Few seniors with early-stage Alzheimer’s will have access to the new Leqembi treatment because of its high cost and very limited Medicare coverage.
The Food and Drug Administration granted accelerated approval Friday to Biogen and Eisai’s monoclonal antibody after the treatment appeared to slightly slow the progression of Alzheimer’s disease in clinical trial participants with mild cognitive impairment.
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Japanese pharmaceutical company Eisai, which led the drug’s development, said Leqembi will cost an estimated $26,500 a year, though the exact price tag will vary by patient.
Most seniors who qualify for the treatment will have to pay for it out of pocket because Medicare has limited coverage for people who participate in studies approved by the federal government.
Medicare recipients have an average income of about $30,000 a year, according to Tricia Neuman, the executive director of the Kaiser Family Foundation’s Medicare Policy Program.
“Without Medicare coverage, this drug is virtually 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 was higher than an independent estimate by the Institute for Clinical and Economic Review, a nonprofit organization that analyzes drug prices based on their benefit.
ICER found in a draft report that the drug would be cost-effective for patients at a cost ranging from $8,500 to $20,600 per year.
Rough estimates put the number of people age 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 in April limited coverage for a slew of experimental Alzheimer’s drugs marketed using the FDA’s accelerated pathway.
CMS made the decision due to safety and efficacy concerns that arose after the controversial early FDA approval in June 2021 of Aduhelm, which was also developed by Biogen and Eisai. Drugs such as 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 “riddled with irregularities.” The FDA approved the treatment despite opposition from TBEN expert panel, which found that the available data showed no clear clinical benefit.
The CMS coverage limitations apply to monoclonal antibodies that target a protein called amyloid, which builds up into a plaque on parts of the brain in patients with Alzheimer’s disease.
CMS said Friday that coverage restrictions currently apply to Leqembi, though the agency is reviewing available information and could reconsider coverage based on the assessment’s conclusions.
“It won’t be widely available, even to people who might qualify based on whether or not they have mild cognitive impairment associated with Alzheimer’s,” Neuman said.
Dr. Joanne Pike, president of the Alzheimer’s Association, called the coverage restrictions “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’s clearly harmful and unfair to people 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 are losing time.”
CMS plans to provide broader coverage for Leqembi if the treatment receives full FDA approval under the traditional process, according to a statement from the agency. But it is not clear if or when this will happen. Eisai filed Friday with the FDA for full approval of Leqembi.
The FDA’s accelerated approval program is designed to get drugs to market faster for patients with serious illnesses who don’t have better options. The pharmaceutical companies are continuing clinical trials and the FDA will give its full approval if the data confirms a clinical benefit.
If the studies don’t confirm clinical benefit, the FDA may remove the drug from the market. Neuman said the stakes are high for Medicare and that CMS is proceeding with caution until there is more data on Leqembi’s safety and effectiveness.
Clinical trial data published in the New England Journal of Medicine showed that participants’ cognitive decline was 27% slower than 18 months for people who received Leqembi.
But 14% of people who received the drug experienced serious side effects, compared to 11% of those who did not receive the treatment.
Neuman said finding a way to meet 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 limited effect, she said. Leqembi has raised hopes that the disease can at least be slowed down.
“Families grapple with the effects of Alzheimer’s disease with no cure in sight,” Neuman said. “So there’s a lot of pent-up demand for drugs that can have a meaningful impact on family members who are beginning to decline cognitively because they have Alzheimer’s disease.”