Lilly to appeal as U.K. declines to endorse use of new Alzheimer’s drugs

Eli Lilly (NYSE:LLY) announced it would appeal a decision by the U.K. health authorities not to recommend the company’s new Alzheimer’s therapy, Kisunla, for use within the country’s state-run healthcare system due to cost concerns.

In a final draft guidance on Thursday, the National Institute for Health and Care Excellence (NICE), which sets drug policy for the U.K.’s National Health Service (NHS), said that Kisunla, as well as Biogen (NASDAQ:BIIB) and Eisai’s (OTCPK:ESALF) rival product Leqembi, shouldn’t be used within the NHS.

NICE said that following a review conducted to assess the previous negative draft recommendations, one of its independent committees has determined that the clinical benefits of the two amyloid-targeting antibodies “remain too small to justify the additional cost to the NHS.”.

Indiana-based drugmaker LLY said it plans to appeal on the basis that NICE has made an unreasonable recommendation given the data the company, clinical experts, and patient advocates have presented, Reuters reported.

In 2024, the U.K. drug regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA) approved Leqembi and Kisunla for adults with mild forms of Alzheimer’s disease. Shortly after the approvals, NICE issued draft guidance, denying the coverage for both treatments within the NHS.

“The committee’s conclusion in final draft guidance published today remains that neither drug can be recommended for treating mild cognitive impairment or mild dementia caused by Alzheimer’s disease,” the agency said.