The Centers for Medicare & Medicaid Services (CMS) will not rethink its current restrictive coverage decision for emerging Alzheimer's disease drugs, much to the dismay of patient advocacy groups.
CMS finalized a narrow national coverage decision for monoclonal antibody drugs that target beta-amyloid plaques to treat Alzheimer's. The first drug in this class, Biogen's Aduhelm, secured accelerated approval from the Food and Drug Administration (FDA) amid pushback from clinical experts about the drug's efficacy.
A second drug in this class, lecanemab, was also approved by the FDA earlier this year. It, too, was developed by Biogen and Eisai.
CMS said in a statement that it "regrets" that the coverage decision could not be broader, but data on these drugs do not do enough to answer the agency's key questions.
"After careful review of the request and supporting documentation, we are making this decision because, as of the date of this letter, there is not yet evidence meeting the criteria for reconsideration," CMS said.
The agency added that it is aware additional data on this class are in the works, and, should additional detail point them in that direction, CMS' team will reevaluate the coverage decision at that point. In addition, should any of the monoclonal antibody drugs secure traditional FDA approval, CMS will roll out broader coverage.
"We recognize that these medications are a unique, new class of drugs, and we regret that the decision could not be more favorable," CMS said.
The response comes as advocacy groups like the Alzheimer's Association as well as legislators are pushing for greater access to these therapies for patients with dementia.
In a response Wednesday, the patient advocacy group called CMS' coverage decision "unjust."
“CMS’ role is to provide health care coverage. Their role is not to stand between a patient and a doctor when deciding what FDA-approved treatments are appropriate. Their role is not to single out people living with Alzheimer’s and decide that their lives, their independence and their memories are not necessary,” said Joanne Pike, Alzheimer’s Association president and CEO.