Final NICE guidance published on Entyvio (vedolizumab), the first gut-selective treatment for ulcerative colitis

The National Institute for Health and Care Excellence (NICE) has published final Technology Appraisal Guidance (TAG) for vedolizumab (Entyvio®), the first gut-selective treatment for ulcerative colitis (UC).¹

NICE has recommended vedolizumab for use on the NHS for adults with moderately to severely active UC across its full licenced indication.¹ NICE recognised that vedolizumab is an innovative, cost effective option, which represents a step change in treatment because of its novel mode of action, providing long-term remission from symptoms, with a safety profile similar to placebo.¹

NICE has listened and responded positively to many stakeholders involved in the Health Technology Assessment of vedolizumab for UC, including people living with the condition, the patient association, Crohn's and Colitis UK, and to healthcare professionals.

Following today's publication of the NICE TAG, clinical commissioning groups have an obligation to ensure that vedolizumab is made available to appropriate patients within three months and no later than 03 September 2015.¹

About Vedolizumab (www.entyvio.co.uk)

Vedolizumab is licensed for the treatment of adults (≥18 years old) with moderately to severely active ulcerative colitis (UC) and adults (≥18 years old) with moderately to severely active Crohns Disease (CD) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or an anti-TNFα biologic.²

Vedolizumab works by binding exclusively to the α4β7 integrin, which is expressed on a sub-group of lymphocytes (a type of white blood cell) that bind to the MAdCAM-1 receptor, expressed preferentially in the gut.² By blocking the α4β7 integrin, vedolizumab selectively reduces the influx of inflammatory cells to the gut.² In clinical trials in adults with moderately to severely active UC and CD, vedolizumab was generally well tolerated and showed statistically significantly better efficacy compared to placebo across a range of endpoints.^3,4

The safety and efficacy of vedolizumab was evaluated in the GEMINITM Studies, the largest Phase 3 clinical trial programme to date evaluating both UC and CD patients in parallel.^5,6,7 In UC studies, vedolizumab has been shown to induce clinical response, remission and mucosal healing in patients with no prior anti-TNFα biological therapy exposure, as well as in those who have not responded or become intolerant to anti-TNFα therapy.³ In CD studies, vedolizumab has been shown to induce clinical remission and to produce an enhanced clinical response and a corticosteroid-free clinical remission (at week 52) in patients with no prior anti-TNFα biological therapy exposure, as well as in those who have not responded or become intolerant to prior anti-TNFα therapy.⁴ The most common side-effects were nausea, nasopharyngitis (common cold), upper respiratory tract infection, arthralgia (joint pain), pyrexia (fever), fatigue, headache, cough and infusion-related reactions.^3,4 As with other biologic treatments, there is an increased risk of infection and patients should be issued with a Patient Alert Card.²