Economic benefits of remimazolam compared to midazolam and propofol for procedural sedation in colonoscopies and bronchoscopies.

BACKGROUND: Sedation is common practice in endoscopic procedures to suppress a patient's level of consciousness while maintaining the cardio-respiratory function. Midazolam and propofol are the sedatives most frequently used for procedural sedation at hospitals in Scandinavia. Remimazolam is a new ultra-short-acting benzodiazepine sedative and the present analysis aimed at estimating the economic benefits of introducing remimazolam for procedural sedation in colonoscopies and bronchoscopies in hospitals in Scandinavia. METHOD: We developed a cost model applying a micro-costing approach that comprised the cost components that are affected by differences in the efficacy of remimazolam, midazolam, and propofol, and the model estimated the cost per successful colonoscopy and bronchoscopy when using remimazolam, midazolam or propofol as sedation. A micro-costing approach was applied, and the model consisted of six stages representing the journey for patients undergoing endoscopies and was informed primarily by data from clinical studies on remimazolam. RESULTS: We found a total cost of DKK 1200 per successful colonoscopy procedure when using remimazolam, a total cost of DKK 1320 when using midazolam, and a total cost of DKK 1255 when using propofol. Hence, the incremental saving per successful colonoscopy procedure of using remimazolam was estimated to be DKK 120 compared to midazolam and DKK 55 compared to propofol. The total cost per successful bronchoscopy procedure when using remimazolam was DKK 1353 and DKK 1724 for midazolam, resulting in an incremental saving per bronchoscopy of DKK 372 when using remimazolam. Performed sensitivity analyses identified the time in recovery as the largest contributor to uncertainty in the analyses of remimazolam compared to midazolam in colonoscopies and bronchoscopies. In the comparison of remimazolam and propofol in colonoscopies, procedure time was the largest contributor to uncertainty. CONCLUSION: We found that procedural sedation with remimazolam was associated with economically meaningful savings compared to procedural sedation with midazolam and propofol in colonoscopies and to midazolam in bronchoscopies.

[ICH-GCP Guideline: quality assurance of clinical trials. Status and perspectives]. / ICH-GCP Guideline: kvalitetssikring af kliniske laegemiddelforsøg. Status og perspektiver.

Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conduction, recording and reporting trials that involve the participating of human subjects. Since 1997 the ICH-GCP Guideline has been a requirement for conducting clinical trials which should be used as documentation to the authorities. The 13 fundamental principles of the ICH-GCP Guideline for conducting clinical trials are described. Furthermore, the most essential responsibilities of the investigator, sponsor and sponsor-investigator are mentioned. Investigator-initiated trials do not need to be conducted according to the GCP-principles but after the implementation of the EU Directive 2001/20/EC this will be changed. Today the GCP-principles only apply to clinical research with drugs but within a few years the GCP-principles will probably be a requirement for all clinical research.