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Upadacitinib (new indication: ulcerative colitis, pretreated patients)

 

Subject:

  • Active Sustance: Upadacitinib
  • Name: Rinvoq®
  • Therapeutic area: Ulcerative colitis
  • Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

 

Time table:

  • Start: 01.09.2022
  • Publication of assessment: 01.12.2022
  • End of public hearing: 22.12.2022
  • Final decision by G-BA: middle of February 2023

 

Comparative therapy:

  1. Patients, who have had an inadequate response, no longer respond to conventional therapy, or have an intolerance or contraindication:
    - TNF-α antagonist (adalimumab or infliximab or golimumab) or vedolizumab or ustekinumab
  2. Patients, who have had an inadequate response, no longer respond, or are intolerant to a biologic (TNF-α antagonist or integrin inhibitor or interleukin inhibitor):
    - A change in therapy to vedolizumab or tofacitinib or ustekinumab or a TNF-α antagonist (adalimumab or infliximab or golimumab), in each case taking into account the marketing authorization and prior therapy(ies)