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New HTA Decisions in England
November 2019
Drug name
BLINCYTO® (blinatumomab)
Decision date
Therapeutic area
Blood and immune system conditions
Therapeutic sub area
Blood and bone marrow cancers
Recommended with restrictions
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%
Decision Detail
Blinatumomab is only recommended if: • the disease is in first complete remission and • the company provides blinatumomab according to the commercial arrangement. The recommendation is not intended to affect treatment with blinatumomab that was started in the NHS before this guidance was published. People having treatment outside the 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.
The clinical evidence for blinatumomab came from 2 single-arm studies (BLAST and MT103‑202). The committee concluded that blinatumomab is clinically effective, but the lack of direct comparative data means the size of this benefit is still unclear. Evidence from the 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. However, 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. 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. Based on the ERG's exploratory analysis, the scenarios with a 3‑year cure point produce an ICER that falls between £21,874 and £25,551 per quality-adjusted life year (QALY) gained, although the committee were aware that there was uncertainty in these estimates. No recommendation can be made for the indication of acute lymphoblastic leukaemia that is in second complete remission due to the lack of cost-effectiveness evidence. 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.