Few seniors with early Alzheimer’s disease will have access to the new treatment Leqembi due to its high cost and very 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 year, though the exact price tag will vary by patient.
Most seniors who are eligible for the treatment will 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 year, according to Tricia Neuman, the executive director of the Kaiser Family Foundation’s Medicare policy program.
“Without Medicare coverage, this drug is pretty much unaffordable,” Neuman said. “Even with Medicare coverage, beneficiaries would still be responsible for 20% coinsurance, and that’s not a trivial amount.”
Eisai’s launch price for Leqembi came in higher than an independent estimate by the Institute for Clinical and Economic Review, a nonprofit that analyzes drug prices based on their benefit.
ICER, in a draft report, found that the drug would be cost effective for patients at a price ranging from $8,500 to $20,600 per year.
Rough estimates put the number of people ages 65 and older suffering from mild cognitive impairment due to Alzheimer’s disease at about 5 million, according to the Alzheimer’s Association
The Centers for Medicare and Medicaid Services restricted coverage back in April for a whole class of experimental Alzheimer’s drugs brought to market using the FDA’s accelerated pathway.
CMS made the decision due to safety and efficacy concerns that arose in 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 can cause brain swelling and bleeding.
An investigation by lawmakers in 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 did not demonstrate clear clinical benefit.
The CMS coverage limitations apply to monoclonal antibodies that target a protein called amyloid, which builds up 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 could reconsider coverage based on the review’s conclusions.
“It’s not going to be widely available even to people who are potentially eligible based on whether or not they have 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 wrong” in a statement 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 is clearly harmful and unfair to those with Alzheimer’s,” Pike said. “Without access to and coverage of this treatment and others in its class, people are losing days, weeks, months — memories, skills and independence. They’re losing time.”
CMS plans to provide broader coverage for Leqembi if the treatment receives full FDA approval under the traditional process, according to an agency statement. But it’s not clear if or when this will happen. 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 don’t have any better options. The drug companies are continuing clinical trials, and the FDA gives its full approval if the data confirms a clinical benefit.
If the trials do not confirm a clinical benefit, 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 in the New England Journal of Medicine found that participants’ cognitive decline was 27% slower over 18 months for people who received Leqembi.
But 14% of people who received the drug suffered serious adverse events, compared with 11% of those who did not receive the treatment.
Neuman said finding a way to address the needs of people with Alzheimer’s is a “huge national challenge.” There is no cure for the disease and the drugs on the market have a limited effect, she said. Leqembi has raised hopes that the disease can at least be slowed.
“Families are struggling with the effects of Alzheimer’s with no cure in sight,” Neuman said. “So there’s a lot of pent-up demand for any drugs that could have a meaningful impact on family members who are starting to decline cognitively because they have Alzheimer’s disease.”