Cost-effectiveness analysis in cardiac surgery: A review of its concepts and methodologies

Abstract

Central MessageCost-effectiveness, a measure of economic value increasingly applied to cardiac surgical procedures, is essential for the rational adoption of new interventions given health care budget constraints.PerspectiveCost-effectiveness analysis in cardiac surgery continues to grow in relevance, with an increasing emphasis on value-based care and the expansion of high-cost devices and procedures. Economic data are increasingly being gathered within clinical trials and in cardiac surgery registries, providing opportunities to integrate economic outcomes into an evolving surgical practice.See Editorial Commentaries pages 1682 and 1684. Cost-effectiveness, a measure of economic value increasingly applied to cardiac surgical procedures, is essential for the rational adoption of new interventions given health care budget constraints. Cost-effectiveness analysis in cardiac surgery continues to grow in relevance, with an increasing emphasis on value-based care and the expansion of high-cost devices and procedures. Economic data are increasingly being gathered within clinical trials and in cardiac surgery registries, providing opportunities to integrate economic outcomes into an evolving surgical practice. See Editorial Commentaries pages 1682 and 1684. More than 80 million adults in the United States suffer from some form of cardiovascular disease, accounting for close to 1 in 3 US deaths annually and more than $300 billion in direct and indirect costs.1Mozaffarian D. Benjamin E.J. Go A.S. Arnett D.K. Blaha M.J. Cushman M. et al.Heart disease and stroke statistics—2016 update: a report from the American Heart Association.Circulation. 2016; 133: e38-e360Crossref PubMed Scopus (801) Google Scholar Coronary heart disease has been estimated to affect more than 6% of the US adult population. Moderate-to-severe aortic stenosis (AS) and mitral regurgitation (MR) have been estimated to affect close to 3% and 9% of US adults ages 75 and older, respectively.1Mozaffarian D. Benjamin E.J. Go A.S. Arnett D.K. Blaha M.J. Cushman M. et al.Heart disease and stroke statistics—2016 update: a report from the American Heart Association.Circulation. 2016; 133: e38-e360Crossref PubMed Scopus (801) Google Scholar, 2Nkomo V.T. Gardin J.M. Skelton T.N. Gottdiener J.S. Scott C.G. Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study.Lancet. 2006; 368: 1005-1011Abstract Full Text Full Text PDF PubMed Scopus (1585) Google Scholar Atrial fibrillation (AF) and heart failure (HF) each affect up to 6 million Americans.1Mozaffarian D. Benjamin E.J. Go A.S. Arnett D.K. Blaha M.J. Cushman M. et al.Heart disease and stroke statistics—2016 update: a report from the American Heart Association.Circulation. 2016; 133: e38-e360Crossref PubMed Scopus (801) Google Scholar The development of new and improved technologies, including minimally invasive and hybrid revascularization procedures, transcatheter aortic valve replacement, MitraClip (Abbott Laboratories, Abbott Park, Ill), continuous-flow left ventricular assist devices (LVADs), and ablation devices for AF, has greatly changed our approach to these conditions and expanded indications for treatment.3Ad N. Suri R.M. Gammie J.S. Sheng S. O'Brien S.M. Henry L. Surgical ablation of atrial fibrillation trends and outcomes in North America.J Thorac Cardiovasc Surg. 2012; 144: 1051-1060Abstract Full Text Full Text PDF PubMed Scopus (63) Google Scholar With increasing health care expenditures,4Anderson J.L. Heidenreich P.A. Barnett P.G. Creager M.A. Fonarow G.C. Gibbons R.J. et al.ACC/AHA statement on cost/value methodology in clinical practice guidelines and performance measures: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures and Task Force on Practice Guidelines.J Am Coll Cardiol. 