IQWiG finds Opdivo (nivolumab) offers added benefit only in treatment-naive patients with melanoma BRAF V600 tumour- BMS

The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether Opdivo (nivolumab), from BMS, offers an added benefit over the appropriate comparator therapy for adults with advanced melanoma. The Federal Joint Committee (G-BA) distinguished between three treatment situations in its commission: In treatment-naive patients whose tumour is BRAF V600+, nivolumab was to be compared with vemurafenib (Zelboraf). In treatment-naive patients whose tumour is BRAF V600- (i.e. BRAF V600 wild type), the G-BA specified dacarbazine or ipilimumab (Yervoy) as appropriate comparator therapy. In pretreated patients, the added benefit was to be assessed in comparison with treatment adapted to the individual patient at the physician’s discretion.

According to the findings, treatment-naive patients with BRAF V600 wild type have an advantage in overall survival. This advantage varies by sex, however. Overall, there is an added benefit of nivolumab only in treatment-naive patients with BRAF V600 wt tumour. The results on side effects are uncertain, and it is therefore not possible to balance benefit and harm, but there is no sign that a negative impact of side effects could completely outweigh the positive impact in overall survival. IQWiG therefore sees an indication of considerable added benefit of nivolumab in comparison with dacarbazine in men, and a hint of a minor added benefit in women.