Scottish Medicine Consortium (SMC)
Advice: following a full submission assessed under the ultra-orphan and end of life medicine process:
- inotuzumab ozogamicin (BESPONSA®) is accepted for restricted use within NHS Scotland.
- 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 NHS Scotland or a list price that is equivalent or lower.
- This advice takes account of views from a Patient and Clinician Engagement (PACE) meeting
PP-INO-GBR-0308. May 2020