Abstract

To assess the cost-effectiveness (CE) of transcatheter aortic valve implantation (TAVI) considering the perspective of the Italian National Health System (INHS), a mid- and long-term time-horizon and patients groups with different surgical risk. A Markov model with 1-month cycle length and comprising eight different health-states defined by New York Heart Association functional classes (NYHA I-IV) with and without stroke plus death was used to estimate the CE of TAVI versus surgical aortic valve replacement for intermediate- and high-risk patients, and versus medical treatment for inoperable from the INHS perspective, over a mid- (5 years) and long-term (15 years) horizon. Patients transitioned between health-states and underwent post-intervention rehabilitation, experienced procedural complications and follow-up events according to published efficacy data (and extrapolation from them). Total direct costs (in Euro) estimated from national tariff and life-years-gained (LYG) were derived in each risk-group to calculate incremental cost-effectiveness ratio (ICER) between treatments. All outcomes and costs were discounted at 3% per annum. One-way (OWSA) and probabilistic (PSA) sensitivity analyses were performed to assess robustness of results. Over 5-years incremental costs for TAVI increased according to patients’ risk ranging from about €4,000/patient to less than €10,000/patient, for intermediate-risk and inoperable groups respectively; similarly for LYG/patient that ranged from 0.2 for intermediate-risk patients to 1.2 among inoperable. Accordingly the ICER were about €24.000/LYG, €20.000/LYG and €8.000/LYG respectively for intermediate-, high-risk and inoperable patients. When considering a 15-years time-horizon ICERs were about €8.000/LYG, €12.000/LYG and €6.000/LYG respectively for intermediate-, high-risk and inoperable patients. OWSA and PSA suggested that results were consistent to variation of model parameters in almost all risk-groups, with mortality being the most relevant driver in all the analyses. TAVI would be considered cost-effective at frequently cited willingness to pay thresholds in Europe; further studies may help shading light about CE of TAVI in real-life scenarios.

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