Eli Lilly's Kisunla (donanemab) has been denied widespread use in the UK's National Health Service (NHS) by the National Institute for Health and Care Excellence (NICE), despite securing regulatory approval for treating Alzheimer's disease. The decision follows concerns over the drug's cost-effectiveness and uncertainties regarding its long-term clinical benefits.
Regulatory Approval and Clinical Trial Data
On October 23, the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK approved Kisunla for treating mild cognitive impairment or mild dementia due to Alzheimer's disease in some adults, mirroring the FDA's approval in July 2024. The approval was based on data from the Phase III TRAILBLAZER-ALZ 2 study (NCT04437511), which demonstrated that the monthly injection slows disease progression by four to seven months.
NICE's Concerns and Cost-Effectiveness
Despite the observed benefits, NICE concluded that there are "significant uncertainties about how much benefit donanemab provides, and how long this lasts for after stopping treatment." The committee also highlighted the need for more evidence on the clinical and cost-effectiveness of Kisunla. Helen Knight, director of medicines evaluation at NICE, stated that the cost-effectiveness estimate for donanemab is 5 to 6 times above what NICE normally considers an acceptable use of NHS resources.
In the US, Kisunla is priced at $695.65 per vial, translating to $12,522 for a six-month treatment plan and $32,000 for a 12-month plan.
Safety Considerations and Monitoring
NICE also addressed safety concerns raised during clinical trials, noting that one-third of patients experienced signs of brain swelling or brain bleeding, identified as amyloid-related imaging abnormalities (ARIAs). These concerns were previously discussed in the FDA's advisory committee meeting in June 2024. Patients in Lilly's trial underwent frequent monitoring, including MRIs at weeks 4, 12, 24, 52, and 76, along with unscheduled MRIs at the investigator's discretion. This intensive monitoring regime contributes to increased costs for payers and raises accessibility issues.
Comparison with Other Alzheimer's Therapies
Kisunla is not the only Alzheimer's therapy facing reimbursement challenges in the UK. Eisai and Biogen's Leqembi (lecanemab), also approved in the UK in August 2024, received a draft guidance from NICE leaning against reimbursement. Leqembi has an annual cost of $26,500 in the US and requires bi-weekly infusions for a minimum of 18 months. The EMA is still reviewing Kisunla, while it rejected Leqembi in July.
Both Kisunla and Leqembi are monoclonal antibodies designed to target and clear amyloid beta plaques in the brain, aiming to slow cognitive decline in early-stage Alzheimer's disease. NICE estimates that approximately 70,000 adults in England could be eligible for treatment with Kisunla.
