UK’s NICE says no to Pfizer’s Chronic Myeloid Leukaemia Drug Bosulif

July 17 2013 | By Márcio Barra

NICE, the UK price regulatory agency, has released this Tuesday preliminary draft guidance rejecting Pfizer’s Bosulif (bosutinib) for previously treated patients with chronic myeloid leukaemia (CML). According to the draft release, Bosulif did not represent good enough value for use in the treatment of patients, even though the drug would be provided to the UK’s NHS patients through a patient access scheme. This follows two earlier rebuffs for new cancer drugs developed by Pfizer this year: lung cancer drug Xalkori and kidney cancer drug Inlyta.

In the draft guidance released, Nice stated that despite Pfizer’s proposed patient-access scheme, which reduces the overall cost of treatment, Bosulif benefits weren’t worth the price, especially when taking in account that CML is a chronic condition.

“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” said NICE chief executive Sir Andrew Dillon, explaining the decision. He also stated that “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 This draft guidance does not mean that people currently taking bosutinib will stop receiving it.

Bosulif has been approved in Europe since April this year, after obtaining a conditional marketing authorization from the European Comission, and by in the US back in September last year.  The drug is approved for the treatment of CML on patients that have resisted other therapies,  and works blocking the signal of the tyrosine kinase that promotes the development of abnormal and unhealthy granulocytes. Other tyronase kinase inhibitors include Novartis’ Gleevec (imatinib) and Tasigna (nilotinib), or Bristol-Myers Squibb’s Sprycel (dasatinib)

Responding to NICE’s recommendation, Pfizer said it was “disappointed”, but will continue to negotiate with NICE on this matter.

“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.” said Pfizer



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