2.1 Darvadstrocel (Alofisel, Takeda) is indicated for the 'treatment of complex perianal fistulae in adult patients with non-active/mildly active luminal Crohn's disease, when fistulae have shown an inadequate response to at least 1 conventional or biologic therapy'.
Dosage in the marketing authorisation
2.2 A single dose of darvadstrocel consists of 120 million cells distributed in 4 vials. Each vial contains 30 million cells in 6 ml of suspension. The full content of the 4 vials must be administered for the treatment of up to 2 internal openings and up to 3 external openings. This means that, with a dose of 120 million cells, it is possible to treat up to 3 fistula tracts that open to the perianal area. There is currently limited experience with the efficacy or safety of repeat administration of darvadstrocel.
2.3 The list price of darvadstrocel is £13,500 per vial. One course of treatment (4 vials) costs £54,000 (company submission). The company has a commercial arrangement, which would apply if the technology had been recommended.