Sufferers would pay as much as $26,500 a yr for Leqembi
Due to the high cost and very limited Medicare coverage, few seniors with early Alzheimer’s disease will have access to the new treatment, Leqembi.
The Food and Drug Administration on Friday granted Biogen and Eisai’s monoclonal antibody fast-track approval 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, although the exact price will vary from patient to patient.
Most seniors who qualify for treatment have to pay for it out of pocket because Medicare only covers people who participate in federally-approved studies.
Medicare recipients have a median income of about $30,000 a year, according to Tricia Neuman, executive director of the Kaiser Family Foundation’s Medicare program.
“Without Medicare coverage, this drug is pretty much unaffordable,” Neuman said. “Even with Medicare coverage, the beneficiaries would still be responsible for 20% of the coinsurance, and that’s not an insignificant amount.”
Eisai’s introductory price for Leqembi beat an independent estimate by the Institute for Clinical and Economic Review, a nonprofit organization that analyzes drug prices based on their utility.
ICER noted in a draft report that the drug would be cost-effective for patients at between $8,500 and $20,600 per year.
According to rough estimates, the number of people ages 65 and older who have mild cognitive impairment due to Alzheimer’s disease is around 5 million, according to the Alzheimer’s Association
The Centers for Medicare and Medicaid Services limited coverage back in April for an entire class of experimental Alzheimer’s drugs that were brought to market through the FDA’s expedited pathway.
CMS made the decision based on safety and efficacy concerns raised by the controversial FDA early approval in June 2021 of Aduhelm, also being developed by Biogen and Eisai. Medications like Aduhelm and Leqembi can cause brain swelling and bleeding.
An investigation by lawmakers in the House of Representatives concluded that the FDA approval process for Aduhelm was “riddled with irregularities.” The FDA approved the treatment despite opposition from its independent panel of experts, who found that the available data did not show clear clinical benefit.
The CMS coverage limitations apply to monoclonal antibodies that target a protein called amyloid, which builds up into a plaque in areas of the brain in patients with Alzheimer’s disease.
CMS said Friday that coverage restrictions currently apply to Leqembi, although the agency is reviewing available information and may reconsider coverage based on the review’s conclusions.
“It won’t even be widely available to people who are potentially eligible based on whether or not they have mild cognitive impairment associated with Alzheimer’s disease,” 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 reporting on Leqembi months ago before considering the available evidence.
“CMS has never done this for a drug before, 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 lose days, weeks, months – memories, skills and independence. You lose time.”
According to an agency statement, CMS plans to provide broader coverage for Leqembi when the treatment under the traditional process receives full FDA approval. But it’s not clear if or when that will happen. Eisai filed an application for full approval of Leqembi with the FDA on Friday.
The FDA’s accelerated approvals program is designed to get drugs to market faster for patients with serious illnesses who don’t have better options. Pharmaceutical companies continue clinical trials and the FDA gives its full approval if the data confirm clinical benefit.
If the studies do not confirm clinical benefit, the FDA can withdraw the drug from the market. Neuman said the stakes are high for Medicare and CMS is taking a cautious approach pending 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 in people who received Leqembi.
But 14% of those who received the drug experienced serious adverse events, compared with 11% of those who didn’t 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 limited effect, she said. Leqembi has raised hopes that the disease can at least be slowed down.
“Families struggle with the effects of Alzheimer’s with no cure in sight,” Neuman said. “So there’s a lot of pent-up demand for drugs that could have a meaningful impact on family members whose cognitive abilities are beginning to decline as a result of their Alzheimer’s disease.”