Early economic evaluation of tissue engineered vascular access grafts for hemodialysis.

AIMS: Vascular access (VA) is essential for hemodialysis in patients with end-stage kidney disease. Expanded polytetrafluoroethylene (ePTFE) grafts are used for VA but are associated with high intervention rates. Tissue-engineered vascular grafts (TEVGs) are emerging as a promising alternative. However, performance and cost thresholds for TEVGs to become clinically and economically competitive to ePTFE grafts remain unclear. This early economic evaluation aims to quantify the clinical and economic impact TEVGs must achieve to be viable in routine hemodialysis care. METHODS: The Dutch VA care pathway was mapped to construct a Markov model simulating intervention rates and costs of patients receiving an ePTFE graft or TEVG. As mature clinical-effectiveness data are not yet available, model inputs were derived from literature and expert opinion. Scenario analyses explored best-case and conservative TEVG performance estimates. Sensitivity analyses identified key cost-drivers. RESULT: Under interview-based performance estimates, TEVGs annually yielded 0.44 fewer interventions and cost savings of €601 per patient. Thrombectomies, PTA procedures and TEVG unit price were cost drivers. CONCLUSIONS: TEVGs could become clinically and economically competitive if they substantially reduce PTA and thrombectomy rates and are manufactured at cost-efficient unit prices. These findings provide actionable thresholds to guide TEVG development and support translation.