CMS said it had a “strong precedent” for using the registry to gather more information about newly approved treatments
According to CMS, Alzheimer’s drugs that slow the progression of cognitive decline will be covered by Medicare as long as they have traditional FDA approval, and clinical teams will have data to register how the drug works in the real world are said to be collecting. “If the FDA grants conventional approval, CMS stands ready to ensure that all eligible Medicare Part B enrollees are covered,” CMS Administrator Chiquita Brooks Rashua said in a statement.
It creates an unnecessary barrier and should not be a requirement for FDA-approved treatments to be applied
The FDA has granted early approval to Alzheimer’s drugs lecanemab and Aduhelm, marketed as Leqembi. The Accelerated Approval Program aims to accelerate the approval of drugs to “fill unmet medical needs” while pharmaceutical companies continue clinical studies to determine their effectiveness. Neither has conventional approval. Medicare last year limited Aduhelm’s coverage to those who participated in eligible clinical trials, saying at the time that “significant or serious unknown factors could cause harm.” Alzheimer’s disease is fatal and there is no cure.