On 6 March 2025, the UK’s National Institute for Health and Care Excellence (NICE) opened a second consultation period in respect of the use of Eisai/Biogen’s Leqembi® (lecanemab) on the NHS in England for treating mild cognitive impairment (MCI) or mild dementia caused by Alzheimer’s disease. The consultation follows NICE’s draft guidance in August 2024 determining that the benefits of lecanemab were too small to warrant making the drug available on the NHS for this indication.
The closing date for comments to be provided to the evaluation committee is 27 March 2025. An evaluation committee meeting is scheduled for 14 May 2025, with publication of the decision expected in July 2025.
The UK was the first country in Europe to authorise Leqembi® in August 2024 for the treatment of MCI or mild dementia due to Alzheimer’s disease. After NICE’s draft guidance against recommending making the drug available on the NHS for this indication, in February 2025, the Scottish Medicines Consortium (SMC) similarly declined to recommend reimbursement of Leqembi® for treating early-stage Alzheimer’s disease, citing uncertainties surrounding the drug’s clinical benefits and cost-effectiveness.
Leqembi® has been approved for MCI and mild dementia due to Alzheimer’s disease in the US, Japan, China, South Korea, Hong Kong and Israel, and the UAE, and applications are under review in Brazil, Canada, India, Russia, Taiwan, Singapore, and Switzerland. While Australia’s Therapeutic Goods Administration (TGA) has declined to approve Leqembi® (lecanemab) for the treatment for early Alzheimer’s Disease, in February 2025, the CHMP reaffirmed its positive recommendation for approval of this indication.