The National Institute for Health and Care Excellence (NICE) have recommended Amgen's acute lymphoblastic leukaemia (ALL) treatment blinatumomab, brand name Blincyto▼, to be made available in England and Wales.
Blincyto has been approved in the EU for treating:
- a blood cancer called B-precursor acute lymphoblastic leukaemia (ALL) in patients above 1 year of age when the cancer has come back (relapsed) or has not improved with previous treatment (refractory)
- adults who have been treated for B-precursor ALL and have minimal residual disease (which means that they still have some detectable cancer cells in their body)
Blincyto is used in patients who are ‘Philadelphia-chromosome-negative’ which means that the patients’ cancer cells do not have an abnormal chromosome called the Philadelphia chromosome, and in patients who have the protein CD19 on their cancer cells (CD19-positive).
NICE have recommended blinatumomab 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% if:
- the disease is in first complete remission and
- the company provides blinatumomab according to the commercial arrangement
Commercial arrangements are agreements between the manufacturer and the NHS, usually specifying a set of conditions under which reimbursement for the medicine will be made.
You can follow developments with Blincyto by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.
Why NICE made these recommendations
Current treatment for acute lymphoblastic leukaemia that is in complete remission with minimal residual disease (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.
Blincyto was first made available in the EU in 2015. It is manufactured by Amgen.
European Medicines Agency website page for Blincyto
Links available in full article
© NICE 
Blinatumomab for treating acute lymphoblastic leukaemia in remission with minimal residual disease activity. Technology appraisal guidance [TA589]. Published date: 24 July 2019
Available from: See Link below. All rights reserved. Subject to Notice of rights
NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
The information provided by NICE was accurate at the time this article was issued.
NICE guidancce on Blincyto
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