17 Jul 2013, BioSpectrum Bureau , BioSpectrum
Singapore: The National Institute for Health and Care Excellence (NICE), UK, has rejected Pfizer's chronic myeloid leukaemia (CML) drug Bosulif (bosutinib) for National Health System (NHS) use in first draft guidance. NICE, which evaluates cost-effectiveness of drugs for use on the NHS in England and Wales, said that the drug did not represent good enough value for use in the treatment of patients with CML.
Sir Andrew Dillon, chief executive, NICE, highlighted that the organization had already recommended Novartis' Glivec (imatinib) and Tasigna (nilotinib) for different stages of CML, and that limited NHS resources. Thus Bosulif could not be added despite Pfizer offering a discount through a patient access scheme.
Sir Andrew said that, "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."
NICE also said in a statement mentioned there were limitations in the evidence provided by Pfizer, which means that the benefit of Bosulif as compared to other treatments in terms of the estimated effect on overall survival was unclear. Regarding the draft NICE guidance for Bosulif, there is now a consultation period during which Pfizer can respond to NICE's recommendation.
Pfizer, while responding to NICE's recommendation, said that, "Despite the availability of existing treatments for CML, there remains a need for additional options for patients. During the course of CML treatment some patients may not respond, may stop responding as the disease develops resistance to the treatment, or may not be able to tolerate their therapy. In addition, some patients may have other ongoing health issues that would make it inappropriate to use one or more of the existing CML therapies."