Maker of Alzheimer’s drug Lekembi hopes for full FDA approval this summer

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Japanese drugmaker Eisai expects the Food and Drug Administration to fully approve Alzheimer’s treatment Leqembi this summer, expanding access to the valuable new antibody under Medicare.

US CEO Evan Cheung said the FDA, which granted accelerated approval in January, could grant full approval as soon as July if the company can demonstrate a significant improvement for its Alzheimer’s treatment through a quick “priority review”. meets.

“We’re talking literally like five months away, so we’re definitely moving forward with CMS immediately,” Cheung told CNBC in an interview on Thursday. The Centers for Medicare and Medicaid Services is the federal agency that will determine how widely Lakenbi, which Eisai puts at $26,500 per year, is covered for patients diagnosed with early-onset Alzheimer’s.

the company that developed the drug biogenIt is estimated that 100,000 people are expected to receive an early Alzheimer’s diagnosis and become eligible for LeKenbi by 2026, although 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 per day with the disease, making them ineligible for Lekembi.

Early Alzheimer’s usually affects people age 65 and older, causing cognitive impairment and other problems. Lakenby has shown promise in slowing disease progression in that population, but it carries a risk of brain swelling and bleeding.

Medicare published guidance in April 2022 that limits coverage to Alzheimer’s drugs such as Lekambi that use antibody treatments to target the plaques that cause the disease. Under Eisai’s current accelerated approval status, Medicare will only cover the costs for people in clinical trials approved by the FDA or the National Institutes of Health.

Eisai has completed its phase three trial and is no longer enrolling patients. This means that the drug is currently out of reach of most except the very wealthy. Cheung said the company isn’t aware of any patients who have managed to get LeKenbi covered through Medicare right now.

Even if it gets full approval under the FDA’s “priority review” process, Medicare can still restrict coverage to patients enrolled in research studies approved by CMS, the agency that runs Medicare and Medicaid federal health insurance programs. .

Timely response from FDA is awaited

The company filed all of its phase three data with its application for full approval in January and should hear back from the FDA in March on whether the agency will approve its application. If the agency decides to review Lekmbi’s application on priority, it may make a final decision within six months.

Medicare beneficiaries who agree to participate in CMS-supported research studies, which are broader than clinical trials, will get coverage if Lexambi receives full approval. But it’s possible that CMS could agree to broader coverage, possibly with no restrictions, if the agency determines there is a high level of evidence supporting the treatment, Cheung said.

“With a high level of evidence … the ban should be very limited, or maybe no ban at all, and that is Christian’s position,” Cheung said. “We believe that Medicare beneficiaries should have seamless, comprehensive and simple access to Lakenby because the data meets those criteria,” he added.

If Medicare continues to restrict coverage, people in rural communities will face a disadvantage as medical institutions and universities are concentrated in large cities.

This month more than 70 members of Congress met with Health Secretary Javier Becerra and CMS Administrator Chiquita Brooks-Lasur to press for loosening coverage restrictions on Lakenby to ensure greater access across the United States.

“Patients, families and caregivers living in rural and under-served areas should have equal opportunities for treatment,” the lawmakers wrote. “It is an enormous physical and financial burden for Medicare beneficiaries to spend countless hours traveling to the limited research institutions hosting the trials.”

Drug rollout will take years

If all goes as Christian hopes, the FDA will grant full approval and unrestricted coverage of CMS Lekembi. In that scenario, Eisai estimates that about 100,000 early diagnosed Alzheimer’s patients would be eligible by the third year of the drug’s rollout. Eisai said Biogen’s plant in Switzerland has sufficient manufacturing capacity.

But Cheung said the big challenge in introducing Lakenbi is that physicians are not ready to diagnose Alzheimer’s early because so few treatments exist. Cheung said CMS also needs to provide comprehensive reimbursement for clinical trials. These include PET scans, currently limited to one per lifetime, and cerebrospinal fluid tests that are reimbursed at a reduced rate, according to the company.

“Every time you have to adopt a new diagnostic procedure, it takes some time,” Cheung said. “Those diagnostic procedures need to be reimbursed, and radiologists and health care providers around the country need to start doing that. And it takes time for people to get up to speed on how to do that.” ,” They said.

Cheung said about 15% of eligible patients are under the age of 65 and most are covered through private insurance. He said private insurers are largely awaiting the CMS coverage decision, although some may decide to make their coverage decisions earlier. Eisai will provide copay assistance to those covered privately, Cheung said.

“There is more flexibility and multiple approaches to provide great access for those individuals with very little out-of-pocket cost,” the CEO said. Eisai has a program to provide Lekambi free of charge to uninsured patients who meet eligibility criteria.

Cheung said the $26,500 annual cost of Lakenby should come down over time. Right now, treatments are administered twice a month, but Eisai is developing a maintenance regimen where patients would receive a monthly dose after the first 18 months of treatment.

“It’s not approved yet. We expect to file for the maintenance dose by the end of the next fiscal year,” Cheung said. The maintenance dose would roughly halve the cost of Lekambi, he said.

Medicare under pressure

CMS said in January that it would broaden coverage if Eisai provided data that answered questions about slowing cognitive decline and potential harm from side effects such as brain bleeding.

“One thing I would like to emphasize right now is that, as you know, in this particular class, [we] “We really wanted more information as we learn what these products are going to do,” CMS Administrator Brooks-Lasur said Tuesday during a call with reporters. “But we are open to hearing new data from manufacturers and advocates.”

Eisai says data from its phase three trial answer those questions with a high level of evidence, Cheung said.

Medicare’s coverage policy is controversial. The Alzheimer’s Association called for full and unrestricted coverage of Lakenby in a letter to CMS in December. Robert Egg, the association’s chief policy officer, said this is the first time CMS has decided not to cover a future class of drugs by default.

The Medicare policy stems from the 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 advisers said the evidence does not demonstrate that it slows the disease. Three advisers resigned over the FDA’s decision. A congressional investigation in December found that Adhelm’s approval was “fraught with irregularities.”

Medicare decided last April to restrict coverage on all monoclonal antibodies that target brain plaques for the treatment of Alzheimer’s until it receives more evidence demonstrating benefit to patients.

“It’s not a fair policy because there’s no reason they have to do it based on class,” Agee said.

The American Academy of Neurology, the world’s largest body of neurologists, said in a letter to Medicare earlier this month that there is a consensus among its experts that the phase three clinical trial for Lekenbi was well designed. was performed and the data was clinically and statistically significant.

Clinical trial results published in the New England Journal of Medicine found that cognitive decline was 27% slower at 18 months in those who received Lekembi, compared to those who did not receive the treatment. But there were also safety concerns, with some patients experiencing swelling and bleeding in the brain.

According to a research paper published in the New England Journal of Medicine in January, the death of a clinical trial participant in the Chicago area may possibly be linked to lecanumab.

AAN President Dr. Orly Awitzur asked CMS to modify its coverage limits so that there would be broader access to LeKenbi if the treatment received traditional FDA approval.

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