CMS refuses to review coverage of FDA-approved Alzheimer’s drugs

The Centers for Medicare and Medicaid Services is not revising the national definition of coverage for FDA-approved Alzheimer’s drugs.

FDA-approved monoclonal antibodies are directed against amyloid or protein accumulation for the treatment of Alzheimer’s disease.

“We recognize that these drugs represent a unique new class of drugs and we regret that the decision could not have been more favorable,” CMS said. “After careful consideration of the request and the accompanying documentation, we are making this decision as, at the time of this letter, there was no evidence yet that met the criteria for reconsideration. The CMS letter to the Alzheimer’s Association outlines key issues and is subject to review.”

WHY IS IT IMPORTANT

The effectiveness of some Alzheimer’s drugs is questionable and factor differences between CMS and the Food and Drug Administration for approval. CMS said that in order to ensure coverage at the national level, it is necessary to check whether the drug is reasonable and necessary. This standard is different from the criteria used by the FDA to evaluate the safety and efficacy of drugs.

However, UsAgainstAlzheimer’s said CMS refused to review Medicare coverage for leqembi and other drugs in its class without seeing any data, according to chairman and co-founder George Vradenburg. In a statement, CMS said it would “promptly review” new data as it became available, but the agency had the data for four months, he said.

“This CMS decision is shameless and unjustified.” Vradenburg said. “Make no mistake, people will continue to suffer at the hands of CMS.”

Additional publications may become available containing information related to matters included in the current National Coverage Definition (NCD), according to CMS.

The agency said that if a monoclonal antibody directed against amyloid for the treatment of Alzheimer’s disease subsequently receives conventional FDA approval, CMS will provide broader coverage using the framework it announced last year through its Coverage with Evidence Development program.

“CMS will promptly review any new data that becomes available that may lead to a review and change of the NIH, such as evidence that answers questions about evidence coverage or is approved by the FDA based on evidence of clinical benefit,” the agency said in a statement. .

Vradenburg said: “The CMS arguments are just empty and misguided rhetoric. The agency says it is committed to providing people with “timely access” to Alzheimer’s treatment, but it has only reaffirmed the decision to withhold Medicare coverage for a promising new drug that clearly slows the progression of Alzheimer’s.”

Evidence-building questions have been answered by clinical trials, Vradenburg said, as shown in a Feb. 4 letter to CMS from the American Academy of Neurology.

BIG TREND

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

In January, CMS released a proposed National Coverage Decision Memorandum stating that NCD would cover FDA-approved monoclonal antibodies that target amyloid for the treatment of Alzheimer’s disease through Evidence-Based Development Coverage, i.e. Medicare recipients enrolled in eligible clinical trials. tests.

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

An estimated 2,000 people a day go from early to moderate Alzheimer’s. According to UsAgainstAlzheimer, the drugs in question will treat the early stage of the disease.

Twitter: @SusanJMorse
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