PNS176 Is the Door for Rwe in Benefit Assessment in German HTA NOW OPEN?

Abstract

GSAV, the German law for more safety in drug supply, stipulates that routine clinical practice data may be included in the benefit (re-)assessment of drugs and since 2019 the G-BA may ask for their collection to supplement submitted data. The concepts for generation of routine practice data and their use for the benefit assessment have recently been published by IQWiG. The objective of this study was to critically assess these. We analysed published evidence and engaged in discussions with internal and external experts in the fields of German assessment methodology, RWE and statistics, focusing on the proposed criteria for routine practice data generation and their potential use for conducting treatment comparisons as part of German benefit assessment, comparing to other markets. In A19-43, IQWiG rules out using EMR and claims data for the benefit assessment, due to limited data availability and inconsistent quality. Disease registries are described as the only suitable tool for data collection for benefit assessment. For non-randomised studies, propensity score methods are described as the main acceptable approach to balance treatment groups. In contrast, other HTA bodies (e.g. NICE) allow for more methodological flexibility when generating treatment effect estimates (e.g. multivariate regression analyses). IQWiG concludes that even following the stringent criteria for establishing a registry and guidelines for confounder adjustment, only evidence of ‘low-qualitative certainty’ can be generated. Therefore, our expert panel recommends exploring the use of EMR or claims data, which may fulfil the outlined quality requirements in some cases, in combination with registries. By not making use of the available routine practice data, IQWiG overlooks a data source widely accepted by other HTA bodies. However, the door for RWE in German HTA has now been opened. Other analyses based on propensity score methods, e.g. matched adjusted comparisons may become acceptable in the future.