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Expanding Health Technology Assessments to Include Effects on the Environment
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Available online at www.sciencedirect.com
journal homepage: www.elsevier.com/locate/jval
Expanding Health Technology Assessments to Include Effects on the Environment Kevin Marsh, PhD1,*, Michael L. Ganz, MS, PhD2, John Hsu, MD, MBA3, Martin Strandberg-Larsen, PhD4, Raquel Palomino Gonzalez, MA5, Niels Lund, MA, MBA6 1 Evidera Inc., London, UK; 2Evidera Inc., Lexington, MA, USA; 3Harvard Medical School, Boston, MA, USA; 4Centre for Health Economics and Policy, University of Copenhagen, Copenhagen, Denmark; 5Independent Researcher, Kampala, Uganda; 6Novo Nordisk A/S, Bagsværd, Denmark
The views expressed herein are those of the authors and do not reflect the views of their employers.
AB STR A CT
There is growing awareness of the impact of human activity on the climate and the need to stem this impact. Public health care decision makers from Sweden and the United Kingdom have started examining environmental impacts when assessing new technologies. This article considers the case for incorporating environmental impacts into the health technology assessment (HTA) process and discusses the associated challenges. Two arguments favor incorporating environmental impacts into HTA: 1) environmental changes could directly affect people’s health and 2) policy decision makers have broad mandates and objectives extending beyond health care. Two types of challenges hinder this process. First, the nascent evidence base is insufficient to support the accurate comparison of technologies’ environmental impacts. Second, cost-utility analysis, which is favored by many HTA agencies, could capture some of the value of environmental impacts,
especially those generating health impacts, but might not be suitable for addressing broader concerns. Both cost-benefit and multicriteria decision analyses are potential methods for evaluating health and environmental outcomes, but are less familiar to health care decision makers. Health care is an important and sizable sector of the economy that could warrant closer policy attention to its impact on the environment. Considerable work is needed to track decision makers’ demands, augment the environmental evidence base, and develop robust methods for capturing and incorporating environmental data as part of HTA. Keywords: economic evaluation, environmental impacts, health technology assessment.
Introduction
industry, has environmental implications. For instance, the National Health Service (NHS) in England has estimated that its CO2 emissions were 24.7 million metric tons of carbon dioxide equivalent (MtCO2e) in 2012 and that pharmaceuticals accounted for 21% of these emissions [3]. In addition, the entire US health care sector produced 546 MtCO2e in 2007, accounting for approximately 8% of the overall greenhouse gas emissions in the United States for that year [4]. The recognition of such effects has been accompanied by a small, though growing, number of instances when health policymakers have included the consideration of environmental impacts in decisions [3,5–10]. These moves have been driven partly by external pressures to take this broader view, such as the recent recommendation from The Global Commission on the Economy and Climate “to accelerate low-carbon transformation by integrating climate into core economic decision-making processes” [11] and international climate change negotiations at the Conference of Parties (the 21st session of which [COP21] held in Paris in December 2015) [12]. Recent prominent developments consistent with these influences include the Swedish government’s consideration of a plan
The role of health technology assessment (HTA) is to assess the impact of health interventions on society, with a view to allocating the limited resources to maximize health and well-being in the broadest possible sense. The limited data available to inform such assessments have, however, put practical restrictions on their objectives and scope. As a result, HTA has predominantly been focused on optimizing the use of resources within the health sector. Specifically, it has tended to consider primarily changes in health-related quality of life (HRQOL) and health care, and related costs, as exemplified by the approach taken by the National Institute for Health and Care Excellence (NICE) in the United Kingdom [1]. The limitations of such an approach are highlighted by the extensive literature on whether, or how, HTA methods should capture other outcomes, such as differences in access to health care or effects on caregivers and families of patients or on productivity [2]. A broader perspective might also consider the clear evidence that the delivery of health care, like any other
Copyright & 2015, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc.
* Address correspondence to: Kevin Marsh, Evidera Inc., Metro Building, 6th Floor, 1 Butterwick, Hammersmith, London, UK. E-mail: [email protected]. 1098-3015$36.00 – see front matter Copyright & 2015, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. http://dx.doi.org/10.1016/j.jval.2015.11.008
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to introduce a voluntary ecoclassification or green premium for generic drugs as a way of encouraging more environmentally friendly production of drugs [8,13], and the English NHS’s commitment to reducing its carbon emissions from an annual 20 MtCO2e in 2004 to 11.20 to 12.20 MtCO2e by 2020 and 6.58 MtCO2e by 2050 [9]. Notwithstanding this handful of initiatives, the fact remains that, to date, the formal inclusion of environmental considerations has not been a part of HTA, despite increasing demand by health care stakeholders for such to occur [14]. Therefore, this article asks whether HTA methods should be expanded to accommodate environmental factors and argues that it is now both politically reasonable and methodologically possible to do so. The arguments in favor of such a change are summarized in the next section. We, however, also recognize that if such factors are to be considered, a number of methodological barriers and challenges will need to be overcome, and these are addressed in the subsequent section. Conversely, we reject the argument that the presence of barriers justifies failure to consider environmental factors. Finally, we offer thoughts on ways to advance the debate usefully beyond these initial considerations.
