Advertisement
Canadian Journal of Cardiology

Open Access Budget Impact Assessment Tools: A Welcome Step in Supporting Evidence-Informed Policy Decisions

  • Derek Chew
    Affiliations
    Department of Cardiac Sciences and the Libin Cardiovascular Institute, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada

    Department of Community Health Sciences and the O’Brien Institute for Public Health, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
    Search for articles by this author
  • Fiona Clement
    Correspondence
    Corresponding author: Dr Fiona Clement, Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, 3280 Hospital Drive NW, CWPH Building, 3rd Floor, Room 3D10, Calgary, AlbertaT2N 1N4, Canada.
    Affiliations
    Department of Community Health Sciences and the O’Brien Institute for Public Health, Cumming School of Medicine, University of Calgary, Calgary, Alberta, Canada
    Search for articles by this author
Published:September 11, 2022DOI:https://doi.org/10.1016/j.cjca.2022.07.003
      Over the past several decades, transcatheter aortic valve replacement (TAVR) has emerged as a disruptive technology that transformed the management of patients with severe aortic stenosis. Initially offered to mostly older patients with aortic stenosis who were not surgical candidates because of excessive operative risk, TAVR has become an acceptable therapeutic option for operative candidates who are at high or moderate surgical risk.
      • Asgar A.W.
      • Ouzounian M.
      • Adams C.
      • et al.
      2019 Canadian Cardiovascular Society position statement for transcatheter aortic valve implantation.
      ,
      • Webb J.
      • Rodes-Cabau J.
      • Fremes S.
      • et al.
      Transcatheter aortic valve implantation: a Canadian Cardiovascular Society position statement.
      More recent randomized studies, such as the landmark Placement of Aortic Transcatheter Valves (PARTNER 3)
      • Mack M.J.
      • Leon M.B.
      • Thourani V.H.
      • et al.
      Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients.
      and Evolut Low Risk
      • Popma J.J.
      • Deeb G.M.
      • Yakubov S.J.
      • et al.
      Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients.
      trials, have further shifted the paradigm by demonstrating noninferiority of TAVR to surgical aortic valve replacement (SAVR) in low-risk surgical patients. This shift is reflected in the most recent iteration of international guidelines, which provide a Class I recommendation for TAVR in selected patients with severe aortic stenosis.
      • Sundt T.M.
      • Jneid H.
      Guideline update on indications for transcatheter aortic valve implantation based on the 2020 American College of Cardiology/American Heart Association Guidelines for Management of Valvular Heart Disease.
      ,
      • Vahanian A.
      • Beyersdorf F.
      • Praz F.
      • et al.
      2021 ESC/EACTS guidelines for the management of valvular heart disease.
      However, as with many new technologies, TAVR comes at an increased cost compared with SAVR.
      This challenges health care systems, particularly publicly funded health systems such as in Canada, where the budget is constrained.
      Thus, it is exciting to see the article by Tam and Sadri published in this issue of the Canadian Journal of Cardiology.
      • Tam D.
      • Sadri H.
      Annual budget impact analysis comparing self-expanding transcatheter and surgical aortic valve replacement in low-risk aortic stenosis patients.
      The article reports the outcomes of a budget impact assessment (BIA) for TAVR and SAVR in patients with low-risk aortic stenosis: an important contribution to support evidence-informed policy decisions about the adoption and balance between TAVR and SAVR.
      BIA has been around for decades but is a far less known health economic methodology than cost-effectiveness analysis.
      • Sullivan S.D.
      • Mauskopf J.A.
      • Augustovski F.
      • et al.
      Budget impact analysis: principles of good practice: report of the ISPOR 2012 budget impact analysis good practice II task force.
