1.1 Darvadstrocel is not recommended, within its marketing authorisation, for previously treated complex perianal fistulas in adults with non-active or mildly active luminal Crohn's disease.
Why the committee made these recommendations
In a single clinical trial comparing remission rates for darvadstrocel and placebo, only an additional 14% of people showed a beneficial effect from darvadstrocel over and above placebo. Reliable follow‑up results are only available for up to 1 year during which time more than 50% of patients who had remission subsequently relapsed in both the darvadstrocel and placebo arms, so it is unclear how long the treatment benefit will last. The additional evidence submitted after consultation did not clarify the uncertainties around long-term benefits of darvadstrocel. The committee considered that further research in this area would be beneficial (see section 4 for further details). The cost-effectiveness estimates are therefore highly uncertain and the committee was unable to decide on the most plausible cost-effectiveness estimate. Because of this, darvadstrocel cannot be recommended for routine commissioning for treating complex perianal fistulas in people with Crohn's disease.