Approval in U.K. for new Alzheimer’s drug, but not approved for reimbursement in U.K. National Health Service

On October 23, 2024, the U.K. Medicines and Healthcare products Regulatory Agency announced approval of donanemab (Kisunla) for use in the early stages of Alzheimer’s disease. This follows FDA approval of the drug in July 2024. Donanemab is a monoclonal antibody that targets beta-amyloid protein in the brain. Eli Lilly markets the antibody which is given as an IV infusion once every four weeks. Clinical trials showed evidence that the drug slowed progression of Alzheimer’s Disease on the order of 4 to 7 months.

The same day donanemab received approval for use in the U.K., the National Institute for Health and Care Excellence (NICE) said more information was needed before the product would be approved for use in U.K.’s National Health Service. NICE raised concerns about the cost of regular infusions and monitoring for potential serious side effects as balanced against what it termed “uncertainties about how much benefit donanemab provides”. The committee acknowledged the need for new treatment options for Alzheimer’s and asked Lilly and NHS England to provide additional information.