Should Environmental Impacts Be Considered in HTAs? This section considers two key reasons why HTA methods should be expanded to also include environmental impacts.
health care decision makers suggests that they agree that a broader perspective is important. For instance, a recent survey of 140 health care decision makers in 23 countries found that about a third of them already considered the environmental impact of health technologies during the decision-making process, and the rest suggested that such impacts should be considered [14]. Nevertheless, support for taking a societal perspective is by no means universal. For instance, it has also been argued that adopting such an approach would be inappropriate in the face of budgets legitimately allocated by governments to invest in improving health, particularly if transfers between sectors were not possible [26]. This difference of opinion is also reflected in the policies adopted by various HTA agencies. As noted earlier, NICE has chosen a relatively narrow perspective. NICE has, however, recently consulted on ways to broaden the perspective of its analysis in the form of the value-based assessment of pharmaceuticals [27]. This proposed approach, though it looks increasingly less likely to be adopted, would involve measuring the burden of illness of the disease targeted by a technology and wider social impact generated by a treatment, and reflecting these concepts in how much NICE is willing to pay for the health gain generated by a technology. The Swedish Dental and Pharmaceutical Benefits Board (Tandvårds- och läkemedelsförmånsverket [TLV]) has adopted a societal perspective for its HTAs (and considers direct and indirect costs, including productivity costs) [28]. Within this approach, it would be possible to include environmental impacts in HTA assessments submitted to the TLV, although this has yet to happen.
The Link between the Environment and Health Outcomes There is a close link between population health and the environment, and therefore decision makers risk not achieving their goals of maximizing health outcomes if they overlook environmental impacts [15]. The relationship between the environment and health outcomes has long been documented in health economics literature [16–19]. For example, the World Health Organization’s World Health Report shows that 85 of the 102 main diseases reported are partially caused by exposure to some form of environmental factor and consequently result in the loss of one-fourth of health life-years [20]. Additional data from the World Health Organization also suggest that climate change accounted for an estimated 5.5 million lost disability-adjusted life-years in 2000 [21] and causes an estimated 150,000 deaths every year [20]. Furthermore, the Intergovernmental Panel on Climate Change (http://www.ipcc.ch/index. htm) has highlighted some other effects of climate change on health, showing that increases in atmospheric temperature globally are related to flooding and associated rises in both mortality and occurrence of various infections [22]. For example, estimates indicate that at least 8% of global disease burden may be a result of the effects of environmental pollution [23].
Health Care Decision Makers’ Objectives Include Broader Social Welfare, Including Environmental Impacts Accounting for a broader set of factors (including environmental impacts) in HTAs than those currently used (health outcomes alone) would allow decision makers to better maximize social welfare [24,25]. This argument assumes that these societies, or their appointed decision makers, value preserving the environment in addition to other health-related objectives. Evidence increasingly supports this assumption and includes the fact that many health care systems have environmental objectives, often dictated by broader political commitments, such as the Kyoto protocol, as exemplified by the NHS targets cited in the Introduction. Such broadening of the assessment approach would be consistent with the wide range of factors already considered—if only informally—by HTA agencies [14]. Furthermore, research on
Ways to Include Environmental Factors into HTAs If it is accepted that environmental factors should be considered in HTAs, the next question is how this could be done. For example, could the current framework be expanded to include environmental factors or would new approaches be required? Although the literature provides little guidance on these specific points, useful insights can be drawn from debates on how a broader perspective could be captured within HTAs and the methods adopted by economists to value environmental resources.
Measuring the Environmental Impact of Health Technologies An estimate of environmental impact of a health technology should consider the entire life cycle of that technology, including the acquisition of raw materials; the manufacturing process, such as the materials and energy consumed in producing both the active pharmaceutical ingredient and its associated packaging (e. g., syringe, injection pen, actuators, and inhalers) and any resulting pollution; the distribution of the technology to the place of use, in particular, the energy this requires; and the use of the product, including disposal of the spent or unused product and its delivery system [29,30]. Furthermore, estimates of the environmental impact of a technology should include its effects on the management of disease. For instance, an effective technology may substitute for an existing technology and may reduce the need for follow-on treatments; in this scenario, a life cycle perspective should be adopted to estimate the environmental impact of the change in the use of each of the treatments. Overall, therefore, it is important that the assessment of environmental impact considers the implications of resources used throughout the care pathway. To date, examples of attempts to measure the environmental impact of health care have fallen short of this ideal. One case illustrating this is the Healthcare Energy Impacts Calculator, which estimates the monetary cost of the environmental impact of energy use in health care in the United States [31]. Data on
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energy use are combined with the Environmental Protection Agency’s Emissions and Generation Resource Integrated Database factors—a widely accepted estimate of the environmental characteristics of electric power generated in the United States— to estimate the emissions of the following: nitrous oxide, sulfur dioxide, particulate matter, and ozone. This model also estimates changes in population-level exposure to these pollutants, the health impact of these changes, and the monetary value of these health impacts. Crucially, however, the model does not capture all the environmental impacts of health care, but just those associated with energy consumption at the point of care. In England, the NHS has an ongoing project to estimate its carbon footprint [32,33], which overcomes some of these limitations seen with the Energy Impacts Calculator. A key part of the NHS methodology is to draw on quantitative input-output models. These represent the interdependence between different parts of the economy, providing insights into inputs required to deliver one unit of output in a particular sector [32]. Combined with data on fossil fuel consumption and emissions, input-output models can be used to produce environmentally extended input-output analysis (EEIOA) to estimate the carbon emissions generated by each unit of output in a sector [34]. The NHS estimates, however, have their own limitations. First, EEIOA provides only a narrow picture of environmental impact because it focuses on carbon emissions. Second, EEIOA provides data only at a sector level. Because the purpose of HTAs is to evaluate health technologies, a method is required that can estimate the variation in environmental impact between different types of health care expenditure. One option that could overcome some of the aforementioned challenges would be to explore an approach based on process analysis. This technique involves a detailed analysis of the environmental impacts across the life cycle, including the use of raw materials and energy consumption [32]. The challenge in using process analysis is that it demands a large amount of data, and so would require significant effort to collect for all the resource use associated with a single treatment pathway, as would be covered in a single HTA. Further work is needed to explore the place of a hybrid that combines the efficiency of EEIOA with the greater accuracy and ability to discriminate between treatments offered by process analysis.
