England’s Drug-Cost Watchdog Rejects Eli Lilly’s Alzheimer’s Drug
Regulator cited significant uncertainties about the drug’s benefits and high costs to treat its severe side effects
England’s drug-cost regulator rejected Eli Lilly’s Alzheimer’s drug for use in the country’s public health system, marking the second time a treatment for the disease has been deemed too costly.
The U.K.’s Medicines and Healthcare products Regulatory Agency approved the drug, donanemab, on Wednesday. Simultaneously however, the National Institute for Health and Care Excellence said the treatment wasn’t good value for money to the taxpayer and rejected it for use in the National Health Service. The independent committee, known as NICE, decides on reimbursement for the public health system in England.
It attributed its decision to what it called significant uncertainties about the drug’s benefits to patients, in addition to high costs to treat its severe side effects.
Clinical trials showed that the U.S. pharma giant’s monthly injection—also known as Kisunla—slowed early-stage Alzheimer’s by four to seven months through the reduction of amyloid proteins. Patients experienced side effects of brain swelling and bleeding that would require extensive monitoring in hospital, NICE said. It is estimated that around 70,000 people would have been eligible for Eli Lilly’s treatment in England, it added.
The health watchdog said it asked the company to provide further information on the drug as it will make a final decision on Nov. 20.
Eli Lilly said it would continue to work closely with NICE during the consultation period ahead of the final decision.
“Lilly remains confident in the clinical and cost-effectiveness of donanemab and the value that it can bring to patients and to the NHS,” a spokesman for Eli Lilly said.
NICE’s decision follows a prior rejection of Japanese Eisai and U.S. Biogen’s Alzheimer’s treatment lecanemab, despite being approved for use in the U.K.