Exploratory Cost-Effectiveness of a Novel Bioprosthetic Valve for Surgical Aortic Valve Replacement in Spain

Objectives Limited information is available regarding the impact of valve choice for patients with aortic stenosis (AS) undergoing surgical aortic valve replacement (SAVR) in Spain. Herein, we aimed to explore the potential cost-effectiveness of a new bioprosthetic valve with RESILIA tissue versus mechanical alternatives from a Spanish healthcare perspective. Methods Health outcomes, including quality-adjusted life years (QALYs), adverse events, and costs were estimated for two cohorts of patients with severe AS (aged ≥ 65 or 55–64 years) over a lifetime horizon employing a UK cost-effectiveness model adapted to Spanish clinical practice to compare a novel bioprosthesis versus mechanical alternatives. This model included a decision tree to describe short-term outcomes and a partitioned survival model to evaluate mortality and long-term outcomes. A panel of clinical experts validated the model methodology, including parameters and assumptions considered. Sensitivity analyses were performed to account for uncertainty. Results The novel bioprosthetic valve led to cost savings for both cohorts (€6209/patient for age ≥ 65 years; €8289/patient for ages 55–64 years). These were mainly driven by a reduction in anticoagulation- and adverse event-associated resources, outweighing the costs derived from more reoperations estimated with the novel bioprosthetic valve. An observable increase in QALYs was detected in both age groups (0.0051 and 0.0191, respectively). Hence, the novel bioprosthetic valve is expected to be a dominant alternative for patients 55 years or older who are eligible for SAVR. It remained cost-effective in > 98% of sensitivity analyses. Conclusions Our exploratory study indicates the novel RESILIA bioprosthetic valve as a potential alternative to mechanical valves for SAVR in patients 55 years or older can lead to budgetary cost savings and improved health outcomes in Spain.