NICE has approved blinatumomab as a treatment option for Philadelphia chromosome-negative CD19-positive B-precursor acute lymphoblastic leukaemia (ALL) in adults with minimal residual disease (MRD) of ≥0.1%, only if the disease is in first complete remission.
This decision to recommend blinatumomab as a cost-effective use of NHS resources follows the submission of new evidence from the company during consultation on earlier draft recommendations.
The clinical evidence for blinatumomab in this setting came from the single-arm BLAST (n=116) and MT103-202 (n=20) studies. Both studies included patients with ALL in complete haematological remission with MRD. NICE remarked on the small cohort in MT103-202 and noted that the overall survival (OS) data in BLAST was immature. The committee was concerned that the single-arm design of the studies meant that the results were potentially biased. It noted that there was no evidence on the effectiveness of blinatumomab directly compared with salvage chemotherapy. The committee concluded that blinatumomab is clinically effective, but immature survival data and the lack of direct comparative data meant the size of the benefit is unclear.
The list price of blinatumomab is £2017 per 38.5 microgram vial, with an average cycle of blinatumomab costing £56,476 at the list price. However, the company has agreed to a discount under a patient access scheme.
Blinatumomab is administered by continuous intravenous infusion delivered at a constant rate using an infusion pump. A single cycle of blinatumomab treatment comprises continuous intravenous infusion at a dose of 28 micrograms/day for 28 days, followed by a 14‑day treatment-free interval.