Negative NICE appraisal of Pfizer's Bosulif for CML

UK drug watchdog the National Institute for Health and Care Excellence (NICE) has issued final guidance that does not recommend US pharma giant Pfizer’s (NYSE: PFE) Bosulif (bosutinib) for previously treated chronic myeloid leukemia.

Bosulif received conditional approval from the European Medicines Agency earlier this year for the treatment of adult patients with chronic phase (CP), accelerated phase (AP) and blast phase (BP) Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) previously treated with one or more tyrosine kinase inhibitor(s) (TKIs) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options, and was cleared in the USA in 2012 (The Pharma Letter March 28). Under the terms of conditional approval, Pfizer committed to generating additional efficacy and safety data.

Chronic myeloid leukemia (CML) develops slowly, over the course of many years and it is estimated that about 560 people are diagnosed in the UK each year. The median age at diagnosis is 60 years.

Commenting on the final guidance, Sir Andrew Dillon, the NICE’s chief executive, said: “CML is a chronic condition, meaning the drugs will be used for a long period of time. Unfortunately, even with the proposed patient access scheme, which reduces the overall cost of treatment, bosutinib doesn’t offer enough benefit to justify its price. Although there is evidence to suggest that bosutinib can be considered to be clinically effective for the treatment of CML, limitations in the evidence provided by the manufacturer meant that the actual benefit compared to other treatments in terms of the estimated effect on overall survival was unclear. This meant that the independent Appraisal Committee could not recommend it as an appropriate use of NHS resources.”

This guidance does not mean that people currently taking bosutinib will stop receiving it. They have the option to continue treatment until they and their clinicians consider it appropriate to stop.

Price structure