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Approval Alert: Eli Lilly’s Kisunla™ (Donanemab-azbt) UK Approved but Not Reimbursed

Oct 23, 2024

On 23 October 2024, Eli Lilly announced that its Kisunla™ (donanemab-azbt) received approval from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as a treatment for mild cognitive impairment and mild dementia due to Alzheimer’s disease in adult patients who are apolipoprotein E ε4 heterozygotes or non-carriers.  According to Eli Lilly, donanemab is the only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed.

Despite this approval, the UK’s National Institute for Health and Care Excellence (NICE) determined that it will not provide coverage of Kisunla™ on the NHS, stating that “the costs of providing donanemab…balanced against the relatively small benefit it provides to patients, means it cannot currently be considered good value for the taxpayer”.

Kisunla™ was first approved in the US (July 2024) and subsequently in Japan (September 2024) for the same indication.  With the UK approval, donanemab becomes the second drug approved by the MHRA as a disease modifying treatment for some people with early-stage Alzheimer’s disease, following the approval of Eisai/Biogen’s Leqembi® (lecanemab) in August 2024.