vedolizumab (Entyvio)

following a full submission

vedolizumab (Entyvio®) is  accepted for restricted use for use within NHS Scotland.

Indication under review: for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.

SMC restriction: for the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response with, lost response to, or were intolerant to a TNFα antagonist.

In two clinical studies, more patients treated with vedolizumab achieved clinical remission at week 6 compared with placebo but the difference was only statistically significant in one study. One study included a maintenance phase, and significantly more patients treated with vedolizumab were in clinical remission at week 52 compared with placebo. 

Patients who continue treatment should be reassessed at least every 12 months to determine whether ongoing treatment is still clinically appropriate. For people in complete remission at 12 months, consider stopping vedolizumab, resuming treatment if there is a relapse.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of vedolizumab. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.