Abstract

A recent Premier study reported that despite hemostat use, uncontrolled bleeding is prevalent across surgery types (32%-68%). Drawbacks of current hemostats include limitations with efficacy on first attempt and sub-optimal ease-of-use; thus, better hemostats are needed. A study was conducted to estimate the cost impact of a novel fibrin sealant patch (EVARREST™) versus standard of care (SoC) in soft tissue and hepatic surgical bleeding. An economic model quantified 30-day cost impact of EVARREST from a U.S. hospital perspective. Key resources, from four trials, included quantity of initial treatment, re-treatment, operating time, hospitalization, transfusion risk, amount transfused, and ventilator utilization. SoC was composed of Surgicel (88% to 100% in soft tissue, 34% to 65% in hepatic tissue) and conventional methods (e.g., manual compression, thrombin). Transplant patients were excluded from analyses. The surgical analysis included resources clinically related to the significant hemostasis benefit of EVARREST vs. control (i.e., initial and re-treatment, operating time, transfusion). A hospital analysis included all resources collected. Published data on U.S. costs were applied to resource use. Sensitivity analyses were conducted on several variables including number of EVARREST products used. The surgical base-case analysis predicted that EVARREST was cost saving vs. SoC by $59 per patient (sensitivity range: -$300 to $900). The hospital analysis predicts further resource reduction with EVARREST with cost-savings of $2,789 per patient (sensitivity range: -$1,830 to -$3,338). Results were most sensitive to the number of pads used. Composite results were primarily driven by the large benefit achieved with EVARREST in severe soft-tissue bleeding. In problematic soft tissue and hepatic bleeding, EVARREST may result in important cost savings for hospitals, in addition to meeting an important unmet need. This analysis suggests EVARREST’s impact on hospital cost may depend on surgical bleeding type and number of pads used. Further study in additional populations may confirm findings.

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