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The content of this website has been produced in line with the BOSULIF®▼ (bosutinib) Summary of Product Characteristics for Great Britain and is intended for Healthcare Professionals based in Great Britain. BOSULIF Prescribing Information for Great Britain and for Northern Ireland, and adverse event reporting information can be found at the bottom of the page.

Guidelines

ELN CML 2020 Guidelines​​​​​​​1

Understand the differences between the 2013 and 2020 Guideline

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NICE APPROVED​​​​​​​2

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 provided bosutinib with the discount agreed in the patient access scheme (as revised in 2016)

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** This is an optional area where footnotes can live.

Scottish Medicines Consortium (SMC)​​​​​​​3

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.

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 This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the SmPC for how to report adverse reactions.
References:
  1. Hochhaus A et al. European LeukemiaNet 2020 recommendations for treating chronic myeloid leukemia. Leukemia. 2020;34(4):966-984
  2. NICE Technology Appraisal Guidance (TA401). Bosutinib for previously treated chronic myeloid leukaemia. Available at: https://www.nice.org.uk/guidance/ta401. Published: 24 August 2016. Accessed: September 2021.
  3. SMC (910/13). Available at: https://www.scottishmedicines.org.uk/medicines-advice/bosutinib-bosulif-resubmission-91013/ Published: 9 February 2015. Accessed: September 2021.
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