Dossier assessment
Donanemab (early Alzheimer’s disease) – Benefit assessment according to §35a Social Code Book V
Report documents
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Extract of dossier assessment
Donanemab (early Alzheimer’s disease) – Benefit assessment according to §35a Social Code Book V
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Dossier assessment
Donanemab (early Alzheimer’s disease) – Benefit assessment according to §35a Social Code Book V
Drug assessment at a glance
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Drug assessment at a glance
Donanemab (early Alzheimer’s disease) – Benefit assessment according to §35a Social Code Book V
Dossier assessment
Adults with early Alzheimer’s disease with confirmed amyloid pathology who are ApoE ε4 non-carriers or heterozygotes
- Patients with clinically diagnosed mild cognitive impairment (MCI) due to Alzheimer’s disease: added benefit not proven
- Patients with clinically diagnosed mild dementia due to Alzheimer’s disease: added benefit not proven
Additional information
IQWiG health information
Donanemab (trade name: Kisunla) has been approved for the treatment of early-stage Alzheimer's disease in Germany since September 2025.
Federal Joint Committee (G-BA)
16-04-2026 A G-BA decision was published.
G-BA documents on this decision
Project details
- Project no.
- A25-134
- Commission
- Commission awarded on 22.10.2025 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/A25-134_en
Connected Projects
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Addendum
Donanemab (early Alzheimer’s disease) – Addendum to Project A25-134
Status: Commission completed