Following a resubmission, the Scottish Medicines Consortium (SMC) has accepted Bosulif (bosutinib) for use within NHS Scotland for the treatment of adult patients with chronic phase (CP), accelerated phase (AP) and blast phase (BP) Philadelphia chromosome positive chronic myelogenous leukaemia (Ph+ CML), who have previously been treated with one or more tyrosine kinase inhibitor(s) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.1
CML patients in Scotland will now have routine, long-term access to bosutinib. Around 60 people in Scotland were diagnosed with CML in 2012, the highest number since 2007.2
Professor Mhairi Copland, Professor of Translational Haematology at the University of Glasgow said: "Today's decision provides a treatment option for eligible CML patients whose current therapies are no longer working or are causing significant side effects. The comprehensive and pragmatic approach of the SMC in evaluating treatment, including consultation with expert clinicians and patient groups, is beginning to pay dividends for patients in Scotland."
David Ryner, Chair/Trustee of the CML Support Group said: "This decision is fantastic news for eligible patients with chronic myeloid leukaemia in Scotland. The addition of the Patient and Clinical Engagement (PACE) group by the Scottish Medicines Consortium means that patients and clinicians now have more of a voice in these decisions and that can only be a positive thing in improving access to medicines for Scottish patients."
In early 2014, following direction from the Scottish Government, the SMC reformed its appraisal process in order to improve access to medicines.
Unfortunately, elsewhere in the UK patients do not have routine access to bosutinib. Patients in Wales and Northern Ireland have no routine access to the medicine and have to prove 'exceptional circumstances' to even be considered.
In England, some eligible patients can access bosutinib via the Cancer Drugs Fund (CDF), however NHS England recently announced that it would remove one of the clinical uses for bosutinib from the list meaning it soon won't be available for those specific patients.3
Pfizer is calling on UK Government to take immediate action to ensure the UK has a medicines assessment system that provides patients in all four nations with routine and fair access to the innovative medicines they need.
Ben Osborn, Head of Pfizer Oncology UK, said: "We believe that the recent changes to the Scottish Medicines Consortium are a step in the right direction in improving access to oncology treatments, such as bosutinib. However, elsewhere in the UK cancer patients are still being denied access to innovative medicines. Government needs to give a clear signal for NICE reform and act immediately to ensure a fair and sustainable solution to allow greater access to innovative medicines for patients."