Eli Lilly’s Alzheimer’s Drug Deemed Too Expensive for NHS Use by UK Regulator

Eli Lilly’s new Alzheimer’s treatment, donanemab, has been ruled too expensive for widespread use in the UK by the National Institute for Health and Care Excellence (NICE), following its approval by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). The decision signals that patients in the UK are unlikely to gain access to the drug through the National Health Service (NHS), despite its regulatory approval.

Donanemab, marketed under the brand name Kisunla, is the second Alzheimer’s treatment to be approved in the UK, following the earlier approval of Leqembi, a treatment developed by Eisai and Biogen. While Eli Lilly has not disclosed specific pricing for donanemab in the UK, the drug costs approximately $32,000 for a year-long treatment in the United States.

In draft guidance released alongside the approval, NICE, the body responsible for evaluating the cost-effectiveness of treatments for NHS use, expressed concerns over the high price of donanemab. “The benefit just isn’t enough to justify the additional cost to the NHS,” NICE stated in its report.

Eli Lilly responded by expressing confidence in donanemab’s value and stated that the company will collaborate with NICE during the consultation period, which is set to end on November 20.

Clinical trials of donanemab have shown that the drug can slow cognitive decline in Alzheimer’s patients by four to seven months when administered through an infusion every four weeks. However, NICE’s report highlighted that the cost-effectiveness estimate for the drug is five to six times higher than what the agency typically considers an acceptable use of NHS resources.

NICE also raised concerns about the uncertainties surrounding donanemab’s long-term benefits and how long the effects of the treatment last once it is stopped. Similar issues were raised in August when NICE deemed Leqembi, which costs $26,500 annually in the US, too expensive for NHS use in its draft guidance.

Both donanemab and Leqembi require careful monitoring of patients during treatment, adding to the challenges of making these drugs accessible within the state-run NHS. Donanemab is also currently under review by European health regulators, who rejected Leqembi earlier this year.

According to NICE, approximately 70,000 adults in England would have been eligible for donanemab treatment had it been deemed cost-effective for NHS use. The drug’s future availability in the UK now hinges on further discussions between Lilly and NICE as the consultation period continues.