The Centers for Medicare & Medicaid Services said Thursday that it will pay for new Alzheimer’s drugs that are granted full approval from the Food and Drug Administration, although it will require physicians to collect data about how well the drugs perform in the real world.
It’s expected to help more Alzheimer’s patients afford the new drugs.
The change, which CMS Administrator Chiquita Brooks-LaSure announced in a news release, is a win for advocacy groups, including the Alzheimer’s Association, that have been seeking broader access to a newer class of medications that have shown signs in clinical trials of slowing the progression of the disease. About 6.7 million people over age 65 have Alzheimer’s in the U.S. and could qualify for coverage under Medicare.
“Alzheimer’s disease takes a toll on not just the people suffering from the disease but also on their loved ones and caregivers in a way that almost no other illness does,” Brooks-LaSure said in a statement.
Until now, Medicare would pay for those medications — which have been granted a fast-tracked version of approval called accelerated approval — only if patients were enrolled in a clinical trial. Two drugs have been granted accelerated approval: Biogen’s Aduhelm and Eisai’s Leqembi.
Accelerated approval is for medications that “fill an unmet medical need,” according to the FDA. To gain full approval, the drugmakers need to conduct additional clinical trials.
Doctors who prescribe the drugs will have to use a government registry to track how well patients are doing. In a statement Thursday, the Alzheimer’s Association said requiring physicians to submit data in a registry is an “unnecessary barrier.”
“We look forward to learning more details from CMS and we are hopeful for the future of health care access for our constituents,” the group said in a statement.
A panel of experts is expected to vote on whether to recommend that the FDA grant full approval to Leqembi at an FDA advisory committee meeting on June 9.
Clinical trials showed the drug appeared to slow the progression of the disease in people with mild cognitive impairment or at an early stage.
The medication costs $26,500 a year, putting it out of reach for most people. But if the advisory committee meeting goes well and the FDA grants traditional approval, people on Medicare who want the drug should be able to get it under the new Medicare rules.
