[A21-155] Filgotinib (ulcerative colitis) - Benefit assessment according to §35a Social Code Book V

Last updated 20.05.2022

Project no.:
A21-155

Commission:
Commission awarded on 01.12.2021 by the Federal Joint Committee (G-BA).

Report type:
Dossier assessment

Status:
Commission completed

Department/Division:
Drug Assessment

Application field:
Digestion, metabolism and hormones

Indication:

Adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or are intolerant to either conventional treatment or a biologic drug

Result of dossier assessment:
  • adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or have intolerance or contraindications to conventional treatment: added benefit not proven
  • Adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or are intolerant to treatment with a biologic drug (TNFα antagonist or integrin inhibitor or interleukin inhibitor): 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.

The current version 2.0 of the dossier assessment replaces version 1.0 published on 2022-03-01.

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