Eli Lilly's Alzheimer's drug Kisunla has been approved by the MHRA but not recommended by NICE

Eli Lilly's amyloid plaque drug for Alzheimer's disease (AD) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) but not recommended for use in the NHS by the National Institute of Health and Care Excellence (NICE).

Kisunla (donanemab-azbt), given as an intravenous infusion every four weeks, has been approved by the UK regulator to treat mild cognitive impairment and mild dementia due to AD in adults who have one or no copy of the apolipoprotein E4 gene. However, NICE said in draft guidance that the cost of providing the drug means it “cannot currently be considered good value for money for the taxpayer”, meaning anyone who is eligible for the drug and wants to receive it should do so privately have to pay.

An estimated 982,000 people live with dementia in the UK, with AD accounting for up to 75% of cases. The neurodegenerative disease slowly destroys memory and thinking skills and eventually the ability to perform simple tasks.

Kisunla is designed to help the body remove the excessive buildup of amyloid plaques in the brain associated with AD and is the “first and only” amyloid plaque-targeting therapy with evidence to support discontinuation of treatment, according to Lilly , when amyloid plaques are removed.

The drug's approval by the MHRA was supported by positive results from the late-stage TRAILBLAZER-ALZ 2 trial, which showed that patients treated with Kisunla had statistically significantly less clinical progression of their AD than those who received placebo.

The NICE independent committee found that the benefit was “relatively small” and that there was “significant uncertainty” about how large the benefit of Kisunla was and how long it lasted after treatment stopped. The committee also heard that clinical trials suggested there were “significant health risks” associated with the treatment.

The Health Technology Assessment Agency has now asked Lilly and NHS England to provide additional information to address areas of uncertainty in the evidence and is expected to make a final decision in 2025.

The setback came just two months after NICE declined to recommend Biogen and Eisai's AD treatment Leqembi (lecanemab), saying the drug's benefits were “too small to justify the cost”.

Fiona Carragher, chief policy and research officer at the Alzheimer's Society, described NICE's recent decision as “disheartening” but noted that “more drugs will be submitted for approval in the next few years” with around 20 AD drugs in the pipeline are in the late phase of clinical trials.