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Cost and controversy are limiting use of new Alzheimer's drug

Nov 8, 2021
Originally published on November 10, 2021 6:18 am

The new Alzheimer's drug Aduhelm isn't reaching many patients. And doctors say reasons include its high cost, insurers' reluctance to cover it, and lingering questions about whether it actually slows memory loss.

"The pendulum of public opinion has swayed strongly against this drug," says Dr. Marwan Sabbagh, an Alzheimer's specialist at the Barrow Neurological Institute in Phoenix, Ariz., who has worked as an advisor to Biogen, which makes the drug.

Aduhelm is the first drug on the market able to remove amyloid, the sticky substance that builds up in the brains of Alzheimer's patients. It's also the first new Alzheimer's drug approved since 2003.

Aduhelm is intended for patients in the early stages of the disease, a population that represents about a quarter of the six million people in the U.S. with Alzheimer's.

The Food and Drug Administration granted conditional approval in June, even though an advisory panel had recommended against allowing the drug on the market.

Since then, sales have been much slower than many analysts expected. Biogen reported that in the three months following its approval, Aduhelm brought in $300,000, a very low number for a drug with a price tag of $56,000 a year.

Insurers aren't paying

One major reason for the lackluster demand is that, so far, insurers are hesitant to cover the drug.

The federal Medicare program, which insures most people with Alzheimer's, won't decide whether to pay for Aduhelm until sometime in 2022. And private insurers appear to be waiting for the government's decision before determining their own coverage policies.

I'm just not aware of that many people who could shell out $56,000 right now - Dr. Mia Yang of Wake Forest University

In the meantime, patients and their families who want Aduhelm will have to pay out of pocket.

"I'm just not aware of that many people who could shell out $56,000 right now," says Dr. Mia Yang, an assistant professor in geriatrics at Atrium Wake Forest Baptist, who has criticized the FDA's decision to approve Aduhelm.

Some patients have asked Yang about the drug. "Once I explain to them the potential benefits and side effects, no one has said, 'sign me up,'" she says.

Of the two large studies of Aduhelm submitted to the FDA, one found that the drug was able to delay the loss of memory and thinking, while the other found no clear benefit.

That equivocal result has confused patients and divided the doctors and medical institutions that provide Alzheimer's care. The Alzheimer's Association is a strong supporter of the drug. Meanwhile, some large medical centers, including the Cleveland Clinic and Massachusetts General Hospital, say they aren't prescribing Aduhelm.

Benefit vs. risk

"This is not a cure," is the message patients get from Dr. Zaldy Tan, who directs the memory and aging program at Cedars-Sinai Medical Center in Los Angeles. "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."

Tan also tells patients that the drug's potential to offer any benefit 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," he says. "So I think that's something that they will need to consider when deciding whether to take this drug or not."

Despite the risks and uncertainty, patients are curious about Aduhelm, says Barrow's Sabbagh.

"My phone was ringing off the hook" after it got approved, he says. "And every patient every visit since then they're like, 'I want to hear more about the new drug.'"

Sabbagh also emphasizes the positives when he speaks about Aduhelm to patients in the early stages of Alzheimer's.

"Here's a new opportunity to see if we can slow it down," he says. "Maybe you keep what you have longer. Maybe you delay getting worse."

But Sabbagh also adds a note of caution. "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," he says.

So far, only a handful of Sabbagh's patients are actually taking Aduhelm.

COVID concerns

The timing of Aduhelm's approval may be another factor contributing to its slow start, says Dr. Rajesh Tampi, a geriatric psychiatrist at the Cleveland Clinic. He says the Alzheimer's patients he sees have been focused on another disease: COVID-19.

"The pandemic has taken a toll on people," he says, "so the majority who are coming are mainly looking for relief from depression and anxiety and sleep problems. And I think the cognitive issues are less important."

Not a single patient has asked me for the drug yet - Cleveland Clinic's Dr. Rajesh Tampi

Perhaps as a result, he says, "not a single patient has asked me for the drug yet."

Because it has been so hard to find any treatment for Alzheimer's, doctors expected the first drug on the market to be imperfect, Tan says.

"I guess most of us didn't anticipate that it [would] be this imperfect," he says.

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RACHEL MARTIN, HOST:

A controversial new drug for Alzheimer's disease is getting off to a slow start. Very few patients are actually receiving the drug. NPR's Jon Hamilton explains why.

JON HAMILTON, BYLINE: Aduhelm is the first drug on the market to remove amyloid, the sticky substance that builds up in the brains of Alzheimer's patients. The Food and Drug Administration approved it in June, even though an advisory panel opposed the move. Dr. Marwan Sabbagh of the Barrow Neurological Institute in Phoenix says the FDA approval generated a lot of excitement.

MARWAN SABBAGH: My phone was ringing off the hook, both from reporters and from patients. And every patient, every visit since then, they're like, I want to hear more about the new drug.

HAMILTON: Sabbagh has worked as an adviser to the drug's maker, Biogen. This is how he describes Aduhelm to his patients in the early stages of Alzheimer's.

SABBAGH: 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.

HAMILTON: Only a handful of Sabbagh's patients are actually taking Aduhelm. And sales figures suggest that, so far, the drug has been a commercial flop. Sabbagh says one reason is negative publicity.

SABBAGH: The pendulum of public opinion has swayed strongly against this drug, and it's unfortunate.

HAMILTON: Aduhelm has support from the Alzheimer's Association and many neurologists. But it also has been criticized by a long list of experts who consider the drug risky and potentially ineffective. Dr. Mia Yang is a geriatrician at Wake Forest School of Medicine, who has criticized Aduhelm's approval. She says only a few of her patients have even asked about the drug.

MIA YANG: They usually hear about it through the media, through a report, and then they ask my thoughts about it. And once I explain to them the potential benefit and side effects, no one has said, sign me up.

HAMILTON: Yang says the drug's cost, about $56,000 a year, is a major obstacle. At the moment, most private insurers aren't covering Aduhelm, and Medicare, which could make or break the drug, won't decide whether to cover it until next year. Yang says that means right now, most patients have to pay for it out of their own pockets.

YANG: I'm just not aware of that many people who could shell out $56,000 right now to pay for Aduhelm.

HAMILTON: The timing of Aduhelm's approval also may have contributed to its slow start. Dr. Raj Tampi of the Cleveland Clinic says the Alzheimer's patients he sees have been focused on another disease, COVID-19.

RAJ TAMPI: 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.

HAMILTON: Tampi says another factor is that some prominent medical institutions have chosen not to prescribe Aduhelm, at least for now. These include Mount Sinai in New York, Massachusetts General Hospital and Tampi's own workplace, the Cleveland Clinic.

TAMPI: I was hoping that institutions which had the ability to prescribe the drug in a safe way would be able to do that by now. And seeing the low numbers, I'm very surprised.

HAMILTON: Other doctors are less surprised. Dr. Zaldy Tan of Cedars-Sinai in Los Angeles says Aduhelm simply isn't the drug his patients have been hoping for.

ZALDY TAN: This is not a cure. The disease will continue, and perhaps the best-case scenario is someone will get a modest improvement in their cognition. But it's not going to stop the disease from progressing.

HAMILTON: Tan adds that the drug's potential to offer any benefit to patients is still in question.

TAN: 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.

HAMILTON: Tan says he and other experts knew that the first drug to treat the brain changes associated with Alzheimer's was likely to be imperfect.

TAN: Most of us didn't anticipate that it will be this imperfect.

HAMILTON: Tan says he remains optimistic that future drugs will offer a better solution.

Jon Hamilton, NPR News.

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