Evaluation Methodologies Many HTA agencies require that an economic evaluation take the form of a cost-utility analysis (CUA). Such bodies include the NICE in the United Kingdom, College voor Zorgverzekeringen in the Netherlands, the Canadian Agency for Drugs and Technologies in Health in Canada, and the TLV in Sweden. In theory, environmental impacts can be incorporated into an “enriched” CUA-based framework in one of two ways. First, it would at least be theoretically possible to incorporate the health gains associated with improved environmental outcomes into estimates of HRQOL. This would involve translating the environmental impact of a technology into health impacts and then converting the health impact into the unit of HRQOL measurement used in the CUA, such as measures of utility based on the EuroQol fivedimensional questionnaire. This approach is likely, however, to pose a number of technical challenges. Much work has been undertaken to catalog empirical studies on the health impacts of environmental outcomes (see, for instance, Regulatory Impact Analysis: Carbon Pollution Emission [35,36] and Regulatory Impact Analysis: Particulate Matter National Ambient Air Quality Standard [37]). Further work is required to determine the feasibility of using these data to estimate the marginal health gains associated with the marginal environmental improvements of using one technology rather than another. If it proved technically feasible to estimate such health impacts and incorporate them
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into a CUA, this approach would still have the limitation of not capturing the broader, nonhealth benefits of reduced environmental impacts. A second possibility is that the amount that decision makers were willing to pay for health gains from a technology could be adjusted to reflect the environmental impact associated with the life cycle of the technology. There is precedent for such an approach in the United Kingdom, where more is paid for quality-adjusted life-year (QALY) gains at the end of life [38]. Value-based assessment in the United Kingdom is likely to apply this same threshold-adjustment approach to pay more for health gains where treatments are for severe diseases or also generate broader social benefits [27]. Similarly, the Health Care Council in the Netherlands explicitly takes into account “cost-effectiveness” and “severity of disease” criteria and suggests a maximum costeffectiveness ratio of €80,000 per QALY gained for a high-severity disease or condition and approximately €10,000 to €15,000 for a low-severity problem [39]. One concern with reflecting nonhealth values by weighting the willingness-to-pay threshold is that these values are not necessarily correlated with incremental health gains. For instance, such a method offers no incentive to develop a product that generates the same health outcomes as the standard of care but with less impact on the environment because these environmental gains would be reimbursed only through a greater willingness to pay for health gains (of which there are none compared with standard care, in this case). These worries about the use of an enriched CUA approach have prompted consideration of alternative methods, including costbenefit analysis (CBA) and multicriteria decision analysis (MCDA) [40]. CBA converts all outcomes into monetary units, thereby capturing and allowing direct comparison between a wide range of social costs and benefits. This technique is better established outside of health economics where it has been regularly used to inform decision making as far back as in the 1960s [41]. This includes a large body of work where CBA has been applied in decisions on environmental policy [42,43]. Accordingly, the evidence base necessary to support the application of CBA to environmental outcomes is well established, therefore supporting the use of the method as a way of incorporating environmental impacts into HTAs. Nevertheless, incorporating environmental outcomes into HTAs by using CBA poses a number of challenges. First, models of the economic value of environmental outcomes are subject to significant uncertainty and debate, for instance, the social costs of carbon (SCC). SCC estimates are influenced by various factors including the discount rate; the environmental impacts included in the analysis, with some estimates not including nonmarket damages, risk of extreme weather, population growth, future productivity growth, or socially contingent effects; and the weights given to impacts in different geographical regions [44,45]. If the CBA is to draw on SCC estimates, further work is required to determine policymakers’ preferred SCC methods. Second, depending on how it is performed, a CBA may face the same challenges as those encountered by an enriched CUA. If the preferred method is to model the impacts of environmental gains and then estimate the monetary value of these impacts, the technical challenges of modeling these impacts need to be addressed. Alternatively, monetary valuations could be elicited for the environmental impacts, though this would place the burden of understanding the implications of these environmental impacts on those participating in the valuation exercise. Finally, CBA is not widely accepted among HTA agencies. So, although Sweden’s TLV may accept HTA evidence from a CBA in which QALYs are difficult to use [28], the technique is currently rejected by HTA agencies in the United Kingdom, France, and Germany. This limited uptake may reflect the challenges associated with placing a monetary value on nonmarket goods such as health or environmental effects [46].
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The other option, MCDA, is also commonly used in environmental assessments. For example, it is often applied to assess the impact of energy, transport, construction, waste, waste water, and mining activities on the environment [47]. It has also recently received much attention in health care circles for its ability to support valuation and decision making in the context of multiple outcomes. Rather than attempting to value these outcomes monetarily, MCDA elicits from decision makers how they trade off outcomes when making decisions to determine the most preferred treatment option. The term MCDA actually covers a range of different methods, including, among others, the analytic hierarchy process, the analytic network process, the multiattribute utility theory, the multiattribute value theory, outranking, the social multicriteria evaluation, and the technique for order of preference by similarity to ideal solution [47]. These all have various steps in common though, including defining the decision problem, identifying value criteria, weighting criteria, measuring the performance of alternatives against the criteria, aggregation into an overall estimate of value, and assessing the impact of uncertainty [40,48]. Using MCDA to incorporate environmental impacts into HTA poses several challenges. First, as with CBA, the valuation (or weighting) of environmental impacts within an MCDA can take place either before or after modeling the implications of the impacts on, for instance, health. Modeling the impacts of changes in environmental outcomes and incorporating these impacts into an MCDA requires that the technical challenges posed by such models be addressed (see earlier). Incorporating environmental impacts into the MCDA places the burden of understanding the value of changes in environmental outcomes on the stakeholders involved in the MCDA (what is referred to in the MCDA literature as “proxy bias” [49]). Second, the application of MCDA to HTA is still in its relative infancy. Although MCDA has had limited application in HTAs to date (see, for instance, Radaelli et al. [50] and Endrei et al. [51]), policymakers are showing interest in the use of the technique. This attention is mirrored in a recent increase in the publication rate for MCDAs of health interventions [40,52]. For example, the Institute for Quality and Efficiency in Health Care in Germany has indicated its intention to use certain MCDA techniques, such as the analytic hierarchy process, in its evaluation of technologies [53]. However, the very novelty of MCDA presents obstacles to its use in HTAs, for example, the lack of established best practices to guide its application. The recent use of MCDA to support health care decision making [50] and the establishment of initiatives to develop best practices should help to overcome this concern [54].
