Extrabudgetary ('NUB') payments: A gateway for introducing new medical devices into the German inpatient reimbursement system?

Abstract Most new medical devices in Germany are first introduced in the inpatient sector. The key hurdles to marketing them are thus to ensure their inclusion in the German Diagnosis-Related Group (G-DRG) system and to bridge the financial gap in the interim. In 2005, a system of extrabudgetary payments was introduced to bridge this gap and to expedite the inclusion of new technologies in the G-DRG system. The present study aims (1) to describe prototypical regulatory pathways for including new medical devices and other technologies in the G-DRG system and (2) to analyse real-world data on applications for extrabudgetary reimbursement to determine the pathways these technologies followed between 2005 and 2009. The findings show that the technologies did indeed follow the prototypical pathways and that patients' access to them has been improved by the system of extrabudgetary payments. Some technologies, however, have still not been fully included in the G-DRG system, even after four years. Moreover, improved access through quick uptake is a double-edged sword. Evidence on the effectiveness and cost-effectiveness of medical devices should ultimately be brought into play and tied intimately to the system of extrabudgetary and G-DRG reimbursement.