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 on how well the drugs perform in the real world.
The change, announced by CMS Administrator Chiquita Brooks-LaSure in a 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 the age of 65 have Alzheimer’s in the U.S. and would potentially 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.
Up until now, Medicare would pay for these medications — which have been granted a fast-tracked version of approval called accelerated approval — only if a patient was 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. In order to gain full approval, the drugmakers need to conduct additional clinical trials.
The move Thursday came ahead of an FDA advisory committee meeting on June 9 at which a panel of experts is expected to vote on whether to recommend that the FDA grant full approval to Leqembi.
Clinical trials showed the drug appeared to slow the progression of the disease in people at an early stage or with mild cognitive impairment.
The medication costs $26,500 a year, making 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.Follow NBC HEALTH on Twitter & Facebook.
Source: | This article originally belongs to Nbcnews.com