Discussion Evidence suggests that health care decision makers are becoming increasingly interested in considering environmental impacts related to health care. For example, governments committed to reducing society’s environmental impact have acknowledged that the health care sector will have to play its part in this regard [55]. There are also various other initiatives to incorporate environmental factors into health care decisions. Although these signals are clearly important (and reflect consumer preferences for products that are less harmful to the environment) [56], they are also relatively recent and struggle for attention among the noise of the multiple challenges facing health care decision makers. Despite the increasing regard given to environmental impacts, there has been little in the way of formal incorporation of such factors into a key area of decision making—HTA. One reason for this may be that there are no readily available HTA methods to capture these elements. Incorporating environmental impacts is
one more concern faced by decision makers (adding to, for instance, distributional considerations [2]) which points us beyond the CUA approach that currently predominates in HTAs. CUA could be enriched to capture the benefits of reducing the environmental impact of health technologies but only imperfectly because the benefits of environmental improvement are only partly reflected in, or correlated with, health impacts. Furthermore, this would come at the expense of significant technical challenges, requiring the modeling of the health impacts of environmental outcomes. Alternative methods, such as CBA and MCDA, may thus be better suited to extending HTA to capture environmental impacts. CBA, however, faces its own technical challenges associated with modeling the long-term economic value of environmental outcomes and has been rejected by a number of HTA agencies. This leads us to recommend that further work would most productively be targeted to the development of MCDA for HTA and in incorporating environmental factors into such an approach. If decision makers are concerned with environmental impacts, in the absence of models to estimate the health impact or economic value of such impacts, judgments are still required on the value of these impacts. MCDA provides a way to elicit these judgments in a structured, coherent, and transparent manner. MCDA is currently unfamiliar to most health care decision makers and will require further development and piloting before it could become widely preferred to CUA. Interest in MCDA, however, is on the rise, evidenced by its use for HTA and the establishment of initiatives to identify good practice in the use of MCDA in health care. This article has outlined arguments for, and methodological implications of, incorporating environmental impacts into HTAs and, as far as we know, this is the first to do so. Therefore, much more work is required before the questions it raises can be answered adequately. First, the existing literature contains only limited insights into the preferences of health care decision makers and consumers of health services with regard to environmental consequences. The methods discussed here—an “enriched” CUA, CBA, and MCDA—assume that decision makers are willing to trade off their existing objective (health) or pay more to achieve improvements in environmental outcomes. Further research is required to determine decision makers’ willingness to make such trade-offs and, therefore, the appropriateness of these methods. This should include consideration of the distributional issues posed by the consideration of environmental impacts. Although the direct health gains generated by a technology generally are accrued to those funding it, such as taxpayers or health-plan members, indirect health losses due to environmental impacts do not necessarily fall wholly, or even primarily, on this group. For example, the impact of CO2 emissions related to a technology is global [22]. An obvious question, therefore, is whether those who fund health care for one group of constituents are willing to pay for environmentally friendly technologies that would generate benefits to others. Second, pilot work should be undertaken to determine the feasibility of estimating the environmental impact of health care interventions, and the health and other effects of these environmental impacts. This research should aim to identify the data and tools available to estimate the environmental impact of health care and the consequent health gains of these impacts, the gaps in the evidence, and the data collection activities required to fill these gaps. There should also be appropriate review of evaluation methods (including CBAs and MCDAs) used to support environmental policymakers to identify challenges and lessons from that field. Finally, the value of data on environmental outcomes to health care decision makers should be tested, including the accessibility and impact of data on decisions, and decision
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makers’ preferences for the different ways of synthesizing the evidence (using, for instance, CUA, MCDA, and CBA).
Conclusions There are important inter-relationships between individual and population health, human activities (including health care), and the environment. Nevertheless, understanding and taking account of how health affects and is affected by the environment have not been significant considerations in classical HTAs. Further work is required on the demand for such data and on methods to capture and synthesize it with the evidence currently considered as part of HTA.
Acknowledgments We acknowledge the medical writing assistance received from Emil Nørtoft (Novo Nordisk A/S), Seye Abogunrin (Evidera Inc.), and Ike Iheanacho (Evidera Inc.). Source of financial support: This research was funded by Novo Nordisk A/S. R EF E R EN CE S
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[50] Radaelli G, Lettieri E, Masella C, et al. Implementation of EUnetHTA core model(R) in Lombardia: the VTS framework. Int J Technol Assess Health Care 2014;30:105–12. [51] Endrei D, Molics B, Ágoston I. Multicriteria decision analysis in the reimbursement of new medical technologies: real-world experiences from Hungary. Value Health 2014;4:487–9. [52] Diaby V, Campbell K, Goeree R. Multi-criteria decision analysis (MCDA) in health care: a bibliometric analysis. Oper Res Health Care 2013;2:20–4. [53] Drummond M, Bridges JFP, Muhlbacher A, Ijzerman MJ. Identification, weighting and prioritization of multiple endpoints for comparative effectiveness research—what have we learned from Germany? ISPOR Panel. International Society for Pharmacoeconomics and Outcomes Research, 2011. Available from: http://www.ispor.org/sigs/Preference BasedMethods/IdentificationandPrioritizationIssuePanelBaltimore2011. pdf [Accessed October 2, 2015]. [54] International Society for Pharmacoeconomics and Outcomes Research. Multi-criteria decision analysis in health care decision making emerging good practices task force. 2015. Available from: 〈http://www. ispor.org/taskforces/multi-criteria-decision-analysis-grp.asp〉. [Accessed October 2, 2015]. [55] Swedish Government. The Constitution: The Instrument of Government. Swedish Government, Stockholm, Sweden, 2011. [56] PricewaterhouseCoopers. Green Products: Using Sustainable Attributes to Drive Growth and Value (Sustainable Business Solutions). Washington, DC, US: PricewaterhouseCoopers, 2010.
