The Centers for Medicare & Medicaid Services will limit its coverage of the Alzheimer’s drug aducanumab (Aduhelm) to clinical trials only, the agency announced late Thursday.
Aduhelm is a monoclonal antibody that was approved by the Food and Drug Administration in 2021. It is recommended for patients in the early stages of dementia and has drawn controversy over its efficacy, safety risks, accessibility and the high costs associated with its coverage.
CMS said that its new official coverage decision was based on peer-reviewed studies and invited input from 10,000 stakeholders. The “vast majority” of these respondents encouraged restricting use of the drug to controlled settings while more evidence is gathered about its safety and efficacy, CMS Administrator Chiquita Brooks-LaSure told The New York Times.
The Medicare coverage decision also applies to other drugs in Aduhelm’s class: monoclonal antibodies that target Alzheimer’s brain plaques. Some are currently in line for FDA approval, officials said.
The FDA originally greenlit Aduhelm under a relatively new, accelerated approval program that required drugmaker Biogen to conduct further clinical trials to verify that the drug indeed reduces brain amyloid plaques
A January announcement that CMS might only cover the drug for participants in clinical trials was met with outrage by the patient community. But many clinicians, including long-term care physician advocates, have lobbied against widespread access to the drug, citing controversial clinical trial results. AMDA–The Society for Post-Acute and Long-Term Care Medicine, for one, has cautioned against using the Aduhelm in the long-term care population without further evidence of its benefits and safety.
Although Aduhelm has been initiated in some patients, neurologists have not flocked to the drug, McKnight’s Clinical Daily has reported.
A national coverage determination is a relatively rare process for CMS, and in this case, was driven by multiple requests for consideration by stakeholders, officials said. But its decision to limit coverage was quickly met with rebuke.
The Alzheimer’s Association reacted to CMS’s announcement with disappointment.
“At no time in history has CMS imposed such drastic barriers to access FDA-approved treatments for people facing a fatal disease,” it said in a preliminary response posted Thursday.
CMS said it is still reviewing how its Aduhelm coverage will figure into overall Medicare costs. In January, it was asked by the Department of Health and Human Services to reconsider a recommendation that would raise the monthly Medicare Part B premium by about $22 to $170.10. Most of the increase would help to cover costs associated with Aduhelm.