Maker of promising Alzheimer’s drug Leqembi expects full FDA approval this summer and expanded Medicare coverage

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 expensive new antibody under Medicare.

U.S. CEO Ivan Cheung said the FDA, which granted fast-track clearance in January, could give full approval as early as July if the company gets an expedited “priority review” to demonstrate significant improvement in the early treatment of the disease. Alzheimers.

“We’re literally talking about five months, so we’re acting urgently with CMS right now,” Cheung told CNBC in an interview Thursday. The Centers for Medicare & Medicaid Services is the federal agency that will determine how much Leqembi, which Eisai has priced at $26,500 a year, is covered for patients diagnosed with early-onset Alzheimer’s disease.

The company, which developed the drug with biogenicestimates that 100,000 people are expected to be diagnosed with Alzheimer’s early and become eligible for Leqembi 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 over progress daily from mild to moderate dementia due to the disease, making them ineligible for Leqembi.

Early-onset Alzheimer’s disease typically strikes people age 65 and older, causing cognitive impairment and other problems. Leqembi has shown promise in slowing disease progression in this population, but it carries risks of brain swelling and bleeding.

Medicare issued guidelines in April 2022 that limit coverage for Alzheimer’s drugs like Leqembi that use antibody treatments to target the plaque that causes the disease. Under Eisai’s current fast-track approval status, Medicare will only cover the costs of people participating in clinical trials approved by the FDA or the National Institutes of Health.

Eisai has completed its phase three trial and is no longer recruiting patients. This means that the drug 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 by Medicare at this time.

Even if it gains 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 administers federal programs. Medicare and Medicaid health insurance.

The company filed all of its phase three data with its application for full approval in January and should hear from the FDA in March about whether the agency will grant its application. If the agency decides to consider Leqembi’s request as a priority, it could issue a final decision within six months.

Medicare beneficiaries who agree to participate in CMS-supported research studies, which are broader than clinical trials, would get coverage if Leqembi received full approval. But it’s possible CMS will accept even broader coverage, possibly without restrictions, if the agency determines there’s a high level of evidence to support the treatment, Cheung said.

“With a high level of evidence…restrictions should be very limited, if any, and that’s Eisai’s position,” Cheung said. “We believe Medicare beneficiaries should have unfettered, broad and simple access to Leqembi because the data meets these criteria,” he said.

If Medicare continues to restrict coverage, residents of rural communities would be disadvantaged because medical institutions and universities are heavily concentrated in major cities.

More than 70 members of Congress this month called on Health Secretary Xavier Becerra and CMS Administrator Chiquita Brooks-LaSure to ease coverage restrictions on Leqembi to ensure better access across America.

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

If all goes according to Eisai’s expectations, the FDA would grant full approval and CMS would provide unlimited coverage of Leqembi. In this scenario, Eisai predicts that approximately 100,000 patients diagnosed with early-stage Alzheimer’s disease will be eligible by the third year of the drug’s rollout. Eisai said Biogen’s factory in Switzerland has sufficient manufacturing capacity.

But Cheung said the main challenge with rolling out Leqembi is that doctors are not geared towards diagnosing early Alzheimer’s disease because there are so few treatments. CMS must also provide broad reimbursement for diagnostic tests, Cheung said. These include PET scans, currently limited to one per lifetime, and cerebrospinal fluid tests which are reimbursed at a low rate, according to the company.

“Every time you have to adopt a new diagnostic procedure, it’s going to take a little time,” Cheung said. “Reimbursement needs to happen for these diagnostic procedures, and radiologists and health care providers across the country need to start doing that. And it takes a while for people to know how to do that,” he said. he declares.

About 15% of eligible patients are under the age of 65 and covered primarily by private insurance, Cheung said. Private insurers are largely waiting for a CMS coverage decision, although some may decide to make their coverage decisions sooner, he said. Eisai will offer co-payment assistance to those covered privately, Cheung said.

“There’s more flexibility and multiple approaches to providing really good access with very, very low fees for these people,” the CEO said. Eisai has a program to provide free Leqembi to uninsured patients who meet the eligibility criteria.

Cheung said Leqembi’s $26,500 annual cost should come down over time. Currently, the treatment is given 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. The maintenance dosage would cut the cost of Leqembi by about half, he said.

CMS said in January it would expand coverage if Eisai provided data answering questions about Leqembi’s benefits for slowing cognitive decline and potential damage from side effects such as brain hemorrhages.

“One of the things I just want to emphasize is that, as you know, in this particular class, [we] I really wanted to get 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 continue to be open to new data from manufacturers and advocates.

Eisai says the data from its phase three trial answers these 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 policy director, said it was the first time CMS had preemptively decided not to cover a future class of default drugs.

The Medicare policy stems from the controversy surrounding Aduhelm, another antibody treatment for Alzheimer’s disease developed by Eisai and Biogen. The FDA granted fast-track approval for this treatment in 2021 despite the agency’s independent advisers saying the evidence did not show it slowed the disease. Three advisers resigned following the FDA’s decision. A congressional investigation in December found that Aduhelm’s endorsement was “riddled with irregularities.”

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

“It’s not a reasonable policy because there’s no reason why they had to do it 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 was consensus among its experts that the phase three clinical trial for Leqembi was well designed and that the data were clinically and statistically significant.

The results of the clinical trial, published in the New England Journal of Medicine, revealed that cognitive decline was 27% slower over 18 months in people who received Leqembi compared to those who did not receive the treatment. But there were also safety concerns with some patients suffering from brain swelling and bleeding.

The death of a clinical trial participant in the Chicago area may also be linked to lecanemab, according to a research letter published in the New England Journal of Medicine in January

AAN President Dr. Orly Avitzur has asked CMS to revise its coverage limits so that there is broader access for Leqembi if the treatment receives traditional FDA approval.