In early 2014, the German Institute for Quality and Efficiency in Health Care (IQWiG) assessed the added benefit of ipilimumab in non-pretreated patients with advanced melanoma. The drug manufacturer claimed a noticeable increase in survival time and thus an added benefit versus dacarbazine, the appropriate comparator therapy specified by the Federal Joint Committee (G-BA). However, the indirect comparison conducted by the company was too uncertain, and the postulated effect was biased in favour of ipilimumab. Hence an added benefit was not proven.

In two addenda, the Institute now also examined updated and corrected analyses by the company as well as a possible added benefit versus a second comparator therapy. The result remained unchanged, however: An added benefit of ipilimumab is not proven for non-pretreated patients versus any of the two comparator therapies.

In October 2013, European approval was expanded to patients who have not been treated for their advanced melanoma. In a new dossier, the manufacturer subsequently also claimed an added benefit for this group versus the appropriate comparator therapy dacarbazine specified by the G-BA. IQWiG did not concur with this claim because the treatment effects presented by the manufacturer were not interpretable: The quality of the relevant indirect unadjusted comparison was too low, the results were biased in favour of ipilimumab, and not all relevant confounders were considered in the analysis.

For more details, go to: https://www.iqwig.de/en/press/press_releases/press_releases/ipilimumab_in_advanced_melanoma_added_benefit_for_non_pretreated_patients_still_not_proven.6126.html