CMS will soon decide whether Medicare program will cover Aduhelm, Biogen's $56,000-a-year Alzheimer's drug that the Food and Drug Administration recently approved under controversy.
The agency kicked off its review process on Monday, noting that the outcome of its analysis will apply to aducanumab, marketed as Aduhelm, and other monoclonal antibodies targeting amyloid for the treatment of Alzheimer's disease.
The public will have 30 days to submit comments before CMS posts its proposed national coverage determination, which will also be open for comment. The agency plans to host two public listening sessions this month.
"Alzheimer's is a devastating illness that has touched the lives of millions of American families, and as CMS opens our National Coverage Determination analysis, we invite interested stakeholders to participate," said CMS Administrator Chiquita Brooks-LaSure in a statement. "We want to consider Medicare coverage of new treatments very carefully in light of the evidence available. That's why our process will include opportunities to hear from many stakeholders, including patient advocacy groups, medical experts, states, issuers, industry professionals, and family members and caregivers of those living with this disease."
Medicare Administrative Contractors currently decide whether to cover Aduhelm, but that could change if CMS chooses to cover it nationwide. According to the Kaiser Family Foundation, Medicare beneficiaries would pay about $11,500 out-of-pocket for the drug each year.
It would cost the Medicare program almost $29 billion annually, much more than all other medications. It could make up 1% of all national healthcare spending by the middle of the decade, according to the not-for-profit research group Altarum.
The FDA granted Biogen accelerated approval for Aduhelm last month, even though experts are debating whether it's an effective treatment for Azheimer's disease. The agency could pull the drug from the market if follow up studies show that it's ineffective, but that's unlikely.