Cost-Effectiveness Analysis of Percutaneous Mitral Valve Repair with the MitraClip Delivery System for Patients with Mitral Regurgitation in Japan.

Aims: The objective of the study is to evaluate the cost-effectiveness of percutaneous mitral valve repair (TMVr) with the MitraClip NT system (MitraClip procedure) for patients with symptomatic severe mitral regurgitation (MR) at high surgical risk in line with the methodological guideline for cost-effectiveness evaluation by the Ministry of Health, Labour and Welfare. Material and Methods: The cost-effectiveness of MitraClip procedure was evaluated using a Markov model. Patients are classified into four New York Heart Association classes in each cycle. The model considered MitraClip complication ("major vascular complication", "major bleeding complication", "non-cerebral thromboembolism"), adverse events, re-implantation with MitraClip device, mitral valve surgery, and congestive heart failure hospitalization. For the evidence on additional benefits, a study compared with propensity score-matched medical therapy group was used in the analysis. The analysis was conducted from the perspective of a public healthcare payer with a discount rate of 2% for both cost and effectiveness. Results: In the base-case analysis, total cost and quality-adjusted life year (QALY) gained (Life year (LY) gained) were 7,541,151 JPY and 3.23 QALYs (3.85 LYs) for MitraClip group, and 4,699,692 JPY and 1.79 QALYs (2.43 LYs) for medical therapy group, respectively. The incremental cost-effectiveness ratio (ICER) of MitraClip procedure versus medical therapy was 1.97 million JPY/QALY (US$18,570/QALY, US$1 = 106 JPY), which was evaluated to be cost-effective. The probability of ICER of MitraClip procedure versus medical therapy being 5 million JPY/QALY was 96.7%. Limitations: There are two limitations. Firstly, the parameters for the comparators were based on some assumptions. However, it was a conservative setting against MitraClip group. Secondary, the mortality rate and adverse events of MitraClip group in a lifetime were estimated from data during a year after the procedure. Conclusions: MitraClip procedure improved life-years and quality of life in patients at high surgical risk and it was also a cost-effective treatment option.