Disappointing decision made on availability of Darvadstrocel in Scotland

10 July 2019

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Following a similar decision last year by the National Institute for Health and Care Excellence (NICE), new stem cell treatment to treat complex perianal fistulas, darvadstrocel (Alofisel) has not been approved by the Scottish Medicines Consortium (SMC).

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

Currently there are limited treatment options for complex perianal fistulas in adults with non-active/mild Crohn’s Disease who have already tried conventional therapies (e.g. immunosuppressants / antibiotics) or biological therapies (e.g. infliximab / adalimumab) and found these have not worked for them.

Therefore, we are disappointed that the SMC has chosen not to recommend this innovative stem cell treatment which could offer hope for those affected.

People with perianal fistulas often need to have multiple surgeries as part of the healing process. This can have a huge impact both physically and psychologically. Furthermore, surgery involves risks including recurring symptoms and faecal incontinence.

The SMC has chosen not to recommend Darvadstrocel as there was not strong enough evidence from the manufacturer that the medicine is cost effective. For more information on their decision, please see the SMC website.


We are really disappointed that the SMC’s decision not to recommend this innovative treatment means that people living with perianal fistulas in another part of UK will not have this new option. We would like to thank everyone in Scotland who submitted evidence and our patient representative who attended the Patient and Clinician Engagement meeting. Although the decision was unfavourable, your honest portrayals of the difficult and sometimes gruelling nature of dealing with this condition was vital to our submission. We know there is real unmet need in this area, and we would encourage everyone affected by perianal fistulas to continue sharing the reality of their situation to encourage further research into treatment options.

Nancy Greig, Health Service Project Manager