At the Intersection of Health, Health Care and Policy Cite this article as: Jason L. Schwartz and Adel Mahmoud When Not All That Counts Can Be Counted: Economic Evaluations And The Value Of Vaccination Health Affairs, 35, no.2 (2016):208-211 doi: 10.1377/hlthaff.2015.1438

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Value Of Vaccines By Jason L. Schwartz and Adel Mahmoud 10.1377/hlthaff.2015.1438 HEALTH AFFAIRS 35, NO. 2 (2016): 208–211 ©2016 Project HOPE— The People-to-People Health Foundation, Inc.

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Jason L. Schwartz (jason.l [email protected]) is an assistant professor in the Department of Health Policy and Management, Yale School of Public Health, in New Haven, Connecticut. Adel Mahmoud is a professor in the Woodrow Wilson School of Public and International Affairs and the Department of Molecular Biology, both at Princeton University, in New Jersey.

P E R S P E C TI V E

When Not All That Counts Can Be Counted: Economic Evaluations And The Value Of Vaccination With vaccination efforts forced to compete for scarce resources at a time when national health budgets, global health resources, and the global donor community are facing considerable strains, advocates of vaccines have sought to better identify, measure, and articulate the value of vaccination. Critics of current analyses of the value of vaccination argue that a broader view is required, one that includes the additional economic benefits of vaccines or acknowledges the social and ethical aims advanced by vaccination programs. Much of this work has paid inadequate attention to the need to apply any expanded view of value consistently across medical interventions, to the close and complex integration of vaccination efforts with other health initiatives, and to the fact that subjectivity and judgments are present in quantitative and qualitative evidence alike. To fully realize the value of vaccination, far more attention, investment, and research are required to better understand the deliberations and decision-making processes by which any kind of evidence is translated into policy. ABSTRACT

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he current state of global vaccination activities is quite strong, and in many respects, the future of those activities has never been brighter. For example, government and private investments in research have accelerated the development and introduction of multiple new vaccines, and work continues on potential future vaccines against Ebola and many other diseases. At the same time, public-private partnerships have played invaluable roles in organizing a coordinated global commitment to vaccination, particularly for children, and delivering recommended vaccines to citizens of low-income countries. Despite these achievements and encouraging future prospects, global vaccination efforts face many challenges. Assuring the public of the safety, benefits, and necessity of vaccination is a perennial difficulty, one complicated by the very achievements of vaccination programs in mak-

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ing vaccine-preventable diseases extremely rare in many parts of the world. Delivering vaccines to children in nations where existing health systems are poor is another long-standing obstacle. But more fundamentally, the vaccinati-on enterprise—from research through global implementation—is becoming increasingly complex and expensive at the same time that national health budgets, global health resources, and the attention of the global donor community are all under considerable strain. With vaccination-related efforts forced to compete more than ever against any number of other laudable priorities—both health- and nonhealth-related—for scarce resources, advocates of vaccination have sought to better identify, measure, and articulate the value of vaccination. As articles in this issue of Health Affairs illustrate, work in this area generally begins with the shared belief in the inadequacy of most current methods of measuring value, which largely con-

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centrate on health and economic benefits directly related to the prevention of disease in vaccinated individuals. From there, however, analysts differ over what kinds of additional benefits ought to be included, let alone how they might be measured or otherwise considered in assessments of the value of vaccination. Little is typically said about how policy makers, their expert advisers, or other decision makers should incorporate broader understandings and estimates of the value of vaccination into their deliberations on funding priorities, program recommendations, or related topics. In this commentary we consider recurring themes that emerge from the growing body of literature on the value of vaccination. We also highlight several assumptions embedded within this work that require further consideration, and we offer perspectives on how any broader assessment of the value of vaccination should contribute to the development and implementation of public health and global health priorities.

Two Approaches To Broadening The ‘Value Of Vaccination’ Critiques of current analyses of the value of vaccination can be divided into two main classes. The first, and more common, focuses strictly on the economic sense of value—a reasonable approach in light of the importance of economic evaluations in the priority-setting and policymaking work of governments. Most elegantly articulated by Till Bärnighausen, David Bloom, and coauthors,1–3 this work notes how most economic measures of the value of vaccination limit their focus to the costs of health care averted by preventing illness and to productivity gains accrued by patients and their caregivers in the absence of convalescence and care, respectively. Instead of that “narrow” perspective on the value of vaccination, a much broader view is proposed by these authors and others. They advocate adding effects such as increased productivity later in life following vaccination, improved cognitive and educational outcomes, community-level health gains through herd effects, and vaccination-related benefits to macroeconomic factors and even political stability.4,5 Adopting this view would require not just a new and broader perspective, but also new methods of analysis to evaluate all of these factors and significant participation of disciplines and experts whose role is typically limited, if not absent altogether, in this work. For example, greater contributions from health economists would be particularly essential to the design of clinical trials for novel vaccines or vaccination strategies and the interpretation of their results in this

