NICE rules against Darvadstrocel

13 November 2018

New stem cell treatment darvadstrocel has not been approved by The National Institute for Health and Care Excellence (NICE) to treat complex perianal fistulas for use in the NHS.

Perianal fistulas in people with Crohn’s Disease can be extremely debilitating, causing intense pain and discomfort and meaning even tasks such as sitting down can be difficult.

Currently there are limited treatment options available for complex perianal fistulas in adults with non-active/mild Crohn’s Disease who have not responded to conventional therapies (e.g. immunosuppressants / antibiotics) or biological therapies (e.g. infliximab / adalimumab).

Therefore, we are disappointed that NICE has chosen not to recommend this innovative stem cell treatment which could offer hope for those affected, as the current options available to treat perianal fistulas are limited and have varying degrees of success.

People often need to undergo multiple surgeries as part of the healing process, which can have a large impact on the individual both physically and psychologically. Furthermore, surgery involves risks including recurring symptoms and faecal incontinence.

NICE has chosen not to recommend darvadstrocel as the trial evidence has not shown sufficient clinical and cost effectiveness over time. For more information on their decision, please see the NICE Final Appraisal Determination. This guidance will be considered for review in 3 years’ time. 


We are disappointed with NICE’s decision not to recommend the stem cell treatment darvadstrocel. There is significant unmet need and this treatment would offer a new option for people living with perianal fistulas alongside the debilitating nature of Crohn's Disease. We value the support of those living with a fistula and their carers who submitted evidence in response to our call out. Although darvadstrocel has not been recommended, we thank you for your evidence which helped greatly in informing our submission to NICE.

Sarah Berry,
Health Policy and Public Affairs Officer, Crohn’s & Colitis UK

NICE’s decision to deny approval for darvadstrocel highlights the need for further research into perianal fistulas and treatment options.

One such project is being undertaken at Kings College London, where researchers are looking for people to take part in a study titled CAFQoL. This is assessing the experience of patients who have lived or a living with a perianal fistula. 

This drug is currently being considered in Scotland by the Scottish Medical Consortium (SMC) and will be discussed within a Patient and Clinician Engagement (PACE) group in November.