Added benefit for non-pre-treated Yervoy patients in advanced melanoma not proven, says IQWiG

The German Institute for Quality and Efficiency in Health Care (IQWiG) has re-assessed the added benefit of ipilimumab, US pharma major Bristol-Myers Squibb’s (NYSE: BMY) Yervoy, this time seeing the data as uncertain.

A considerable added benefit was found for patients who had already received previous treatment. In the new dossier compiled by the drug manufacturer, the drug was now compared with the appropriate comparator therapy dacarbazine specified by the Federal Joint Committee (G-BA) also for non-pre-treated patients.

Again, the company claimed a noticeable gain in survival time and thus an added benefit. This time, the IQWiG did not concur with the interpretation: The effect was estimated on the basis of an indirect comparison of individual patient data. The data were very uncertain and, moreover, by unilaterally excluding patients with particularly unfavorable prognosis, the effect was biased in favor of ipilimumab. Hence an added benefit of ipilimumab in advanced melanoma for non-pre-treated patients is not proven.