OBJECTIVES: In the German HTA process the medical benefit is evaluated against an appropriate comparator, which is determined by G-BA. The aim of this study was to give an overview on the change in appropriate comparators in the Melanoma setting.

METHODS: A database containing all assessed AMNOG dossiers published until end of May 2018 was screened for Melanoma dossiers; information on appropriate comparators and added benefit was extracted for relevant dossiers.

RESULTS: Twelve relevant assessments were identified. Appropriate comparators were assigned depending on BRAF mutation status and treatment line.

Vemurafenib showed a considerable added medical benefit against Dacarbazine for patients with BRAF+ mutation. As a result, in 2013 G-BA changed the appropriate comparator for Dabrafenib from Dacarbazine to Vemurafenib. The following six assessments till 2015 were evaluated against Vemurafenib. After both Dabrafenib+Trametinib and Cobimetinib proved advantages over Vemurafenib, these drugs were added to the list of appropriate comparators for the assessments of Talimogen laherparepvec and Nivolumab+Ipilimumab in 2016.

For patients with BRAF wildtype in 2013 Ipilimumab had no added medical benefit over Dacarbazine. Still, both Dacarbazine and Ipilimumab were defined as appropriate comparator for Nivolumab and only Ipilimumab for Pembrolizumab in 2015. As both Nivolumab and Pembrolizumab were granted a considerable added medical benefit, subsequently G-BA updated the already set appropriate comparators for Talimogen laherparepvec and Nivolumab+Ipilimumab in 2016 from Ipilimumab to Nivolumab or Pembrolizumab.

In 2011, for pretreated Melanoma patients (regardless of BRAF mutation status) Ipilimumab was compared with BSC, as there was no adequate treatment available. Although Ipilimumab was granted a considerable added medical benefit, G-BA defined patient individual therapy as appropriate comparator for four drugs assessed thereafter.

CONCLUSIONS: In the field of Melanoma, the setting of appropriate comparators by G-BA is dynamic and changes quickly. G-BA takes into consideration current developments and recently published resolutions.