inotuzumab ozogamicin (Besponsa)

following a full submission assessed under the ultra-orphan and end of life medicine process:

inotuzumab ozogamicin (BESPONSA®) is accepted for restricted use within NHSScotland.

Indication under review: as monotherapy for the treatment of adults with relapsed or refractory CD22-positive B cell precursor acute lymphoblastic leukaemia (ALL). Adult patients with Philadelphia chromosome positive relapsed or refractory B cell precursor ALL should have failed treatment with at least one tyrosine kinase inhibitor.

SMC restriction: in patients for whom the intent is to proceed to stem cell transplantation.

A phase III open label randomised controlled study demonstrated improvements in remission rates and overall survival for the patient population under review when treated with inotuzumab ozogamicin compared with standard chemotherapy.

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

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