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)