[A21-116] Upadacitinib (atopic dermatitis) - Benefit assessment according to §35a Social Code Book V

Last updated 01.12.2021

Project no.:
A21-116

Commission:
Commission awarded on 01.09.2021 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Skin and hair

Indication:

Moderate to severe atopic dermatitis in adults and adolescents 12 years and older who are candidates for systemic therapy

Result of dossier assessment:
  • Adult women for whom 30 mg is the appropriate dose: hint of considerable added benefit
  • Adult men for whom 30 mg is the appropriate dose: hint of major added benefit
  • Adults for whom 15 mg is the appropriate dose: added benefit not proven
  • Adolescents (12-17 years of age): 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.

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