The National Institute for Health and Care Excellence (NICE) have published a final appraisal document recommending that Amgen's acute lymphoblastic leukaemia
(ALL) treatment blinatumomab
, brand name Blincyto
▼, be made available on the NHS 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 are recommending 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.
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  %NICE_TITLE% 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 information on Blincyto
New medicines and vaccines that are under additional monitoring have an inverted black triangle symbol (▼) displayed in their package leaflet and summary of product characteristics, together with a short sentence explaining what the triangle means – it does not mean the medicine is unsafe. You should report all suspected adverse drug reactions (ADRs) for these products. ADRs can be reported by your doctor, pharmacist or online via the Yellow Card
Reporting of suspected adverse reactions
Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.
Disclaimer: This site is designed to offer information for general educational purposes only. The health information furnished on this site and the interactive responses are not intended to be professional advice and are not intended to replace personal consultation with a qualified physician, pharmacist, or other healthcare professional. We cannot provide individual medical advice. You must always seek the advice of a professional for questions related to a disease, disease symptoms, and appropriate therapeutic treatments.