CMS to pay for Alzheimer's drugs granted full approval

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, though it will require physicians to collect data on how well the drugs perform in the real world.

The move, announced in a release by CMS Administrator Chiquita Brooks-LaSure, is a victory for advocacy groups, such as the Alzheimer's Association, that have been seeking broader access to a newer class of drugs 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 and would be eligible for Medicare coverage.

The disease is taking a toll on not only the people suffering from the disease but also their loved ones and caregivers in a way that almost no other illness does, Brooks-LaSure said.

Medicare would pay for these drugs — which have been granted a fast-tracked version of approval known as accelerated approval — only if a patient was enrolled in a clinical trial. Two drugs have been granted accelerated approval by Biogen, Eisai's Aduhelm and Biogen's Leqembi.

Achieving Accelerated approval is for drugs that fill an unmet medical need, according to the FDA. In order to gain full approval, the drugmakers must conduct additional clinical trials.

The move came ahead of a FDA advisory committee meeting on June 9 on which a panel of experts is expected to vote on whether to recommend that the FDA grant full approval to Leqembi.

In clinical trials, the drug appeared to slow the disease's progress in individuals at an early stage or with mild cognitive impairment.

The drug cost $26,500 per year, making it out of reach for most people. But if theAdvisory Committee meeting went well and the FDA granted traditional approval, those people on Medicare who want the drug should be able to get it under the new Medicare rules.