      The 2 approaches answer fundamentally different questions. Cost effectiveness asks the question: “Does this technology represent good value for money?” BIA asks the question: “How much will adoption of this technology cost?” Cost effectiveness produces a ratio. The costs and benefits of 2 or more alternatives are compared with each other, resulting in an incremental cost per unit of benefit.
      • Drummond M.F.
      • Sculpher M.J.
      • Torrance G.W.
      • O'Brien B.J.
      • Stoddart G.L.
      Methods for the Economic Evaluation of Health Care Programmes.
      This is commonly reported as a cost per quality-adjusted life year (QALY). This measure of value is often then compared with a threshold, defined by country-specific societal preferences, to determine if the technology being assessed might be considered reasonable value for money. In Canada, threshold ranges from $20,000 to $100,000 have been commonly adopted, whereas in other nations, thresholds of $50,000 US, £20,000 to 30,000, or 3 times gross domestic product (GDP) per capita have been adopted.
      • Laupacis A.
      • Feeny D.
      • Detsky A.S.
      • Tugwell P.X.
      How attractive does a new technology have to be to warrant adoption and utilization? Tentative guidelines for using clinical and economic evaluations.
      • Rawlins M.D.
      • Culyer A.J.
      National Institute for Clinical Excellence and its value judgments.
      • Hirth R.A.
      • Chernew M.E.
      • Miller E.
      • Fendrick A.M.
      • Weissert W.G.
      Willingness to pay for a quality-adjusted life year: in search of a standard.
      • Woods B.
      • Revill P.
      • Sculpher M.
      • Claxton K.
      Country-level cost-effectiveness thresholds: initial estimates and the need for further research.
      In the case of TAVR, incremental cost-effectiveness ratios ranging from approximately $5000 to $175,000 per QALY have been reported, depending on the country-specific context, the patient population undergoing TAVR vs SAVR (ie, low, moderate, or high surgical-risk populations), and the time horizon of the model.
      • Tam D.Y.
      • Azizi P.M.
      • Fremes S.E.
      • Chikwe J.
      • Gaudino M.
      • Wijeysundera H.C.
      The cost-effectiveness of transcatheter aortic valve replacement in low surgical risk patients with severe aortic stenosis.
      • Mennini F.S.
      • Meucci F.
      • Pesarini G.
      • et al.
      Cost-effectiveness of transcatheter aortic valve implantation versus surgical aortic valve replacement in low surgical risk aortic stenosis patients.
      • Zhang W.
      • Lou Y.
      • Liu Y.
      • Wang H.
      • Zhang C.
      • Qian L.
      Economic evaluation of transcatheter aortic valve replacement compared to surgical aortic valve replacement in Chinese intermediate-risk patients.
      So, from the perspective of the policy or decision maker, TAVR may represent reasonable value for money. But, the question “How much will adoption of this technology cost?” remains unanswered through the cost-effectiveness modelling.
      BIA estimates the total budget required to adopt a technology. The methodological approach is different from that of a cost-effectiveness model. Essentially, one develops a model that takes into account the resource utilization required to implement the technology within a specific context—such as a specific hospital or region—compared with the current standard of care. This includes the costs of the technology itself, operational costs, human-resource costs, and the total expected number of patients receiving the technology.
      • Sullivan S.D.
      • Mauskopf J.A.
      • Augustovski F.
      • et al.
      Budget impact analysis: principles of good practice: report of the ISPOR 2012 budget impact analysis good practice II task force.
      ,
      • Mauskopf J.A.
      • Sullivan S.D.
      • Annemans L.
      • et al.
      Principles of good practice for budget impact analysis: report of the ISPOR Task Force on good research practices–budget impact analysis.
