Leqembi, Biogen and Eisai’s Alzheimer’s Drug, Gains UK Approval but Faces Cost-Effectiveness Hurdle

UK Approval:
Leqembi, developed by Biogen and Eisai, has been approved by the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for treating mild cognitive impairment and dementia in Alzheimer’s disease patients.

NICE's Stance:
Despite the approval, the National Institute for Health and Care Excellence (NICE) has deemed Leqembi too expensive for widespread use in the UK's National Health Service (NHS), citing that its benefits are "too small to justify the cost."

Clinical Benefits:
Leqembi provides an average of 4 to 6 months of slowing in the progression from mild to moderate Alzheimer’s disease.

Global Approvals:
Leqembi has also been approved in the US, Japan, South Korea, Israel, and China.

European Rejection:
The European Medicines Agency (EMA) declined to approve Leqembi, citing that its benefits do not outweigh the risks of serious adverse events such as amyloid-related imaging abnormalities (ARIA).

Cost-Effectiveness Concerns:
NICE highlighted the high cost of Leqembi and the need for intensive monitoring for side effects, making it not a cost-effective use of NHS resources.

Future Prospects:
Eisai is working with NICE, the Scottish Medicines Consortium (SMC), and the NHS to address uncertainties and make Leqembi available as soon as possible.