England’s National Institute for Health and Care Excellence (NICE) has given a second thumbs down to a pair of Alzheimer’s disease treatments—one from partners Biogen and Eisai and the other from Eli Lilly.
The rejections of coverage come after an independent committee considered additional clinical data on the effectiveness of the medicines, NICE explained in a note to media outlets.
“Unfortunately, this has confirmed that the medicines are not currently cost effective, and the committee’s recommendation remains that they should not be provided on the (National Health Service) at this time,” NICE wrote.
In August, NICE declined to recommend Biogen and Eisai’s Leqembi (lecanemab) for reimbursement. Three months later, NICE followed with the same decision on Lilly’s Kisunla (donanemab).
The knock-backs came shortly after both were approved by the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA).
The FDA granted an accelerated approval to Leqembi in January of 2023 and converted it to a full nod six months later. Kisunla’s FDA approval came in July of last year. Both treatments are working their way through the regulatory process in Europe.
“Lilly remains confident in the clinical efficacy and cost-effectiveness of donanemab and the value that it can bring to patients, their caregivers and to the NHS,” the company said in a statement.
Biogen did not respond immediately to a request for comment.
“The cost-effectiveness estimates for donanemab and lecanemab remain substantially higher than NICE can consider an acceptable use of taxpayers’ money and NHS resources,” the drug price watchdog wrote on Thursday. “The evidence presented so far shows neither donanemab nor lecanemab provide enough benefit to justify the substantial resources the NHS would need to commit to implement access to them, even with a managed access arrangement.”
There will be a three-week “public consultation” period on the draft guidance, followed by a third committee meeting in May to discuss final draft recommendations, NICE added.
“Lilly will continue to work closely with NICE during the consultation period ahead of a final reimbursement decision for use in the NHS,” the company added.