OBJECTIVES: To ensure an assessment process of highest quality, the proposed guidelines of the European Network for Health Technology Assessment (EUnetHTA) have been assembled based on input from various HTA bodies of the member states. However, it is unclear to which degree these guidelines overlap with existing and presumably differing guidelines from the member states and if recommendations from particular member states are better represented. This induces some uncertainty for pharmaceutical companies regarding the assessment and acceptance of some methods. Our aim was to identify similarities between the EUnetHTA guidelines and guidelines from one member state, Germany, regarding direct and indirect comparisons.

METHODS: We listed recommendations for direct and indirect comparisons presented in the practical and methodological guidelines of the EUnetHTA (D4.3.1/D4.3.2). In a qualitive approach, we compared these recommendations to those stated in the method paper version 6.1 of the German HTA body (IQWiG).

RESULTS: We found a high degree of similarity between the proposed guidelines and the recommendations of the IQWiG method paper. We found a high correspondence between the guidelines for both direct and indirect comparisons. However, we also identified recommendations in the EUnetHTA guidelines, that were not stated in the method paper, e.g. population-adjusted methods.

CONCLUSIONS: Given the high degree of similarity between the guidelines of EUnetHTA and IQWiG, the overall assessment process seems to be in agreement with existing guidelines from the German side. Therefore, benefit assessments might run into similar problems as experienced during the German dossier process, i.e., a low acceptance of indirect comparisons.