The Use Of Real World Evidence To Support Market Access Of Medical Devices - Implications For The German Setting

Upcoming changes in German healthcare regulation strengthen the need for real world evidence (RWE) analyses during market access of medical devices. RWE offers various opportunities to address different needs of diverse stakeholders of medical devices. Aim of this analysis was to identify the current status of RWE studies in the field of medical devices in Germany. A PubMed based literature review was performed. All publications in German/English language describing the use of medical devices in a real world setting in Germany were included. Publications were stratified by study design, type of RWE data and type of research question. Data categories were claims data, registry data and other data sources. Research questions were distinguished between brand-specific and non-brand-specific assessments. In total, 39 publications were included in the analyses. Most of them used data from registries (44%), while claims data were analyzed in 18% of cases and other data sources were represented in 38%. The majority (74%) used a prospective study design. Two thirds of the studies analyzed data on a brand specific level whereas the remainder mainly distinguished between different types of medical devices. Registry data was mostly used to address brand specific research questions (88%) while all claims data based studies investigated research questions on a non-brand specific level. Common research questions were cost comparisons, survival analyses, and burden of disease. Various research questions can be answered by referring to RWE. Given the wide spectrum of medical devices, RWE is used only to a limited extent in the German setting, but is expected to become more important with changing regulation. However, careful considerations have to be made whether existing data sources can be utilized or new data needs to be generated to address specific research questions.