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Patients would pay as much as $26,500 per yr for Leqembi

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Few seniors with early Alzheimer’s disease could have access to the brand new treatment Leqembi resulting from its high cost and really limited coverage by Medicare.

The Food and Drug Administration on Friday granted accelerated approval to Biogen and Eisai’s monoclonal antibody after the treatment appeared to modestly slow the progression of Alzheimer’s disease in clinical trial participants with mild cognitive impairment.

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The Japanese pharmaceutical company Eisai, which led the drug’s development, said Leqembi will cost an estimated $26,500 per yr, though the precise price tag will vary by patient.

Most seniors who’re eligible for the treatment could have to pay for it out of pocket because Medicare has limited coverage to people participating in studies approved by the federal government.

Medicare recipients have a median income of about $30,000 per yr, in accordance with Tricia Neuman, the chief director of the Kaiser Family Foundation’s Medicare policy program.

“Without Medicare coverage, this drug is just about unaffordable,” Neuman said. “Even with Medicare coverage, beneficiaries would still be answerable for 20% coinsurance, and that is not a trivial amount.”

Eisai’s launch price for Leqembi got here in higher than an independent estimate by the Institute for Clinical and Economic Review, a nonprofit that analyzes drug prices based on their profit.

ICER, in a draft report, found that the drug could be cost effective for patients at a price starting from $8,500 to $20,600 per yr.

Rough estimates put the number of individuals ages 65 and older affected by mild cognitive impairment resulting from Alzheimer’s disease at about 5 million, in accordance with the Alzheimer’s Association

The Centers for Medicare and Medicaid Services restricted coverage back in April for an entire class of experimental Alzheimer’s drugs delivered to market using the FDA’s accelerated pathway.

CMS made the choice resulting from safety and efficacy concerns that arose within the wake of the FDA’s controversial early approval in June 2021 of Aduhelm, which was also developed by Biogen and Eisai. Drugs like Aduhelm and Leqembi may cause brain swelling and bleeding.

An investigation by lawmakers within the House concluded that the FDA approval process for Aduhelm was “rife with irregularities.” The FDA approved the treatment despite opposition from its independent expert panel, which found that the available data didn’t reveal clear clinical profit.

The CMS coverage limitations apply to monoclonal antibodies that concentrate on a protein called amyloid, which builds up right into a plaque on areas of the brain in patients with Alzheimer’s disease.

CMS said on Friday that the coverage limitations currently apply to Leqembi, though the agency is examining the available information and will reconsider coverage based on the review’s conclusions.

“It is not going to be widely available even to people who find themselves potentially eligible based on whether or not they’ve mild cognitive impairment related to Alzheimer’s disease,” Neuman said.

Dr. Joanne Pike, president of the Alzheimer’s Association, called the coverage limitations “unprecedented and incorrect” in a press release Friday. Pike said CMS denied coverage for Leqembi months ago before reviewing the available evidence.

“CMS has never done this before for any drug, and it’s clearly harmful and unfair to those with Alzheimer’s,” Pike said. “Without access to and coverage of this treatment and others in its class, individuals are losing days, weeks, months — memories, skills and independence. They’re losing time.”

CMS plans to offer broader coverage for Leqembi if the treatment receives full FDA approval under the standard process, in accordance with an agency statement. Nevertheless it’s not clear if or when it will occur. Eisai submitted an application to the FDA on Friday for full approval of Leqembi.

The FDA’s accelerated approval program is designed to bring drugs to market faster for patients with serious illnesses who have no higher options. The drug corporations are continuing clinical trials, and the FDA gives its full approval if the information confirms a clinical profit.

If the trials don’t confirm a clinical profit, the FDA can remove the drug from the market. Neuman said the stakes are high for Medicare and CMS is taking a cautious approach until there’s more data on Leqembi’s safety and effectiveness.

Clinical trial data published within the Latest England Journal of Medicine found that participants’ cognitive decline was 27% slower over 18 months for individuals who received Leqembi.

But 14% of people that received the drug suffered serious hostile events, compared with 11% of those that didn’t receive the treatment.

Neuman said finding a strategy to address the needs of individuals with Alzheimer’s is a “huge national challenge.” There isn’t any cure for the disease and the drugs available on the market have a limited effect, she said. Leqembi has raised hopes that the disease can no less than be slowed.

“Families are battling the results of Alzheimer’s with no cure in sight,” Neuman said. “So there’s numerous pent-up demand for any drugs that might have a meaningful impact on members of the family who’re beginning to decline cognitively because they’ve Alzheimer’s disease.”

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