Cost-effectiveness analysis of transcatheter aortic valve implantation in aortic stenosis patients at low- and intermediate-surgical risk in Japan

Abstract

Objective

To analyze the cost-effectiveness of transcatheter aortic valve implantation (TAVI) using the SAPIEN 3 (Edwards Lifesciences, Irvine, CA) compared to surgical aortic valve replacement (SAVR) in low- and intermediate-risk patients from a Japanese public healthcare payer perspective.

Methods

A Markov model cost-effectiveness analysis was developed. Clinical and utility data were extracted from a systematic literature review. Cost inputs were obtained from analysis of the Medical Data Vision claims database and supplemented with a targeted literature search. The robustness of the results was assessed using sensitivity analyses. Scenario analyses were performed to determine the impact of lower mean age (77.5 years) and the effect of two different long-term mortality hazard ratios (TAVI versus SAVR: 0.9–1.09) on both risk-level populations. This analysis was conducted according to the guidelines for cost-effectiveness evaluation in Japan from Core 2 Health.

Results

In intermediate-risk patients, TAVI was a dominant procedure (TAVI had lower cost and higher effectiveness). In low-risk patients, the incremental cost effectiveness ratio (ICER) for TAVI was ¥750,417/quality-adjusted-life-years (QALY), which was below the cost-effectiveness threshold of ¥5 million/QALY. The ICER for TAVI was robust to all tested sensitivity and scenario analyses.

Conclusions

TAVI was dominant and cost-effective compared to SAVR in intermediate- and low-risk patients, respectively. These results suggest that TAVI can provide meaningful value to Japanese patients relative to SAVR, at a reasonable incremental cost for patients at low surgical risk and potentially resulting in cost-savings in patients at intermediate surgical risk.

Graphical abstract

Cost-effectiveness analysis of transcatheter aortic valve implantation in aortic stenosis patients at low- and intermediate-surgical risk in Japan. Results demonstrate that TAVI can provide meaningful value to Japanese patients with severe symptomatic aortic stenosis relative to SAVR, at a reasonable incremental cost for low-risk patients and potentially resulting in cost-savings in intermediate-risk patients.

PLAIN LANGUAGE SUMMARY

Aortic Stenosis (AS) is the most common valvular heart disease in Japan, and, if left untreated, severe symptomatic AS (sSAS) is associated with a dramatic increase in mortality and morbidity. Transcatheter Aortic Valve Implantation (TAVI) is a minimally invasive treatment option for replacing the aortic valve in patients with sSAS and has been associated with similar or better outcomes compared to Surgical Aortic Valve Replacement (SAVR), which involves open-heart surgical replacement of the aortic valve. The objective of this study was to compare the costs and health outcomes associated with TAVI compared to SAVR in Japanese patients deemed low- or intermediate-risk for surgery. Despite the expanding use of TAVI in Japan, a cost-effectiveness analysis (CEA) does not exist that evaluates the economics of TAVI with the current generation SAPIEN 3 implant in patients with low- and intermediate-risk from a public perspective. Our study suggests that TAVI represents strong value for money among low- and intermediate-risk patients in Japan: compared to SAVR, TAVI is associated with better clinical outcomes and quality of life for patients, at a reasonable additional cost for low-risk patients and at a lower cost for intermediate-risk patients.

Keywords:

• Aortic stenosis
• cost utility analysis
• transcatheter aortic valve replacement
• incremental cost-effectiveness ratio
• Japan

JEL CLASSIFICATION CODES:

• I10
• I1
• I
• I13
• I00

Transparency

Declaration of financial/other relationships

JK has no conflict of interest.

SB discloses the following: Abiomed (Consultant; Research Grant); Boston Scientific Corp (Advisory Board Member; Research Grant); Edwards Lifesciences (Speaking Honoraria); Medtronic (Speaking Honoraria; Advisory Board member); Shockwave (Advisory Board Member; Consultant); Zoll Medical (Advisory Board Member; Speaking Honoraria).

KT received lecture fees from Abbott Medical Japan Co., Ltd and Edwards Lifesciences, Medtronic, and Daiichi Sankyo Co., Ltd., and is a Proctor of Edwards Lifesciences and Medtronic.

CT, XJ, and KY disclose employment with Edwards Lifesciences.

Author contributions

JK, SB, and CT participated in study design. CT and XJ conducted the statistical analyses. All authors interpreted the results. JK, KT, and SB wrote the manuscript. All authors reviewed and approved the final version of the manuscript.

Acknowledgements

The authors thank Emily Farra. and Farah Pathan of Boston Strategic Partners, Inc. for editorial contributions and assistance with manuscript preparation, supported by Edwards Lifesciences.

Data availability and materials

Due to its proprietary nature, supporting data cannot be made openly available. All summary data relevant to these results are present within the report. Further information about the data and conditions for access are available from Medical Data Vision, Co. (https://en.mdv.co.jp).

Reviewer disclosures

Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Additional information

Funding

This research was supported by Edwards Lifesciences.