The Committee deems that the clinical benefit is substantial for XELJANZ (tofacitinib) in the treatment of moderate to severe active ulcerative colitis for adult patients who have had an inadequate response, loss of response or intolerance to conventional treatments, at least one TNFα inhibitor and vedolizumab, and where the alternatives are less suitable.
Insufficient
The Committee deems that the clinical benefit is insufficient for XELJANZ (tofacitinib) to justify public funding in view of the alternatives available in the other MA contexts.
Clinical Added Value
no clinical added value
In view of:
the latest clinical efficacy data not affecting the assessment of efficacy versus placebo;
the lack of sound efficacy data comparing JAK inhibitors with each other or with medicinal alternatives (TNF inhibitor and vedolizumab as second-line treatment and ustekinumab as third-line treatment);
the lack of established effects on long-term quality of life (apart from upadacitinib up to 52 weeks versus placebo), on complications and referral for colectomy;
and the updated safety profile of the JAK inhibitor class, with in particular an increased risk of tumours, venous or arterial thromboembolic events and severe infections, or death, compared to TNF inhibitors, and the lack of clinical data making it possible to rule out these risks compared to medicinal alternatives.
the Committee deems that XELJANZ (tofacitinib) provide no clinical added value (CAV V) in the current therapeutic strategy of UC in adults.
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