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[A26-49] Dupilumab (chronic spontaneous urticaria in children >= 2 to < 12 years) – Benefit assessment according to §35a Social Code Book V

Last updated 17.08.2026

Project no.:
A26-49

Commission:
Commission awarded on 13.05.2026 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Topic:
Skin and hair

Indication:

Children aged ≥ 2 years to < 12 years with moderate to severe chronic spontaneous urticaria (CSU) with inadequate response to histamine H1 receptor (H1) antihistamines and who are naive to anti-immunoglobulin E (IgE) therapy for CSU

Result of dossier assessment:

Added benefit not proven

Note:

After completion of the assessment by IQWiG the Federal Joint Committee (G-BA) 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 G-BA website.

DOI:

https://doi.org/10.60584/A26-49

Project no. Title Status
A17-63 Dupilumab (atopic dermatitis) - Benefit assessment according to §35a Social Code Book (SGB) V Commission completed
A19-74 Dupilumab (asthma) - Benefit assessment according to §35a Social Code Book V Commission completed
A19-75 Dupilumab (atopic dermatitis in adolescents) - Benefit assessment according to §35a Social Code Book V Commission completed
A19-96 Dupilumab (chronic rhinosinusitis with nasal polyposis) - Benefit assessment according to §35a Social Code Book V Commission completed
A20-123 Dupilumab (atopic dermatitis in children) - Benefit assessment according to §35a Social Code Book V Commission completed
A22-46 Dupilumab (severe asthma with type 2 inflammation) - Benefit assessment according to §35a Social Code Book V Commission completed
A23-23 Dupilumab (eosinophilic oesophagitis) – Benefit assessment according to §35a Social Code Book V Commission completed
A23-24 Dupilumab (prurigo nodularis) – Benefit assessment according to §35a Social Code Book V Commission completed
A24-79 Dupilumab (COPD) – Benefit assessment according to §35a Social Code Book V Commission completed
A24-117 Dupilumab (eosinophilic oesophagitis, 1 to 11 years) – Benefit assessment according to §35a Social Code Book V Commission completed
A26-50 Dupilumab (chronic spontaneous urticaria in adults and adolescents 12 years and above) – Benefit assessment according to §35a Commission completed

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