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Dossier assessment

Dupilumab (chronic spontaneous urticaria in adults and adolescents 12 years and above) – Benefit assessment according to §35a

Status
Status: Commission completed
Project no.
A26-50
Last updated

Report documents

  1. Extract of dossier assessment

    Dupilumab (chronic spontaneous urticaria in adults and adolescents 12 years and above) – Benefit assessment according to §35a

    published on
    Document type
    PDF document, 169 kB, DE, not accessible
    Download file : Extract of dossier assessment (PDF document, 169 kB, DE, not accessible)

  2. Dossier assessment

    Dupilumab (chronic spontaneous urticaria in adults and adolescents 12 years and above) – Benefit assessment according to §35a

    published on
    Document type
    PDF document, 601 kB, DE, not accessible
    DOI-Link
    https://doi.org/10.60584/A26-50
    Download file : Dossier assessment (PDF document, 601 kB, DE, not accessible)

Drug assessment at a glance

  1. Drug assessment at a glance

    Dupilumab (chronic spontaneous urticaria in adults and adolescents 12 years and above) – Benefit assessment according to §35a

    published on
    Document type
    PDF document, 197 kB, EN, not accessible
    Download file : Drug assessment at a glance (PDF document, 197 kB, EN, not accessible)

Dossier assessment

Indication:

Adults and adolescents 12 years and above 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

Project details

Project no.
A26-50
Commission
Commission awarded on 13.05.2026 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Skin and hair
Note

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/A26-50

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