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.