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Medicare has decided to sharply limit coverage of Aduhelm, a new Alzheimer drug

LEILA FADEL, HOST:

The nation's Medicare program for older Americans has decided to sharply limit coverage of a new Alzheimer's drug. The decision announced yesterday comes after months of debate about the costly and controversial drug. Joining us now to explain is NPR science correspondent Jon Hamilton. Hi, Jon.

JON HAMILTON, BYLINE: Hi.

FADEL: So, Jon, remind us about what this drug is that we're talking about.

HAMILTON: OK. The drug is called aducanumab, though it's probably better known by its brand name Aduhelm. And what this drug does really well is remove those sticky plaques that build up in the brains of Alzheimer's patients. What it may not do so well is actually preserve a person's memory and thinking. There's been a lot of debate about that. So a lot of people were surprised when the Food and Drug Administration approved the drug last year even though the FDA's own advisory committee said that was a bad idea. Then in January of this year, the Centers for Medicare and Medicaid Services - that's the agency that oversees these government health programs - it made a preliminary ruling that Medicare would cover the drug but only for patients enrolled in a clinical trial.

FADEL: So what happened yesterday?

HAMILTON: Yesterday, CMS, the Centers for Medicare and Medicaid Services, basically affirmed its earlier decision. And I should say, this came after reviewing a lot of input from doctors and patients and Biogen, the company that makes Aduhelm. The government got something like 10,000 comments about the drug, which is unusual. And the drug's price, which is originally $56,000 a year, was cut in half. Even so, at the announcement yesterday, health officials repeated what they had said in January - they just aren't prepared to authorize full coverage for a drug that hasn't been proved effective and has dangerous side effects, like bleeding and swelling in the brain. CMS did make a couple of small concessions, though. One was to change a part of the earlier decision that said coverage would be limited to people in studies that the agency itself approved. In this version, they said they would accept any study done as part of an FDA review or done by the National Institutes of Health.

FADEL: So what does this mean for patients?

HAMILTON: It won't mean anything for patients in the later stages of Alzheimer's. That's because the drug is only approved for people in the earliest stages of the disease. And for them, the effect depends on who you ask. The Alzheimer's Association put out a statement saying the decision is creating, quote, "unnecessary barriers" for people with Alzheimer's. They say Medicare is willing to cover last-ditch cancer drugs so it should cover this drug, too. On the other hand, a lot of neurologists - you know, those are the doctors who often treat Alzheimer's - agree with the decision, and so do a lot of scientists, who say the FDA should have waited until it had clear evidence that Aduhelm makes a difference in people's lives. And yesterday's decision may not even be the biggest obstacle for patients who want Aduhelm. Some prominent medical institutions, like the Cleveland Clinic, are simply refusing to prescribe it. And sales of the drug have been really poor so far.

FADEL: So what happens now? Is this a done deal?

HAMILTON: It's not quite a done deal. Obviously, the decision will have a huge impact in the short term, and that's because Alzheimer's primarily affects people who are older than 65 - in other words, Medicare patients. But Aduhelm's eventual fate may come down to a new clinical trial, which is just beginning to enroll patients now. It's being done by the drug's maker, Biogen. There were two previous trials, I should say. One showed the drug worked; one showed it didn't. This is supposed to be the tiebreaker. And Medicare could change its mind if the results are positive. But these drug trials take years to complete. So by the time this is done, you know, it's possible that other similar drugs will already be on the market. And by the way, Medicare says its decision about this drug will apply to other similar drugs as well.

FADEL: NPR's Jon Hamilton. Thank you.

HAMILTON: You're welcome. Transcript provided by NPR, Copyright NPR.