Anatomy of a launch: As Leqembi takes first steps, Eisai maps Alzheimer's med's rollout

After Aduhelm’s implosion out the gate back in 2021, Eisai is taking a slow-and-steady approach with the launch of its second amyloid-busting Alzheimer’s disease med Leqembi.

The main goal during the first phase of the launch is to “ensure market readiness” ahead of a potential full approval at the FDA, Ivan Cheung, Eisai’s global Alzheimer’s disease officer, said on a briefing call Monday. 

The same day Eisai scored its accelerated nod in early January, the company filed for a full, traditional approval for Leqembi, which will be needed to counter a strict national coverage determination handed down by the Centers for Medicare & Medicaid Services (CMS) in 2022.  

But, in the meantime, “we will make every effort to support healthcare providers and patients for those who are able to access Leqembi,” Cheung said.

Eisai rolled out its patient assistance program for the $26,500-a-year Leqembi “immediately after” receiving its accelerated approval from the FDA on Jan. 6, Cheung explained.

Commercial availability of Leqembi kicked off sooner than expected, with the first batch of vials arriving at the warehouse on Jan. 17, the executive added. The first sales of Leqembi were logged the very next day on Jan. 18.

Inaugural Leqembi prescriptions followed on Jan. 23, with the first patient infusion taking place earlier this month on Feb. 3, Cheung said.

For now, patients are receiving the drug under the assistance program or “paying cash,” he noted.

Attempting to avoid the same pricing pitfalls as Aduhelm, Eisai has strived for transparency when it comes to Leqembi’s cost. In turn, the company was able to “go straight to the important clinical discussions” when talking to payers in the U.S. about its new med, Cheung said.

Back in 2021, Aduhelm rolled out an initial list price of $56,000 a year, irking the public along with one of Eisai and Biogen’s closest allies, the Alzheimer’s Association.

In Leqembi’s case, meanwhile, Eisai is prioritizing access by “accelerating” its efforts with payers, Cheung said. That includes working with CMS to "establish broad and simple Medicare access to Leqembi.”

Eisai has also been working on coverage through Veterans Affairs, having had “several productive engagements” that could lead to wider Leqembi access even before potential receipt of a full, traditional approval from the FDA.

Overall, fiscal year 2023 will be “critical” for Eisai and Leqembi, Cheung said, highlighting myriad approval and launch milestones on the horizon.

First and foremost, assuming the FDA grants priority review to the company’s supplemental filing for Leqembi, the drug could snare a full, traditional approval and “broader coverage from the CMS in the summer of this year,” Cheung said.

Elsewhere, Leqembi is looking at potential approvals in Japan by the middle of the fiscal year, and by the end of the financial period—which concludes March 31, 2024—in Europe and China.