1.1 Blinatumomab is recommended as an option for treating Philadelphia-chromosome-negative CD19‑positive B‑precursor acute lymphoblastic leukaemia in adults with minimal residual disease (MRD) of at least 0.1%, only if:
the disease is in first complete remission and
the company provides blinatumomab according to the commercial arrangement.
1.2 This recommendation is not intended to affect treatment with blinatumomab that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Why the committee made these recommendations
Current treatment for acute lymphoblastic leukaemia that is in complete remission with MRD of at least 0.1% is continued chemotherapy followed by haematopoietic stem cell transplantation (HSCT) if possible. Some people with MRD can have HSCT without chemotherapy.
Evidence from 2 clinical studies suggests that blinatumomab may help increase the time people have without their disease relapsing and may lead to more disease being cured. But there are no data directly comparing blinatumomab with continued chemotherapy, with or without HSCT. This means that the exact size of the benefit of blinatumomab compared with continued chemotherapy is uncertain.
Blinatumomab meets the extension-to-life criterion, but not the short life-expectancy criterion. Therefore, blinatumomab does not meet NICE's criteria to be considered a life-extending treatment at the end of life.
There is some uncertainty about the cost effectiveness of blinatumomab compared with continued chemotherapy in people with acute lymphoblastic leukaemia with MRD because of the way survival curves are fitted to the clinical data in the new semi-Markov model. Also, there is no evidence presented about the cost effectiveness of blinatumomab in people with acute lymphoblastic leukaemia that is in second complete remission. Because no cost-effectiveness evidence for the second complete remission group is presented, no recommendation for this group can be made. However, all plausible cost-effectiveness estimates of blinatumomab compared with continued chemotherapy are within the range that NICE normally considers a cost-effective use of NHS resources. Therefore, blinatumomab is recommended for routine use in the NHS for people with Philadelphia-chromosome-negative CD19‑positive B‑precursor acute lymphoblastic leukaemia with MRD of at least 0.1% whose disease is in first complete remission.