UK Approves Eli Lilly's Alzheimer's Drug Donanemab, NICE Raises Cost Concerns

The UK’s Medicines and Healthcare products Regulatory Agency has approved Eli Lilly's new treatment for early-stage Alzheimer’s disease, donanemab, marketed under the brand name Kisunla. This makes it the second drug in the UK shown to slow the progression of Alzheimer’s. However, despite the regulatory approval, the drug faces significant hurdles to widespread use due to cost concerns.

According to a Reuters report, the UK's cost-effectiveness body, the National Institute for Health and Care Excellence (NICE), indicated that donanemab is unlikely to be made widely available through the National Health Service (NHS). In draft guidance issued the same day, NICE stated that the drug's benefits did not justify its high cost, making it unaffordable for public healthcare resources.

NICE, which assesses the cost-effectiveness of treatments for public funding, highlighted that while donanemab can slow cognitive decline by four to seven months, its price is five to six times higher than what is usually deemed an acceptable expense for the NHS. The drug is administered through infusions every four weeks, and NICE raised concerns about uncertainties regarding the extent and duration of its benefits once treatment stops.

The agency also pointed to the challenges posed by donanemab’s intensive monitoring requirements, which include regular MRI scans due to the risk of side effects such as brain swelling and bleeding. NICE had similarly rejected another Alzheimer’s drug, Leqembi, in August over cost concerns.

In the United States, donanemab is priced higher than Leqembi, costing around $32,000 for a year’s treatment, which consists of 13 infusions. In comparison, Leqembi costs $26,500 annually and requires slightly fewer MRI scans. Both treatments demand careful patient monitoring.

NICE estimates that approximately 70,000 adults in England could have been eligible for donanemab treatment. However, the agency has called for further evidence to support its use, requesting additional data from Eli Lilly and the NHS to address uncertainties. The U.S. Food and Drug Administration (USFDA) had approved the drug in July, though its competitor Leqembi has faced a slow rollout in the U.S. due to insurance and logistical challenges.

NICE experts acknowledged the need for new Alzheimer’s treatment options but emphasized that Kisunla, as it stands, does not offer good value for taxpayers. They urged Eli Lilly and the NHS to work together to resolve the outstanding concerns.