      The result is an estimated dollar value that a budget holder must find, or reallocate, to be able to introduce the technology. The models in BIA range from simple to complex, depending on the technology. Further, there are best-practice guidelines that establish the methodological standards and the expected rigour.
      • Sullivan S.D.
      • Mauskopf J.A.
      • Augustovski F.
      • et al.
      Budget impact analysis: principles of good practice: report of the ISPOR 2012 budget impact analysis good practice II task force.
      ,
      • Mauskopf J.A.
      • Sullivan S.D.
      • Annemans L.
      • et al.
      Principles of good practice for budget impact analysis: report of the ISPOR Task Force on good research practices–budget impact analysis.
      For example, Tam and Sadri
      • Tam D.
      • Sadri H.
      Annual budget impact analysis comparing self-expanding transcatheter and surgical aortic valve replacement in low-risk aortic stenosis patients.
      have clearly stated the payer perspective adopted, the costs and resources included have been clearly described, included costs are relevant to the payer identified, the time horizon adopted in the model matches the budget cycle of the payer, and a variety of adoption scenarios are presented to assess uncertainty. All these are methodological decisions in which they have exemplified best practice. The results are a useful model that policy and decision makers can use to answer the question: “How much will adoption of this technology cost?”
      BIA is deeply embedded in a specific context. For example, Tam and Sadri
      • Tam D.
      • Sadri H.
      Annual budget impact analysis comparing self-expanding transcatheter and surgical aortic valve replacement in low-risk aortic stenosis patients.
      have developed the base of their model using the Ontario case-costing initiative, among other costs, and report the outcomes in a hypothetical cohort of 100 patients. Thinking about our own local context, one could imagine that decision makers in Calgary would be more interested in Alberta-specific costs and the exact number of eligible patients within the Calgary zone. Thinking more broadly, decision makers in international contexts will want to see an estimated budget impact that takes into account their specific costs and patient volumes. Further, the estimated budget is affected by intensive care unit (ICU) length of stay, new permanent pacemaker implantation rate, and total hospital length of stay; these are 3 key variables that are likely to vary across hospitals, provinces, and country as practice varies.
      The true value of the work by Tam and Sadri
      • Tam D.
      • Sadri H.
      Annual budget impact analysis comparing self-expanding transcatheter and surgical aortic valve replacement in low-risk aortic stenosis patients.
      is the open access model now available to decision makers and researchers globally. This model represents a significant infrastructure. By making the model open access, the required investment of time and human resources need not be duplicated in as a decision makers face similar questions about shifting from SAVR to TAVR. Further, the model can be responsive as science continues to develop. Key model inputs can be updated as TAVR technology evolves or SAVR techniques are refined with advances such as minimally invasive SAVR approaches through lateral thoracotomy or hemisternotomy, which reduce ICU length of stay,
      • Ghanta R.K.
      • Lapar D.J.
      • Kern J.A.
      • et al.
      Minimally invasive aortic valve replacement provides equivalent outcomes at reduced cost compared with conventional aortic valve replacement: a real-world multi-institutional analysis.
      a key input affecting the estimated budget.
      • Hirji S.A.
      • Funamoto M.
      • Lee J.
      • et al.
      Minimally invasive versus full sternotomy aortic valve replacement in low-risk patients: which will stand against transcatheter aortic valve replacement?.
      ,
      • Neely R.C.
      • Boskovski M.T.
      • Gosev I.
      • et al.
