Economic Analysis Of Evicel® Compared With Standard Of Care For Dural Closure In Elective Cranial Surgery: A United Kingdom Hospital Perspective

Abstract

Intraoperative watertight dural closure is critical as CSF leakage can lead to an increased risk of costly clinical consequences (e.g., wound infection, meningitis). Although there are several fibrin sealants available, not all are indicated for sealing dura mater. An economic analysis compared a fibrin sealant (EVICEL® Solutions for Sealant) with standard of care (SoC) for sutured dural closure in cranial surgery in the United Kingdom (UK). The economic analysis quantified the 30-day cost impact of EVICEL® from a U.K. hospital perspective based on a surgical approach using clinical trial data. SoC was composed of sutures in addition to rescue therapy for the majority of the population. Trial-reported resources used included the quantity of initial treatment, adjunctive and rescue therapy product utilization, operating room (OR) time, hospitalization duration, and risk of dural-related adverse events. Only SoC treatment successes were allowed to receive additional adjunctive therapies to ensure durability of closure; however, treatment failures in both Evicel® and SoC could receive rescue therapies. Adjunctive therapies consisted of sutures, collagen, and haemostats (not fibrin sealants); where as rescue therapies consisted of various glues, haemostats and autologous dural patches. Published data on U.K. costs were applied to resource use and several one-way sensitivity analyses were conducted. The analysis estimated that resource savings with EVICEL® completely offset its acquisition cost and resulted in cost savings of £207 per patient (sensitivity range: -£727.02 to £313.40) compared with SoC. Results remained robust to the majority of sensitivity analyses; however were most sensitive to assumptions regarding OR time and hospitalization duration. The use of EVICEL® for suture line dural closure may result in important cost savings for hospitals, partly driven by the reduced need for other adjunctive and rescue therapies. Further studies in larger populations may help to substantiate findings.