Amyloid plaques are characteristic features of Alzheimer's disease. The new drug Aduhelm is able to remove this sticky substance that builds up in the brains of patients with the disease, but many doctors are still skeptical of how well it really works. Kateryna Kon/Science Photo Libra via Getty Images
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.
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."
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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