Eisai/Biogen’s Leqembi Gets Some Medicare Coverage Certainty In CMS Update

CMS said Medicare will cover anti-amyloid antibodies for early Alzheimer’s disease upon traditional approval from the US FDA if prescribed by doctors participating in a patient registry. 

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CMS has answered the question of whether Leqembi will be covered by Medicare upon full approval

The US Centers for Medicare and Medicaid Services (CMS) has answered a big question about Eisai Co., Ltd./Biogen, Inc.’s Leqembi (lecanemab) for early Alzheimer’s disease: Will the product garner Medicare coverage if its accelerated approval converts to full approval as expected by its 6 July action date with the US Food and Drug Administration? CMS said on 1 June that Medicare Part B will cover the costs of anti-amyloid antibodies on the same day that the FDA grants traditional approval, with one caveat.

While CMS said in its statement that it wants to make sure patients with mild cognitive impairment or early dementia caused by Alzheimer’s disease are able to access these medicines, the agency also noted Medicare Part B will cover the drugs “in appropriate settings that also support the collection of real-world information to study the usefulness of these drugs.” That means covered patients can access anti-amyloid therapies only when they are prescribed by doctors who participate in a CMS-administered registry to collect real-world data.

CMS previously issued a national coverage determination (NCD) in April 2022 that limited Medicare coverage for anti-amyloid antibodies granted accelerated approval to patients treated with the medicines in clinical trials. The NCD was issued following the FDA’s accelerated approval of Biogen/Eisai’s Aduhelm (aducanumab) in June 2021, blocking reimbursement for the vast majority of patients eligible for treatment. (Also see "How Biogen’s Aduhelm Bet Became A Commercial Bust" - Scrip, 6 Jun, 2022.)

The FDA granted accelerated approval for Leqembi on 6 January, but Eisai has said that it does not expect the product to generate significant sales in 2023 because it is not likely to be covered by Medicare until sometime after it wins full traditional approval in July. The FDA has scheduled an advisory committee meeting for 9 June to receive advice on whether Leqembi should be fully approved.

Eisai expressed some concern about the CMS plan for Medicare coverage of anti-amyloid therapies, however, pointing out in a statement given to Scrip that without knowing the design and details of the registry this requirement could limit patients’ access to Leqembi.

“Historically, registries have not equally or comprehensively served all patients, especially those in underserved communities and geographical regions that have barriers to medical care,” the company said. “Eisai looks forward to CMS releasing details that we hope confirm statements previously made by CMS and Administrator [Chaquita Brooks-]LaSure about broad access to this class of Alzheimer’s disease therapies and easy-to-use format for registries.”

The company said it will “continuously and strenuously work to ensure all appropriate patients who meet the criteria set forth in the potential new FDA label have access.”

Registry Requirement May Not Deter Doctors

CMS said in its statement that the registry will have an easy-to-use format and adhere to federal privacy laws. The agency also said the registry will be available when any product wins traditional approval, suggesting there will not be a lag between Leqembi approval and physician access to the registry.

Analysts, in notes issued on 1 June, saw the CMS decision about Medicare coverage for anti-amyloid therapies as immediately positive for Eisai and Biogen as well as their nearest-term competitor Eli Lilly and Company and other firms developing amyloid-targeting Alzheimer’s therapies. The FDA denied accelerated approval for Lilly’s donanemab earlier this year, but the company reported top-line Phase III results for its anti-amyloid candidate in May and plans a near-term filing for traditional approval. (Also see "Lilly’s Donanemab Slows Cognitive Decline; FDA Filing Imminent" - Scrip, 3 May, 2023.)

“We believe broader CMS reimbursement will be a tailwind for Eisai and Biogen but also Eli Lilly and earlier-stage players like Prothena Corporation plc among others in the anti-amyloid space given over 5 million Medicare beneficiaries suffer from AD,” William Blair’s Myles Minter wrote in a 1 June note.

Minter noted that requiring prescribers to participate in a registry should not be a substantial hurdle for doctors at specialist centers, who are most likely to prescribe Leqembi. “Patients on anti-amyloid therapy will be high touch with required MRI monitoring as per label and clinicians wanting to track cognitive outcomes in the real world given the class is not without safety risks,” such as amyloid-related imaging abnormalities (ARIA), he said.

Wells Fargo analyst Mohit Bonsal agreed that the CMS decision on Medicare coverage is “a win” for Biogen and Lilly, saying that the registry requirement should not be difficult for prescribers to navigate.

While Eisai has indicated that it was optimistic about broad Medicare coverage for Leqembi with no registry requirement, Bonsal said, the CMS statement “suggests the registry is primarily for data collection and ensuring patients meet requirements similar to Leqembi's current label. Our key question would be which physicians would be qualified under CMS standards, as Eisai's launch strategy extends into primary [care] over time.”

Guggenheim’s Yatin Suneja also singled out Biogen and Lilly as both benefitting from CMS’s Medicare decision despite the registry requirement. “We believe, indeed, that given the large enthusiasm shared by most physicians for [this] new class of drugs, most AD experts would join the registry,” Suneja said.

Minter, from William Blair, maintained his forecast for blockbuster sales of Leqembi despite the Medicare coverage caveat.

“We currently model global peak sales of just over $8bn and believe this is achievable despite any registry requirements, but does rely on success of the subcutaneous formulation for which we expect data in the first quarter of 2024,” he said.