following a full submission assessed under the orphan medicine process:
imlifidase (Idefirix®): accepted for use within NHSScotland.
Indication under review: for desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. The use of imlifidase should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.
In a phase II study, imlifidase reduced donor specific antibodies and converted positive crossmatch to negative in highly sensitised patients awaiting kidney transplantation from a deceased donor.
This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Medicine details
- Medicine name:
- imlifidase (Idefirix)
- SMC ID:
- SMC2445
- Indication:
Desensitisation treatment of highly sensitised adult kidney transplant patients with positive crossmatch against an available deceased donor. The use of imlifidase should be reserved for patients unlikely to be transplanted under the available kidney allocation system including prioritisation programmes for highly sensitised patients.
- Pharmaceutical company
- Hansa Biopharma
- BNF chapter
- Malignant disease and immunosuppression
- Submission type
- Full
- Status
- Accepted
- Date advice published
- 12 September 2022