes, as well as swelling and bleeding in the brain.
Before making its final decision the CMS said it reviewed 250 peer-reviewed documents and more than 10,000 comments after proposing its initial coverage plan in January.
“This final National Coverage Determination reflects CMS’ commitment to providing the American public with a transparent, trusted, evidence-based decision — without regard to cost — that is made only after a thorough analysis of public feedback,” CMS Administrator Chiquita Brooks-LaSure said in a statement. “Through this decision, we are creating a pathway for people with Medicare to quickly access drugs the FDA determines have shown a clinical benefit and encourages manufacturers and trial administrators to ensure that the clinical trials recruit racially diverse participants.”