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Japanese drugmaker Eisai expects the Food and Drug Administration to fully approve its Alzheimer’s treatment Leqembi this summer, which would expand access to the pricey new antibody under Medicare.
U.S. CEO Ivan Cheung said the FDA, which granted accelerated clearance in January, could give full approval as soon as July if the company gets an expedited “priority review” for demonstrating a significant improvement in how early Alzheimer’s is treated.
“We’re literally talking about maybe like five months away, so we are moving with urgency definitely with CMS right now,” Cheung told CNBC in an interview Thursday. The Centers for Medicare and Medicaid Services is the federal agency that will determine how broadly Leqembi, which Eisai has priced at $26,500 a year, is covered for patients diagnosed with early Alzheimer’s.
The company, which developed the drug with ជីវអ៊ីន, estimates 100,000 people are expected to receive an early Alzheimer’s diagnosis and become eligible for Leqembi by 2026 though though the number of undiagnosed people is almost certainly higher.
The Alzheimer’s Association estimates that more than 2,000 people aged 65 and older progress from mild to moderate dementia due to the disease per day, making them ineligible for Leqembi.
Early Alzheimer’s typically hits people ages 65 and older, causing cognitive impairment and other issues. Leqembi has shown promise in slowing the disease’s progression in that population, but it carries risks of brain swelling and bleeding.
Medicare published guidance in April 2022 that limits coverage for Alzheimer’s drugs like Leqembi that use antibody treatments to target the plaque that causes the disease. Under Eisai’s current accelerated approval status, Medicare will only cover the costs of people in clinical trials approved by the FDA or National Institutes of Health.
Eisai has completed its phase three trial and is no longer enrolling patients. This means the medication is currently out of reach for most, except the very wealthy. Cheung said the company is not aware of any patients who have managed to get Leqembi covered through Medicare right now.
Even if it gets full approval under the FDA’s “priority review” process, Medicare could still restrict coverage to patients enrolled in research studies approved by CMS, the agency that runs the Medicare and Medicaid federal health insurance programs.
Awaiting FDA answer on timing
“អ្នកជំងឺ ក្រុមគ្រួសារ និងអ្នកថែទាំដែលរស់នៅក្នុងតំបន់ជនបទ និងតំបន់ក្រីក្រ គួរតែមានឱកាសដូចគ្នាសម្រាប់ការទទួលបានការព្យាបាល”។ lawmakers wrote. “It is an enormous physical and financial burden for Medicare beneficiaries to spend countless hours traveling to limited research institutions that host the trials.”
Drug rollout will take years
“There are more flexibility and multiple approaches to offer very good access with very, very low out of pocket costs for those individuals,” the CEO said. Eisai has a program to provide Leqembi at no cost to uninsured patients who meet eligibility criteria.
Cheung said the $26,500 annual cost of Leqembi should come down over time. Right now, the treatment is administered twice a month, but Eisai is developing a maintenance regimen where patients would receive a single monthly dose after the first 18 months of treatment.
“It’s not approved yet. We expect to file for maintenance dosing by the end of next fiscal year,” Cheung said. Maintenance dosing would reduce the cost of Leqembi by about half, he said.
Medicare under pressure
Medicare’s coverage policy is controversial. The Alzheimer’s Association, in a December letter to CMS, called for full and unrestricted coverage of Leqembi. Robert Egge, the association’s chief policy officer, said it’s the first time CMS has pre-emptively decided to not cover a future class of drugs by default.
The Medicare policy stems from controversy surrounding Aduhelm, another Alzheimer’s antibody treatment developed by Eisai and Biogen. The FDA granted accelerated approval for that treatment in 2021 despite the fact that the agency’s independent advisors said the evidence didn’t demonstrate that it slowed the disease. Three advisors resigned over the FDA’s decision។ មួយ ការស៊ើបអង្កេតរបស់សភា in December found that the approval of Aduhelm was “rife with irregularities.”
Medicare decided last April to restrict coverage on all monoclonal antibodies that target brain plaque for treating Alzheimer’s until it receives more evidence demonstrating a benefit to patients.
“It’s not a reasonable policy because there’s no reason why they had to do this on a class basis,” Egge said.
The American Academy of Neurology, the world’s largest association of neurologists, told Medicare in a letter earlier this month that there is a consensus among its experts that the phase three clinical trial for Leqembi was well designed and the data was clinically and statistically significant.
The clinical trial results, បានចុះផ្សាយក្នុង New England Journal of Medicine, found that cognitive decline was 27% slower over 18 months in people who received Leqembi compared with those who did not receive the treatment. But there were also safety concerns with some patients experiencing brain swelling and bleeding.
The death of a clinical trial participant in the Chicago area could also possibly be linked to lecanemab, according to a research letter published in the New England Journal of Medicine នៅខែមករា
AAN’s President Dr. Orly Avitzur called on CMS to revise its coverage limitations so there’s broader access for Leqembi should the treatment receive traditional FDA approval.
Source: https://www.cnbc.com/2023/02/17/maker-of-promising-alzheimer-drug-leqembi-expects-fdas-full-approval-this-summer.html