Newly Approved Alzheimer's Drug
A newly approved drug intended to slow the progression of Alzheimer’s disease. This new drug may offer patients hope, but it will come with a big price: $26,500 a year. "Leqembi" and was approved by the Food and Drug Administration on Friday for use in people with mild cognitive impairment or early Alzheimer’s disease.
This is the second drug approved in the United States — behind Biogen’s Aduhelm. It is aimed at attacking what is thought to be one of the underlying causes of the disease — build-ups in the brain called amyloid plaques.
Will Medicare & Medicaid Services provide coverage for the drug?
In order for Medicare to cover the costs of the drug, patients need to be enrolled in a clinical trial, which will limit coverage.
The price for Leqembi is a lot higher than recommended by the Institute for Clinical and Economic Review, a Boston-based research group that helps determine fair prices for drugs. Dr. David Rind, the institute's chief medical officer, said an appropriate cost for the drug is $8,500 to $20,600 a year. “We think this is overpriced right now,” he said. Because of the high price tag, experts say, the number of people who will be able to get the drug will be extremely limited. More than 6 million people in the U.S. have Alzheimer's disease, according to the Alzheimer's Association.
As a rule, the Centers for Medicare & Medicaid Services restricts coverage for new Alzheimer's treatments that target amyloid, including Leqembi, to only those patients participating in clinical trials. John Domeck, 60, of Aurora, Ohio is currently enrolled in phase 3 clinical trial testing Leqembi. Because of that, he gets the medication free every two weeks. But his wife, Ann Domeck, says she doesn't know if that will continue when the trial ends in the next two years, even though John qualifies for Medicare.
Covering Alzheimer's Treatments
Holly Fernandez Lynch, an assistant professor of medical ethics at the University of Pennsylvania, stated that the CMS standards for covering new Alzheimer’s treatments are higher than those the FDA uses to get new treatments on the market quickly.
Leqembi was approved under the FDA's accelerated pathway, which allows early approval for new drugs that “fill an unmet medical need" and are found to be safe and effective. In its review for accelerated approval of Leqembi, the FDA looked at data from a phase 2 clinical trial of more than 800 patients. Eisai and Biogen will still need to submit data from an additional phase 3 clinical trial that confirms the benefits of the drug to gain full approval. "The standard for CMS coverage is not that the drug is safe and effective," Lynch said. "It is that 'is it reasonable and necessary for the Medicare population.'" Lynch said the CMS can't determine that until it has seen the full data from both clinical trials.
Arthur Caplan, the head of the Division of Medical Ethics at NYU Langone Medical Center in New York City, said the CMS has to be especially cautious about what medications it covers because drugs, like Leqembi, could cost it billions. About 6.5 million people over the age of 65 have Alzheimer's and would qualify for Medicare. The CMS may be willing to swallow that cost if the drug is shown to provide a lot of benefits for patients, he said. But right now, the clinical trial for Leqembi shows that the drug provides "modest efficacy at a big, big price," Caplan said.
It's possible, Lynch said, that the CMS will consider covering Leqembi once the drug receives full approval. Eisai announced late Friday that it had submitted an application for full approval. Ivan Cheung, the U.S. chairman, and CEO of Eisai, told NBC News that the FDA could reach a decision in six months. But, as of right now, it appears the CMS is unwilling to budge on its policy stance, Lynch said.
"The CMS has said, 'Look, something might be safe and effective from the FDA's perspective, but we have too many qualms about the qualify of evidence,'" she said. In the meantime, many patients who want the drug will not be able to afford it, said Dr. Alberto Espay, a neurologist at the University of Cincinnati College of Medicine.
It’s “very unfortunate,” he said, noting that physicians will have to explain to patients the potential benefits — a modest slowing of the disease — alongside the risks, which may include a great financial burden.
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