NICE backs Amgen's Blincyto in rare leukaemia

Amgen’s Blincyto (blinatumomab) should receive National Health Service funding in a rare form of leukaemia, NICE has said – and commissioners have also okayed its use in a paediatric blood cancer.

NICE said in its final draft guidance that Blincyto can be funded in its licensed use, for previously treated Philadelphia-chromosome-negative acute lymphoblastic leukaemia (ALL) in adults, after Amgen agreed a confidential discount.

Following publication of the document, England’s Cancer Drugs Fund (CDF) will reimburse Blincyto until NICE issues final guidance mandating regular funding from the NHS. This is in line with new arrangements for the CDF.

NICE noted that Blincyto extends overall survival by around 3.7 months compared with standard chemotherapy, according to findings of the phase 3 TOWER trial.

There is a degree of uncertainty about the drug’s long-term benefits, NICE noted, saying that trial data gathered so far shows there are very few patients alive after 15 months.

NICE said that the NHS will have to spend £49,150 per Quality Adjust Life Year gained in patients who had not had previous salvage therapy – the patient group showing the best response to Blincyto.

This is above the £30,000 per QALY maximum spend allowed in most situations, but NICE in this case allowed more leeway under arrangements for end-of-life therapies.

And the latest version of the list of drugs reimbursed by the CDF shows that Blincyto will also be available in paediatric ALL under specialised commissioning arrangements.

This is in accordance with a phase 2 trial protocol, as Blincyto is not licensed for use in children. The funding allows for a maximum of five cycles of therapy.

NICE is not publicising its decisions in the build-up to the general election because of purdah restrictions.

Blincyto was the first bispecific antibody, binding to two different receptors. It works by binding with a CD3 on cancer-killing T-cells, and with the CD19 site on the target malignant B-cell. This directs the immune system to act against the cancer cell.