FDA approves pricy new treatment for Alzheimer’s: What you need to know

(WGN Radio) – A new drug that shows promising results of slowing memory decline recently received the Food and Drug Administration’s stamp of approval – but will anyone be able to afford it?

The FDA endorsed the IV drug, Leqembi, for patients with mild dementia and other symptoms caused by early Alzheimer’s disease. It works by clearing a sticky brain plaque linked to the disease, and it’s the first medicine that’s been convincingly shown to modestly slow the cognitive decline caused by Alzheimer’s.

But Leqembi doesn’t come cheap. It is priced at about $26,500 for a year’s supply of IVs every two weeks.

“If we had to pay out of pocket, you’d certainly have to have substantial funds to do this,” said Dr. Kevin Most, chief medical officer at Northwestern Central DuPage Hospital, in an interview with WGN Radio.

But the recent FDA approval paves the way for Medicare and other insurers to cover the drug.

Medicare administrator, Chiquita Brooks-LaSure, said the program will begin paying for the drug now that it has full FDA approval. But the government is also setting extra requirements, including enrollment in a federal registry to track the drug’s real-world safety and effectiveness.

“I look at it and say it’s our opportunity to prove that the drug is really working well. It will advance the other five, six, seven drugs that are in the pipeline right now that are doing similar things to remove that beta amyloid from the brain,” said Dr. Most.

Even ignoring cost or insurance coverage, not every person with Alzheimer’s will be able to get their hands on the drug. Doctors will need to confirm that patients have the brain plaque targeted by Leqembi before prescribing it.

“When you look at the 6.5 million people with Alzheimer’s, it’s going to come down to a classification of probably between 1 to 2 million individuals will be available – or will be allowed – to do it,” said Dr. Most. “Because we’re looking at those with the early stages of Alzheimer’s, the minor symptoms, to see if we can stop it in its tracks.”

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Leqembi’s drugmaker Eisai has told investors that about 100,000 Americans could be diagnosed and eligible to receive Leqembi by 2026. 

Eisai studied the drug in people with early or mild disease who were evaluated using a scale measuring memory, thinking and other basic skills. After 18 months, those who got Leqembi declined more slowly — a difference of less than half a point on the scale — than participants who received a dummy infusion. Some Alzheimer’s experts say that delay is likely too subtle for patients or their families to notice.

Hear more from Dr. Most in the audio player below:

The Associated Press contributed to this report.