Available online at www.sciencedirect.com
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Expanding Health Technology Assessments to Include Effects on the Environment Kevin Marsh, PhD1,*, Michael L. Ganz, MS, PhD2, John Hsu, MD, MBA3, Martin Strandberg-Larsen, PhD4, Raquel Palomino Gonzalez, MA5, Niels Lund, MA, MBA6 1 Evidera Inc., London, UK; 2Evidera Inc., Lexington, MA, USA; 3Harvard Medical School, Boston, MA, USA; 4Centre for Health Economics and Policy, University of Copenhagen, Copenhagen, Denmark; 5Independent Researcher, Kampala, Uganda; 6Novo Nordisk A/S, Bagsværd, Denmark
The views expressed herein are those of the authors and do not reflect the views of their employers.
AB STR A CT
There is growing awareness of the impact of human activity on the climate and the need to stem this impact. Public health care decision makers from Sweden and the United Kingdom have started examining environmental impacts when assessing new technologies. This article considers the case for incorporating environmental impacts into the health technology assessment (HTA) process and discusses the associated challenges. Two arguments favor incorporating environmental impacts into HTA: 1) environmental changes could directly affect people’s health and 2) policy decision makers have broad mandates and objectives extending beyond health care. Two types of challenges hinder this process. First, the nascent evidence base is insufficient to support the accurate comparison of technologies’ environmental impacts. Second, cost-utility analysis, which is favored by many HTA agencies, could capture some of the value of environmental impacts,
especially those generating health impacts, but might not be suitable for addressing broader concerns. Both cost-benefit and multicriteria decision analyses are potential methods for evaluating health and environmental outcomes, but are less familiar to health care decision makers. Health care is an important and sizable sector of the economy that could warrant closer policy attention to its impact on the environment. Considerable work is needed to track decision makers’ demands, augment the environmental evidence base, and develop robust methods for capturing and incorporating environmental data as part of HTA. Keywords: economic evaluation, environmental impacts, health technology assessment.
Introduction
industry, has environmental implications. For instance, the National Health Service (NHS) in England has estimated that its CO2 emissions were 24.7 million metric tons of carbon dioxide equivalent (MtCO2e) in 2012 and that pharmaceuticals accounted for 21% of these emissions [3]. In addition, the entire US health care sector produced 546 MtCO2e in 2007, accounting for approximately 8% of the overall greenhouse gas emissions in the United States for that year [4]. The recognition of such effects has been accompanied by a small, though growing, number of instances when health policymakers have included the consideration of environmental impacts in decisions [3,5–10]. These moves have been driven partly by external pressures to take this broader view, such as the recent recommendation from The Global Commission on the Economy and Climate “to accelerate low-carbon transformation by integrating climate into core economic decision-making processes” [11] and international climate change negotiations at the Conference of Parties (the 21st session of which [COP21] held in Paris in December 2015) [12]. Recent prominent developments consistent with these influences include the Swedish government’s consideration of a plan
The role of health technology assessment (HTA) is to assess the impact of health interventions on society, with a view to allocating the limited resources to maximize health and well-being in the broadest possible sense. The limited data available to inform such assessments have, however, put practical restrictions on their objectives and scope. As a result, HTA has predominantly been focused on optimizing the use of resources within the health sector. Specifically, it has tended to consider primarily changes in health-related quality of life (HRQOL) and health care, and related costs, as exemplified by the approach taken by the National Institute for Health and Care Excellence (NICE) in the United Kingdom [1]. The limitations of such an approach are highlighted by the extensive literature on whether, or how, HTA methods should capture other outcomes, such as differences in access to health care or effects on caregivers and families of patients or on productivity [2]. A broader perspective might also consider the clear evidence that the delivery of health care, like any other
Copyright & 2015, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc.
* Address correspondence to: Kevin Marsh, Evidera Inc., Metro Building, 6th Floor, 1 Butterwick, Hammersmith, London, UK. E-mail: [email protected]. 1098-3015$36.00 – see front matter Copyright & 2015, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. http://dx.doi.org/10.1016/j.jval.2015.11.008
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to introduce a voluntary ecoclassification or green premium for generic drugs as a way of encouraging more environmentally friendly production of drugs [8,13], and the English NHS’s commitment to reducing its carbon emissions from an annual 20 MtCO2e in 2004 to 11.20 to 12.20 MtCO2e by 2020 and 6.58 MtCO2e by 2050 [9]. Notwithstanding this handful of initiatives, the fact remains that, to date, the formal inclusion of environmental considerations has not been a part of HTA, despite increasing demand by health care stakeholders for such to occur [14]. Therefore, this article asks whether HTA methods should be expanded to accommodate environmental factors and argues that it is now both politically reasonable and methodologically possible to do so. The arguments in favor of such a change are summarized in the next section. We, however, also recognize that if such factors are to be considered, a number of methodological barriers and challenges will need to be overcome, and these are addressed in the subsequent section. Conversely, we reject the argument that the presence of barriers justifies failure to consider environmental factors. Finally, we offer thoughts on ways to advance the debate usefully beyond these initial considerations.
