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Medicare has proposed covering the controversial and costly Alzheimer's drug Aduhelm only for those enrolled in qualifying clinical trials, the Centers for Medicare and Medicaid Services announced Tuesday.
The draft decision, the latest step in the drug's contentious path to market, would have far-reaching consequences both for millions of Alzheimer's patients and for tens of millions of Medicare enrollees. A final decision should be released by April 11.
"CMS has proposed an evidence-based coverage policy after experts reviewed all relevant publicly available evidence and feedback received from stakeholders," said Chiquita Brooks-LaSure, the agency's administrator.
The move is expected to restrict the number of people who could receive the medication. CMS did not have an estimate of how many patients might have access to Aduhelm through the trials.
The agency will accept public comments for 30 days and hopes to hear from Americans with Alzheimer's, their family members, patient advocacy groups, medical experts and others. Also, CMS emphasized that the clinical trials must reflect the diversity of the Medicare population with Alzheimer's.
It is weighing the benefits versus the risks associated with Aduhelm and similar Alzheimer's medications, including headaches, dizziness, falls and brain bleeds, said Dr. Lee Fleisher, CMS' chief medical officer.
It's unprecedented to require Medicare enrollees to participate in a clinical trial for a drug already approved by the US Food and Drug Administration that's being used for its intended purpose, said Tricia Neuman, executive director of the Kaiser Family Foundation's Program on Medicare Policy.
"CMS is moving forward cautiously in covering (Aduhelm) and similar drugs for Alzheimer's disease," she said, "to be sure that the drug actually works and doesn't cause harm."
