Few older people with early Alzheimer’s disease will have access to the new Legembi treatment because of 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, a treatment that appeared to slightly slow the progression of Alzheimer’s disease in clinical trial participants with mild cognitive impairment.
related investment news
Eisai, the Japanese pharmaceutical company leading the drug’s development, said Legembi would cost about $26,500 a year, although the exact price tag would vary depending on the patient.
Most seniors eligible for the treatment will have to pay for it out of pocket because Medicare has limited coverage for people participating in federally approved studies.
According to Tricia Neuman, executive director of the Kaiser Family Foundation’s Medicare policy program, the median income for Medicare recipients is about $30,000 a year.
“Without Medicare coverage, this drug is almost unaffordable,” Neuman said. “Even with Medicare coverage, beneficiaries would still be responsible for 20% of the coinsurance, and that’s not an insignificant amount.”
Eisai’s sales price for Legembi is higher than an independent estimate by the Institute for Clinical and Economic Review, a nonprofit organization that analyzes drug prices based on benefits.
ICER found in a draft report that the drug would cost patients between $8,500 and $20,600 a year.
A rough estimate, according to the Alzheimer’s Association, is about 5 million people age 65 and older who suffer from mild cognitive impairment due to Alzheimer’s disease.
The Centers for Medicare and Medicaid Services in April limited coverage for an entire class of experimental Alzheimer’s drugs brought to market through the FDA’s fast track.
CMS made the decision because of safety and efficacy concerns that arose after the FDA’s controversial early approval in June 2021 of Aduhelm, developed by Biogen and Eisai. Medicines such as Aduhelm and Legembi can cause brain swelling and bleeding.
An investigation by lawmakers in the House of Representatives concluded that the FDA’s approval process for Aduhelm was “rife with irregularities.” The FDA approved the treatment despite objections from an independent expert panel that found existing data did not demonstrate a clear clinical benefit.
CMS coverage restrictions apply to monoclonal antibodies that target a protein called amyloid that causes plaques to form in areas of the brain in patients with Alzheimer’s disease.
CMS said Friday that the coverage restrictions currently apply to Legembi, although the agency is reviewing available information and may revise the coverage based on the results of the review.
“It won’t even be widely available to people who are potentially eligible, whether they have mild cognitive impairment related to Alzheimer’s disease,” Neuman said.
Alzheimer’s Association president Dr. Joanne Pike called the coverage restrictions “unprecedented and wrong” in a statement Friday. Pike said CMS denied coverage for Legembi several months ago before reviewing the available evidence.
“CMS has never done this for any drug before, and it’s clearly harmful and unfair to Alzheimer’s patients,” Pike said. “Without access and coverage to this treatment and others in its class, people lose days, weeks, months — memories, skills, independence. They lose time.”
CMS plans to provide broader coverage for Legembi if the treatment receives full FDA approval under the traditional process, according to the agency’s statement. But it is not clear when this will happen. Eisai submitted an application to the FDA on Friday for full approval of Legembi.
The FDA’s accelerated approval program is designed to bring drugs to market faster for patients with serious illnesses who have no better options. Drug companies continue clinical trials, and the FDA grants full approval if the data confirm clinical benefit.
If trials do not confirm clinical benefit, the FDA can remove the drug from the market. Neuman said the risks to Medicare are high, and CMS is taking a cautious approach until more is known about Legembi’s safety and effectiveness.
Clinical trial data published in the New England Journal of Medicine showed that participants’ cognitive performance was 27% slower over 18 months for people taking Legembi.
But 14% of those taking the drug experienced serious side effects, compared with 11% of those not receiving treatment.
Finding a way to meet the needs of people with Alzheimer’s is a “huge national challenge,” Neuman said. According to him, there is no cure for the disease and the drugs on the market have limited effect. Legembi raised hopes that the disease could at least slow down.
“Families struggle with the effects of Alzheimer’s, for which there is no apparent cure,” Neuman said. “So there’s a lot of demand for any drug that can have a meaningful impact on family members who are starting to decline cognitively because they have Alzheimer’s disease.”