Dossier assessment

Dupilumab (atopic dermatitis, 6 months to 5 years) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A23-25
Last updated

Report documents

  1. Extract of dossier assessment

    Dupilumab (atopic dermatitis, 6 months to 5 years) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 654 kB, EN, not accessible
  2. Dossier assessment

    Dupilumab (atopic dermatitis, 6 months to 5 years) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 886 kB, DE, not accessible

Dossier assessment

Indication:

Children with severe atopic dermatitis, 6 months to 5 years old, who are candidates for systemic therapy

Result of dossier assessment:
  • Children whose clinical picture is sufficiently similar to that of adults: hint of a non-quantifiable added benefit
  • Children whose clinical picture is not sufficiently similar to that of adults: added benefit not proven

Project details

Project no.
A23-25
Commission
Commission awarded on 30.03.2023 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Children's and adolescents' health
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.

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