Should Environmental Impacts Be Considered in HTAs? This section considers two key reasons why HTA methods should be expanded to also include environmental impacts.
health care decision makers suggests that they agree that a broader perspective is important. For instance, a recent survey of 140 health care decision makers in 23 countries found that about a third of them already considered the environmental impact of health technologies during the decision-making process, and the rest suggested that such impacts should be considered [14]. Nevertheless, support for taking a societal perspective is by no means universal. For instance, it has also been argued that adopting such an approach would be inappropriate in the face of budgets legitimately allocated by governments to invest in improving health, particularly if transfers between sectors were not possible [26]. This difference of opinion is also reflected in the policies adopted by various HTA agencies. As noted earlier, NICE has chosen a relatively narrow perspective. NICE has, however, recently consulted on ways to broaden the perspective of its analysis in the form of the value-based assessment of pharmaceuticals [27]. This proposed approach, though it looks increasingly less likely to be adopted, would involve measuring the burden of illness of the disease targeted by a technology and wider social impact generated by a treatment, and reflecting these concepts in how much NICE is willing to pay for the health gain generated by a technology. The Swedish Dental and Pharmaceutical Benefits Board (Tandvårds- och läkemedelsförmånsverket [TLV]) has adopted a societal perspective for its HTAs (and considers direct and indirect costs, including productivity costs) [28]. Within this approach, it would be possible to include environmental impacts in HTA assessments submitted to the TLV, although this has yet to happen.
The Link between the Environment and Health Outcomes There is a close link between population health and the environment, and therefore decision makers risk not achieving their goals of maximizing health outcomes if they overlook environmental impacts [15]. The relationship between the environment and health outcomes has long been documented in health economics literature [16–19]. For example, the World Health Organization’s World Health Report shows that 85 of the 102 main diseases reported are partially caused by exposure to some form of environmental factor and consequently result in the loss of one-fourth of health life-years [20]. Additional data from the World Health Organization also suggest that climate change accounted for an estimated 5.5 million lost disability-adjusted life-years in 2000 [21] and causes an estimated 150,000 deaths every year [20]. Furthermore, the Intergovernmental Panel on Climate Change (http://www.ipcc.ch/index. htm) has highlighted some other effects of climate change on health, showing that increases in atmospheric temperature globally are related to flooding and associated rises in both mortality and occurrence of various infections [22]. For example, estimates indicate that at least 8% of global disease burden may be a result of the effects of environmental pollution [23].
Health Care Decision Makers’ Objectives Include Broader Social Welfare, Including Environmental Impacts Accounting for a broader set of factors (including environmental impacts) in HTAs than those currently used (health outcomes alone) would allow decision makers to better maximize social welfare [24,25]. This argument assumes that these societies, or their appointed decision makers, value preserving the environment in addition to other health-related objectives. Evidence increasingly supports this assumption and includes the fact that many health care systems have environmental objectives, often dictated by broader political commitments, such as the Kyoto protocol, as exemplified by the NHS targets cited in the Introduction. Such broadening of the assessment approach would be consistent with the wide range of factors already considered—if only informally—by HTA agencies [14]. Furthermore, research on
Ways to Include Environmental Factors into HTAs If it is accepted that environmental factors should be considered in HTAs, the next question is how this could be done. For example, could the current framework be expanded to include environmental factors or would new approaches be required? Although the literature provides little guidance on these specific points, useful insights can be drawn from debates on how a broader perspective could be captured within HTAs and the methods adopted by economists to value environmental resources.
Measuring the Environmental Impact of Health Technologies An estimate of environmental impact of a health technology should consider the entire life cycle of that technology, including the acquisition of raw materials; the manufacturing process, such as the materials and energy consumed in producing both the active pharmaceutical ingredient and its associated packaging (e. g., syringe, injection pen, actuators, and inhalers) and any resulting pollution; the distribution of the technology to the place of use, in particular, the energy this requires; and the use of the product, including disposal of the spent or unused product and its delivery system [29,30]. Furthermore, estimates of the environmental impact of a technology should include its effects on the management of disease. For instance, an effective technology may substitute for an existing technology and may reduce the need for follow-on treatments; in this scenario, a life cycle perspective should be adopted to estimate the environmental impact of the change in the use of each of the treatments. Overall, therefore, it is important that the assessment of environmental impact considers the implications of resources used throughout the care pathway. To date, examples of attempts to measure the environmental impact of health care have fallen short of this ideal. One case illustrating this is the Healthcare Energy Impacts Calculator, which estimates the monetary cost of the environmental impact of energy use in health care in the United States [31]. Data on
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energy use are combined with the Environmental Protection Agency’s Emissions and Generation Resource Integrated Database factors—a widely accepted estimate of the environmental characteristics of electric power generated in the United States— to estimate the emissions of the following: nitrous oxide, sulfur dioxide, particulate matter, and ozone. This model also estimates changes in population-level exposure to these pollutants, the health impact of these changes, and the monetary value of these health impacts. Crucially, however, the model does not capture all the environmental impacts of health care, but just those associated with energy consumption at the point of care. In England, the NHS has an ongoing project to estimate its carbon footprint [32,33], which overcomes some of these limitations seen with the Energy Impacts Calculator. A key part of the NHS methodology is to draw on quantitative input-output models. These represent the interdependence between different parts of the economy, providing insights into inputs required to deliver one unit of output in a particular sector [32]. Combined with data on fossil fuel consumption and emissions, input-output models can be used to produce environmentally extended input-output analysis (EEIOA) to estimate the carbon emissions generated by each unit of output in a sector [34]. The NHS estimates, however, have their own limitations. First, EEIOA provides only a narrow picture of environmental impact because it focuses on carbon emissions. Second, EEIOA provides data only at a sector level. Because the purpose of HTAs is to evaluate health technologies, a method is required that can estimate the variation in environmental impact between different types of health care expenditure. One option that could overcome some of the aforementioned challenges would be to explore an approach based on process analysis. This technique involves a detailed analysis of the environmental impacts across the life cycle, including the use of raw materials and energy consumption [32]. The challenge in using process analysis is that it demands a large amount of data, and so would require significant effort to collect for all the resource use associated with a single treatment pathway, as would be covered in a single HTA. Further work is needed to explore the place of a hybrid that combines the efficiency of EEIOA with the greater accuracy and ability to discriminate between treatments offered by process analysis.
