Budget impact model of acellular tissue engineered vessel for the repair of extremity arterial trauma when autologous vein is not feasible.

Abstract

Aims: To predict the budget impact of Symvess (Symvess is a trademark of Humacyte Global, Inc.) (acellular tissue engineered vessel-tyod [ATEV]) for extremity arterial trauma repair when autologous vein repair is not feasible.

Materials and methods: The 3-year budget impact of adding ATEV as a repair option alongside autologous vein, prosthetic graft, and "non-autologous other" grafts was evaluated from the perspectives of a Level I trauma center and third-party commercial payers. Conduit-specific complication rates were obtained from two clinical studies for ATEV and from the published literature and analysis of the PROOVIT registry for other conduits. Costs were compared pre- and post-ATEV availability. Conduit-related costs and complications included conduit infections, amputations, vein harvest site infection, surgical re-interventions, rehabilitation after amputation, and 12-month post-discharge costs. Impact on operating room (OR) time and readmissions was evaluated. A sensitivity analysis was conducted to evaluate parameter uncertainty.

Results: With introduction of ATEV, there was a 29.8% reduction in amputations and a 29.5% reduction in graft infections over 3 years. From a Level I trauma center perspective, seven patients were expected to receive an ATEV over 3 years, with cumulative cost savings of $80,650 (2.3% decrease). OR time would decrease by 8.6 h, and readmission-related costs would be reduced by 16.7% with ATEV availability. From the third-party commercial payer perspective, 35 patients were expected to receive ATEV, with a budget impact showing a savings of -$0.08 per member per month after 3 years. For trauma centers, sensitivity analysis showed that cost drivers were amputation risk associated with "non-autologous other" graft types and market share of autologous vein (short ischemia time).

Limitations: Uncertainty surrounding model parameters.

Conclusions: ATEV was projected to be cost-saving over 3 years for both trauma centers and third-party payers due to reductions in the costs related to amputations and conduit infections.