In a final blow to Eli Lilly’s Kisunla (donanemab) and Eisai’s Leqembi (lecanemab) UK reimbursement prospects, the National Institute for Health and Care Excellence (NICE) has decided against recommending the two Alzheimer’s drugs for NHS use.
NICE, the watchdog for the NHS, said that neither drug can be recommended for treating mild cognitive impairment or mild dementia caused by Alzheimer’s disease because their benefits do not outweigh their high costs.
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Eisai shares opened 0.2% lower on June 19, the day NICE announced its final decision. The US stock market, where Eli Lilly is listed, had not yet opened at the time of writing.
The published final draft guidance means the regulator stands by initial decisions previously made to bar the medicines’ use on the NHS. There were two separate decisions for each drug in 2024, followed by another draft guidance in March 2025 after new data was submitted.
Because Kisunla and Leqembi are both approved by the Medicines and Healthcare products Regulatory Agency (MHRA), they will be available only privately.
Kisunla and Leqembi were touted as the most promising treatments to emerge from Alzheimer’s drug development in recent times. In clinical trials, they have both demonstrated ability to slow the rate of cognition and memory decline. However, side effects from the drugs can be serious, and their high cost has been a barrier to reimbursement.
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By GlobalDataIn the US, Kisunla has a list price of $695.65 per vial, which translates to about $32,000 for a year’s treatment given the monthly dosing. Meanwhile Leqembi has a yearly cost of $26,500 with dosing every two weeks.
In 2024, NHS England published a report that suggested adding the drugs to the health service roster could cost between £500m and £1bn per year. Annual costs not only include the price of the medicine, but the need for regular diagnostic scans and routine check-ups.
NICE said in a statement: “The treatments have been shown to delay progression from mild to moderate Alzheimer’s by 4-6 months but the overall costs of purchasing and administering the drug remain high and the benefits too small.”
NICE’s director of medicines evaluation Helen Knight said: “We have done everything we possibly can to try and achieve a positive outcome in our assessments of these treatments, including providing an additional opportunity for new evidence to be submitted.”
Eisai confirmed to Pharmaceutical Technology that it would appeal against this decision, adding that it “categorically stands by the clinical and cost effectiveness of lecanemab in its licensed indication.”
Eli Lilly also stated it would appeal, commenting that it “remains confident in the clinical efficacy and cost-effectiveness of donanemab.”
Professor Fiona Carragher, Alzheimer’s Society’s chief policy and research officer, said: “There is no doubt that today’s decision is a setback for people with Alzheimer’s disease. It is highly disappointing that we are in a situation where treatments that slow the progression of the condition are not available on the NHS.”
“The reality we’re faced with is that these treatments remain out of reach of both the NHS and most eligible people with Alzheimer’s disease. In other diseases like cancer, treatments have become more effective, safer and cheaper over time. It’s essential we see similar progress in dementia,” Professor Carragher added.
Despite the UK reimbursement setback, Eli Lilly and Eisai are set to generate significant money from drug sales, according to GlobalData analysis. Kisunla is forecast to hit $1.6bn in sales by 2031, while Leqembi will achieve sales of $3.8bn by the same year.
GlobalData is the parent company of Pharmaceutical Technology.
Editor’s note: This article was updated shortly after publication to include comment from Eisai and Eli Lilly.
