PAN MERSEY AREA PRESCRIBING COMMITTEE PRESCRIBING POLICY STATEMENT Pan Mersey REF: PS76 FINAL Area Prescribing Committee APC BOARD DATE: 28 JAN 2015 PENDING CCG APPROVAL VEDOLIZUMAB 300mg powder for solution for infusion (Entyvio®▼) in Crohn’s Disease G R E Y The Pan Mersey Area Prescribing Committee does not currently recommend the prescribing of VEDOLIZUMAB 300mg powder for solution for infusion (Entyvio®▼) in Crohn’s disease  A NICE Technology Appraisal (TA) is currently in development that will review the use of vedolizumab for treating moderate to severe Crohn’s disease following intolerance, inadequate response or loss of response to conventional therapy or TNF alpha antagonists. This recommendation will be reviewed following publication of the TA.1  Following release of the negative Appraisal Consultation Document (ACD) for vedolizumab for treating moderately to severely active Crohn’s disease after prior therapy [ID690], NICE has received a request from the company for an extension in timings to allow for a proposed update to the Patient Access Scheme and the submission of a revised economic model to address the issues identified in the ACD.  In the meantime clinicians should continue to follow the Crohn’s disease NICE clinical guideline (CG152 October 2012) and pathway.  Infliximab and adalimumab within their licensed indications are recommended by NICE as treatment options for adults with severe active Crohn's disease whose disease has not responded to conventional therapy (including immunosuppressive and/or corticosteroid treatments), or who are intolerant of or have contraindications to conventional therapy. Infliximab or adalimumab should be given as a planned course of treatment until treatment failure (including the need for surgery), or until 12 months after the start of treatment, whichever is shorter. People should then have their disease reassessed at least every 12 months to determine whether ongoing treatment is still clinically appropriate.2 References National Institute for Health and Care Excellence. Crohn's disease (moderate to severe) – vedolizumab. Accessed 29January 2015 at: http://www.nice.org.uk/Guidance/InDevelopment/GID-TAG461 2. National Institute for Health and Care Excellence. Infliximab (review) and adalimumab for the treatment of Crohn's disease. Technology Appraisal Guidance 187. May 2010. Accessed 29 January 2015 at http://www.nice.org.uk/guidance/ta187 1. Note: Patients who are not eligible for treatment under this statement may be considered on an individual basis where their GP or consultant believes exceptional circumstances exist that warrant deviation from the rule of this policy. In this situation, follow locally defined processes. Version: 2 Review date: January 2017 (or earlier if there is significant new evidence relating to this recommendation)