Evaluation Methodologies Many HTA agencies require that an economic evaluation take the form of a cost-utility analysis (CUA). Such bodies include the NICE in the United Kingdom, College voor Zorgverzekeringen in the Netherlands, the Canadian Agency for Drugs and Technologies in Health in Canada, and the TLV in Sweden. In theory, environmental impacts can be incorporated into an “enriched” CUA-based framework in one of two ways. First, it would at least be theoretically possible to incorporate the health gains associated with improved environmental outcomes into estimates of HRQOL. This would involve translating the environmental impact of a technology into health impacts and then converting the health impact into the unit of HRQOL measurement used in the CUA, such as measures of utility based on the EuroQol fivedimensional questionnaire. This approach is likely, however, to pose a number of technical challenges. Much work has been undertaken to catalog empirical studies on the health impacts of environmental outcomes (see, for instance, Regulatory Impact Analysis: Carbon Pollution Emission [35,36] and Regulatory Impact Analysis: Particulate Matter National Ambient Air Quality Standard [37]). Further work is required to determine the feasibility of using these data to estimate the marginal health gains associated with the marginal environmental improvements of using one technology rather than another. If it proved technically feasible to estimate such health impacts and incorporate them
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into a CUA, this approach would still have the limitation of not capturing the broader, nonhealth benefits of reduced environmental impacts. A second possibility is that the amount that decision makers were willing to pay for health gains from a technology could be adjusted to reflect the environmental impact associated with the life cycle of the technology. There is precedent for such an approach in the United Kingdom, where more is paid for quality-adjusted life-year (QALY) gains at the end of life [38]. Value-based assessment in the United Kingdom is likely to apply this same threshold-adjustment approach to pay more for health gains where treatments are for severe diseases or also generate broader social benefits [27]. Similarly, the Health Care Council in the Netherlands explicitly takes into account “cost-effectiveness” and “severity of disease” criteria and suggests a maximum costeffectiveness ratio of €80,000 per QALY gained for a high-severity disease or condition and approximately €10,000 to €15,000 for a low-severity problem [39]. One concern with reflecting nonhealth values by weighting the willingness-to-pay threshold is that these values are not necessarily correlated with incremental health gains. For instance, such a method offers no incentive to develop a product that generates the same health outcomes as the standard of care but with less impact on the environment because these environmental gains would be reimbursed only through a greater willingness to pay for health gains (of which there are none compared with standard care, in this case). These worries about the use of an enriched CUA approach have prompted consideration of alternative methods, including costbenefit analysis (CBA) and multicriteria decision analysis (MCDA) [40]. CBA converts all outcomes into monetary units, thereby capturing and allowing direct comparison between a wide range of social costs and benefits. This technique is better established outside of health economics where it has been regularly used to inform decision making as far back as in the 1960s [41]. This includes a large body of work where CBA has been applied in decisions on environmental policy [42,43]. Accordingly, the evidence base necessary to support the application of CBA to environmental outcomes is well established, therefore supporting the use of the method as a way of incorporating environmental impacts into HTAs. Nevertheless, incorporating environmental outcomes into HTAs by using CBA poses a number of challenges. First, models of the economic value of environmental outcomes are subject to significant uncertainty and debate, for instance, the social costs of carbon (SCC). SCC estimates are influenced by various factors including the discount rate; the environmental impacts included in the analysis, with some estimates not including nonmarket damages, risk of extreme weather, population growth, future productivity growth, or socially contingent effects; and the weights given to impacts in different geographical regions [44,45]. If the CBA is to draw on SCC estimates, further work is required to determine policymakers’ preferred SCC methods. Second, depending on how it is performed, a CBA may face the same challenges as those encountered by an enriched CUA. If the preferred method is to model the impacts of environmental gains and then estimate the monetary value of these impacts, the technical challenges of modeling these impacts need to be addressed. Alternatively, monetary valuations could be elicited for the environmental impacts, though this would place the burden of understanding the implications of these environmental impacts on those participating in the valuation exercise. Finally, CBA is not widely accepted among HTA agencies. So, although Sweden’s TLV may accept HTA evidence from a CBA in which QALYs are difficult to use [28], the technique is currently rejected by HTA agencies in the United Kingdom, France, and Germany. This limited uptake may reflect the challenges associated with placing a monetary value on nonmarket goods such as health or environmental effects [46].