2014; 63: 2304-2322Crossref PubMed Scopus (114) Google Scholar and a health policy environment promoting greater efficiency and value-based care,5Koeckert M.S. Ursomanno P.A. Williams M.R. Querijero M. Zias E.A. Loulmet D.F. et al.Reengineering valve patients' postdischarge management for adapting to bundled payment models.J Thorac Cardiovasc Surg. 2017; 154: 190-198Abstract Full Text Full Text PDF PubMed Scopus (0) Google Scholar the relevance of evaluating cost-effectiveness in cardiac surgery has become more critical. The growing focus on cost-effectiveness research in cardiac surgery can be shown by an increasing number of publications in the field (Figure 1). Although a portion of this trend may be the result of the aforementioned health care system factors, the continuously changing surgical landscape with approval of new devices has also been an enabler of cost-effectiveness analysis (CEA) in cardiac surgery. For example, there has been a steady increase in the number of CEA publications that have focused on the treatment of AS and MR since 2011, and almost all have evaluated new procedures such as transcatheter aortic valve replacement and MitraClip (Figure 1). Although other countries have adopted CEAs into their budgetary considerations, US federal payers have not explicitly used CEA to establish guidelines, and costs have only been considered implicitly.4Anderson J.L. Heidenreich P.A. Barnett P.G. Creager M.A. Fonarow G.C. Gibbons R.J. et al.ACC/AHA statement on cost/value methodology in clinical practice guidelines and performance measures: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures and Task Force on Practice Guidelines.J Am Coll Cardiol. 2014; 63: 2304-2322Crossref PubMed Scopus (114) Google Scholar, 6Matchar D.B. Mark D.B. Strategies for incorporating resource allocation and economic considerations: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition).Chest. 2008; 133: 132s-140sAbstract Full Text Full Text PDF PubMed Scopus (0) Google Scholar, 7Neumann P.J. Sanders G.D. Cost-effectiveness analysis 2.0.N Engl J Med. 2017; 376: 203-205Crossref PubMed Scopus (10) Google Scholar, 8Sanders G.D. Neumann P.J. Basu A. Brock D.W. Feeny D. Krahn M. et al.Recommendations for conduct, methodological practices, and reporting of cost-effectiveness analyses: second panel on cost-effectiveness in health and medicine.JAMA. 2016; 316: 1093-1103Crossref PubMed Scopus (129) Google Scholar However, more recently, the American College of Cardiology/American Heart Association has recommended the inclusion of CEA in their clinical guidelines, whereas other public and private sector organizations have also incorporated value-based measures in their analyses.4Anderson J.L. Heidenreich P.A. Barnett P.G. Creager M.A. Fonarow G.C. Gibbons R.J. et al.ACC/AHA statement on cost/value methodology in clinical practice guidelines and performance measures: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures and Task Force on Practice Guidelines.J Am Coll Cardiol. 2014; 63: 2304-2322Crossref PubMed Scopus (114) Google Scholar, 7Neumann P.J. Sanders G.D. Cost-effectiveness analysis 2.0.N Engl J Med. 2017; 376: 203-205Crossref PubMed Scopus (10) Google Scholar, 9Institute for Clinical and Economic Review.https://icer-review.org/methodology/icers-methods/icer-value-assessment-framework/Date accessed: September 5, 2017Google Scholar, 10Centers for Disease Control and Prevention.https://www.cdc.gov/vaccines/acip/committee/guidance/economic-studies.htmlDate: 2017Date accessed: September 5, 2017Google Scholar Clinicians, as well as payers, are critical for effectively and efficiently allocating society's health care resources and maximizing value through evidence-based decisions. Although health care economics education has been increasingly incorporated into the standard medical school curriculum for physicians in training, it may not be sufficient.4Anderson J.L. Heidenreich P.A. Barnett P.G. Creager M.A. Fonarow G.C. Gibbons R.J. et al.ACC/AHA statement on cost/value methodology in clinical practice guidelines and performance measures: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures and Task Force on Practice Guidelines.J Am Coll Cardiol. 