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The American Journal of Managed Care February 2020
Care Coordination for Veterans With COPD: A Positive Deviance Study
Ekaterina Anderson, PhD; Renda Soylemez Wiener, MD, MPH; Kirsten Resnick, MS; A. Rani Elwy, PhD; and Seppo T. Rinne, MD, PhD
Expand Predeductible Coverage Without Increasing Premiums or Deductibles
A. Mark Fendrick, MD
From the Editorial Board: Jeffrey D. Dunn, PharmD, MBA
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Lisa M. Lines, PhD, MPH; Wayne L. Anderson, PhD; Harper Gordek, MPH; and Anne E. Kenyon, MBA
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Hsueh-Fen Chen, PhD; J. Mick Tilford, PhD; Robert F. Schuldt, MA; and Fei Wan, PhD
Preventive Drug Lists as Tools for Managing Asthma Medication Costs
Melissa B. Gilkey, PhD; Lauren A. Cripps, MA; Rachel S. Gruver, MPH; Deidre V. Washington, PhD; and Alison A. Galbraith, MD, MPH
Co-payment Policies and Breast and Cervical Cancer Screening in Medicaid
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A Population-Based Assessment of Proton Beam Therapy Utilization in California
Arti Parikh-Patel, PhD, MPH; Cyllene R. Morris, DVM, PhD; Frances B. Maguire, PhD, MPH; Megan E. Daly, MD; and Kenneth W. Kizer, MD, MPH
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Economic Value of Transcatheter Valve Replacement for Inoperable Aortic Stenosis
Jesse Sussell, PhD; Emma van Eijndhoven, MS, MA; Taylor T. Schwartz, MPH; Suzanne J. Baron, MD, MSc; Christin Thompson, PhD; Seth Clancy, MPH; and Anupam B. Jena, MD, PhD
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Economic Value of Transcatheter Valve Replacement for Inoperable Aortic Stenosis

Jesse Sussell, PhD; Emma van Eijndhoven, MS, MA; Taylor T. Schwartz, MPH; Suzanne J. Baron, MD, MSc; Christin Thompson, PhD; Seth Clancy, MPH; and Anupam B. Jena, MD, PhD
Transcatheter aortic valve replacement for inoperable severe, symptomatic aortic stenosis will create significant social value in the next decade, mostly accruing to patients versus manufacturers.
ABSTRACT

Objectives: To project the social value of transcatheter aortic valve replacement (TAVR) for inoperable patients with severe, symptomatic aortic stenosis (SSAS).

Study Design: This study used an economic model with parameters obtained from the literature and from US Census Bureau population projections.

Methods: Our model estimated the economic value that will accrue to inoperable patients with SSAS and to device manufacturers as a result of TAVR utilization. We estimated individual patient value as the monetized gain in quality-adjusted life-years as estimated in the cost-effectiveness literature, net of device costs and cost offsets. We estimated manufacturer value by applying an assumed profit margin to revenue from device sales. We created population-level estimates by combining these individual-level estimates with age-stratified Census Bureau population projections and estimates of the incidence of AS. We assessed model uncertainty through the use of probabilistic sensitivity analyses.

Results: Between 2018 and 2028, approximately 465,000 inoperable Americans with SSAS will be treated with TAVR. These procedures will yield a cumulative social benefit of up to $48 billion, with roughly 80% of that benefit accruing to patients and 20% accruing to device manufacturers.

Conclusions: Policy makers and payers should take this social value into account when considering decisions related to the care of inoperable patients with SSAS.

Am J Manag Care. 2020;26(2):e50-e56. https://doi.org/10.37765/ajmc.2020.42401
Takeaway Points

