2 The technology

2 The technology

Description of the technology

Bosutinib (Bosulif, Pfizer) is a second-generation tyrosine kinase inhibitor that inhibits Abl-kinases, including Bcr‑Abl kinase. It also inhibits the Src family kinases, which have been implicated in driving chronic myeloid leukaemia (CML) progression.

Marketing authorisation

It has a UK marketing authorisation 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) previously treated with one or more tyrosine kinase inhibitor(s) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options'.

Adverse reactions

The summary of product characteristics lists the following adverse reactions as being the most common (that is, affecting more than 1 in 20 people): thrombocytopenia, anaemia, diarrhoea, nausea, vomiting, abdominal pain, fever, rash and increased levels of liver enzymes. For full details of adverse reactions and contraindications, see the summary of product characteristics.

Recommended dose and schedule

Bosutinib is administered orally. The recommended dose is 500 mg once daily. The dose can be increased up to 600 mg if there has not been a complete haematological response by week 8 or a complete cytogenetic response by week 12.

Price

Bosutinib costs £3,436.67 for 28 × 500 mg tablets and £859.17 for 28 × 100 mg tablets (excluding VAT; British national formulary [BNF], accessed online May 2016). The average cost is £122.74 for 500 mg/day. The annual cost of bosutinib at this dose is £44,799 per patient.

The company has agreed a patient access scheme with the Department of Health. This scheme provides a simple discount to the list price of bosutinib, with the discount applied at the point of purchase or invoice. The level of the discount is commercial in confidence. The Department of Health considered that this patient access scheme does not constitute an excessive administrative burden on the NHS.

  • National Institute for Health and Care Excellence (NICE)