Dossier assessment

Risankizumab (Crohn’s disease) - Benefit assessment according to § 35a SGB V

Status
Status: Commission completed
Project no.
A22-133
Last updated

Report documents

  1. Extract of dossier assessment

    Risankizumab (Crohn’s disease) - Benefit assessment according to § 35a SGB V

    published on
    Document type
    PDF-Dokument, 612 kB, EN, PDF
  2. Dossier assessment

    Risankizumab (Crohn’s disease) - Benefit assessment according to § 35a SGB V

    published on
    Document type
    PDF-Dokument, 791 kB, DE, PDF

Dossier assessment

Indication:

Adults with moderately to severely active Crohn’s disease

Result of dossier assessment:
  • who have had an inadequate response to, lost response to, or were intolerant to conventional therapy: added benefit not proven
  • who have had an inadequate response to, lost response to, or were intolerant to a biologic therapy (TNF-alpha antagonist or integrin inhibitor or interleukin inhibitor): added benefit not proven

Additional information

Federal Joint Committee (G-BA)

2023-06-15 A G-BA decision was published.

G-BA documents on this decision

Project details

Project no.
A22-133
Commission
Commission awarded on 21.12.2022 by the Federal Joint Committee (GBA).
Report type
Dossier assessment
Status
Commission completed
Department/Division
Drug Assessment
Topic
Digestion, metabolism and hormones
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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