According to a recently released collection of papers (dossier) by the Institute for Quality and Efficiency in Health Care (IQWiG), use of the drug Nivolumab (trade name: Opdivo) may be clinically beneficial for male patients who are treatment-naïve (never underwent treatment) and have BRAF V600 mutation-negative melanoma tumors.
About the Institute for Quality and Efficiency in Health Care
The IQWiG is set up as an advisory organization to provide Germany’s Federal Joint Committee with the needed information to make objective and evidence-based decisions on policies relating to health care and drug availability. According to German law, insurance funds must cover any service that is medically necessary; therefore, it is important that cost-effective analysis be used to ensure the effectiveness of drugs that are prescribed to limit the potential for financial waste on pharmaceuticals that are either inferior or have a cheaper equivalent alternative that is already available.
The Dossier compared and evaluated the following treatment protocols for the Federal Joint Committee:
- Treatment-naive patients whose tumor is BRAF V600-positive: nivolumab was compared with vemurafenib.
- Treatment-naive patients whose tumor is BRAF V600-negative: the G-BA specified dacarbazine or ipilimumab as an appropriate comparative therapy.
- Pretreated patients: the added benefit was assessed in comparison with treatment adapted to the individual patient at the physician’s discretion.
After a systematic review of the available evidence within the primary literature the findings included:
- Data from one randomized controlled trial (RCT), which compared nivolumab with dacarbazine, only for treatment-naive patients with BRAF V600 tumor, showing that patients in the nivolumab arm survived longer.
- Treatment advantage in the RCT varied by gender, with men having a greater survival advantage when compared to women in the same treatment arm.
- The data available to evaluate potential side effects and possible adverse events was sparse; therefore, the IQWiG could not make any recommendations to the Federal Joint Committee on safety advantages for the drugs that were compared in the evaluation.
- In light of the limited adverse event data, the IQWiG did conclude that there was no sign of a negative effect in side events that could completely outweigh the positive effect in overall survival.
After evaluation by the IQWiG it is now the responsibility of Germany’s Federal Joint Committee to make a final decision on the extent of Nivolumab’s added benefit for treatment-naïve male patients with BRAF V600 mutation-negative melanoma tumors.