Leqembi®(lecanemab) enters second consultation period

Posted on 6 March, 2025 - Alzheimer's Disease, Dementia

National Institute for Health and Care Excellence (NICE) makes unusual decision to convene a third committee meeting for additional consideration of lecanemab’s appraisal1,2

Although the NICE second draft guidance document did not recommend the use of lecanemab, this is not the final decision1

6 March 2025: Eisai Europe Ltd. and Biogen Idec Ltd. announced today that the National Institute for Health and Care Excellence (NICE) will convene a third appraisal committee meeting as part of its ongoing evaluation of Leqembi® (lecanemab).1 Lecanemab was authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of mild cognitive impairment (MCI) and mild dementia due to Alzheimer’s disease (AD) in adult patients that are apolipoprotein E ε4 (ApoE ε4)* heterozygotes or non-carriers on 22 August 2024.3

NICE continues to assess the cost-effectiveness of lecanemab and the associated costs of administering it to patients based on current National Health Service (NHS) services and capabilities.1,4  Following discussions with Eisai and other patient, clinical and commissioning experts, NICE has determined that further consultation is required before it finalises its guidance.1 NICE’s interim second draft guidance does not recommend lecanemab for use within the NHS in England and Wales at this time.1 However, a second consultation period has now begun which will conclude on 27 March 2025.1 The date of the third appraisal committee meeting is planned for 14 May 2025.1

“We are encouraged by NICE’s decision to convene a third committee meeting as it enables further evaluation of lecanemab and how it could be introduced to the NHS. However, today’s decision means that eligible early Alzheimer’s disease patients in England and Wales still cannot access the medicine through the NHS. Therefore, the significant unmet need for new innovative treatment options that target an underlying cause of disease progression remains,” said Nick Burgin, President & COO President Global Value & Access, Eisai EMEA. “We recognise that introducing a new class of medicine is not always straightforward; substantial changes are needed to improve Alzheimer’s disease management and lecanemab is just one part of the bigger picture. To facilitate change, the NHS will need to prioritise those impacted by dementia and consider not just individual treatment costs but diagnostic and management pathways collectively, so people living with Alzheimer’s disease can benefit from innovative treatments now and in the future.”

There is a critical need for innovative treatments to slow the progress of early Alzheimer’s disease and preserve the identity and independence of those impacted for as long as possible. While the additional delay is disappointing news for this community, we are encouraged that the dialogue to secure reimbursement for lecanemab will continue. Together with Eisai, we look forward to further discussions with NICE and NHS England to find a way to ensure that appropriate patients can access this medicine across the NHS in England and Wales.

Kylie Bromley, Biogen’s General Manager and Managing Director in the UK & Ireland

Eisai serves as the lead of lecanemab development and regulatory submissions globally with both Eisai and Biogen co-commercialising and co-promoting the product and Eisai having final decision-making authority. In the UK, Eisai and Biogen co-promote the medicine, with Eisai distributing the product as the Marketing Authorisation Holder.

*Apolipoprotein E is a protein involved in the metabolism of fats in humans. It is implicated in AD. People with only one (heterozygous) or no copy (non-carriers) of the ApoE ε4 gene are less likely to experience amyloid-related imaging abnormalities (ARIA) than people with two ApoE ε4 copies (homozygous).5 ARIA is a recognised important side effect with lecanemab that involves swelling and potential bleeding in the brain.5

: This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via Yellow Card Scheme at http://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play and Apple App store. By reporting side effects, you can help provide more information on the safety of this medicine.

References

  1. National Institute for Health and Care Excellence (NICE). 2025. Draft guidance consultation:Lecanemab for treating mild cognitive impairment or mild dementia caused by Alzheimer’s disease. Available at: https://www.nice.org.uk/guidance/indevelopment/gid-ta11220/documents. Last accessed: March 2025.
  2. Clark, S., et al. The impact of rarity in NICE’s health technology appraisals. Orphanet Journal of Rare Diseases. 2021;16(1):218.
  3. Lecanemab United Kingdom Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/product/15908. Last accessed: March 2025.
  4. National Institute for Health and Care Excellence. Technology appraisal guidance. Available at: https://www.nice.org.uk/about/what-we-do/our-programmes/nice-guidance/nice-technology-appraisal-guidance. Last accessed: March 2025.
  5. van Dyck, C.H., et al. Lecanemab in Early Alzheimer’s Disease. New England Journal of Medicine. 2023;388:9-21. https://www.nejm.org/doi/full/10.1056/NEJMoa2212948.