The maker of Alzheimer’s drug Leqembi expects full FDA approval this summer time

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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 expensive new antibody under Medicare.

US CEO Ivan Cheung said the FDA, which granted accelerated approval in January, could grant full approval as early as July if the company receives an accelerated “priority review” to show significant improvement in the early treatment of Alzheimer’s.

“We’re literally talking about maybe in five months, so we’re definitely moving urgently with CMS now,” Cheung said in an interview with CNBC on Thursday. The Centers for Medicare & Medicaid Services is the federal agency that will determine the extent to which Leqembi, priced by Eisai at $26,500 per year, is covered for patients with early-stage Alzheimer’s.

The company that helped develop the drug biogenicestimates that 100,000 people will be diagnosed early with Alzheimer’s and be 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 older progress from mild to moderate dementia due to the disease each day, making them unsuitable for Leqembi.

Early-stage Alzheimer’s typically strikes people over the age of 65 and causes cognitive impairment and other problems. Leqembi has shown promise in slowing the progression of the disease in this population, but it carries the risk of brain swelling and bleeding.

Medicare released guidance in April 2022 limiting coverage for Alzheimer’s drugs like Leqembi, which use antibody treatments to target the plaque that causes the disease. Under Eisai’s current accelerated approval status, Medicare will only pay for people in clinical trials approved by the FDA or the National Institutes of Health.

Eisai has completed its phase 3 study and is no longer accepting patients. This means the drug is currently out of the reach of most but the very wealthy. Cheung said the company is currently not aware of any patients who have managed to get Leqembi insured through Medicare.

Even if it gets full approval under the FDA’s “priority review” process, Medicare could limit coverage to patients participating in research studies approved by CMS, the agency that operates the Medicare and Medicaid state health insurance programs .

Awaiting FDA response on timing

The company submitted all of its phase three data with its submission for full approval in January and was due to hear from the FDA in March on whether the agency will accept its submission. If the agency decides to give Leqembi’s application priority consideration, it could make a final decision within six months.

Medicare beneficiaries who agree to participate in CMS-supported research studies that are broader in scope than clinical trials would receive coverage if Leqembi receives full approval. But it’s possible that CMS could agree to even broader coverage, possibly without restrictions, if the agency determines there is a high level of evidence supporting the treatment, Cheung said.

“With a high level of evidence… the restrictions should be very limited, or maybe even no restrictions at all, and that is Eisai’s position,” Cheung said. “We believe Medicare beneficiaries should have unhindered, broad and easy access to Leqembi because the data meets those criteria,” he said.

If Medicare continues to limit coverage, people in rural communities would be disadvantaged because medical facilities and universities are heavily concentrated in larger cities.

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

“Patients, families and carers living in rural and underserved areas should have an equal opportunity to access treatment,” lawmakers wrote. “It’s a tremendous physical and financial drain on Medicare beneficiaries to spend countless hours traveling to limited research facilities hosting the studies.”

Drugs will take years to market

If all goes according to Eisai’s expectations, the FDA would grant full approval and CMS would give Leqembi full coverage. In this scenario, Eisai estimates that by the drug’s third year on the market, about 100,000 early-diagnosed Alzheimer’s patients will be eligible. Eisai said there is sufficient production capacity at Biogen’s facility in Switzerland.

But Cheung said the biggest challenge in launching Leqembi is that doctors aren’t geared to diagnose early-stage Alzheimer’s because there are so few treatments. CMS must also provide broad reimbursement for diagnostic tests, Cheung said. These include PET scans, which are currently limited to one per life, and CSF testing, which the company says will be reimbursed at a low rate.

“Every time you need to use a new diagnostic method, it just takes time,” Cheung said. “These diagnostic procedures need to be reimbursed, and radiologists and healthcare providers across the country need to start doing them. And it takes a while for people to get used to how to do that,” he said.

About 15% of eligible patients are under the age of 65 and mostly privately insured, Cheung said. Private insurers are largely awaiting a CMS coverage decision, although some may choose to make their coverage decisions sooner, he said. Eisai will offer co-payment assistance to people who are privately insured, Cheung said.

“There’s more flexibility and multiple approaches to give these people very good access at a very, very low cost of ownership,” the CEO said. Eisai has a program to provide Leqembi free of charge to uninsured patients who meet eligibility criteria.

Cheung said Leqembi’s annual cost of $26,500 should decrease over time. Currently, 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 a maintenance dosing application by the end of next fiscal year,” Cheung said. Maintenance dosing would cut Leqembi’s cost by about half, he said.

Medicare under pressure

CMS said in January that it would expand coverage if Eisai provided data answering questions about Leqembi’s usefulness in slowing cognitive decline and potential harm from side effects like cerebral hemorrhage.

“One of the things I want to emphasize is, as you know, in this particular class, [we] We really wanted more information when we learned what these products will do,” CMS Administrator Brooks-LaSure said Tuesday during a call with reporters. “But we remain open to new data from manufacturers and advocates.”

Eisai says the data from its phase 3 study 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, requested full and unqualified reporting on Leqembi. Robert Egge, the association’s chief public policy officer, said it was the first time that CMS had made a pre-emptive decision not to provide standard coverage for a future class of drugs.

The Medicare policy stems from controversy surrounding Aduhelm, another Alzheimer’s antibody treatment developed by Eisai and Biogen. The FDA granted fast-track approval for this treatment in 2021, although the agency’s independent consultants said the evidence didn’t show it slowed the disease. Three consultants have resigned because of the FDA’s decision. A congressional investigation in December found that Aduhelm’s admission was “riddled with irregularities.”

Medicare decided last April to limit coverage of all monoclonal antibodies that target brain plaque for the treatment of Alzheimer’s pending more evidence demonstrating benefit for patients.

“It’s not a sensible 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 their experts agreed that the Phase 3 clinical trial for Leqembi was well designed and the data were clinically and statistically significant be.

The results of the clinical study, published in the New England Journal of Medicine, found that people who received Leqembi had 27% slower cognitive decline than those who did not receive the treatment over 18 months. But there were also safety concerns in some patients who experienced brain swelling and bleeding.

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

The President of AAN, Dr. Orly Avitzur, urged CMS to revise its coverage limitations to allow Leqembi broader access should the treatment receive traditional FDA approval.

CNBC Health & Science

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