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Dossier assessment

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

Status
Status: Commission completed
Project no.
A21-116
Last updated

Report documents

  1. Extract of dossier assessment

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

    published on
    Document type
    PDF document, 729 kB, EN, not accessible
    Download file : Extract of dossier assessment (PDF document, 729 kB, EN, not accessible)

  2. Dossier assessment

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

    published on
    Document type
    PDF document, 345 kB, DE, not accessible
    Download file : Dossier assessment (PDF document, 345 kB, DE, not accessible)

Dossier assessment

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

Press releases

Upadacitinib in moderate to severe atopic dermatitis: high doses produce added benefit for adults

Women have to expect more frequent severe side effects than men. Due to a lack of adequate study data, an added benefit is not proven for adolescents and for the lower dose.
Press release

Project details

Project no.
A21-116
Commission
Commission awarded on 01.09.2021 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.

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