2 The technology

Description of the technology

Blinatumomab (Blincyto, Amgen) is a T-cell engager antibody targeting CD19 and the CD3/T-cell receptor.

Marketing authorisation

Blinatumomab is indicated for the treatment of adults with Philadelphia-chromosome-negative relapsed or refractory B-precursor acute lymphoblastic leukaemia.

Adverse reactions

The most common frequently reported adverse reactions are infusion-related reactions, infections, pyrexia, headache and febrile neutropenia. For full details of adverse reactions and contraindications, see the summary of product characteristics.

Recommended dose and schedule

Patients may have 2 cycles of treatment. A single cycle of treatment is 28 days (4 weeks) of continuous infusion. Each cycle of treatment is separated by a 14 day (2 week) treatment-free interval.

Patients who experience complete remission after 2 treatment cycles may have up to 3 additional cycles of consolidation treatment, based on an individual benefits-risks assessment.

Blinatumomab is administered at a dose of 9 micrograms per day for the first 7 days of the first cycle. All doses after that are 28 micrograms per day.

Price

Blinatumomab costs £2,017 per 38.5‑microgram vial (excluding VAT, BNF online March 2017).

The company has agreed a patient access scheme with the Department of Health. This scheme provides a simple discount to the list price of blinatumomab, with the discount applied at the point of purchase or invoice. The level of the discount is commercial in confidence. The Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS.