Log in/register to download an educational resource that provides an in-depth view of both the ELN and BSH 2020 guidelines for the management of CML in relation to a selection of TKIs. The download also summaries the key similarities and differences between both guidelines
Understand the differences between the 2013 and 2020 Guideline
BOSULIF (bosutinib) is approved as an option, within its marketing authorisation, for chronic, accelerated and blast phase Philadelphia chromosome positive chronic myeloid leukaemia in adults, when:
- they have previously had 1 or more tyrosine kinase inhibitor and
- imatinib, nilotinib and dasatinib are not appropriate and
- the company provides bosutinib with the discount agreed in the patient access scheme (as revised in 2016)
Statement from Scottish Medicines Consortium website on Bosulif
Following a re-submission considered under the ultra-orphan medicine process1:
Bosutinib (Bosulif) is accepted for use within NHS Scotland.
Indication under review: Treatment of adult patients with chronic phase (CP), accelerated phase (AP), and blast phase (BP) Philadelphia chromosome positive chronic myelogenous leukaemia (Ph+ CML) previously treated with one or more tyrosine kinase inhibitor(s) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.
Major cytogenetic response was achieved in 23/52 patients who represented “unmet medical need” within a non-comparative phase I/II study, in which the full population included 546 patients with CP, AP or BP imatinib pre-treated Ph+ CML.
This SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost-effectiveness of bosutinib. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
BSH, British Society of Haematology; CML, chronic myelogenous leukaemia; ELN, European LeukaemiaNet; TKI, tyrosine kinase inhibitor
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PP-PFE-GBR-3863. November 2021