Lecanemab (Leqembi®). HTA ID: 24052

Assessment Status NCPE Assessment Process Complete
HTA ID 24052
Drug Lecanemab
Brand Leqembi®
Indication Lecanemab (Leqembi®) is indicated for the treatment of adult patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease (Early Alzheimer’s disease) who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology.
Assessment Process
Rapid review commissioned 19/12/2024
Rapid review completed 28/01/2025
Rapid review outcome A full HTA is recommended to assess the clinical effectiveness and cost effectiveness of lecanemab compared with the current standard of care.
Full HTA commissioned by the HSE 29/05/2025
Pre-submission consultation with Applicant 02/07/2025
Full submission received from Applicant 13/01/2026
Preliminary review sent to Applicant 10/04/2026
NCPE assessment re-commenced 08/06/2026
Follow-up to preliminary review sent to Applicant 29/06/2026
NCPE assessment re-commenced 20/07/2026
Factual accuracy sent to Applicant 04/09/2026
NCPE assessment re-commenced 11/09/2026
NCPE assessment completed 13/10/2026
NCPE assessment outcome The NCPE recommends that lecanemab for the treatment of adult patients, with a clinical diagnosis of Early Alzheimer’s disease (mild cognitive impairment or mild dementia due to Alzheimer’s disease), who are APOE ε4 non-carriers or heterozygotes with confirmed amyloid pathology, not be considered for reimbursement.

The assessment was paused on 11 May 2026 at the request of the Applicant.

Summary

Plain English Summary

 

*Next steps: The NCPE Assessment Report and recommendation and Patient Organisation submission, will be considered by the HSE when making their decision on reimbursement, while also having regard to the criteria specified in the Health Pricing and Supply of Medical Goods Act 2013.

Further information on this process may be found here.

Please see the HSE Pricing and Reimbursement Tracker for any updates on the reimbursement status of this drug.

HSE Pricing and Reimbursement Tracker