2014; 63: 2304-2322Crossref PubMed Scopus (114) Google Scholar, 11Parikh R.B. Milstein A. Jain S.H. Getting real about health care costs—a broader approach to cost stewardship in medical education.N Engl J Med. 2017; 376: 913-915Crossref PubMed Scopus (1) Google Scholar, 12Cooke M. Cost consciousness in patient care–what is medical education's responsibility?.N Engl J Med. 2010; 362: 1253-1255Crossref PubMed Scopus (0) Google Scholar As such, this paper was written as a primer on the theory and application of CEA for cardiac surgeons. We additionally summarized the findings from recent CEAs on 5 cardiac conditions: coronary artery disease, AS, MR, AF, and end-stage HF, with a focus on the latter to illustrate the use of CEA for guiding surgical decision-making. We developed a PubMed search for CEAs published since January 2000 and in the English language that evaluated cardiac surgical interventions for management of these 5 cardiac conditions. Search terms included combinations of Medical Subject Headings terms and key word variations for coronary artery bypass graft, aortic valve replacement, mitral valve surgery, surgical ablation, maze, LVAD, and the applicable cardiac conditions. To capture CEAs, Medical Subject Headings terms and variations of “cost-effectiveness analysis” and “quality-adjusted life years” were combined with the aforementioned search terms. Articles were selected based on a review of titles and abstracts followed by a text review. We only included analyses with both cost and effectiveness components. The effectiveness component was limited to quality-adjusted life years (QALYs) or life-years. We selected 63 articles in which the analysis included at least 1 cardiac surgical intervention (Figure E1). We extracted all of the relevant information from the CEAs and developed matrices, grouped by the 5 conditions. For each matrix, we delineated the target population, setting and location, comparisons made, time horizon, and base case measures of cost-effectiveness. Table 113Samson D. Special report: cost-effectiveness of left-ventricular assist devices as destination therapy for end-stage heart failure.Technol Eval Cent Assess Program Exec Summ. 2004; 19: 1PubMed Google Scholar, 14Clegg A.J. Scott D.A. Loveman E. Colquitt J. Royle P. Bryant J. Clinical and cost-effectiveness of left ventricular assist devices as destination therapy for people with end-stage heart failure: a systematic review and economic evaluation.Int J Technol Assess Health Care. 2007; 23: 261-268Crossref PubMed Scopus (0) Google Scholar, 15Rogers J.G. Bostic R.R. Tong K.B. Adamson R. Russo M. Slaughter M.S. Cost-effectiveness analysis of continuous-flow left ventricular assist devices as destination therapy.Circ Heart Fail. 2012; 5: 10-16Crossref PubMed Scopus (75) Google Scholar, 16Neyt M. Van den Bruel A. Smit Y. De Jonge N. Erasmus M. Van Dijk D. et al.Cost-effectiveness of continuous-flow left ventricular assist devices.Int J Technol Assess Health Care. 2013; 29: 254-260Crossref PubMed Scopus (5) Google Scholar, 17Long E.F. Swain G.W. Mangi A.A. Comparative survival and cost-effectiveness of advanced therapies for end-stage heart failure.Circ Heart Fail. 2014; 7: 470-478Crossref PubMed Scopus (39) Google Scholar, 18Baras Shreibati J. Goldhaber-Fiebert J.D. Banerjee D. Owens D.K. Hlatky M.A. Cost-effectiveness of left ventricular assist devices in ambulatory patients with advanced heart failure.JACC Heart Fail. 2016; 5: 110-119Crossref PubMed Scopus (7) Google Scholar, 19Clegg A.J. Scott D.A. Loveman E. Colquitt J.L. Royle P. Bryant J. Clinical and cost-effectiveness of left ventricular assist devices as a bridge to heart transplantation for people with end-stage heart failure: a systematic review and economic evaluation.Eur Heart J. 2006; 27: 2929-2938Crossref PubMed Scopus (0) Google Scholar, 20Sharples L.D. Dyer M. Cafferty F. Demiris N. Freeman C. Banner N.R. et al.Cost-effectiveness of ventricular assist device use in the United Kingdom: results from the evaluation of ventricular assist device programme in the UK (EVAD-UK).J Heart Lung Transplant. 2006; 25: 1336-1343Abstract Full Text Full Text PDF PubMed Scopus (0) Google Scholar, 21Moreno S.G. Novielli N. Cooper N.J. Cost-effectiveness of the implantable HeartMate II left ventricular assist device for patients awaiting heart transplantation.J Heart Lung Transplant. 2012; 31: 450-458Abstract Full Text Full Text PDF PubMed Scopus (0) Google Scholar, 22Alba A.C. Alba L.F. Delgado D.H. Rao V. Ross H.J. Goeree R. Cost-effectiveness of ventricular assist device therapy as a bridge to transplantation compared with nonbridged cardiac recipients.Circulation. 