New legislation endorsed by several Alzheimer’s disease patient groups aims to revamp how federal regulators determine Medicare coverage of new treatments.
The Access to Innovative Treatments Act, introduced Tuesday, would require the Centers for Medicare & Medicaid Services (CMS) to evaluate new drugs for coverage individually as opposed to an entire class amid other reforms. The bill comes after promising findings in recent months for a new Alzheimer’s drug.
“CMS’ current policy of applying its coverage decision to an entire class of drugs is detrimental to the families and individuals suffering from this heartbreaking disease,” said Rep. Nannette Diaz Barragan, D-California, one of the chief co-sponsors, in a statement.
The legislation is the latest attempt by Congress to address CMS’ decision back in April to only narrowly cover a class of Alzheimer’s drugs that rely on monoclonal antibodies to fight amyloid plaques in the brain and treat mild cognitive impairment caused by the disease. So far, only one such drug—Biogen’s Aduhelm—has been approved in the class.
CMS was concerned about the efficacy of the drug, which the FDA’s own advisers called into question, and in April only allowed Medicare coverage of the drug class for patients in a qualifying clinical trial. The decision drew major opposition from the pharmaceutical industry and Alzheimer’s patient groups as well as some lawmakers.
“Less than 1% of Medicare beneficiaries can access currently available treatments,” according to a statement from Barragan and Rep. John Joyce, R-Pennsylvania, the other lead co-sponsor.
The lawmakers said currently there is no mandatory review process for any of CMS’ NCDs.
“This means if a new drug in this class is produced, even if the FDA approves it and deems it effective, it will be subject to the same coverage restrictions,” the release said.
If the legislation becomes law, it requires CMS to quickly reopen Medicare coverage decisions once enough clinical data are collected to better prove the drug’s effectiveness. The agency would not be able to implement “limited coverage policies for an entire class of drugs,” the lawmakers added.
The new legislation comes after positive clinical trial results were released Tuesday for Eisai and Biogen’s drug lecanemab, which also aims to slow cognitive decline caused by Alzheimer’s. The results, published in The New England Journal of Medicine, showed the drug had moderately less decline on certain cognition measures compared to a placebo, but longer trials are warranted "to determine the efficacy and safety of lecanemab in early Alzheimer’s disease."