Short Wave - Why Aduhelm, a new Alzheimer's treatment, isn't reaching many patients

Episode Date: November 5, 2021

Aduhelm, known generically as aducanumab, is the first drug to actually affect the underlying disease process associated with Alzheimer's. Yet sales have been limited, and the drug is reaching very few patients — at least so far. It's expensive, risky and likely doing little to improve patients' lives. NPR science correspondent Jon Hamilton explains why doctors and patients aren't excited about the new drug and what it could mean for future Alzheimer's drugs.Additional links:- Jon's reporting on aducanumab: https://n.pr/3bDV0MY- Jon's reporting on future Alzheimer's treatments: https://n.pr/3bDUsqoYou can always reach the show by emailing [e-mail] pcm.adswizz.com for information about our collection and use of personal data for sponsorship and to manage your podcast sponsorship preferences.NPR Privacy Policy

You're listening to Shortwave from NPR. Hey, shortwavers, Maria Godoy here. And today we've got an update on a new drug for Alzheimer's disease. It was supposed to be a huge seller. But so far, doctors and patients are pretty much ignoring it. NPR's Brain Maven, John Hamilton, is here to help us understand why. Welcome, John. Hey, Maria.

Okay, John, remind me, what is this drug called? The generic name is aducanamap, but it's marketed under the brand name adduhelm. And this drug is a big deal because it's the first one on the market that can actually affect the underlying disease process associated with Alzheimer's. It does that by removing amyloid from the brain. Now amyloid is, of course, that sticky plaque that tends to build up in the brains of people with Alzheimer's. So if this is the only drug out there, to me it sounds like sales should be going gangbusters. And yet they're not. at least not so far. The Food and Drug Administration approved this drug in June, but sales

figures show that it's reaching very few patients. We're talking about hundreds. That's out of more than a million people in the U.S. who are potential candidates for this drug. Whoa. Why are so few people taking this drug? What happened? A lot of things. But the short answer is that Adhue Helm has a major image problem. I spoke about that with Dr. Marwan Sabah at the Barrow Neuroh Neurological Institute in Phoenix. He's a big fan of Adhuehom, and he's also working as an advisor to the company that makes it, biogen. The pendulum of public opinion has swayed strongly against this drug, and it's unfortunate. But a lot of other doctors think Aduhlalm deserves all the negative publicity it has received.

In their view, it's too expensive, too risky, and probably won't do much to improve the lives of Alzheimer's patients. On today's show, we're going to explore why doctors and patients aren't that excited about a new Alzheimer's treatment. and what that could mean for future Alzheimer's drugs. You're listening to Shortwave, the Daily Science Podcast from NPR. Okay, John, so Adahelm isn't exactly taking the medical world by storm. Why did people think it would in the first place? Well, before this drug came along, doctors had nothing they could prescribe that would slow down Alzheimer's disease. There were a few drugs, but they only helped with symptoms, and then really not very much.

So investors thought that any drug that offered even a modest benefit would be hugely profitable. After all, there are more than 6 million people in the U.S. with Alzheimer's. So Adelm comes along and it's not really the drug anyone was hoping for. It's really expensive. It's only for people in the very earliest stages of Alzheimer's. It has some alarming side effects. And there's still no strong evidence that it actually slows down the disease. But if there's nothing else, wouldn't patients and their families,

families want to give it a try? That's what investors thought. When Adilhelm got approved, Biogen's value shot way up. Since then, it's come back down. So I've been talking to Alzheimer's experts about why Adjuhelm hasn't taken off. One thing they all mention is that most insurance plans, including Medicare, still aren't covering this drug. Medicare coverage is critical because the vast majority of people who get Alzheimer's are older than 65. The federal government has started a process that will determine whether its health programs should cover, not just AdiHelis. but other Alzheimer's drug that work the same way. In other words, drugs designed to go after those sticky amyloid plaques in the brain.

But this process isn't going to wrap up until sometime in 2022. Well, so what happens in the meantime? In theory, private insurers could cover adieu, but most seem to be waiting to see what the federal government will do. So for now, if you want to get this drug, you probably have to pay for it out of pocket. And that is about $56,000 a year just for the drug. that's probably a huge deal breaker for a lot of people. It is. Of course, that could change if Medicare and private insurers start covering the drug. But cost is just one of the reasons Ad Helm is off to this really slow start.

