The UK’s National Institute for Health and Care Excellence (NICE) has issued further draft guidance reaffirming its decision not to recommend the Alzheimer’s treatments Kisunla (donanemab) and Leqembi (lecanemab) for use on the National Health Service (NHS) in England.
This is the second time NICE made a decision not to approve these treatments for NHS use. Leqembi, marketed by Biogen and Eisai, was first rejected for NHS coverage in August 2024, while a negative coverage decision for Eli Lilly’s Kisunla came in October 2024.
Following a request for additional evidence, NICE’s independent appraisal committee reviewed new data but maintained its stance that the medicines are not cost-effective.
NICE stated that neither treatment provides sufficient benefit to justify the significant cost of provision and administration within the NHS.
The committee concluded that even under a managed access arrangement – where drugs are provided at a discounted price for a fixed period while additional evidence is collected – was not acceptable. “The cost-effectiveness estimates for donanemab and lecanemab remain substantially higher than we can consider an acceptable use of taxpayers’ money and NHS resources,” said NICE in the 6 March announcement.
The draft guidance has now been opened for public consultation, which will close on 27 March 2025, after which NICE will convene a third appraisal meeting to consider responses before issuing final recommendations.
Kisunla and Leqembi are both monoclonal antibodies designed to slow early cognitive decline in Alzheimer’s patients by targeting amyloid beta plaques in the brain. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved both treatments in 2024, becoming the first regulatory agency to do so.
Clinical trials have shown that the drugs modestly slow cognitive decline. Kisunla slows disease progression by four to seven months, as demonstrated in the Phase III TRAILBLAZER-ALZ 2 (NCT04437511) study, and Leqembi has been shown to slow progression by four to six months in the Phase III CLARITY AD study (NCT03887455).
However, NICE expressed concerns about the extent and durability of these benefits, as well as the high costs associated with their administration. In the US, the cost of a six- and 12-month treatment plan for Kisunla would amount to $12,522 and $32,000, respectively, as per Eli Lilly. Leqembi has an annual cost of $26,500 per year in the US, and its infusions are administered every two weeks for a minimum of 18 months.
According to GlobalData’s Pharma Intelligence Center, Kisunla is set to generate up to $1.8bn in 2030, and Leqembi is forecast to make $5.3bn in the same year.
GlobalData is the parent company of Pharmaceutical Technology.
