isavuconazole (Cresemba)

following a full submission considered under the orphan process

isavuconazole (Cresemba®) is accepted  for use within NHS Scotland.

Indication under review: in adults for the treatment of: 
• invasive aspergillosis 
• mucormycosis in patients for whom amphotericin B is inappropriate

A phase III, randomised, double-blind, non-inferiority study demonstrated that, in the treatment of invasive aspergillosis, isavuconazole was non-inferior to a triazole antifungal for all-cause mortality through day 42, and had a similar overall response at the end of treatment. A phase III, open-label, single-arm study demonstrated that, in the treatment of mucormycosis, isavuconazole had a treatment effect on all-cause mortality and overall response. The treatment effect was considered to be comparable to that observed in external control studies of a polyene antifungal.

This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of isavuconazole. This advice is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.

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