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The other option, MCDA, is also commonly used in environmental assessments. For example, it is often applied to assess the impact of energy, transport, construction, waste, waste water, and mining activities on the environment [47]. It has also recently received much attention in health care circles for its ability to support valuation and decision making in the context of multiple outcomes. Rather than attempting to value these outcomes monetarily, MCDA elicits from decision makers how they trade off outcomes when making decisions to determine the most preferred treatment option. The term MCDA actually covers a range of different methods, including, among others, the analytic hierarchy process, the analytic network process, the multiattribute utility theory, the multiattribute value theory, outranking, the social multicriteria evaluation, and the technique for order of preference by similarity to ideal solution [47]. These all have various steps in common though, including defining the decision problem, identifying value criteria, weighting criteria, measuring the performance of alternatives against the criteria, aggregation into an overall estimate of value, and assessing the impact of uncertainty [40,48]. Using MCDA to incorporate environmental impacts into HTA poses several challenges. First, as with CBA, the valuation (or weighting) of environmental impacts within an MCDA can take place either before or after modeling the implications of the impacts on, for instance, health. Modeling the impacts of changes in environmental outcomes and incorporating these impacts into an MCDA requires that the technical challenges posed by such models be addressed (see earlier). Incorporating environmental impacts into the MCDA places the burden of understanding the value of changes in environmental outcomes on the stakeholders involved in the MCDA (what is referred to in the MCDA literature as “proxy bias” [49]). Second, the application of MCDA to HTA is still in its relative infancy. Although MCDA has had limited application in HTAs to date (see, for instance, Radaelli et al. [50] and Endrei et al. [51]), policymakers are showing interest in the use of the technique. This attention is mirrored in a recent increase in the publication rate for MCDAs of health interventions [40,52]. For example, the Institute for Quality and Efficiency in Health Care in Germany has indicated its intention to use certain MCDA techniques, such as the analytic hierarchy process, in its evaluation of technologies [53]. However, the very novelty of MCDA presents obstacles to its use in HTAs, for example, the lack of established best practices to guide its application. The recent use of MCDA to support health care decision making [50] and the establishment of initiatives to develop best practices should help to overcome this concern [54].
Discussion Evidence suggests that health care decision makers are becoming increasingly interested in considering environmental impacts related to health care. For example, governments committed to reducing society’s environmental impact have acknowledged that the health care sector will have to play its part in this regard [55]. There are also various other initiatives to incorporate environmental factors into health care decisions. Although these signals are clearly important (and reflect consumer preferences for products that are less harmful to the environment) [56], they are also relatively recent and struggle for attention among the noise of the multiple challenges facing health care decision makers. Despite the increasing regard given to environmental impacts, there has been little in the way of formal incorporation of such factors into a key area of decision making—HTA. One reason for this may be that there are no readily available HTA methods to capture these elements. Incorporating environmental impacts is
one more concern faced by decision makers (adding to, for instance, distributional considerations [2]) which points us beyond the CUA approach that currently predominates in HTAs. CUA could be enriched to capture the benefits of reducing the environmental impact of health technologies but only imperfectly because the benefits of environmental improvement are only partly reflected in, or correlated with, health impacts. Furthermore, this would come at the expense of significant technical challenges, requiring the modeling of the health impacts of environmental outcomes. Alternative methods, such as CBA and MCDA, may thus be better suited to extending HTA to capture environmental impacts. CBA, however, faces its own technical challenges associated with modeling the long-term economic value of environmental outcomes and has been rejected by a number of HTA agencies. This leads us to recommend that further work would most productively be targeted to the development of MCDA for HTA and in incorporating environmental factors into such an approach. If decision makers are concerned with environmental impacts, in the absence of models to estimate the health impact or economic value of such impacts, judgments are still required on the value of these impacts. MCDA provides a way to elicit these judgments in a structured, coherent, and transparent manner. MCDA is currently unfamiliar to most health care decision makers and will require further development and piloting before it could become widely preferred to CUA. Interest in MCDA, however, is on the rise, evidenced by its use for HTA and the establishment of initiatives to identify good practice in the use of MCDA in health care. This article has outlined arguments for, and methodological implications of, incorporating environmental impacts into HTAs and, as far as we know, this is the first to do so. Therefore, much more work is required before the questions it raises can be answered adequately. First, the existing literature contains only limited insights into the preferences of health care decision makers and consumers of health services with regard to environmental consequences. The methods discussed here—an “enriched” CUA, CBA, and MCDA—assume that decision makers are willing to trade off their existing objective (health) or pay more to achieve improvements in environmental outcomes. Further research is required to determine decision makers’ willingness to make such trade-offs and, therefore, the appropriateness of these methods. This should include consideration of the distributional issues posed by the consideration of environmental impacts. Although the direct health gains generated by a technology generally are accrued to those funding it, such as taxpayers or health-plan members, indirect health losses due to environmental impacts do not necessarily fall wholly, or even primarily, on this group. For example, the impact of CO2 emissions related to a technology is global [22]. An obvious question, therefore, is whether those who fund health care for one group of constituents are willing to pay for environmentally friendly technologies that would generate benefits to others. Second, pilot work should be undertaken to determine the feasibility of estimating the environmental impact of health care interventions, and the health and other effects of these environmental impacts. This research should aim to identify the data and tools available to estimate the environmental impact of health care and the consequent health gains of these impacts, the gaps in the evidence, and the data collection activities required to fill these gaps. There should also be appropriate review of evaluation methods (including CBAs and MCDAs) used to support environmental policymakers to identify challenges and lessons from that field. Finally, the value of data on environmental outcomes to health care decision makers should be tested, including the accessibility and impact of data on decisions, and decision
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makers’ preferences for the different ways of synthesizing the evidence (using, for instance, CUA, MCDA, and CBA).
Conclusions There are important inter-relationships between individual and population health, human activities (including health care), and the environment. Nevertheless, understanding and taking account of how health affects and is affected by the environment have not been significant considerations in classical HTAs. Further work is required on the demand for such data and on methods to capture and synthesize it with the evidence currently considered as part of HTA.
Acknowledgments We acknowledge the medical writing assistance received from Emil Nørtoft (Novo Nordisk A/S), Seye Abogunrin (Evidera Inc.), and Ike Iheanacho (Evidera Inc.). Source of financial support: This research was funded by Novo Nordisk A/S. R EF E R EN CE S
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