Scottish Medicine Consortium decision on Bosulif: Briefing Note
Using its ultra-orphan decision making framework, the output from the PACE meeting, and the application of SMC modifiers, SMC accepted bosutinib for use in NHSScotland because it is an effective treatment and offers additional patient and service benefits. This SMC advice is dependent upon the continuing availability of the PAS or a list price that is equivalent or lower.
SMC has accepted bosutinib for treatment of adult patients with chronic phase, accelerated phase, and blast phase 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.
What is the evidence to support this advice?
• An analysis showed that in a subgroup of patients who could not take other tyrosine kinase inhibitors, a major cytogenetic response (a measurement that shows a large reduction in cells with the Philadelphia chromosome in the patient’s bone marrow) was achieved in 23/52 of those treated with bosutinib.
• An economic analysis compared bosutinib with best supportive care (assumed to be hydroxycarbamide). There were some uncertainties in the clinical and economic evidence presented by the submitting company.
• This SMC advice takes account of a patient access scheme (PAS) that improves the cost-effectiveness of bosutinib. A PAS is a scheme proposed by a pharmaceutical company in order to improve the cost effectiveness of a medicine and thus enable patients to receive access to new medicines that may otherwise not have been judged to be a cost-effective use of NHS resources. The proposed PAS gives a discount on the price of the medicine.
• This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting. Participants highlighted that for this very small group of patients who cannot tolerate or did not respond to other tyrosine kinase inhibitors, access to this medicine could allow them to live longer with a greater quality of life.
• Bosutinib also met a number of criteria that SMC can take into consideration in reaching a decision (known as modifiers) including the absence of other treatments of proven benefit and offering an improvement in quality of life.
• Bosutinib was considered using the ultra-orphan decision-making framework. This allows the Committee to consider the impact of the technology and the wider impact that treatment may have on patients and their family or carers.
https://www.scottishmedicines.org.uk/SMC_Advice/Advice/910_13_bosutinib_...