Alternative Strategies for Dispensing Exogenous Surfactant: Drug Cost Implications and in Vitro Feasibility Studies

Surfactant replacement therapy is highly effective in treating Respiratory Distress Syndrome, but remains expensive despite market competition. Objectives (1) to model potential surfactant drug cost savings under alternative dispensing strategies compared with the current, FDA-approved, single-patient, single-dose vial dispensing strategy; and (2) to determine whether alternative dispensing strategies potentially would maintain efficacy and safety by measuring surfactant surface activity and sterility under conditions designed to simulate alternative dispensing conditions. Design Potential drug cost savings were modeled by comparing the current, FDA-approved single-patient, single-dose vial dispensing guidelines with alternative dispensing strategies including single patient, multidose vials; multipatient, multidose vials; and reduced volume surfactant vials (ie, “half-sized”) to decrease drug wastage. To assess whether surface activity or sterility of exogenous surfactant could be reduced under these alternative dispensing conditions, serial surface tension measurements and bacterial and fungal cultures were conducted with aliquots of exogenous surfactant under conditions designed to simulate each strategy. Results Potential savings of $49,000 to $61,000/year (28.5%), depending on drug usage and cost, were identified in a model comparing a single-patient, multidose vial dispensing protocol with the current FDA-approved dispensing strategy. The greatest cost savings, $57,000 to $72,000/year (33.3%), were for multipatient, multidose drug dispensing. Simulating alternative dispensing conditions, three cycles of warming, entering, and cooling surfactant vials over 1 to 2 days or 1 to 2 weeks did not cause a measurable decrement in in vitro surface activity or compromise in drug sterility. Conclusion Substantial cost savings could be realized through use of multidose surfactant dispensing strategies.