scenario.4 The second category of critiques points to the exclusive focus on economic measures at the expense of a broader reading of value that also includes moral, social, and ethical aims furthered by vaccination programs.6 In this formulation, an assessment of the value of vaccination should also consider how vaccination programs can advance efforts to promote equity and social justice, both within communities and across generations; further the role of societies in showing concern for their most vulnerable members; and strengthen efforts to promote goodwill and trust within nation-states and across the global community. The difficulty of isolating the specific role of vaccination programs in these praiseworthy social initiatives—not to mention subsequently translating these benefits into the language of quality-adjusted life-years (QALYs) used to compare disease burdens and interventions or into the monetary amounts required in economic analyses—has caused these additional benefits of vaccines to be overlooked, if not ignored entirely. These types of calls for a fuller interpretation and assessment of the value of vaccination beyond familiar economic measures are closely connected with more general critiques of costeffectiveness and cost-benefit analyses and their role in health policy making.7

Assumptions And Complications These two dominant approaches to more broadly defining the value of vaccination are by no means mutually exclusive. They share a common aim of putting vaccination programs in their most favorable light, in hopes of generating greater enthusiasm, attention, and investment from policy makers. However, proponents of these efforts would be well advised to acknowledge and address three assumptions embedded in much of this work to date that, without attention, could impede their admirable efforts to make the strongest possible case for vaccines. First, regardless of the merits of criticisms of economic analyses such as cost-effectiveness analysis or cost-benefit analysis, their chief attribute for policy making is their ability to assist in the evaluation of disparate interventions—within health programs or more broadly—on an ostensibly level playing field. Implicit in most claims that traditional economic analyses of the benefits of vaccines fail to reflect the full value of vaccination is the belief that a new and broader approach would correct a shortcoming that undervalues vaccines compared to other investments. However, vaccination is far from the only Febr uary 201 6

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Value Of Vaccines health intervention that would be susceptible to the kinds of undervaluing observed by proponents of new models for assessing the value of vaccines. Other prevention programs, for example, are particularly likely to yield similar kinds of community and societal benefits that are seldom included in current economic analyses. To adopt a broader model for the value of vaccination without also applying this perspective across other medical interventions would, in effect, tip the scales unfairly in favor of vaccination programs. Of note, one recent effort that endorsed a new and broader approach to evaluating potential health investments, Global Health 2035, does advocate for applying such a model consistently, thereby avoiding the potential problems of what might be called vaccine exceptionalism in this regard.8 A second complication of efforts to broaden assessments of the value of vaccination is the tendency to view vaccination programs in isolation, forced to compete with other proposals— both health-related and not—for scarce funding, personnel, or other resources. While this is the case in some circumstances, as in the decision to launch a new vaccination program in a country, focusing on this perspective can preclude a more nuanced appreciation of the manner in which vaccination efforts very often can—and should— work in tandem with other health and governmental initiatives in wealthy and developing countries alike. Vaccination activities can be both a contributor to and a beneficiary of well-functioning health systems. The Ebola outbreak centered in West Africa underscored the need to think broadly about the role of vaccines and vaccine development as part of both global preparedness efforts and efforts to build, strengthen, and sustain national health systems. Vaccination is best positioned to thrive if it is seamlessly integrated within larger efforts to prevent disease and improve health, an integration that admittedly complicates efforts to isolate and measure the economic benefits brought specifically by vaccination programs. With respect to social and ethical considerations that might be included as part of a broader approach to evaluating the value of vaccination, here, too, the relationships between vaccination and other activities are complex and multifaceted. To be sure, vaccination efforts can promote equity across communities and generations as well as greater trust in health officials, but the very success of those activities depends on a foundation of public confidence in government, health officials, and health workers. Attacks on health workers participating in polio eradication efforts tragically highlight the 210

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consequences of these important considerations. Once again, the complexity of these relationships poses challenges to efforts to assess the degree to which vaccination programs are an engine to promote social and ethical imperatives or a beneficiary of general efforts in those areas. Finally, virtually all work on the value of vaccination to date has relied on an unstated assumption that quantitative measures provide the strongest evidence and the greatest claims to objectivity among all of the tools and resources available to policy makers and governments. Even commentators who lament the absence or underinclusion of the many social and ethical benefits of vaccination in traditional economic analyses suggest that the optimal solution is to develop new quantitative metrics to assess those gains alongside traditional measures of benefits. Such proposals purport to reduce the likelihood that so-called softer arguments (that is, those without quantitative measures associated with them) might lead to arbitrary or inconsistent policy decisions.6 These considerations reflect the long-standing tendency in science and other fields to view quantification as a process more capable than other kinds of evidence or arguments of producing objective truths.9 However, the very debates discussed above about which measures ought to be included in economic analyses of the value of vaccination, how best to obtain those data, and how to consider the relative merits of different approaches to cost-effectiveness or cost-benefit analyses all provide clear reminders that any evidence produced from this work is necessarily— and appropriately—the product of considerable deliberation and innumerable judgments by researchers. Policy makers and others tasked with translating evidence into policy would be best served by remaining vigilant in seeking to identify and critically assess the judgments embedded in any argument regarding the value of vaccination or that of any potential investment priority. This is all the more important for quantitative measures such as cost per QALY or dollars saved, in which many relevant and nonobvious judgments (and the consequences thereof) are often latent in the final outcomes of the work.

