OBJECTIVES Identify correlations between Brazil’s ‘Câmara de Regulação do Mercado de Medicamentos’ (CMED), Germany’s ‘Gemeinsamer Bundesausschuss’ (G-BA) and France’s ‘Haute Autorité de Santé’ (HAS) decision-making process by comparing the assessments of recently-launched oncology treatments.

METHODS A total of 22 oncology therapies were selected for the assessment using the following filters: FDA registration between 2013 - 2017, EMA registration, ANVISA registration and availability of G-BA / HAS / CMED scores for the same indication. The categories received and the number of competitors available at time of assessment were compared. For the assessment, CATEGORY I (Brazil), ASMR I – III (France) and ‘ERHEBLICH – NICHT QUANTIFIZIERBAR’ (Germany) were considered relatable categories that demonstrate significant improvement vs. Standard of Care (SoC), while CATEGORY II (Brazil), ASMR IV – V (France) and ‘NICHT BELEGT – GERINGER’ (Germany) were considered categories that demonstrate non-superiority vs. SoC.

RESULTS Of the 22 therapies assessed, 59%, 77% and 27% were categorized as a significant improvement vs. SoC in Brazil, Germany and France, respectively, and eligible for international reference pricing (Brazil) / price negotiations (France / Germany). Only 27% of the outcomes were consistent across markets, suggesting there is variability in the decision-drivers or local comparators used by different agencies. Pairwise comparison of markets suggests that categories aligned most frequently between Brazil and Germany (55%), followed by Brazil and France (45%) and France and Germany (41%). Potential differences in decision-drivers were also identified through the assessment: osimertinib exemplifies the importance of overall survival in France and Germany, while pembrolizumab and daratumumab highlight the relevance of being first-in-class in Brazil.

CONCLUSIONS Although Brazil, Germany and France use a comparative efficacy and safety assessment to define the therapeutic value and inform pricing decisions, comparison of outcomes across suggests there is limited correlation in the decision-making criteria across markets for oncologics.