Addendum
Lecanemab (early Alzheimer’s disease) – Addendum to Project A25-111
Report documents
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Addendum
Lecanemab (early Alzheimer’s disease) – Addendum to Project A25-111
Dossier assessment
Adults with early Alzheimer’s disease who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes with confirmed amyloid pathology
- 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)
Additional information
IQWiG health information
Lecanemab (trade name Leqembi) has been available in Germany since September 2025 for the treatment of early-stage Alzheimer's disease. To find out whether someone can have treatment with this medication, an accurate diagnosis and special tests are needed first.
Federal Joint Committee (G-BA)
19-02-2026 A G-BA decision was published.
G-BA documents on this decision
Project details
- Project no.
- A26-01
- Commission
- Commission awarded on 13.01.2026 by the Federal Joint Committee (GBA).
- Report type
- Addendum
- Status
- Commission completed
- Department/Division
- Drug Assessment
- Topic
- Head and nerves
- Note
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If the need for additional work on a project commissioned by the GBA arises during consultations, IQWiG submits an addendum. The subsequent decides on the extent of the added benefit concludes the early benefit assessment.
- DOI
https://doi.org/10.60584/A26-01_en
Connected Projects
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Dossier assessment
Lecanemab (early Alzheimer’s disease) – Benefit assessment according to §35a Social Code Book V
Status: Commission completed