NICE Rejects Alzheimer’s Drug Kisunla Despite UK Regulatory Approval

NICE Decision:
The National Institute for Health and Care Excellence (NICE) has refused to approve the Alzheimer's drug donanemab (sold as Kisunla by Eli Lilly) for NHS use due to concerns over clinical and cost effectiveness.

Regulatory Approval:
Despite NICE's rejection, the Medicines and Healthcare products Regulatory Agency (MHRA) has granted the drug a licence, allowing it to be available privately.

Efficacy:
Research indicates that donanemab can slow the progression of Alzheimer’s disease by 35% in the early stages, but NICE considers the benefit too small to justify the additional cost to the NHS.

Cost Concerns:
The cost-effectiveness of donanemab is estimated to be five-to-six times above what NICE would usually consider an acceptable use of NHS resources.

Impact:
Approximately 70,000 people could benefit from the drug if it were approved for NHS use. Alzheimer’s Research UK has expressed disappointment and called for leadership to address the issue.

Future Considerations:
NICE has asked NHS England and Eli Lilly to provide more evidence to address areas of uncertainty, with a final decision expected next year.