[A25-111] Lecanemab (early Alzheimer’s disease) – Benefit assessment according to §35a Social Code Book V

Last updated 01.12.2025

Project no.:
A25-111

Commission:
Commission awarded on 28.08.2025 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Topic:
Head and nerves

Indication:

Adults with early Alzheimer’s disease who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology

Result of dossier assessment:

Patients with a clinical diagnosis of mild cognitive impairment due to Alzheimer’s disease: added benefit not proven (based on the results of the relevant study)
Patients with a clinical diagnosis of mild dementia due to Alzheimer’s disease and lecanemab as add-on therapy to acetylcholinesterase inhibitors: added benefit not proven (based on the results of the relevant study)
Patients with a clinical diagnosis of mild dementia due to Alzheimer’s disease and lecanemab monotherapy: added benefit not proven (no relevant study)

Note:

After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) conducts a commenting procedure. This may provide supplementary information and as a result lead to a modified benefit assessment. Further information and the decision on the early benefit assessment can be found on the relevant page of the G-BA website.

DOI:

https://doi.org/10.60584/A25-111