Favourable opinion for reimbursement only in the treatment of patients 16 years of age and older with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response, or were intolerant to conventional therapy, at least one prior TNFα antagonist and vedolizumab.
Unfavourable opinion for reimbursement in the other situations covered by the MA indication.
Clinical Benefit
Moderate
The clinical benefit of VELSIPITY 2 mg film-coated tablets is moderate in the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response, lost response, or were intolerant to conventional therapy, at least one prior TNFα antagonist and vedolizumab.
Insufficient
The clinical benefit of VELSIPITY 2 mg film-coated tablets is le alternatives in the other MA situations.
Clinical Added Value
no clinical added value
Considering:
data from the two pivotal phase 3 studies, ELEVATE UC12 and ELEVATE UC52, which, although comparative and randomised, were conducted versus placebo, despite the fact that a comparison of etrasimod (VELSIPITY 2 mg film-coated tablets) with a clinically relevant comparator both as second-line treatment (TNFα antagonist, vedolizumab) and as third-line treatment (in particular, ustekinumab) would have been possible but was not conducted by the pharmaceutical company, and the unusual conduct of just one study in maintenance therapy,
the absence of efficacy and safety data enabling estimation of the relative efficacy and potential contribution of VELSIPITY 2 mg film-coated tablets (etrasimod) compared to these clinically relevant comparators,
the inadequately established efficacy of etrasimod (VELSIPITY 2 mg film-coated tablets) in patients requiring third-line treatment and for whom the pharmaceutical company is requesting funding (exploratory analysis in a small subgroup),
the safety profile of etrasimod (VELSIPITY 2 mg film-coated tablets) established on the basis of limited exposure,
the Committee deems that VELSIPITY 2 mg film-coated tablets provides no clinical added value (CAV V) in the current care pathway.
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