Dossier assessment

Dupilumab (asthma) - Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A19-74
Last updated

Report documents

  1. Extract of dossier assessment

    Dupilumab (asthma) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 241 kB, EN, not accessible
  2. Dossier assessment

    Dupilumab (asthma) - Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 646 kB, DE, not accessible

Dossier assessment

Indication:

Adolescents and adults with inadequately controlled severe asthma with type 2 inflammation who are already receiving high-dose inhaled corticosteroids and at least 1 other medicinal product for maintenance treatment

Result of dossier assessment:

Added benefit not proven due to lack of suitable study data

Project details

Project no.
A19-74
Commission
Commission awarded on 29.08.2019 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Airways and respiratory system
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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