rezafungin acetate (Rezzayo)

following a full submission assessed under the orphan medicine process:

rezafungin acetate (Rezzayo®) is accepted for restricted use within NHSScotland.

Indication under review: for the treatment of invasive candidiasis in adults.

SMC restriction: use should be on the advice of local microbiologists or specialists in infectious disease.

In a randomised, double-blind, phase III study, rezafungin was non-inferior to another echinocandin for global cure at day 14 in patients with candidaemia and/or invasive candidiasis and one or more systemic signs attributable to these conditions.

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.