IQWiG finds added benefit for Opdivo in certain patients

The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined in a dossier assessment whether US pharma major Bristol-Myers Squibb’s (NYSE: BMY) Opdivo (nivolumab) offers an added benefit over the appropriate comparator therapy for advanced melanoma.

According to the findings, treatment-naive patients with BRAF V600 mutation-negative tumor have an advantage in overall survival. This advantage varies by sex, however. Overall, IQWiG sees an indication of considerable added benefit in men, and a hint with the extent “minor” in women. The dossier contained no evaluable data for further patient groups.

The Federal Joint Committee (G-BA), which makes final decisions, distinguished between three treatment situations in its commission: In treatment-naive patients whose tumor is BRAF V600-positive (BRAF V600 mut tumor), nivolumab was to be compared with vemurafenib. In treatment-naive patients whose tumour is BRAF V600-negative (BRAF V600 wt tumour), the G-BA specified dacarbazine or ipilimumab as appropriate comparator therapy. In pre-treated patients, the added benefit was to be assessed in comparison with treatment adapted to the individual patient at the physician’s discretion.