2013; 127: 2424-2435Crossref PubMed Scopus (0) Google Scholar, 23Sutcliffe P. Connock M. Pulikottil-Jacob R. Kandala N.B. Suri G. Gurung T. et al.Clinical effectiveness and cost-effectiveness of second- and third-generation left ventricular assist devices as either bridge to transplant or alternative to transplant for adults eligible for heart transplantation: systematic review and cost-effectiveness model.Health Technol Assess. 2013; 17 (v-vi): 1-499Google Scholar, 24Clarke A. Pulikottil-Jacob R. Connock M. Suri G. Kandala N.B. Maheswaran H. et al.Cost-effectiveness of left ventricular assist devices (LVADS) for patients with advanced heart failure: analysis of the British NHS bridge to transplant (BTT) program.Int J Cardiol. 2014; 171: 338-345Abstract Full Text Full Text PDF PubMed Scopus (20) Google Scholar, 25Pulikottil-Jacob R. Suri G. Connock M. Kandala N.B. Sutcliffe P. Maheswaran H. et al.Comparative cost-effectiveness of the HeartWare versus HeartMate II left ventricular assist devices used in the United Kingdom National Health Service Bridge-to-Transplant Program for patients with heart failure.J Heart Lung Transplant. 2014; 33: 350-358Abstract Full Text Full Text PDF PubMed Scopus (12) Google Scholar depicts the matrix for end-stage HF, and Table E1, Table E2, Table E3, Table E4 depict the matrices for the 4 other conditions.Table 1Summary of cost-effectiveness analysis findings for end-stage heart failureAuthorYearComparisonCountryHorizonCost yearΔCostsΔEffectiveness∗ΔEffectiveness and ICERs were calculated using QALYs unless specified to be LY.ICER∗ΔEffectiveness and ICERs were calculated using QALYs unless specified to be LY.LVAD destination therapy Samson and colleagues13Samson D. Special report: cost-effectiveness of left-ventricular assist devices as destination therapy for end-stage heart failure.Technol Eval Cent Assess Program Exec Summ. 2004; 19: 1PubMed Google Scholar2004Pulsatile LVAD vs MMUSALifetime2002$338,8820.42$802,700 Clegg and colleagues14Clegg A.J. Scott D.A. Loveman E. Colquitt J. Royle P. Bryant J. Clinical and cost-effectiveness of left ventricular assist devices as destination therapy for people with end-stage heart failure: a systematic review and economic evaluation.Int J Technol Assess Health Care. 2007; 23: 261-268Crossref PubMed Scopus (0) Google Scholar2007Pulsatile LVAD vs MMUnited Kingdom5 y2003£101,9980.59£170,616 Rogers and colleagues15Rogers J.G. Bostic R.R. Tong K.B. Adamson R. Russo M. Slaughter M.S. Cost-effectiveness analysis of continuous-flow left ventricular assist devices as destination therapy.Circ Heart Fail. 2012; 5: 10-16Crossref PubMed Scopus (75) Google Scholar2012CF LVAD vs MMUSA5 y2009$297,5511.5$198,184 Neyt and colleagues16Neyt M. Van den Bruel A. Smit Y. De Jonge N. Erasmus M. Van Dijk D. et al.Cost-effectiveness of continuous-flow left ventricular assist devices.Int J Technol Assess Health Care. 2013; 29: 254-260Crossref PubMed Scopus (5) Google Scholar2013CF LVAD vs MMDutchLifetime2010€299,1002.83€107,600 Long and colleagues17Long E.F. Swain G.W. Mangi A.A. Comparative survival and cost-effectiveness of advanced therapies for end-stage heart failure.Circ Heart Fail. 2014; 7: 470-478Crossref PubMed Scopus (39) Google Scholar2014CF LVAD vs MMUSALifetime2012$480,4002.38$201,600 Baras Shreibati and colleagues18Baras Shreibati J. Goldhaber-Fiebert J.D. Banerjee D. Owens D.K. Hlatky M.A. Cost-effectiveness of left ventricular assist devices in ambulatory patients with advanced heart failure.JACC Heart Fail. 2016; 5: 110-119Crossref PubMed Scopus (7) Google Scholar2016LVAD vs MMUSALifetime2016$364,4001.74$209,400LVAD bridge-to-transplant Clegg and colleagues19Clegg A.J. Scott D.A. Loveman E. Colquitt J.L. Royle P. Bryant J. Clinical and cost-effectiveness of left ventricular assist devices as a bridge to heart transplantation for people with end-stage heart failure: a systematic review and economic evaluation.Eur Heart J. 2006; 27: 2929-2938Crossref PubMed Scopus (0) Google Scholar2006Pulsatile LVAD vs MMUnited Kingdom5 y2003£99,4751.53£65,242 Sharples and colleagues20Sharples L.D. Dyer M. Cafferty F. Demiris N. Freeman C. Banner N.R. et al.Cost-effectiveness of ventricular assist device use in the United Kingdom: results from the evaluation of ventricular assist device programme in the UK (EVAD-UK).J Heart Lung Transplant. 