Realizing The Value Of Vaccination: A Way Forward The assumptions and complications we raise here are not intended to detract from the importance of efforts under way to better articulate the value of vaccination or the obvious need for and benefits of new kinds of evidence. Developing

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the most robust evidence of value for vaccines and other health investments, understanding the complex relationships between vaccination programs and the health settings in which they occur, and appropriately identifying the full range of economic and noneconomic benefits of vaccination programs are all activities that will doubtless improve the policy conclusions that emerge from this work. But all evidence is only as good as the deliberations and decision-making processes that lead to its translation into policy. Attention from researchers to how national and international policy makers evaluate different types of evidence, deliberate about competing priorities and their relative merits, and ultimately arrive at policy decisions has lagged far behind work that seeks to develop new and better kinds of evidence to inform these practices. Far more attention, investment, and research are needed to improve our collective understanding of the decision-making processes of policy makers and their expert advisers. This work can lead to a clearer understanding of the needs of these groups when evaluating the value of vaccination or other potential investments, as well as the challenges encountered when considering evidence as part of priority-setting activities. It can also facilitate the development of best practices that can be shared among national and international bodies. Some encouraging collaborations and comparative investigations along these lines have already occurred at the level of national immunization technical advisory groups, the expert pan-

els that advise governments on the design of national immunization programs.10 However, these bodies are almost exclusively tasked with offering advice within the confines of vaccination efforts; they are not charged with undertaking the broader assessments of competing priorities that an expanded view of the value of vaccination aims to influence. Assessments of cost-effectiveness or other economic measures is sometimes part of the mandates of these groups, but their primary expertise and mission generally relate—as they should—to the evaluation of scientific evidence and the public health implications of various vaccination strategies. A fuller articulation of the value of vaccination would provide substantial benefits to wealthy and less wealthy nations alike. It offers the potential for greater government attention to and enthusiasm for vaccination, broader public support for vaccination programs, and increased private investment in vaccine research and development. A robust economic analysis of the value of vaccination is an essential starting point for these efforts, including analyses of additional factors not typically included in most work in this area to date. But only a broader view that also embraces difficult- or impossible-to-quantify benefits of successful vaccination programs, in tandem with far greater attention to the poorly understood ways in which evidence of all kinds contributes to the development of public policy, will allow the true value of vaccination to be realized in the health of individuals and communities worldwide. ▪

NOTES 1 Bärnighausen T, Bloom DE, CafieroFonseca ET, O’Brien JC. Valuing vaccination. Proc Natl Acad Sci U S A. 2014;111(34):12313–9. 2 Bloom DE. The value of vaccination. Adv Exp Med Biol. 2011;697:1–8. 3 Bärnighausen T, Berkley S, Bhutta ZA, Bishai DM, Black MM, Bloom DE, et al. Reassessing the value of vaccines. Lancet Glob Health. 2014; 2(5):e251–2. 4 Bloom DE, Fan V. The value of vaccination: concepts, measures, evidence, and policy implications. Health Aff (Millwood). 2016;35(2): xx–xx.

5 Deogaonkar R, Hutubessy R, van der Putten I, Evers S, Jit M. Systematic review of studies evaluating the broader economic impact of vaccination in low and middle income countries. BMC Public Health. 2012; 12:878. 6 Luyten J, Beutels P. The social value of vaccination programs: beyond cost-effectiveness. Health Aff (Millwood). 2016;35(2):212–18. 7 Brock DW. Ethical issues in applying quantitative models for setting priorities in prevention. In: Dawson A, Verweij M, editors. Ethics, prevention, and public health. Oxford:

Clarendon Press; 2009. p. 111–28. 8 Jamison DT, Summers LH, Alleyne G, Arrow KJ, Berkley S, Binagwaho A, et al. Global health 2035: a world converging within a generation. Lancet. 2013;382(9908):1898–955. 9 Porter TM. Trust in numbers: the pursuit of objectivity in science and public life. Princeton (NJ): Princeton University Press; 1995. 10 Ricciardi GW, Toumi M, Weil-Olivier C, Ruitenberg EJ, Dankó D, Duru G, et al. Comparison of NITAG policies and working processes in selected developed countries. Vaccine. 2015; 33(1):3–11.

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When Not All That Counts Can Be Counted: Economic Evaluations And The Value Of Vaccination.

With vaccination efforts forced to compete for scarce resources at a time when national health budgets, global health resources, and the global donor ...
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