CMS Continues Block on Alzheimer’s Drug Coverage

The Centers for Medicare & Medicaid Services (CMS) says it is not reconsidering its national coverage determination (NCD) that restricts Medicare coverage on Alzheimer’s monoclonal antibodies approved under FDA’s accelerated approval pathway. CMS reiterated its position in response to an Alzheimer’s Association request for reconsideration. Currently, FDA has granted accelerated approval on Biogen/Eisai BLAs for Leqembi (lecanemab-irmb) and Aduhelm (aducanumab-avwa).

The CMS letter to the Alzheimer’s Association outlines the key questions that need to be addressed for reconsideration, such as documentation that meets one of the following criteria:

• Additional scientific evidence that was not considered during the most recent review along with a sound premise by the requester that new evidence may change the NCD
• Plausible arguments that CMS's conclusion materially misinterpreted the existing evidence at the time the NCD was decided.

Additionally, CMS said that if FDA “determines a clinical benefit for a drug within this class through its traditional approval program, CMS will provide enhanced access and coverage for people with Medicare participating in CMS-approved studies, such as a registry-based study where the drug is tested in real-world settings.” FDA is currently reviewing a traditional approval submission on Leqembi and a review decision is expected later this year.

CMS also said in an online statement that registry-based studies could answer clinical benefit questions and “potentially provide greater access nationwide at more treatment sites, more rapidly, than any other coverage pathway,” adding that the registry data could help fill evidence gaps for patients who were underrepresented in the initial clinical trials.

In reaction to the CMS denial letter, the Alzheimer’s Association said it was appalled that the Biden Administration is extending its unjust decision to deny access to FDA-approved treatments for people living with Alzheimer’s — a fatal disease. This "despite significant new evidence published since the release of its decision. CMS covers all FDA-approved drugs except for monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease. Despite unequivocal evidence confirmed by the scientific community, CMS continues to state it is not reasonable and necessary for people living with Alzheimer’s to have access to an FDA-approved treatment without barriers.”