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A new Alzheimer's drug will cost $26,500 a year. Who can buy it?


The price of Leqembi is much higher than that recommended by the Institute for Clinical and Economic Review. In order for Medicare to cover its cost, patients must be enrolled in a clinical trial.

By Berkeley Lovelace Jr. -

NBC News

A newly approved drug to slow the progression of Alzheimer's offers hope to patients, but its price tag is high: $26,500 a year.

The drug, called Leqembi, from the pharmaceutical companies Eisai and Biogen, was approved Friday by the Food and Drug Administration (FDA) for use in people with mild cognitive impairment or early Alzheimer's.

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It is the second drug approved in the United States - after Biogen's Aduhelm - aimed at attacking what is believed to be one of the underlying causes of the disease: accumulations in the brain called amyloid plaques.

Leqembi's annual price, $26,500, is lower than that of Aduhelm, approved by the FDA in 2021 despite strong objections from its group of outside advisers.

That drug initially cost $56,000 a year before Biogen cut the price in half, to $28,000 a year.

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Even so, Leqembi's price is far higher than recommended by the Institute for Clinical and Economic Review, a Boston-based research group that helps determine fair drug prices.

Dr. David Rind, the institute's chief medical officer, said an adequate cost for the drug is $8,500 to $20,600 a year.

“We believe that the current price is excessive,” he said.

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Due to its high price, according to experts, the number of people who will be able to obtain the drug when it becomes available -predictably the week of January 16- will be extremely limited.

More than six million people have Alzheimer's in the US, according to the Alzheimer's Association.

As a general rule, the Centers for Medicare & Medicaid Services (CMS) restricts coverage of new amyloid-targeted Alzheimer's treatments, including Leqembi, to patients participating in clinical trials.

John Domeck, 60, of Aurora, Ohio, is participating in a Phase 3 clinical trial testing Leqembi.

Therefore, he receives the medicine for free every two weeks.

Brain scan of an Alzheimer's patient. BSIP / Universal Images Group via Getty Images

But his wife, Ann Domeck, says she doesn't know if it will stay that way when the trial ends two years from now, even if John is eligible for Medicare.

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"I don't know if we could afford it, but we'll cross that bridge when we get to it," he said.

Holly Fernandez Lynch, associate professor of medical ethics at the University of Pennsylvania, said CMS's rules for covering new Alzheimer's treatments are stricter than those the FDA uses to get new treatments to market quickly.

Leqembi was approved under the FDA's fast track, which allows for early approval of new drugs that "meet an unmet medical need" and are considered safe and effective.

In its review for the accelerated approval of Leqembi, the FDA considered data from a Phase 2 clinical trial involving more than 800 patients.

Eisai and Biogen will still have to submit data from an additional Phase 3 clinical trial confirming the drug's benefits to gain full approval.

“The standard for CMS coverage is not that the drug is safe and effective.

It's that 'it's reasonable and necessary for the Medicare population,'' Lynch said.

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Lynch said CMS can't determine that until it has seen the complete data from both clinical trials.

Arthur Caplan, director of the Division of Medical Ethics at NYU Langone Medical Center, said CMS has to be especially careful about the drugs it covers because drugs like Leqembi could cost you billions.

About 6.5 million people age 65 and older have Alzheimer's and may be eligible for Medicare.

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CMS might be willing to bear that cost if the drug is shown to bring many benefits to patients.

But right now, Leqembi's clinical trial shows that the drug provides "modest efficacy at a very, very high price," according to Caplan.

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CMS may consider covering Leqembi once the drug receives full approval.

Eisai announced late on Friday that he had submitted a full approval application.

Ivan Cheung, president and CEO of Eisai in the US, told NBC News, the sister network of Noticias Telemundo, that the FDA could make a decision in six months.

But for the moment, it appears that CMS is unwilling to budge on its political stance.

“CMS has said, 'Look, something may be safe and effective from the FDA's perspective, but we have too many qualms about the quality of the evidence,'' he said.

Meanwhile, many patients who want the drug won't be able to afford it, recalled Alberto Espay, a neurologist at the University of Cincinnati School of Medicine.

It's "very unfortunate," he said, noting that doctors will have to explain to patients the potential benefits -- a modest slowing of the disease -- along with the risks, which can include a large financial burden.

Source: telemundo

All news articles on 2023-01-10

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