16 August 2018 - The Department of Health and Social Care has asked NICE to produce guidance on using darvadstrocel in the NHS in England.
Darvadstrocel is not recommended, within its marketing authorisation, for previously treated complex perianal fistulas in adults who have non- active/mildly active luminal Crohn’s disease.
Darvadstrocel showed only a modest improvement in the proportion of people achieving complete remission compared with placebo in one clinical trial. Reliable follow-up results are only available for up to 1 year, so it is unclear how long the treatment benefit will last. The cost-effectiveness estimates are therefore highly uncertain and the committee was unable to conclude on the most plausible cost-effectiveness estimate.