Cost-utility and cost-benefit analysis of TAVR availability in the US severe symptomatic aortic stenosis patient population

Abstract

Aims

We evaluated the availability of transcatheter aortic valve replacement (TAVR) to determine its value across all severe symptomatic aortic stenosis (SSAS) patients, especially those untreated because of concerns regarding invasive surgical AVR (SAVR) and its impact on active aging.

Methods

We performed payer perspective cost-utility analysis (CUA) and societal perspective cost-benefit analysis (CBA). The CBA’s benefit measure is active time: salaried labor, unpaid work, and active leisure. The study population is a cohort of US elderly SSAS patients. We compared a “TAVR available” scenario in which SSAS patients distribute themselves across TAVR, SAVR, and medical management (MM); and a “TAVR not available” scenario with only SAVR and MM. We structured each scenario with a decision-tree model of SSAS patient treatment allocation. We measured the association between health and active time in the US Health and Retirement Study and used this association to impute active time to SSAS patients given their health.

Results

The incremental cost-effectiveness ratio (ICER) and rate of return (RoR) of TAVR availability were $8,533 and 395%, respectively. CUA net monetary benefits (NMB) were $212,199 per patient and $43.4 billion population-wide. CBA NMB were $50,530 per patient and $10.3 billion population-wide.

Limitations

Among study limitations were scarcity of evidence regarding key parameters and the lack of long-term survival, health utility, and treatment cost data. Our analysis did not account for TAVR durability, retreatments, and valve-in-valve treatments.

Conclusion

Across risk-, age-, and treatment-eligibility groups, TAVR is the economically optimal treatment choice. It represents strong value-for-money per patient and population-wide. The vast majority of TAVR value involves raising treatment uptake among the untreated.

PLAIN LANGUAGE SUMMARY

Aortic stenosis (AS) is a common and lethal heart disease. Surgical treatment has long been available, but its invasiveness limits uptake. More recently, transcatheter aortic valve replacement (TAVR) has emerged as a treatment alternative. Its minimal invasiveness has significantly increased treatment rates, but economic evaluations omit this benefit, risking undervaluation. We evaluated TAVR in elderly US severe symptomatic AS patients, using payer perspective cost-utility analysis (CUA) and societal perspective cost-benefit analysis (CBA). Both CUA and CBA incorporated TAVR’s impact on treatment rates. Given patient preferences for treatment options promoting active aging, our CBA used the value of active time as a benefit measure. We found that CUA/CBA net monetary benefits are $212,199/$50,530 per patient. Across risk-, age-, and treatment-eligibility groups, TAVR is the economically optimal treatment choice over surgery and medical management. It represents strong value-for-money per patient and population-wide. Increased treatment uptake accounts for the vast share of TAVR's value.

Keywords:

• Active aging
• cost-benefit analysis
• cost-utility analysis
• severe symptomatic aortic stenosis
• time use
• transcathether aortic valve replacement

JEL CLASSIFICATION CODES:

• J14
• 1
• J
• I10
• I1
• I
• D61
• D6
• D

Transparency

Declaration of funding

This study was supported by Edwards Lifesciences.

Declaration of financial/other interests

JS and JK are employees of Data for Decisions, LLC (DfD), which received funding from Edwards Lifesciences (ELS) for this work. YS and DB are consultants to DfD. CT, XJ, and SC are employees and shareholders at ELS. MR has received research grant support and consulting fees from ELS and consulting fees from Abbott and JenaValve.

Author contributions

JS: conceptualization, methodology, validation, formal analysis, writing – original draft, writing – review and editing, supervision. JK: methodology, software, validation, formal analysis, investigation, data curation, writing – original draft, writing – review and editing, visualization, project administration. YS: methodology, software, validation, formal analysis, data curation, writing – review and editing, visualization. MR: methodology, validation, resources, writing – review and editing, supervision. CT: conceptualization, methodology, validation, data curation, writing – review and editing, visualization, supervision, project administration. XJ: methodology, validation, data curation, writing – review and editing, visualization, project administration. SC: conceptualization, methodology, validation, resources, writing – review and editing, visualization, supervision, project administration, funding acquisition. DB: conceptualization, writing – review and editing, supervision, funding acquisition.

Acknowledgements

Janina Broker contributed to the conception and design of this article as well as to acquisition and analysis of data. David Kantor contributed to conception and design of this article as well as to the acquisition of data. Daria Burnes supported critical revision.

Data availability statement

The authors confirm that the data supporting the findings of this study are available within the article and its supplementary materials.

Reviewer disclosure

Peer reviewers on this manuscript have received an honorarium from JME for their review work but have no other relevant financial relationships to disclose.

Correction Statement

This article has been corrected with minor changes. These changes do not impact the academic content of the article.