2006; 25: 1336-1343Abstract Full Text Full Text PDF PubMed Scopus (0) Google Scholar2006CF/pulsatile LVAD vs MMUnited KingdomLifetime2004/05£42,936−1.72LVAD dominated by MM Moreno and colleagues21Moreno S.G. Novielli N. Cooper N.J. Cost-effectiveness of the implantable HeartMate II left ventricular assist device for patients awaiting heart transplantation.J Heart Lung Transplant. 2012; 31: 450-458Abstract Full Text Full Text PDF PubMed Scopus (0) Google Scholar2012CF LVAD vs MMUnited KingdomLifetime2011£142,4950.55£258,922 Alba and colleagues22Alba A.C. Alba L.F. Delgado D.H. Rao V. Ross H.J. Goeree R. Cost-effectiveness of ventricular assist device therapy as a bridge to transplantation compared with nonbridged cardiac recipients.Circulation. 2013; 127: 2424-2435Crossref PubMed Scopus (0) Google Scholar2013CF LVAD vs MM†High, medium, and low risk from top to bottom.Canada20 y2011$100,8411.19 (LY)$84,964 (/LY)CF LVAD vs MM†High, medium, and low risk from top to bottom.Canada20 y2011$112,7791.14 (LY)$99,039 (/LY)CF LVAD vs MM†High, medium, and low risk from top to bottom.Canada20 y2011$144,3341.21 (LY)$119,574 (/LY) Sutcliffe and colleagues23Sutcliffe P. Connock M. Pulikottil-Jacob R. Kandala N.B. Suri G. Gurung T. et al.Clinical effectiveness and cost-effectiveness of second- and third-generation left ventricular assist devices as either bridge to transplant or alternative to transplant for adults eligible for heart transplantation: systematic review and cost-effectiveness model.Health Technol Assess. 2013; 17 (v-vi): 1-499Google Scholar2013CF LVAD vs MMUnited KingdomLifetime2010£135,7262.46£55,173CF LVAD ATT vs CF LVADUnited KingdomLifetime2010−£32,813−1.59£20,637 Clarke and colleagues24Clarke A. Pulikottil-Jacob R. Connock M. Suri G. Kandala N.B. Maheswaran H. et al.Cost-effectiveness of left ventricular assist devices (LVADS) for patients with advanced heart failure: analysis of the British NHS bridge to transplant (BTT) program.Int J Cardiol. 2014; 171: 338-345Abstract Full Text Full Text PDF PubMed Scopus (20) Google Scholar2014CF LVAD vs MMUnited KingdomLifetime2011£127,3912.38£53,527 Pulikottil-Jacob and colleagues25Pulikottil-Jacob R. Suri G. Connock M. Kandala N.B. Sutcliffe P. Maheswaran H. et al.Comparative cost-effectiveness of the HeartWare versus HeartMate II left ventricular assist devices used in the United Kingdom National Health Service Bridge-to-Transplant Program for patients with heart failure.J Heart Lung Transplant. 2014; 33: 350-358Abstract Full Text Full Text PDF PubMed Scopus (12) Google Scholar2014HeartWare CF LVAD vs HeartMate II CF LVADUnited KingdomLifetime2011£27,0421.14£23,530 Long and colleagues17Long E.F. Swain G.W. Mangi A.A. Comparative survival and cost-effectiveness of advanced therapies for end-stage heart failure.Circ Heart Fail. 2014; 7: 470-478Crossref PubMed Scopus (39) Google Scholar2014CF LVAD vs MM vs no transplantUSALifetime2012CF LVAD vs MM: $482,900; MM vs no transplant: $398,700CF LVAD vs MM: 2.13; MM vs no transplant: 4.12CF LVAD vs MM: $226,300; MM vs no transplant: $96,900ICER, Incremental cost-effectiveness ratio; LVAD, left-ventricular assist device; MM, medical management; CF, continuous-flow; LY, life-years; ATT, alternative to transplant.∗ ΔEffectiveness and ICERs were calculated using QALYs unless specified to be LY.† High, medium, and low risk from top to bottom. Open table in a new tab ICER, Incremental cost-effectiveness ratio; LVAD, left-ventricular assist device; MM, medical management; CF, continuous-flow; LY, life-years; ATT, alternative to transplant. Within a formal CEA, the average costs, in currency units, and health outcomes of the relevant competing medical options can be compared for a particular patient, eg, the “average” or typical patient, or a heterogeneous population. Health outcome (the measure of effectiveness) is preferably expressed as life expectancy adjusted for time spent at less than full quality, ie, “quality-adjusted life expectancy,” typically measured in QALYs (Figure 2). Generally, CEAs are pragmatic in that they