[A26-01] Lecanemab (early Alzheimer’s disease) – Addendum to Project A25-111

Last updated 19.02.2026

Project no.:
A26-01

Commission:
Commission awarded on 13.01.2026 by the Federal Joint Committee (G-BA).

Report type:
Addendum

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: Unchanged after addendum: 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: Unchanged after addendum: 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: Unchanged after addendum: added benefit not proven (no relevant study)
Note:

If the need for additional work on a project commissioned by the G-BA arises during consultations, then IQWiG presents a report in the form of an "addendum". The G-BA subsequently decides on the extent of the added benefit, thus completing the early benefit assessment.

DOI:

https://doi.org/10.60584/A26-01

informedhealth.org logo Accompanying information

Further information for consumers and patients is provided on IQWiG's health information website www.informedhealth.org.

Federal Joint Committee (G-BA)

19-02-2026 A G-BA decision was published.
G-BA documents on this decision

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