Ozanimod (2) – Zeposia®

a) Adults with moderate to severe active ulcerative colitis who have responded inadequately to conventional therapy, no longer respond to it, or have an intolerance or contraindication.

• An additional benefit is not proven.
• To assess the additional benefit of ozanimod compared with the appropriate comparator therapy in adult patients with moderate to severe active ulcerative colitis who have responded inadequately to conventional therapy or to a biologic, no longer respond to it, or who are intolerant to such treatment, there are no suitable data available for comparing ozanimod with the appropriate comparator therapy determined by the G-BA.
• The TRUE NORTH study is therefore not suitable for assessing the additional benefit of ozanimod compared with the G-BA’s appropriate comparator therapy, as patients receiving placebo in the study did not receive active therapy in the sense of the appropriate comparator therapy.
• In the absence of directly comparable data, the pharmaceutical manufacturer is examining the possibility of conducting an adjusted indirect comparison using placebo as the bridge comparator.
• The pharmaceutical manufacturer argues, however, that the TRUE NORTH trial—which consists of an induction and a maintenance phase—is not suitable for conducting an adjusted indirect comparison for methodological reasons (including the selection and re-randomisation of ozanimod responders from the induction phase for the maintenance phase) is not suitable for conducting an adjusted indirect comparison.

b) Adults with moderate to severe active ulcerative colitis who have responded inadequately to a biologic (TNF-α antagonist, integrin inhibitor or interleukin inhibitor), have had an inadequate response to it, no longer respond to it, or are intolerant to such treatment.

• The additional benefit is not proven.
• To assess the additional benefit of ozanimod compared with the appropriate comparator therapy in adult patients with moderate to severe active ulcerative colitis who have responded inadequately to conventional therapy or to a biologic, no longer respond to it, or are intolerant to such treatment, there are no suitable data available for comparing ozanimod with the appropriate comparator therapy specified by the G-BA.
• The TRUE NORTH study is therefore not suitable for assessing the additional benefit of ozanimod compared with the G-BA’s appropriate comparator therapy, as patients receiving placebo in the study did not receive active therapy in the sense of the appropriate comparator therapy.
• In the absence of directly comparable data, the pharmaceutical manufacturer is examining the possibility of conducting an adjusted indirect comparison using placebo as the bridge comparator.
• The pharmaceutical manufacturer argues, however, that the TRUE NORTH trial—which consists of an induction and a maintenance phase—is not suitable for conducting an adjusted indirect comparison for methodological reasons (including the selection and re-randomisation of ozanimod responders from the induction phase for the maintenance phase) is not suitable for conducting an adjusted indirect comparison.
• Overall, therefore, for b) adults with moderate to severe active ulcerative colitis who have responded inadequately to a biologic (TNF-α antagonist, integrin inhibitor or interleukininhibitor) and who have an inadequate response to, no longer respond to, or are intolerant of such treatment, an additional benefit of ozanimod over the appropriate comparator therapy is not proven.
• Overall assessment
  • In summary, for b) adults with moderate to severe active ulcerative colitis who have responded inadequately to a biologic (TNF-α antagonist, integrin inhibitor or interleukin-inhibitor), no longer respond to it, or are intolerant to such treatment, additional benefit for ozanimod compared with the appropriate comparator therapy is not proven.

Courtesy translation only, please refer to the German original.