GSK’s leukaemia drug rejected by NICE
pharmafile | September 16, 2010 | News story | Sales and Marketing | Arzerra, GSK, NHS, NICE
GSK’s leukaemia treatment Arzerra has been rejected by NICE, which says the drug does not represent good value for the NHS.
Arzerra (ofatumumab) is for patients with chronic lymphoycytic leukaemia that is refractory to treatment with fludarabine and alemtuzumab.
Patients who are refractory to both these drugs (called ‘double refractory disease or DR) have a very poor prognosis (a median survival of eight months) and are particularly difficult to treat.
NICE calculated that treatment with Arzerra would cost on average £18,449 – nearly four times as much as ‘best supportive care’ at £4,885.
NICE’s draft guidance says the extra cost of the drug is not justified, even though it would help patients live an extra seven months on average.
NICE says GSK was asked to submit evidence of Arzerra’s effectiveness compared with best supportive care, but instead submitted data on a small sub group of patients in an ongoing clinical trial where all participants received ofatumumab.
The cost-effectiveness body says that meant a direct comparison with best supportive care was not possible, and its Appraisal Committee concluded the data didn’t show much extra time the drug may give patients compared with best supportive care.
NICE explained further that clinical experts said other studies help estimate the relative effectiveness of ofatumumab. However the Appraisal Committee concluded that preliminary data suggested survival figures were similar to the ones originally estimated by the manufacturer, and that the evidence would therefore not change its decision.
The decision is bad news for Arzerra, which was only launched in the UK in May this year. The drug has been given a conditional marketing authorisation by the EMA, which will require GSK to provide further data supporting its clinical efficacy and safety.
Consultees have the opportunity to appeal before NICE issues its final guidance to the NHS.
Andrew McConaghie
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