vedolizumab (Entyvio)

following a full submission

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

Indication under review: 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 either conventional therapy or a tumour necrosis factor-alpha (TNFα) antagonist.

A higher proportion of patients treated with vedolizumab achieved a clinical response at week six and clinical remission at week 52 compared with placebo in a controlled phase III study.

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 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.

Vedolizumab is also indicated 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.  A submission for this indication is currently undergoing SMC assessment.