Despite CMS snub, Eisai is 'not so nervous' about Leqembi's long-term coverage prospects: US CEO

Figuring it has the backing of the pharma industry writ-large—and doubling down on the social worth of its new Alzheimer's disease drug—Eisai is playing it cool after the Centers for Medicare & Medicaid Services (CMS) rebuffed a petition to overturn coverage constraints on its new launch Leqembi and other anti-amyloid medicines.

Ultimately, when it comes to Medicare access for Leqembi, “we do not believe this has any impact,” Ivan Cheung, Eisai’s U.S. CEO and global Alzheimer’s disease officer, said during a recent sit-down interview at Eisai’s U.S. headquarters.

The Eisai exec was referring to CMS’ decision late last month to reject a petition from the Alzheimer’s Disease Association (ADA) seeking to overturn the strict reimbursement parameters around Leqembi and other anti-amyloid medicines like Aduhelm before it. 

Ivan Cheung, Eisai
US CEO Ivan Cheung (Eisai)

Under the CMS' rules, the drugs can only be covered when used in a clinical trial setting under what’s known as the “coverage with evidence development” pathway. This effectively cuts them off from most Medicare patients. The CMS made its original determination on the drug class in response to Aduhelm's controversial launch in 2021 and 2022.

The call from CMS to uphold its coverage decision for Leqembi didn’t come as a shock, Cheung said. Eisai is “not so nervous” about the new med's long-term access prospects, he added.

That’s because the company has long figured a full, traditional approval would be required before Eisai can meet its goal of achieving “broad and simple” access, Cheung reiterated.

Spurned but not surprised

Leqembi scored an accelerated approval in January, and Eisai filed for a traditional approval the very same day. Eisai believes its phase 3 trial, Clarity AD, along with its phase 2 study and long-term data on Leqembi “fully answers” CMS’ questions and qualifies as the sort of high-level evidence sought by the agency.

Even still, Cheung posited that most in the pharmaceutical industry would’ve rather seen CMS side with the ADA. That's because the CMS' so-called National Coverage Determination (NCD) is "rarely ever done for pharmaceuticals," he noted.

Beyond drugmakers, Cheung noted there are many healthcare providers who “want us to be successful with Leqembi.”

“If we are both successful, then maybe that can be a small step in a revolution for patients and families living with early Alzheimer’s disease.”

For its part, CMS said last month there wasn’t “evidence meeting the criteria for reconsideration.” That conclusion came despite new phase 3 data showing Leqembi’s ability to improve cognitive decline.

Eisai is far from done rolling out new data, according to Cheung. Later this month, the company will present more data from Clarity AD at the 2023 Alzheimer’s and Parkinson’s Diseases Conference (AD/PD) in Sweden, Cheung pointed out.

Separately, Eisai on Monday touted an analysis of Leqembi’s societal value published in the journal Neurology and Therapy. The analysis placed the yearly societal worth of Leqembi at around $19,710 to $37,351.

Leqembi's halcyon days

Eisai is still in the first phase of its slow-and-steady Leqembi launch, Cheung said. During this stage of the drug’s rollout, “there’s really one objective,” Cheung said, which is “getting ready for the full launch.”

In tandem with that goal, Eisai is ironing out the patient experience, which includes prepping of hospital systems, confirmatory diagnostic testing locations, infusion centers, monitoring sites and more. Plus, the company continues to work with those who can afford to access Leqembi in the short-term.

Eisai has placed a $26,500 price tag on Leqembi—which is less than half the cost of Eisai and Biogen’s controversial prior Alzheimer’s attempt Aduhelm. For now, patients are paying cash for the drug or receiving Leqembi through Eisai’s patient assistance program, which the company rolled out immediately after it received its accelerated nod from the FDA.

Launching in earnest

Assuming Eisai unlocks that broad and simple coverage with a full approval for Leqembi this summer, the company will enter phase 2 of the drug’s launch. Once that occurs, Eisai will start scaling up its sales and marketing efforts, plus those on the medical and market access fronts, Cheung said.

When it comes to that scale-up, Eisai will “both leverage existing resources and also bring in new talent,” he added. 

“We need to make sure that no family is left behind,” Cheung said, adding, “no eligible American senior should be discriminated against having access to Leqembi.”

Editor's note: This story has been updated to clarify that Eisai filed for full approval of Leqembi the same day it received an accelerated nod from the U.S. FDA.