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Japanese drugmaker Eisai expects the Food and Drug Administration to completely approve its Alzheimer’s treatment Leqembi this summer, which might expand access to the pricey latest 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 corporate gets an expedited “priority review” for demonstrating a big improvement in how early Alzheimer’s is treated.
“We’re literally talking about possibly like five months away, so we’re moving with urgency definitely with CMS at once,” Cheung told CNBC in an interview Thursday. The Centers for Medicare & Medicaid Services is the federal agency that can determine how broadly Leqembi, which Eisai has priced at $26,500 a yr, is roofed for patients diagnosed with early Alzheimer’s.
The corporate, which developed the drug with Biogen, estimates 100,000 persons are expected to receive an early Alzheimer’s diagnosis and turn into eligible for Leqembi by 2026 though the variety of undiagnosed people is sort of definitely higher.
The Alzheimer’s Association estimates that greater than 2,000 people aged 65 and older progress from mild to moderate dementia because of 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, however 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 focus on the plaque that causes the disease. Under Eisai’s current accelerated approval status, Medicare will only cover the prices of individuals in clinical trials approved by the FDA or National Institutes of Health.
Eisai has accomplished its phase three trial and is not any longer enrolling patients. This implies the medication is currently out of reach for many, except the very wealthy. Cheung said the corporate shouldn’t be aware of any patients who’ve managed to get Leqembi covered through Medicare at once.
Even when 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 medical health insurance programs.
Awaiting FDA answer on timing
The corporate filed all of its phase three data with its application for full approval in January and may hear back from the FDA in March on whether the agency will accept its application. If the agency decides to review Leqembi’s application with priority, it could render a final decision inside six months.
Medicare beneficiaries who comply with take part in CMS-backed research studies, that are broader than clinical trials, would get coverage if Leqembi receives full approval. However it’s possible that CMS could comply with even broader coverage, possibly with no restrictions, if the agency determines that there is a high level of evidence supporting the treatment, Cheung said.
“With a high level of evidence … the restrictions ought to be very limited, or possibly even no restrictions and that’s Eisai’s position,” Cheung said. “We consider Medicare beneficiaries must have unimpeded access, broad and easy access to Leqembi because the info fulfill those criteria,” he said.
If Medicare continues to limit coverage, people in rural communities would face an obstacle because medical institutions and universities are heavily concentrated in larger cities.
Greater than 70 members of Congress this month called on Health Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure to ease the coverage restrictions on Leqembi to make sure more access across America.
“Patients, families, and caregivers living in rural and underserved areas must have the identical opportunity for access to treatment,” the lawmakers wrote. “It’s an unlimited 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
If all the pieces goes in keeping with Eisai’s expectations, the FDA would grant full approval and CMS would offer unrestricted coverage of Leqembi. In that scenario, Eisai anticipates that about 100,000 diagnosed early Alzheimer’s patients will likely be eligible by yr three of the drug’s rollout. Eisai said there’s sufficient manufacturing capability at Biogen’s plant in Switzerland.
But Cheung said the foremost challenge with rolling out Leqembi is that physicians aren’t geared toward diagnosing early Alzheimer’s because so few treatments exist. CMS also needs to supply broad reimbursement for diagnostic tests, Cheung said. These include PET scans, currently limited to 1 per lifetime, and cerebrospinal fluid tests, that are reimbursed at a low rate, in keeping with the corporate.
“Each time when you could have to adopt a latest diagnostic procedure it will just take a while,” Cheung said. “Reimbursement must occur for those diagnostic procedures, and radiologists and health-care providers across the country need to start out doing that. And there is a time period it takes for people to get in control on easy methods to try this,” he said.
About 15% of eligible patients are younger than age 65 and are mostly covered through private insurance, Cheung said. Private insurers are largely waiting for a CMS coverage decision though some may determine to make their coverage decisions earlier, he said. Eisai will offer copay assistance to people who find themselves covered privately, Cheung said.
“There are more flexibility and multiple approaches to supply superb access with very, very low out-of-pocket costs for those individuals,” the CEO said. Eisai has a program to supply Leqembi for gratis to uninsured patients who meet eligibility criteria.
Cheung said the $26,500 annual cost of Leqembi should come down over time. Immediately, the treatment is run twice a month, but Eisai is developing a maintenance regimen where patients would receive a single monthly dose after the primary 18 months of treatment.
“It is not approved yet. We expect to file for maintenance dosing by the tip of next fiscal yr,” Cheung said. Maintenance dosing would cut back the fee of Leqembi by about half, he said.
Medicare under pressure
CMS said in January that it might broaden coverage if Eisai provides data that answers questions on the advantages of Leqembi in slowing cognitive decline and potential harm from uncomfortable side effects corresponding to brain hemorrhages.
“One in all the things I’d just emphasize is as you realize, on this particular class, [we] really desired to have more information as we learn what these products are going to do,” CMS Administrator Brooks-LaSure said Tuesday during a call with reporters. “But we proceed to be open to hearing latest data from manufacturers and advocates.”
Eisai says the info from its phase three trial answers those questions with a high level of evidence, Cheung said.
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 public policy officer, said it’s the primary time CMS has preemptively decided to not cover a future class of medicine by default.
The Medicare policy stems from controversy surrounding Aduhelm, one other Alzheimer’s antibody treatment developed by Eisai and Biogen. The FDA granted accelerated approval for that treatment in 2021 despite the incontrovertible fact that the agency’s independent advisors said the evidence didn’t show that it slowed the disease. Three advisors resigned over the FDA’s decision. A congressional inquiry in December found that the approval of Aduhelm was “rife with irregularities.”
Medicare decided last April to limit coverage on all monoclonal antibodies that focus on brain plaque for treating Alzheimer’s until it receives more evidence demonstrating a profit to patients.
“It is not an inexpensive policy because there isn’t any reason why that they had to do that on a category 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’s a consensus amongst its experts that the phase three clinical trial for Leqembi was well designed and the info was clinically and statistically significant.
The clinical trial results, published within the Latest England Journal of Medicine, found that cognitive decline was 27% slower over 18 months in individuals who received Leqembi compared with those that didn’t receive the treatment. But there have been also safety concerns with some patients experiencing brain swelling and bleeding.
The death of a clinical trial participant within the Chicago area could also possibly be linked to lecanemab, in keeping with a research letter published within the Latest England Journal of Medicine in January
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.