Considering the US population between 2018 and 2028, we estimated the annual and cumulative social value accruing to patients and to manufacturers as a result of uptake of transcatheter aortic valve replacement (TAVR) for the treatment of severe, symptomatic aortic stenosis (SSAS) in inoperable patients.
  • In 2018, approximately 39,000 inoperable patients with SSAS were treated with TAVR in the United States.
  • That number is projected to increase as the population ages and as TAVR uptake grows.
  • TAVR treatment of the inoperable population with SSAS will generate approximately $48 billion in social value between 2018 and 2028, with 80% of that value accruing to patients.
Aortic stenosis (AS) is a common disease, affecting 2% to 7% of the global population older than 65 years.1 Although the condition can be asymptomatic for years, when symptoms do appear, untreated patients with severe AS have high mortality (up to 50% within 2 years).2,3 Surgical aortic valve replacement (SAVR), in which the sternum is opened to replace the aortic valve, has been shown to improve survival and quality of life in patients with severe, symptomatic AS (SSAS).4,5 Despite data supporting the use of SAVR for the treatment of SSAS, at least 30% of patients do not undergo SAVR, because of either patient preference to avoid invasive surgery or ineligibility for surgery as a result of advanced age and associated comorbidities (the latter referred to as inoperable patients).6,7 Historically, this population of untreated patients was treated with medical management alone, resulting in 3-year mortality rates as high as 80%.8,9 Transcatheter aortic valve replacement (TAVR) is a less invasive method of AVR in which the aortic valve is replaced through either the femoral artery or a small incision in the chest. Clinical trial data have demonstrated that TAVR for inoperable patients extends median survival by approximately 19 months and significantly improves quality of life compared with medical therapy alone,10,11 thereby offering an alternative treatment for this patient population. Accordingly, TAVR was first approved for commercialization in Europe in 200712 and by the US FDA in 2011 for the treatment of SSAS in inoperable patients.

With commercial approval of TAVR, the volume of these procedures in the United States has grown dramatically. Within Medicare, TAVR grew from 8.9% of all AVR procedures (across all risk groups) in 2012 to 50.3% in 2017.13 This rapid growth suggests a need for an analysis of the aggregate economic impact of TAVR treatment on the distribution of social welfare for inoperable patients; this type of study is referred to as social value analysis.14 These types of studies provide a useful complement to traditional cost-effectiveness analyses, as they incorporate the value to consumers, as well as the value to innovators, allowing policy makers to consider new technologies in a context that is both broad and deep. Inoperable patients who are treated with TAVR realize benefits in the form of increased quantity and quality of life relative to medical management. In addition, firms that manufacture TAVR devices realize benefits by way of profits earned on units sold. Payers may realize both costs (eg, via incremental new spending on TAVR devices) and benefits (eg, cost offsets realized through the avoidance of downstream events, such as postoperative inpatient readmissions). Assessing the value of TAVR to both payers and manufacturers allows for the estimation of the relative share of economic surplus returning to manufacturers (as opposed to consumers), therefore informing a broader discussion regarding optimal incentives for future innovation.

The purpose of this study was to estimate the present and future economic impact of TAVR adoption for inoperable patients with SSAS and for TAVR device manufacturers in the United States, using recently developed approaches for the assessment of economic value.15-20 Using an analysis time frame of 2018 to 2028, we aimed to project the size of the inoperable population with SSAS, estimate the fraction of this population who will receive TAVR, and calculate the economic returns of that utilization, for both the patients and the device manufacturers.

METHODS

Projecting TAVR-Eligible Population From 2018 to 2028

To estimate the future economic impact of TAVR adoption for patients with inoperable SSAS and for TAVR manufacturers, we began by projecting the size of the inoperable population eligible for TAVR treatment.

To determine the number of inoperable patients with SSAS between 2018 and 2028, we first projected the number of patients with SSAS nationally, regardless of surgical risk status. We did this by multiplying current estimates of severe AS incidence rates (stratified by age) by the proportion of patients with severe AS whose disease is symptomatic,21,22 and then multiplying the resulting quantity by age-stratified US population projections for each year in the analysis period.23 Finally, we multiplied the values described earlier by the estimated fraction of patients with SSAS considered inoperable.7 The parameters used to perform these calculations are presented in Table 1.7,21,22,24-26

Projecting TAVR Utilization From 2018 to 2028

Only a fraction of incident inoperable SSAS cases are treated with TAVR.21,27 As such, we estimated the number of inoperable patients using TAVR in the future as the product of (1) the projected eligible inoperable population in each year (described previously), and (2) an estimate of the fraction of eligible inoperable patients who ultimately receive TAVR, extracted from the literature.21 As a conservative assumption, we assumed that this fraction remains constant over time. We also assumed that individuals can receive the treatment only once.


 
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