      Minimally invasive aortic valve replacement versus aortic valve replacement through full sternotomy: the Brigham and Women's Hospital experience.
      Other fields have advanced the concept of open science more than health economics, but there is a growing and necessary movement to make models openly accessible. In this work, Tam and Sadri
      • Tam D.
      • Sadri H.
      Annual budget impact analysis comparing self-expanding transcatheter and surgical aortic valve replacement in low-risk aortic stenosis patients.
      have contributed with 1 more step forward.
      Despite this excellent model being available, decision and policy makers still will not have answered the broader question of TAVR adoption among patients with low surgical risk. The health care system can be thought of as a highly interconnected system acting as stewards for the health of all individuals, not only those with severe aortic stenosis in isolation. This complex role introduces a fundamental principle of the field of health economics: opportunity cost.
      • Drummond M.F.
      • Sculpher M.J.
      • Torrance G.W.
      • O'Brien B.J.
      • Stoddart G.L.
      Methods for the Economic Evaluation of Health Care Programmes.
      Technically, opportunity cost is defined as the benefits forgone by not pursing the next best alternative.
      • Drummond M.F.
      • Sculpher M.J.
      • Torrance G.W.
      • O'Brien B.J.
      • Stoddart G.L.
      Methods for the Economic Evaluation of Health Care Programmes.
      Colloquially described, it represents the possible benefits on the path not taken. As a concrete example, the opportunity cost here is the benefits that may be realized with the $129,540 required to increase the use of TAVR from 10 of the hypothetical 100 patients to 50. Although this may seem like a small increase to the budget, these are real dollars that must be found either by decreasing funding elsewhere in the cardiac budget, if we are to hold the cardiac budget constant; decreasing a budget elsewhere in the hospital, if the hospital budget is to remain constant; or, thinking more broadly, decreasing a budget elsewhere in the social sector to increase the funds to health care. It would only be reasonable to reallocate budget to TAVR if its health benefits exceed the benefits of the intervention(s) selected to lose funding.
      Costs alone should not drive the discussion of technology adoption and implementation. There is increasing recognition of other important considerations such as whether an intervention is immediately life-saving, the impact on quality of life, the number of people eligible, vulnerable patient populations (eg, children or the elderly), the underlying baseline health, the likelihood of the treatment being successful, and its impact on equality of access to therapy.
      • Dolan P.
      • Cookson R.
      A qualitative study of the extent to which health gain matters when choosing between groups of patients.
      ,
      • Schwappach D.L.
      Resource allocation, social values and the QALY: a review of the debate and empirical evidence.
      Looking through this lens with respect to TAVR funding underscores the complexity of the decision-making process in the context of finite resources and the associated opportunity costs. These decisions will only become more challenging as innovation continues, often coming at increased cost.
      Nevertheless, Tam and Sadri
      • Tam D.
      • Sadri H.
      Annual budget impact analysis comparing self-expanding transcatheter and surgical aortic valve replacement in low-risk aortic stenosis patients.
      should be commended on their contribution to the health economic literature. Assessment of costs, through budget-impact analysis, is 1—albeit necessary—component of the decision-making process. High-quality methodological studies, as published by Tam and Sadri,
      • Tam D.
      • Sadri H.
      Annual budget impact analysis comparing self-expanding transcatheter and surgical aortic valve replacement in low-risk aortic stenosis patients.
      will help facilitate robust evidence-informed policy decisions.

