The Committee deems that the clinical benefit of OMVOH 300 mg solution for injection and OMVOH 100 mg solution for injection (mirikizumab) is moderate in the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to conventional therapy, at least one prior TNFα antagonist and vedolizumab.
Insufficient
The Committee deems that the clinical benefit of OMVOH 300 mg solution for injection and OMVOH 100 mg solution for injection (mirikizumab) is insufficient to justify public funding +/- in view of the available alternatives in the other MA situations.
Clinical Added Value
no clinical added value
Considering:
the methodological quality of the two pivotal studies (controlled, randomised, double-blind, relevant choices of outcome measures including bowel urgency affecting quality of life, sample size), but given that the choice of placebo is regrettable, particularly in patients with no prior biologic therapy, and that the efficacy was assessed in a heterogeneous population including biologic therapy-naive (majority) and non-naive patients;
demonstration of the superiority of mirikizumab compared to placebo, with an at best moderate effect size on clinical remission;
the lack of evidence of an effect on recourse to colectomy and on quality of life,
the lack of comparative data versus TNFα antagonists in patients having responded inadequately to a conventional disease-modifying therapy and with no prior TNFα antagonist therapy, and versus vedolizumab (ENTYVIO), despite these comparisons being possible;
and the good safety profile of mirikizumab.
The Committee deems that OMVOH 300 mg solution for injection and OMVOH 100 mg solution for injection (mirikizumab)provide no clinical added value (CAV V) in the current care pathway.
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