I talked to some doctors who specialize in treating Alzheimer's patients, and they gave me this whole list of obstacles. For one thing, you have to be in the earliest stages of Alzheimer's disease to even be a candidate for the drug. So if you're already having problems with your memory, you're probably not going to get it. And even if you are a good candidate, this is a drug that has a lot of caveats. So remember Dr. Marwan Sabah, he's a big advocate for the drug. But here's how he describes Ad Helm to patients with early Alzheimer's. Here's a new opportunity to see if we can slow it down. Maybe you keep what you have longer.

Maybe you delay getting worse. But then I say, you know, it's not easy either. We're talking about a monthly infusion. There are costs. There are authorizations. there are MRIs, there are risks and complications that we need to manage. Wait, John, so what I heard is that he said maybe it will help. What does he mean by that?

He means that the study so far have been mixed on whether Aduhelm actually slows down Alzheimer's. We know it does a great job removing those amyloid plaques from your brain, but one study that was submitted to the FDA showed that it slowed down the cognitive problems like memory loss, and a second study showed that it didn't. So that's why a panel that advises the FDA recommended against approving the drug. Then the FDA did this sort of end run. They gave the drug something known as accelerated approval solely on the basis that it's good at removing amyloid from the brain. That sort of approval means the company needs to do another study to show whether Aduhelm actually slows down damage to the brain.

Well, how common is it for the FDA to do this kind of end run? It has happened, you know, with some cancer drugs. But there you're talking about a very small number of patients who are going to die soon if a drug doesn't help them. So clearly, the evidence for Etahelm isn't a slam dunk. How are doctors explaining all this to their patients? Because it's a lot. Let me play you the answer I got from one doctor. This is Dr. Zaldi Tan of Cedars Sinai in Los Angeles.

What we're trying to tell patients is that this is not a cure. The disease will continue. And perhaps the best case scenario is that someone, will get a modest improvement in their cognition, but it's not going to stop the disease from progressing. And that's the upbeat part of Tan's message to his patients. Then he tells them that the potential to see any benefit from this drug is still in question. What's not in question is the fact that it can cause cerebral hemorrhage and swelling

in a significant number of patients. So I think that's something that they would need to consider when deciding whether to take this drug or not. Whoa, so it might not have a lot of benefits. It could cause serious side effects and it's expensive. Yep. I can very much see how all of that would scare off a lot of patients and their families. For sure. And that may be where all the negative publicity about this drug is having an impact. So I talked with Dr. Mia Yang. She's an assistant professor in the geriatrics department at Wake Forest Baptist Health.

She's unhappy with the FDA's decision to approve an Alzheimer's. drug just because it removes amyloid from the brain. You know, to her, that's like approving a drug that reduces cholesterol without any proof that it cuts the risk of a heart attack. Anyway, Dr. Yang told me that all the publicity about Adjouhom means that Alzheimer's patients and their families are pretty educated about it even before she talks to them. They usually hear about it through the media, through a report, and then they ask my thoughts about it.

And once I explained to them kind of the potential benefit and side effects, no one has said sign me up. Wow. So has all the publicity been negative? Not at all. There are a lot of neurologists who say they are in favor of any drug that might help. And the Alzheimer's Association has been a really strong supporter of Adelheim. The group's position is that this is just the first small step toward treating a disease that has been pretty much untreatable. So what do you see ahead, John? I mean, is Adelm doomed? I think it would be premature to say that. Obviously, if Medicare decides to cover Ad Helm, you could see the drug reaching many more patients. And then COVID-19 has been making everything more complicated for the past 18 months. It's disrupted pretty much

every part of life, including how seniors are interacting with their doctors. Yeah, makes sense. I talked about that with Dr. Raj Tampi of the Cleveland Clinic. He told me that Alzheimer's patients and family members that he sees have had a lot of other concerns in the past couple of years. The pandemic has taken a toll on people. So majority of the people who are coming are mainly looking for relief from depression and anxiety and other things, sleep problems. And I think the cognitive issues are less important. Tampi told me it's possible that will change when COVID-19 tapers off. And biogen, which makes Aduhlund, expects sales to pick up in 2022.

Thanks for bringing us this reporting, John. My pleasure. Today's episode was edited by Sarah Saracen, produced by Rebecca. Rebecca Ramirez and fact check by Margaret Serino. I'm Maria Godoy. Thanks for listening to Shortwave, the Daily Science Podcast from NPR.