      Funding Sources

      No funding was provided for this article.

      Disclosures

      The authors have no conflicts of interest to disclose.

      References

        • Asgar A.W.
        • Ouzounian M.
        • Adams C.
        • et al.
        2019 Canadian Cardiovascular Society position statement for transcatheter aortic valve implantation.
        Can J Cardiol. 2019; 35: 1437-1448
        • Webb J.
        • Rodes-Cabau J.
        • Fremes S.
        • et al.
        Transcatheter aortic valve implantation: a Canadian Cardiovascular Society position statement.
        Can J Cardiol. 2012; 28: 520-528
        • Mack M.J.
        • Leon M.B.
        • Thourani V.H.
        • et al.
        Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients.
        N Engl J Med. 2019; 380: 1695-1705
        • Popma J.J.
        • Deeb G.M.
        • Yakubov S.J.
        • et al.
        Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients.
        N Engl J Med. 2019; 380: 1706-1715
        • Sundt T.M.
        • Jneid H.
        Guideline update on indications for transcatheter aortic valve implantation based on the 2020 American College of Cardiology/American Heart Association Guidelines for Management of Valvular Heart Disease.
        JAMA Cardiol. 2021; 6: 1088-1089
        • Vahanian A.
        • Beyersdorf F.
        • Praz F.
        • et al.
        2021 ESC/EACTS guidelines for the management of valvular heart disease.
        Eur Heart J. 2022; 43: 561-632
        • Tam D.
        • Sadri H.
        Annual budget impact analysis comparing self-expanding transcatheter and surgical aortic valve replacement in low-risk aortic stenosis patients.
        Can J Cardiol. 2022; 38: 1478-1484
        • Sullivan S.D.
        • Mauskopf J.A.
        • Augustovski F.
        • et al.
        Budget impact analysis: principles of good practice: report of the ISPOR 2012 budget impact analysis good practice II task force.
        Value Health. 2014; 17: 5-14
        • Drummond M.F.
        • Sculpher M.J.
        • Torrance G.W.
        • O'Brien B.J.
        • Stoddart G.L.
        Methods for the Economic Evaluation of Health Care Programmes.
        3rd ed. Oxford University Press, Oxford2005
        • Laupacis A.
        • Feeny D.
        • Detsky A.S.
        • Tugwell P.X.
        How attractive does a new technology have to be to warrant adoption and utilization? Tentative guidelines for using clinical and economic evaluations.
        CMAJ. 1992; 146: 473-481
        • Rawlins M.D.
        • Culyer A.J.
        National Institute for Clinical Excellence and its value judgments.
        BMJ. 2004; 329: 224-227
        • Hirth R.A.
        • Chernew M.E.
        • Miller E.
        • Fendrick A.M.
        • Weissert W.G.
        Willingness to pay for a quality-adjusted life year: in search of a standard.
        Med Decis Making. 2000; 20: 332-342
        • Woods B.
        • Revill P.
        • Sculpher M.
        • Claxton K.
        Country-level cost-effectiveness thresholds: initial estimates and the need for further research.
        Value Health. 2016; 19: 929-935
        • Tam D.Y.
        • Azizi P.M.
        • Fremes S.E.
        • Chikwe J.
        • Gaudino M.
        • Wijeysundera H.C.
        The cost-effectiveness of transcatheter aortic valve replacement in low surgical risk patients with severe aortic stenosis.
        Eur Heart J Qual Care Clin Outcomes. 2021; 7: 556-563
        • Mennini F.S.
        • Meucci F.
        • Pesarini G.
        • et al.
        Cost-effectiveness of transcatheter aortic valve implantation versus surgical aortic valve replacement in low surgical risk aortic stenosis patients.
        Int J Cardiol. 2022; 357: 26-32
        • Zhang W.
        • Lou Y.
        • Liu Y.
        • Wang H.
        • Zhang C.
        • Qian L.
        Economic evaluation of transcatheter aortic valve replacement compared to surgical aortic valve replacement in Chinese intermediate-risk patients.
        Front Cardiovasc Med. 2022; 9896062
        • Mauskopf J.A.
        • Sullivan S.D.
        • Annemans L.
        • et al.
        Principles of good practice for budget impact analysis: report of the ISPOR Task Force on good research practices–budget impact analysis.
        Value Health. 2007; 10: 336-347
        • Ghanta R.K.
        • Lapar D.J.
        • Kern J.A.
        • et al.
        Minimally invasive aortic valve replacement provides equivalent outcomes at reduced cost compared with conventional aortic valve replacement: a real-world multi-institutional analysis.
        J Thorac Cardiovasc Surg. 2015; 149: 1060-1065
        • Hirji S.A.
        • Funamoto M.
        • Lee J.
        • et al.
        Minimally invasive versus full sternotomy aortic valve replacement in low-risk patients: which will stand against transcatheter aortic valve replacement?.
        Surgery. 2018; 164: 282-287
        • Neely R.C.
        • Boskovski M.T.
        • Gosev I.
        • et al.
        Minimally invasive aortic valve replacement versus aortic valve replacement through full sternotomy: the Brigham and Women's Hospital experience.
        Ann Cardiothorac Surg. 2015; 4: 38-48
      1. (Peer Models Network. Available at:)
        https://www.peermodelsnetwork.com/
        Date accessed: June 24, 2022
        • Dolan P.
        • Cookson R.
        A qualitative study of the extent to which health gain matters when choosing between groups of patients.
        Health Policy. 2000; 51: 19-30
        • Schwappach D.L.
        Resource allocation, social values and the QALY: a review of the debate and empirical evidence.
        Health Expect. 2002; 5: 210-222

      Linked Article