OBJECTIVES: In Germany, HTA of pharmaceuticals and their outcome influence subsequent price negotiations (AMNOG process). The HTA authorities demand certain requirements in relation to study design and study results In general, if the study design is not appropriate, then the HTA authorities will stop any further assessment of results. In our analysis we aimed to investigate the relationship between HTA outcomes based on the non-fulfillment of study design vs. the assessment of study results and price rebates.

METHODS: First, all non-orphan AMNOG dossiers evaluated by the G-BA between January 2014 and June 2018 were extracted from the IQVIA HTA databaseincluding the extent of additional benefit. Second, the dossiers were categorized by HTA requirements in non-fulfilment of study design or assessment of results. Third, product prices of the drugs were extracted from the official database for drug prices (LAUER-Taxe) for the timepoints of market access and after price negotiations. Price changes for each product were calculated and products were categorized according to the extent of price change. Finally, price changes between the group that does not fulfil the study design and the group including the assessment of study results were analyzed.

RESULTS: Pharmaceuticals “without benefit” were mainly criticized on the study design (70.0 %) - study results were not assessed. Whereas HTA of pharmaceuticals with additional benefit (“minor” or “considerable benefit”) were based on study results. Nevertheless, independently of the non-fulfilment of study design and assessment of study results, the most common price change was the “- 20 % price decrease” category (47.5 % vs. 53.5 %).

CONCLUSIONS: HTA outcomes based on the non-fulfilment of study design or the assessment of results seemed not to have an impact on pricing.