Late last week, an Alzheimer’s patient received the first commercial dose of the recently approved drug Leqembi, marking an important milestone in the treatment’s launch.
Leqembi and its lead developer, the Japanese pharmaceutical firm Eisai, secured what’s known as an accelerated approval from the Food and Drug Administration on Jan. 6. In the month since then, the drug has had its first U.S. sale, on Jan. 18, its first prescription written, on Jan. 23, and its first administration, on Feb. 3, according to an earnings report Eisai issued Monday.
Eisai said it is still actively engaging with payers, including Medicare, the government insurance program that covers the vast majority of patients who are eligible for Leqembi.
Currently, the agency which oversees Medicare has a policy in place strictly limiting coverage of Alzheimer’s medicines like Leqembi that come to market through accelerated approvals. This policy proved to be a major challenge for Aduhelm, a drug from Biogen and Eisai that, in June 2021, became the first Alzheimer’s treatment to get an accelerated approval from the FDA. Despite huge expectations, Aduhelm has so far made very little money for its developers, which have scrapped their commercial support for the drug.
Given the example set by Aduhelm, analysts believe Leqembi will need to obtain full or traditional approval before it can generate significant sales.
Eisai is already working toward that goal, having submitted Leqembi for full approval the same day the FDA granted it accelerated clearance. The company’s application hinges on results from a large clinical trial that enrolled nearly 1,800 patients with early Alzheimer’s disease and found the cognition and function of those given Leqembi as opposed to a placebo declined 27% slower over an 18-month period.
Ivan Cheung, CEO of Eisai’s U.S. subsidiary Eisai Inc., said during a call with investors Monday that Leqembi could receive full approval and broader Medicare coverage as soon as this summer, if the FDA agrees to an expedited review. Eisai estimates Medicare covers around 85% of eligible U.S. patients with early Alzheimer’s.
Cheung also said many stakeholders have responded well to how Eisai set and disclosed Leqembi’s price, which in the U.S. is $26,500 per year for the average eligible patient.
In announcing the price, Eisai took the unusual step of detailing the math and models it used to assess Leqembi’s value. The company ultimately determined its drug had a per-patient societal value of $37,600; but, by setting the price lower, Eisai claimed it was trying to “promote broader patient access, reduce overall financial burden, and support health system sustainability.”
Leqembi’s price hasn’t sat well with everyone, however. With roughly 6 million Alzheimer’s patients in the U.S. alone, there are concerns the drug could strain healthcare budgets if enough patients seek it out. A prominent watchdog of drug costs, the Institute for Clinical and Economic Review, previously concluded that Leqembi’s annual price would need to be in the range of $8,500 to $20,600 in order to be considered cost-effective.
“With something as big as Alzheimer’s disease for Medicare, even at a value-based price there would be real burden on the budget,” David Rind, ICER’s chief medical officer, said in a January interview.
Outside the U.S., Eisai has filed for marketing authorization in Japan and the European Union, and begun the process of submitting an approval application in China.
Eisai previously said it expects uptake of Leqembi will be gradual, though some on Wall Street view that guidance as conservative. Analysts generally anticipate that the drug will drive billions of dollars in annual sales at its peak, provided it gets broader coverage from insurers.