blinatumomab (Blincyto)

following a full submission considered under the end of life and orphan equivalent process:

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

Indication under review: As monotherapy for the treatment of adults with Philadelphia chromosome negative, CD19 positive, B-precursor acute lymphoblastic leukaemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.

SMC restriction: to patients who are in first complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.

In a single arm phase II study of patients with B-cell precursor ALL in first or later complete remission and with persistent or recurrent MRD, blinatumomab was associated with clinically relevant complete MRD response rates.

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 views from a Patient and Clinician Engagement (PACE) meeting.