Abstract
Due to the Pharmaceutical Care Strengthening Act (AMVSG), new drugs in the German inpatient sector have been subject to early benefit assessment pursuant to § 35a SGB V since 2018. For the first time, antibiotics for parenteral application in hospital are evaluated as part of the Health Technology Assessment (HTA) process and the antibiotic resistance situation is taken into account. The aim of this research is to evaluate to which extent the resistance situation in Germany can be adequately measured by randomized controlled trials (RCTs) and what additional insights can be provided by in vitro data?. RCTs of antibiotics commonly used to treat drug resistant gram-negative bacteria were identified via clinicaltrials.gov and descriptively analyzed regarding the involvement of German study centers. Differences in resistance rates between European countries were identified using data from the ECDC Surveillance Atlas for Antimicrobial resistance. It was analyzed to which extent the German in vitro data study reflects the German resistance situation. Since 1999, 1376 registered studies (investigational/observational) have been identified, including 503 phase II/III studies, of which 45 (8,9%) had German study centers. Despite a small sample size, an in vitro study with exemplary samples from different hospitals across Germany (2014/2015) can be used to emulate the German resistance situation, as described by the ECDC in 2014. The biggest deviations from the study were observed for fluoroquinolones (Escherichia coli: +9,1%, Pseudomonas aeruginosa: +8,8%) and carbapenems (P. aeruginosa: -9,8%). The strong heterogeneity of antibiotic resistance rates across Europe may pose difficulties when extrapolating RCT study results for the German healthcare system. Although resistance rates from in vitro data do not perfectly match the German resistance situation, the resemblance is high enough that such data can be used to build a bridge between RCT results and the effectiveness of antibiotics in the German healthcare system.
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