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.
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.
- Find out more information about living with a fistula