Advice

following a full submission assessed under the orphan medicine process:

darvadstrocel (Alofisel®) is not recommended for use within NHSScotland.

Indication under review: For the treatment of complex perianal fistulas in adult patients with non-active / mildly active luminal Crohn’s disease, when fistulas have shown an inadequate response to at least one conventional or biologic therapy.

In a randomised, double-blind, phase III study, the rate of combined remission at week 24 was significantly higher with darvadstrocel than placebo in patients with Crohn’s disease and complex perianal fistulas.

The submitting company did not present a sufficiently robust economic analysis to gain acceptance by SMC.

This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting.

Medicine details

Medicine name:
darvadstrocel (Alofisel)
SMC ID:
SMC2115
Indication:
Treatment of complex perianal fistula(s) in adult patients with non-active/mildly active luminal Crohn’s disease (CD), when fistula(s) have shown an inadequate response to at least one conventional or biologic therapy.
Pharmaceutical company
Takeda UK Ltd
BNF chapter
Gastro-intestinal system
Submission type
Full
Status
Not recommended
Date advice published:
08 July 2019