Cost-Effectiveness Analysis of the Application of a Porcine-Derived Fibrin Sealant for the Treatment of Cerebrospinal Fluid Leak in China.

Purpose: This study aimed to evaluate the cost-effectiveness of a porcine-derived fibrin sealant (PFS) for treating cerebrospinal fluid (CSF) leaks in cranial surgery compared with sutures alone from the perspective of public hospital management in China.

Methods: A decision tree model of cranial surgery patients with intraoperative CSF leak was constructed in R 3.6.3. The cost-effectiveness of using PFS with dural sutures was compared versus using sutures alone. Efficacy and safety data were obtained from a randomized controlled, single-blinded clinical trial that enrolled 200 patients (NCT03110783). Effectiveness was measured as the success rate of CSF leak treatment and the rate of postoperative complication. Hospital procurement costs were used to provide cost measurements from the hospital administrator's perspective.

Findings: The PFS strategy had a higher success rate of CSF leak treatment (97.81% vs 49.21%) and a lower complication rate (9.49% vs 14.29%), based on results from the clinical trial. Using PFS also resulted in cost savings amounting to $374.97 in additional intraoperative CSF leak repairs ($18.07 vs $393.04) and $66.68 in postoperative complication treatment ($131.90 vs $198.58). Both one-way sensitivity analysis and probabilistic sensitivity analysis confirmed that the model results were stable against input variations.

Implications: The decision tree analysis revealed that using PFS in conjunction with sutures was associated with improved clinical performance and lower overall costs. PFS in combination with sutures is the dominant strategy for treating CSF leak from the perspective of hospital decision-makers.