UK approves Kisunla for the treatment of Alzheimer’s disease but NICE …does not pay for it.

SPECIAL REPORT 24.12

On October 23, the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the licensing of Eli Lilly’s Donanemab or Kisunla for the treatment of early stage Alzheimer’s disease, but the health technology agency National Institute for Health and Care Excellence (NICE) said that the product
“does not currently demonstrate value” for the National Health Service. Under Britain’s health care system people receive free health care paid by the government if NICE considers the treatment worth the cost.

This is a kind of “Déjà Vu”. Indeed, in August the MHRA authorized BioArtic/Eisai/Biogen’s Lequembi, a similar amyloid antibody for the treatment of mild Alzheimer’s disease, and the same watchdog NICE had refused its reimbursement considering that the drug “cannot be considered good value for the taxpayer”.

NICE agreed that Kisunla “showed some evidence of efficacy in slowing down Alzheimer’s progression” but asked Eli Lilly “to provide additional information to address areas of uncertainty in the evidence”.

As a reminder its is important to recall that on July 25, the Committee for Medicinal Products for Human Use (CHMP) of the European Medecines Agency (EMA) recommended against marketing authorisation of Lequembi. It is now noteworthy to follow the handling of Eli Lilly’s donanemab or Kisunla by the EMA.

^{This document has been prepared by Jean-Claude Muller and is provided for information purposes only. The information contained herein has been obtained from sources believed to be reliable but is not warranted to be accurate or complete. The views presented are those of the author at the time of writing and are subject to change. Jean-Claude Muller has no obligation to update these opinions or the information presented.}