blinatumomab (Blincyto)

following a full submission assessed under the orphan medicine process:

blinatumomab (Blincyto®) is accepted for restricted use within NHSScotland.

Indication under review: for the treatment of adult patients with Philadelphia chromosome negative CD19-positive B-cell precursor acute lymphoblastic leukaemia (ALL) in the consolidation phase.

SMC restriction: in the frontline consolidation phase.

In a phase III study of patients with minimal residual disease negative, Philadelphia chromosome negative, B-cell precursor ALL, the addition of blinatumomab to standard of care consolidation chemotherapy significantly improved overall survival.

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.