Addendum

Donanemab (early Alzheimer’s disease) – Addendum to Project A25-134

Report documents

Indication:

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

Result of dossier assessment:

Patients with clinically diagnosed mild cognitive impairment (MCI) due to Alzheimer’s disease: unchanged after addendum: added benefit not proven
Patients with clinically diagnosed mild dementia due to Alzheimer’s disease: unchanged after addendum: added benefit not proven

16-04-2026 A G-BA decision was published.
G-BA documents on this decision

Project no.: A26-29
Commission: Commission awarded on 10.03.2026 by the Federal Joint Committee (GBA).
Report type: Addendum
Status: Commission completed
Department/Division: Drug Assessment
Topic: Head and nerves
Note: 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/A26-29_en

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