Ozanimod (2) (Zeposia®) – Ulcerative colitis (UC), pre-treated patients

Characteristics

Start date 15.12.2021
Resolution 16.06.2022
INN Ozanimod
Brand name Zeposia®
Pharm. company Bristol-Myers Squibb GmbH & Co. KGaA
G-BA procedure ID 2021-12-15-D-769
Therapeutic area Digestive system diseases
Reason for procedure New Indication
Specialty ACT change

Indication (German)

Zeposia is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to either conventional therapy or a biologic agent.

Subpopulation Indication Comparator
a) Adults with moderate to severe active ulcerative colitis (CU) who have had an inadequate response, no longer respond to conventional therapy or have an intolerance or contraindication. A TNF-α antagonist (Adalimumab or Infliximab or Golimumab) or Vedolizumab or Ustekinumab
b) Adults with moderate to severe active ulcerative colitis (CU) 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 switch of 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 authorisation and the previous therapy(s).

9. Associated procedures



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