The CMS has declined to reconsider its pivotal decision to deny coverage of future Alzheimer's anti-amyloid drugs — for now.
UPDATE: 3 March 2024, 8:21 P.M. ET. In February 2024, Biogen took Aduhelm off the market, citing financial concerns. Although the drug did receive accelerated, conditional FDA approval for the treatment of early Alzheimer’s disease in 2021, it is no longer available to new patients. The company announced it would sunset trials in May 2024 and cease supplying the drug to current patients in November 2024.
Last April, the Centers for Medicare and Medicaid Services (CMS) decided to limit the coverage of the controversial Alzheimer’s drug Aduhelm and similar drugs in the future because of the uncertain relationship between beta-amyloid clearance and cognition. Even if these drugs received approval from the Food and Drug Administration (FDA), their sky-high costs would only be covered in clinical trials until more evidence is collected.
At the end of 2020, following the presentation of positive clinical trial data for Leqembi — which showed that amyloid plaque clearance was linked to improved cognition — the Alzheimer’s Association sent a request to reconsider the policy. Although the drug received accelerated approval from the FDA in January 2023, the CMS was mum on whether Leqembi would receive coverage. Now, the CMS has responded to the request from the Alzheimer’s Association saying that they will not reconsider the policy at this time.
“As defined in statute, to provide coverage nationally, CMS is required to examine whether a medication is reasonable and necessary,” they wrote in their press release. “This standard differs from the criteria used by the FDA to assess whether medications are safe and effective.”
This isn’t a hard no — Medicare will continue monitoring the evidence — meaning it is possible that more data will overturn this requirement. According to Federal statutes, the standard of what is “reasonable and necessary” involves three elements: “an item or service must be (1) safe and effective, (2) not experimental or investigational, and (3) appropriate for the Medicare patients.”
The Alzheimer’s Association believes the CMS decision creates barriers between patients and new disease-modifying drugs. “Their [The CMS’] role is not to stand between a patient and a doctor when deciding what FDA-approved treatments are appropriate,” said Joanne Pike, DrPH, Alzheimer’s Association president and CEO. “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.”
Members of other advocacy organizations were also displeased with the response. “As a person living with Alzheimer’s, I am astounded and infuriated [that] CMS would keep Medicare beneficiaries from receiving treatment,” said Terrie Montgomery, a founding Board member of Voices of Alzheimer’s who also has Alzheimer’s. “The advances we have seen in new treatments have given us hope – I feel like CMS is taking away part of my life.”
