Days after suffering a rejection in Australia, the Alzheimer’s drug hit another roadblock in the U.K., which found the drug not cost-effective.
The U.K.’s National Institute for Health and Care Excellence on Thursday again denied to recommend Biogen and Eisai’s Alzheimer’s disease therapy Leqembi, noting that its clinical benefits do not justify its price tag.
Thursday’s draft guidance also covers Eli Lilly’s Kisunla, according to a press statement. The agency explained that after a re-evaluation of additional evidence, it “has confirmed that the medicines are not currently cost effective and the committee’s recommendation remains that they should not be provided on the [National Health Service (NHS)] at this time.”
The National Institute of Health Care and Excellence (NICE) also declined to recommend Leqembi for NHS coverage in August 2024, when the Medicines and Healthcare products Regulatory Agency (MHRA) granted Leqembi marketing approval in the U.K., similarly finding that the drug’s benefits were “too small to justify the cost.” NICE’s draft guidance will now undergo consultation with stakeholders and the agency will accept comments through March 27.
With this latest rebuff from NICE, Biogen and Eisai suffer another overseas setback for their Alzheimer’s disease therapy. Earlier this week, Australia’s health regulatory authority, the Therapeutic Goods Administration, refused to overturn a previous decision to deny marketing approval for Leqembi “on the basis that the demonstrated efficacy did not outweigh the safety risks” associated with its use.
Specifically, the agency said that while patients on Leqembi saw lower disease progression versus placebo, “this difference was not deemed significant enough to provide a meaningful clinical benefit.” Nor was it sufficient to justify the risk of “frequent occurrence of amyloid-related imaging abnormalities” related to Leqembi.
In a statement following Australia’s rejection, Eisai chief clinical officer Lynn Kramer said that the company is “extremely disappointed and surprised” by the verdict, particularly as “eleven countries and regions across the globe have granted marketing authorization” to Leqembi.
The pharma is currently “exploring options” for the drug in Australia, “including potentially seeking review by the Administrative Review Tribunal,” Kramer added.
Despite winning the FDA’s first traditional approval for an anti-amyloid Alzheimer’s therapy, Leqembi has suffered from a rough roll-out in the U.S. Sales have been underwhelming enough that Eisai in November 2024 lowered its full fiscal year 2024 projections for the asset down from $370 million to $280 million.
However, Eisai reported in its most recent quarterly report last month that uptake is picking up, driven by increased amyloid-beta PET testing and better provider education. Biogen, too, pointed to the growing sales of Leqembi and is now shifting its focus to establishing its “value proposition,” CEO Chris Viehbacher said during the company’s fourth-quarter report.
Recently, the European Union’s Committee for Medicinal Products for Human Use reiterated its positive opinion on Leqembi, recommending its use in all 27 member states plus Norway, Liechtenstein and Iceland. Leqembi’s application is moving on to the European Commission, which will have the final say over its approval.
