Dossier assessment

Bimekizumab (non-radiographic axial spondyloarthritis) – Benefit assessment according to §35a Social Code Book V

Status
Status: Commission completed
Project no.
A23-62
Last updated

Report documents

  1. Extract of dossier assessment

    Bimekizumab (non-radiographic axial spondyloarthritis) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 287 kB, EN, not accessible
  2. Dossier assessment

    Bimekizumab (non-radiographic axial spondyloarthritis) – Benefit assessment according to §35a Social Code Book V

    published on
    Document type
    PDF document, 501 kB, DE, not accessible

Dossier assessment

Indication:

Adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein and/or demonstrated by magnetic resonance imaging

Result of dossier assessment:
  • Patients who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs: added benefit not proven
  • Patients who have responded inadequately or are intolerant to prior therapy with biological antirheumatic drugs: added benefit not proven

Project details

Project no.
A23-62
Commission
Commission awarded on 03.07.2023 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Muscles, bones and joints
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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