Dossier assessment
Lecanemab (early Alzheimer’s disease) – Benefit assessment according to §35a Social Code Book V
Report documents
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Extract of dossier assessment
Lecanemab (early Alzheimer’s disease) – Benefit assessment according to §35a Social Code Book V
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Dossier assessment
Lecanemab (early Alzheimer’s disease) – Benefit assessment according to §35a Social Code Book V
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: 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)
Press releases
Lecanemab for early-stage Alzheimer’s disease: Previously unpublished data show no added benefit
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.
IQWiG health information
The CDR ("Clinical Dementia Rating") scale is a questionnaire that doctors use to assess the degree of Alzheimer's disease in patients. Read about the kind of questions it covers and what the results mean.
IQWiG health information
Responder analyses are commonly used to statistically evaluate clinical trial data. Find out what responder analysis results can mean for patients, based on the example of treatment with lecanemab in Alzheimer's disease.
Federal Joint Committee (G-BA)
19-02-2026 A G-BA decision was published.
G-BA documents on this decision
Project details
- Project no.
- A25-111
- Commission
- Commission awarded on 28.08.2025 by the Federal Joint Committee (GBA).
- Report type
- Dossier assessment
- Status
- Commission completed
- Department/Division
- Drug Assessment
- Topic
- Head and nerves
- Note
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After completion of the assessment by IQWiG the Federal Joint Committee (GBA) 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 GBA website.
- DOI
https://doi.org/10.60584/A25-111
Connected Projects
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Addendum
Lecanemab (early Alzheimer’s disease) – Addendum to Project A25-111
Status: Commission completed