The National Institute for Health and Care Excellence issued preliminary draft guidance Tuesday recommending against NHS reimbursement of Pfizer's Bosulif (bosutinib) for patients with previously treated chronic myeloid leukaemia (CML). The oral, once-daily, kinase inhibitor gained conditional approval from European regulators in March for use in adults with chronic phase, accelerated phase and blast phase Philadelphia chromosome positive CML.
NICE's chief executive Andrew Dillon noted that "although there is evidence to suggest that [Bosulif] was considered clinically effective...limitations in the evidence...meant that the actual benefit compared to other treatments in terms of the estimated effect on overall survival was unclear." Dillon remarked that as CML is a chronic condition, drugs will be used for a long time. He added "even with the proposed patient access scheme, which reduces the overall cost of treatment, [Bosilif] doesn't offer enough benefit to justify its price."
Bosulif is approved for the treatment of CML in those for whom Novartis' Glivec (imatinib) and Tasigna (nilotinib) and Bristol-Myers Squibb's Sprycel (dasatinib) are not appropriate. Dillon noted that NICE already recommends Glivec and Tasigna "for treating different stages of CML.
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