Eli Lilly to Appeal UK Rejection of Alzheimer’s Drug Kisunla Reimbursement

Eli Lilly (NYSE: LLY) said it will appeal a recommendation issued by the UK’s National Institute for Health and Care Excellence (NICE) that opposes reimbursement for its Alzheimer’s drug Kisunla (donanemab). The decision, which effectively prevents access through the National Health Service (NHS), was criticized by the company as unreasonable, especially in light of clinical evidence and input from medical experts and patient organizations.

Approved in the UK in 2023, Kisunla is indicated for patients with mild cognitive impairment or mild dementia caused by Alzheimer’s. The treatment works by targeting and removing amyloid beta plaques from the brain—abnormal protein deposits associated with disease progression. NICE, however, concluded the drug does not offer sufficient value for its cost, a determination that could limit its availability across the public healthcare system.

This marks the second time in less than a year that NICE has denied coverage for an amyloid-targeting Alzheimer’s drug. Leqembi (lecanemab), a similar treatment developed by Eisai (TSE: 4523) and Biogen (NASDAQ: BIIB), was also rejected in August 2023 due to concerns about price and clinical impact.

Further compounding Kisunla’s challenges, the European Medicines Agency (EMA) rejected the drug in March 2024, citing safety concerns and limited evidence of meaningful cognitive benefit. The EMA found that the drug’s ability to slow disease progression did not outweigh risks such as amyloid-related imaging abnormalities, which can include brain swelling and bleeding.

Although Kisunla and Leqembi represent a new class of disease-modifying Alzheimer’s treatments, their adoption has been limited. In the United States, logistical hurdles such as the need for PET scans, MRIs, and specialist oversight have slowed uptake. As of early 2024, fewer than 2,000 patients had started treatment with Leqembi under Medicare (Centers for Medicare & Medicaid Services, 2024).

Eli Lilly maintains that early intervention with Kisunla can reduce long-term healthcare burdens by delaying the need for intensive care and support. The company’s appeal will attempt to reverse the NICE decision and secure broader access for eligible patients across the UK.