2 Information about darvadstrocel

Marketing authorisation

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.

Price

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.