NICE rejects Bosulif
pharmafile | November 28, 2013 | News story | Sales and Marketing | CML, NHS, NICE, Pfizer, bosulif
In a blow for Pfizer NICE has categorically rejected the manufacturer’s Bosulif as a treatment for previously-treated chronic myeloid leukaemia (CML).
The final guidance means the drug will not be considered an option for NHS patients suffering from the disease – even though Pfizer offered a discount on the list price of £44,799 per year through a patient access scheme.
The bad news had been on the cards since NICE’s draft guidance came to the same conclusion in the summer, but Pfizer has clearly not been able to convince the watchdog of Bosulif (bosutinib)’s cost-effectiveness or survival benefit since.
“CML is a chronic condition, meaning the drugs will be used for a long period of time,” said NICE chief executive Sir Andrew Dillon. “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.”
Even though the drug is considered clinically effective in CML, Dillon blamed Pfizer for not giving NICE’s appraisal committee enough to go on.
“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,” he said.
Pfizer submitted data from a trial called Study 200, a single-arm study in which only a small proportion of people met the licensed indication for Bosulif, NICE explained.
The committee found that the available data for the comparators was limited and that there was ‘great uncertainty’ around how comparable the data were to Study 200.
It decided that – while there were indicative data on the survival of patients receiving Bosulif and the comparator treatments – “the relative treatment effect between bosutinib and the comparators was subject to uncertainty”.
CML is a cancer of the myeloid cells which develops slowly over many years and is estimated to affect about 560 people, whose median age at diagnosis is 60, in the UK each year.
Bosulif is licenced to treat the disease in patients for whom Novartis’s Glivec (imatinib) and Tasigna (nilotinib), or Bristol-Myers Squibb’s Sprycel (dasatinib), are not appropriate.
NICE currently recommends Glivec and Tasigna for treating different stages of CML – although not Sprycel due to cost issues.
Adam Hill
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