Eli Lilly’s amyloid plaque-targeting Alzheimer’s disease (AD) drug has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA), but has not been recommended by the National Institute of Health and Care Excellence (NICE) for use on the NHS.
Kisunla (donanemab-azbt), administered 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 copies 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 However, NICE said in draft guidance that the cost of providing the drug means it “cannot currently be considered good value for the taxpayer”, meaning anyone eligible for the drug who wishes to receive it will have to pay for it privately.
An estimated 982,000 people are living 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 carry out 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 stopping treatment when amyloid plaques are removed, according to Lilly.
The MHRA’s approval of the drug was supported by positive results from the late-stage TRAILBLAZER-ALZ 2 study, which showed that patients treated with Kisunla had statistically significantly less clinical progression in their AD compared to those receiving placebo.
NICE’s independent committee noted that the benefit was “relatively small” and that there are “significant uncertainties” about how much benefit Kisunla provides and how long this lasts after stopping treatment. The committee also heard that clinical trial evidence suggests that there are “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 comes just two months after NICE declined to recommend Biogen and Eisai’s AD treatment Leqembi (lecanemab), outlining that the drug’s benefits are “too small to justify the costs”.
Fiona Carragher, chief policy and research officer at Alzheimer’s Society, described NICE’s latest decision as “disheartening”, but noted that, with around 20 AD drugs in late-stage clinical trials, “more drugs will be submitted for approval within the next few years”.