MHRA Approves Eli Lilly's Alzheimer’s Drug Kisunla, NICE Does Not Recommend

Eli Lilly’s drug targeting amyloid plaques in Alzheimer's disease (AD), known as Kisunla (donanemab-azbt), has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) but has not gained a recommendation from the National Institute of Health and Care Excellence (NICE) for usage within the NHS. Kisunla, delivered as an intravenous infusion every four weeks, is intended for adults with mild cognitive impairment or mild dementia caused by AD, particularly those with one or no copies of the apolipoprotein E4 gene. The MHRA approved the drug for its potential to treat these conditions, while NICE expressed concerns over the drug's cost-effectiveness for taxpayers, indicating that those eligible for Kisunla would need to pay out-of-pocket to access it.

In the UK, around 982,000 individuals are affected by dementia, with AD constituting approximately 75% of these cases. This neurodegenerative disorder progressively erodes memory, cognitive skills, and the capacity to perform everyday activities. Kisunla aims to combat AD by assisting the body in removing amyloid plaques that accumulate excessively in the brain, a hallmark of the disease. According to Lilly, Kisunla is the pioneering amyloid plaque-targeting therapy with substantiated evidence allowing treatment cessation once amyloid plaques are sufficiently cleared.

The approval by MHRA was underpinned by promising results from the advanced TRAILBLAZER-ALZ 2 study. This research demonstrated that patients administered Kisunla experienced significantly slower clinical progression of their AD symptoms compared to those on a placebo. Despite these findings, NICE's independent evaluation committee highlighted that the drug's benefits were "relatively small" and raised concerns about the degree and duration of its efficacy post-treatment. Additionally, the committee pointed out significant health risks associated with the drug, as observed in clinical trials.

NICE has requested further information from Eli Lilly and NHS England to address uncertainties in the existing evidence. A final decision on Kisunla's recommendation is anticipated in 2025.

This situation follows closely on the heels of NICE's recent decision not to endorse Biogen and Eisai’s AD medication, Leqembi (lecanemab), citing an insufficient benefit-to-cost ratio. Fiona Carragher, Alzheimer’s Society’s chief policy and research officer, commented on NICE's latest ruling, describing it as "disheartening." Nonetheless, she remains optimistic, noting that approximately 20 AD drugs are currently in late-stage clinical trials, with more expected to be submitted for approval in the coming years.