Cost-Effectiveness of Transcatheter Aortic Valve Implantation Using a Balloon-Expandable Valve in Japan: Experience From the Japanese Pilot Health Technology Assessment.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an innovative and effective treatment in high-surgical-risk (HR) and inoperable patients with symptomatic severe aortic stenosis. OBJECTIVES: This cost-effectiveness analysis of transfemoral TAVI (TF-TAVI) compared with surgical aortic valve replacement (SAVR) conforms with the methodological guidelines for cost-effectiveness evaluation by the Ministry of Health, Labor, and Welfare in Japan. METHODS: The cost-effectiveness of TF-TAVI using SAPIEN XT was evaluated using a lifetime Markov simulation from the national payer perspective. Comparators were SAVR for HR patients and standard of care (SOC) for inoperable patients. A systematic literature review for clinical evidence of TF-TAVI and comparators was conducted. The evidence for TF-TAVI was derived from the SOURCE XT registry and Japanese post marketing surveillance. Because there was no literature directly or indirectly comparing TF-TAVI using SAPIEN XT with comparators, the comparator data were selected from relevant published studies, considering the similarity of study eligibility criteria and patient backgrounds (eg, age and surgical risk scores). Sensitivity analyses were used to validate the robustness of results. RESULTS: The incremental cost-effectiveness ratio of TF-TAVI versus SAVR for HR patients was ¥1.3 million/quality-adjusted life-years (QALYs). The incremental cost-effectiveness ratio of TF-TAVI versus SOC for inoperable patients was ¥3.5 million/QALY. CONCLUSIONS: TF-TAVI was cost-effective when compared with SAVR for HR patients and when compared with SOC for inoperable patients, using a threshold of ¥5 million/QALY.

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.