The UK National Institute for Health and Care Excellence (NICE) has rejected Pfizer’s new chronic myeloid leukaemia (CML) drug, Bosulif (bosutinib).
NICE chief executive Sir Andrew Dillon said there is evidence to suggest that bosutinib was considered clinically effective for the treatment of CML.
However, the manufacturer had provided limited evidence, which led to unclear comparison of bosutinib's actual benefit to other treatments in terms of the estimated effect on overall survival, Sir Andrew said.
"CML is a chronic condition, meaning the drugs will be used for a long period of time and even with the proposed patient access scheme, which reduces the overall cost of treatment, bosutinib doesn't offer enough benefit to justify its price," Sir Andrew added.
CML is a cancer of the myeloid cells, which progresses slowly over the course of several years and it is estimated that about 560 people are diagnosed in the UK each year.
Bosutinib is licensed for the treatment of CML in those for whom imatinib, nilotinib and dasatinib are not appropriate1.
Currently, NICE has recommended two drugs, imatinib and nilotinib, for treating different stages of CML.