New Alzheimer’s drugs to be covered by Medicare, if FDA approved

The Centers for Medicare & Medicaid Services said Thursday it will pay for new Alzheimer’s drugs that gain full approval from the Food and Drug Administration, though it will require doctors to collect data on how well the drugs work in the real world. .

It is hoped that it will help more Alzheimer’s patients pay for the new drugs.

The change, announced by CMS administrator Chiquita Brooks-LaSure in a release, is a victory for advocacy groups, including the Alzheimer’s Association, which have been seeking broader access to a new class of drugs that have shown signs in clinical trials of slowing the progression of the disease. About 6.7 million people over 65 years of age have Alzheimer’s in the US and would potentially qualify for Medicare coverage.

“Alzheimer’s disease affects not only people with the disease, but also their loved ones and caregivers in a way that almost no other disease does,” Brooks-LaSure said in a statement.

Until now, Medicare would pay for these drugs, which have been given an accelerated version of approval called expedited 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.

Expedited approval is for drugs that “meet an unmet medical need,” according to the FDA. To gain full approval, drug manufacturers must 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 doctors to submit data in a registry is an “unnecessary barrier.”

“We look forward to learning more from CMS and are hopeful for the future of healthcare access for our constituents,” the group said in a statement.

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

Clinical trials showed that the drug appeared to slow the progression of the disease in people at an early stage or with mild cognitive impairment.

The drug 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 with Medicare who want the drug should be able to get it under Medicare’s new rules.Continue NBC HEALTH in Twitter & Facebook.