CMS declines to reconsider coverage for FDA-approved drugs for Alzheimer's disease

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The Centers for Medicare and Medicaid Services is not reconsidering the national coverage determination for Food and Drug Administration (FDA)-approved medications for Alzheimer's disease.

The FDA-approved monoclonal antibodies are directed against amyloid, or the protein buildup, for the treatment of Alzheimer's disease. 

"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. "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's letter to the Alzheimer's Association outlines the key questions that need to be addressed for reconsideration."

WHY THIS MATTERS
 
At question is the effectiveness of certain Alzheimer's drugs and differing factors between CMS and the Food and Drug Administration for approval. CMS said that to provide coverage nationally, it is required to examine whether a medication is reasonable and necessary. This standard differs from the criteria used by the FDA to assess whether medications are safe and effective. 

However, UsAgainstAlzheimer's has said CMS has refused to reconsider Medicare coverage for leqembi and other drugs in its class without seeing any data, according to Chair and co-founder George Vradenburg. In its statement CMS said it would "expeditiously review" new data as it becomes available, but the agency has had that data for four months, he said. 

"This decision by CMS is unconscionable and unjustifiable." Vradenburg said. "Make no mistake, people will continue to suffer at the hands of CMS."

Additional publications may be forthcoming that include information relevant to the questions included in the current National Coverage Determination (NCD), CMS said. 

If a monoclonal antibody directed against amyloid for the treatment of Alzheimer's disease subsequently receives traditional FDA approval, CMS would provide broader coverage using the framework it announced last year, under the Coverage with Evidence Development, on the same day, the agency said. 

"CMS will expeditiously review any new evidence that becomes available that could lead to a reconsideration and change in the NCD, such as evidence that answers the Coverage with Evidence Development questions or approval by the FDA based upon evidence of clinical benefit," the agency said.

Vradenburg said, "CMS' arguments are simply empty and erroneous rhetoric. The agency says it is committed to getting people 'timely access' to Alzheimer's treatments, but it just reiterated a decision to deny Medicare coverage of a promising new drug that demonstrably slows the progression of Alzheimer's."

Coverage with Evidence Development questions have been answered by clinical trial, as shown in February 4 letter to CMS from the American Academy of Neurology, Vradenburg said. 
 
THE LARGER TREND

A December 2022 staff report by two House committees pointed to alleged irregularities in the Food and Drug Administration's approval of the Alzheimer's drug Aduhelm.

In January, CMS released a proposed National Coverage Determination decision memorandum that said the NCD would cover FDA-approved monoclonal antibodies that target amyloid for the treatment of Alzheimer's disease through coverage with evidence development, meaning for Medicare recipients enrolled in qualifying clinical trials.

AHIP said it agreed with the decision to have Medicare cover the drug only for beneficiaries in clinical trials, saying more evidence was needed on Aduhelm and similar drugs.

An estimated 2,000 people a day advance from the early stage of Alzheimer's disease to the moderate stage. The drugs in question would treat the early stage of the disease, UsAgainstAlzheimer's said.

Twitter: @SusanJMorse
Email the writer: SMorse@himss.org