Leqembi to get third NICE appraisal committee meeting

In what is seen as an unusual decision, the UK’s National Institute for Health and Care Excellence (NICE) says it will convene a third appraisal committee meeting as part of its ongoing evaluation of Leqembi (lecanemab), the drug’s developers, Eisai (TYO: 4523) and Biogen (Nasdaq: BIIB) announced today.

The companies noted that lecanemab was authorized 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 August 22, 2024.

The 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.  Following discussions with Eisai and other patient, clinical and commissioning experts, the NICE has determined that further consultation is required before it finalizes its guidance. The NICE’s interim second draft guidance does not recommend lecanemab for use within the NHS in England and Wales at this time. However, a second consultation period has now begun which will conclude on March 27, 2025. The date of the third appraisal committee meeting is planned for May 14, 2025.