evaluate and compare the effects of medical options on costs and health outcomes in the setting of usual clinical practice. Although many of the CEAs we identified compared just 2 treatment options, in instances in which there are greater than 2 relevant treatment options, all should be considered in the analysis. Once the average cost and effectiveness of all of the relevant alternative options are measured, one can then order them by cost, from lowest to highest. Any option that costs the same or more than a competing option but is less effective is clearly less desirable and should be rejected from further consideration. Such options are said to be dominated. The options that remain, ie, those that are not eliminated due to dominance, are now in order of both increasing costs and increasing effectiveness and can be compared 2 at a time to determine whether the added cost of the more expensive and more effective option in the pair meets our expectation of good value. The metric used for estimating value is the incremental cost-effectiveness ratio (ICER), which is measured in costs per additional unit of health gained, and is calculated as the difference in average costs of the 2 options under consideration divided by the difference in their average effectiveness, ie, Costs¯1−Costs¯2¯QALYs¯1− QALYs¯2. After further eliminating less efficient (“extendedly dominated”) options, cost-effectiveness is then assessed in pairs for all remaining options by comparing the ICER for each pair with a cost-effectiveness threshold value, ie, the presumed maximum dollar amount that society would be willing to pay for a gain in a unit of health. For the United States, there is currently no single agreed-on cost-effectiveness threshold, but measures in the range of $50,000 to $200,000 per QALY have been used and recommended.4Anderson J.L. Heidenreich P.A. Barnett P.G. Creager M.A. Fonarow G.C. Gibbons R.J. et al.ACC/AHA statement on cost/value methodology in clinical practice guidelines and performance measures: a report of the American College of Cardiology/American Heart Association Task Force on Performance Measures and Task Force on Practice Guidelines.J Am Coll Cardiol. 2014; 63: 2304-2322Crossref PubMed Scopus (114) Google Scholar Conclusions from a CEA about implementing interventions are based on the mean cost and QALY estimates, irrespective of their uncertainty. Uncertainty around the estimates is more relevant to deciding whether further research is required. Table 2 and Video 1 illustrate these principles comparing 3 treatment options for patients with end-stage HF (medical management, axial-flow LVAD, and centrifugal-flow LVAD).Table 2Hypothetical examples of CEAs comparing centrifugal continuous-flow LVAD versus axial continuous-flow LVAD versus medical managementScenarios∗The values provided have been loosely adapted from actual studies and serve as illustrations.Costs ($)QALYsICER ($/QALY)ComparisonScenario 1: Dominance Medical management53,0000.41N/AN/A Centrifugal LVAD390,0001.92223,179Centrifugal LVAD vs medical management Axial LVAD416,0001.88Dominated by centrifugal LVADAxial LVAD vs centrifugal LVADScenario 2: Extended dominance Medical management53,0000.41N/AN/A Axial LVAD392,0001.91(226,000) Extended dominanceAxial LVAD vs medical management Centrifugal LVAD406,0001.99(175,000)Centrifugal LVAD vs axial LVAD223,418Centrifugal LVAD vs medical managementScenario 3: 1 ICER found to be below cost-effectiveness threshold of $200,000/QALY Medical management53,0000.41N/AN/A Centrifugal LVAD252,0002.01124,375Centrifugal LVAD vs medical management Axial LVAD392,0001.91Dominated by centrifugal LVADAxial LVAD vs centrifugal LVADScenario 4: 2 ICERs found to be below cost-effectiveness threshold of $200,000/QALY Medical management53,0000.33N/AN/A Axial LVAD301,0002.33124,000Axial LVAD vs medical management Centrifugal LVAD352,1002.7137,838Centrifugal LVAD vs axial LVADIn scenario 1, axial LVAD is dominated by centrifugal LVAD because, on average, it both costs more and is the least effective of the 2. Therefore, it should be eliminated from further consideration. The ICER that compares the 2 remaining treatment options (centrifugal LVAD and medical management) is $223,379, which is above the proposed cost-effectiveness threshold of $200,000/QALY. Consequently, in this scenario, medical management is the most cost-effective option for treating advanced heart failure. Scenario 2 illustrates the concept of extended dominance. Centrifugal LVAD both costs more and is more effective than the axial flow LVAD option. However, what we observe here is that the cost per each additional unit of health gained by centrifugal flow LVAD therapy over axial flow LVAD therapy ($175,000) is less than the cost for each additional unit of health gained with axial flow LVAD over medical management ($226,000). It follows that centrifugal flow LVAD will generate health at a rate cheaper than axial flow therapy ($223,418) and therefore should be the preferred option. So, by “extended dominance,” axial flow therapy is eliminated. However, because the ICER for centrifugal therapy compared to medical therapy is over the $200,000/QALY threshold, medical management is likely the most cost-effective option for treating advanced heart failure in this scenario. In scenario 3, axial LVAD is dominated by centrifugal LVAD and the ICER for centrifugal LVAD versus medical management is below the cost-effectiveness threshold, indicating centrifugal LVAD is the best option. In scenario 4, although both ICERs lie below the cost-effectiveness threshold, centrifugal LVAD offers the greatest overall health benefit and is considered the most attractive option here. QALY, Quality-adjusted life year; ICER, incremental cost-effectiveness ratio; N/A, not available; LVAD, left ventricular assist device.∗ The values provided have been loosely adapted from actual studies and serve as illustrations. Open table in a new tab In scenario 1, axial LVAD is dominated by centrifugal LVAD because, on average, it both costs more and is the least effective of the 2. Therefore, it should be eliminated from further consideration. The ICER that compares the 2 remaining treatment options (centrifugal LVAD and medical management) is $223,379, which is above the proposed cost-effectiveness threshold of $200,000/QALY. Consequently, in this scenario, medical management is the most cost-effective option for treating advanced heart failure. Scenario 2 illustrates the concept of extended dominance. Centrifugal LVAD both costs more and is more effective than the axial flow LVAD option. However, what we observe here is that the cost per each additional unit of health gained by centrifugal flow LVAD therapy over axial flow LVAD therapy ($175,000) is less than the cost for each additional unit of health gained with axial flow LVAD over medical management ($226,000). It follows that centrifugal flow LVAD will generate health at a rate cheaper than axial flow therapy ($223,418) and therefore should be the preferred option. So, by “extended dominance,” axial flow therapy is eliminated. However, because the ICER for centrifugal therapy compared to medical therapy is over the $200,000/QALY threshold, medical management is likely the most cost-effective option for treating advanced heart failure in this scenario. In scenario 3, axial LVAD is dominated by centrifugal LVAD and the ICER for centrifugal LVAD versus medical management is below the cost-effectiveness threshold, indicating centrifugal LVAD is the best option. In scenario 4, although both ICERs lie below the cost-effectiveness threshold, centrifugal LVAD offers the greatest overall health benefit and is considered the most attractive option here. QALY, Quality-adjusted life year; ICER, incremental cost-effectiveness ratio; N/A, not available; LVAD, left ventricular assist device. A key component of CEA is calculating the average cost of each alternative intervention. Typically, CEAs are conducted from a health care or societal perspective. CEAs from a health care perspective should capture current and future formal health care costs, including those incurred by third-party payers and patients' out-of-pocket expenses.8Sanders G.D. Neumann P.J. Basu A. Brock D.W. Feeny D. Krahn M. et al.Recommendations for conduct, methodological practices, and reporting of cost-effectiveness analyses: second panel on cost-effectiveness in health and medicine.JAMA. 2016; 316: