Few seniors with early-onset Alzheimer’s may have access to the brand new Leqembi treatment due to its high cost and really limited Medicare coverage.
The Food and Drug Administration on Friday granted accelerated approval for Biogen and Eisai’s monoclonal antibody after the treatment appeared to be moderately slow progress Alzheimer’s disease in clinical trial participants with mild cognitive impairment.
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Said the Japanese pharmaceutical company Eisai, which led the event of the drug Leqembi will cost around $26,500 a yearalthough the precise price will vary from patient to patient.
Most seniors who qualify for treatment may have to pay for it out of pocket because Medicare is restricted to those participating in federally approved trials.
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 Policy Program.
“Without Medicare coverage, this drug is sort of unavailable,” Neuman said. “Even with Medicare coverage, beneficiaries would still be responsible for 20% of co-insurance, and that is not a trivial amount.”
Eisai’s starting price for Leqembi was higher than an independent estimate by the Clinical and Economic Review Institute, a non-profit organization that analyzes drug prices based on their advantages.
FRIDGE, within the draft reportstated that the drug can be cost-effective for patients at a cost of $8,500 to $20,600 per year.
A rough estimate puts the number of individuals aged 65 and over affected by mild cognitive impairment due to Alzheimer’s at around 5 million, according to the Alzheimer’s Association
Medicare and Medicaid service centers limited coverage in April for a whole class of experimental Alzheimer’s drugs brought to market using the FDA’s accelerated track.
CMS made the choice due to safety and efficacy concerns raised within the wake of the controversial June 2021 FDA approval of Aduhelm, which was also developed by Biogen and Eisai. Medicines equivalent to Aduhelm and Leqembi may cause brain swelling and bleeding.
An investigation by lawmakers within the House of Representatives found that the FDA’s approval process for Aduhelm was “ridden with irregularities.” The FDA approved the treatment despite objections from an independent expert panel, which said the available data showed no clear clinical profit.
The restrictions of the scope of CMS relate to monoclonal antibodies that focus on a protein called amyloid that accumulates in plaques in areas of the brain in Alzheimer’s patients.
CMS said on Friday that coverage restrictions currently apply to Leqembi, although the agency is examining available information and should reconsider coverage based on the findings of the review.
“It won’t be widely available even to individuals who potentially qualify 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 cuts “unprecedented and fallacious” in a statement Friday. Pike said CMS declined to cover Leqembi months ago before reviewing available evidence.
“CMS has never done this for any drug before, and it’s clearly damaging and unfair to individuals with Alzheimer’s,” Pike said. “Without access to this treatment and others on this class of treatment and its reach, people lose days, weeks, months – memories, skills and independence. They’re wasting time.”
CMS plans to provide wider coverage of Leqembi if the treatment receives full FDA approval through the standard process, according to the agency statement. But it surely’s not clear if and when that may occur. Hey filed with the FDA on Friday for Leqembi’s full approval.
The FDA’s accelerated approval program is designed to get drugs to market faster for patients with serious illnesses who haven’t got higher options. Pharmaceutical corporations proceed clinical trials, and the FDA gives full approval if the information confirms a clinical profit.
If the studies don’t confirm a clinical profit, the FDA may withdraw the drug from the market. Neuman said the stakes are high for Medicare, and CMS is taking a cautious approach until more data is obtainable on Leqembi’s safety and effectiveness.
Clinical trial data published within the Recent England Journal of Medicine showed participants’ cognitive decline was 27% slower over 18 months in those that received Leqembi.
But 14% of those that received the drug suffered serious antagonistic events, compared with 11% of those that didn’t receive treatment.
Neuman said finding a way to meet the needs of individuals with Alzheimer’s is “a huge national challenge.” She said there isn’t a cure for the disease and the drugs available available on the market have limited effect. Leqembi raised hopes that the disease could at the least be slowed down.
“Families are combating the results of Alzheimer’s disease and there isn’t a cure in sight,” Neuman said. “So there’s a lot of pent-up demand for any drugs that would have a significant impact on relations who’re starting to decline cognitively from Alzheimer’s.”