At the Intersection of Health, Health Care and Policy Cite this article as: Mark V. Pauly, Frank A. Sloan and Sean D. Sullivan An Economic Framework For Preventive Care Advice Health Affairs, 33, no.11 (2014):2034-2040 doi: 10.1377/hlthaff.2013.0873
The online version of this article, along with updated information and services, is available at: http://content.healthaffairs.org/content/33/11/2034.full.html
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Health Affairs is published monthly by Project HOPE at 7500 Old Georgetown Road, Suite 600, Bethesda, MD 20814-6133. Copyright © 2014 by Project HOPE - The People-to-People Health Foundation. As provided by United States copyright law (Title 17, U.S. Code), no part of Health Affairs may be reproduced, displayed, or transmitted in any form or by any means, electronic or mechanical, including photocopying or by information storage or retrieval systems, without prior written permission from the Publisher. All rights reserved.
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Preventive Care By Mark V. Pauly, Frank A. Sloan, and Sean D. Sullivan 10.1377/hlthaff.2013.0873 HEALTH AFFAIRS 33, NO. 11 (2014): 2034–2040 ©2014 Project HOPE— The People-to-People Health Foundation, Inc.
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Mark V. Pauly (pauly@wharton .upenn.edu) is the Bendheim Professor and a professor in the Health Care Management Department at the Wharton School, University of Pennsylvania, in Philadelphia. Frank A. Sloan is the J. Alexander McMahon Professor of Health Policy and Management and a professor in the Department of Economics at Duke University, in Durham, North Carolina. Sean D. Sullivan is the Stergachis Family Professor and Dean, School of Pharmacy, at the University of Washington, in Seattle.
An Economic Framework For Preventive Care Advice
Under the Affordable Care Act, preventive care measures, including vaccinations and screenings, recommended by the Advisory Committee on Immunization Practices and the US Preventive Services Task Force must be covered in full by insurance. These recommendations affect the cost of medical care. Yet neither organization explicitly incorporates measures of efficiency or cost-effectiveness in making its recommendations. To redress this shortcoming, we propose a decisionmaking framework for these two organizations based on the principles of economic efficiency. Our analysis suggests that routine use of a preventive service should be recommended for full insurance coverage if the service’s cost-effectiveness exceeds a socially determined threshold. For less costeffective services, we suggest that information about effectiveness and cost should be provided to consumers by physicians or government, but the choice of care and insurance coverage for care should be made by individuals. For the least cost-effective services, the two organizations should discourage public and private insurers from covering such services and report their unfavorable cost-effectiveness. ABSTRACT
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nder the Affordable Care Act (ACA), all vaccinations recommended by the Advisory Committee on Immunization Practices (ACIP) must be covered in full by public and private insurance. In addition, insurance must also cover all non-immunizationrelated preventive care services (such as screening tests) receiving a grade of A (strongly recommended) or B (recommended) by the US Preventive Services Task Force.1,2 Recommendations of these advisory bodies (both created by federal legislation before 1994, with fifteen or sixteen physician and health professional members) affect both health outcomes and medical spending. Yet neither organization is explicitly mandated to give cost or cost-effectiveness information an important role in making its recommendations. They are asked to advise on policies that affect cost without being given specific guid2034
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ance in considering those costs. ACIP was established to make general recommendations on immunization practices and recommend specific vaccinations for routine use. It is not required to base advice on any specific criteria; it is only instructed by law to offer advice on the most appropriate use of vaccines for the control of disease. Federal regulations permit ACIP to include “consideration of vaccine efficacy, as well as cost-benefit and risk-benefit analyses” in making its recommendations, but there is no specific guidance in these regulations or in the organization’s standard procedures as to how such analyses should be used, and ACIP recommendations do not incorporate cost-effectiveness analysis in an explicit, systematic, or rigorous fashion.3 In contrast, the US Preventive Services Task Force explicitly refrains from any consideration of cost or cost-effectiveness in developing its recommendations.4
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While all services or immunizations these bodies recommend must be approved by the Food and Drug Administration (FDA) if subject to FDA scrutiny as involving new drugs or devices, they recommend neither all FDA-approved vaccines nor all preventive care measures commonly rendered by physicians. So cost-effectiveness is not a regular part of the process by which either organization decides to impose costs on insurers and premium payers. Either it is ignored by the US Preventive Services Task Force or it is considered only in an ad hoc way by ACIP. Our intent in this article is to offer a decisionmaking framework based on the principles of economic efficiency as a starting point for the public conversation that ought to occur about how consideration of costs should factor into binding recommendations about insurance coverage. Our target audience includes policy makers setting guidelines for these advisory committees or, in cases such as ACIP, where discretion is permitted, the committee members themselves. Before the ACA, one function of these advisory bodies was to provide information on the economic implications of recommendations to users, including both insurers and consumers, who could use that information if they saw a need to do so in deciding whether to cover or comply.5 For example, the varicella (chicken pox) vaccine, which received an ACIP recommendation in 1995, represented an increased cost to insurers and consumers but was considered cost-effective. An insurer might decide to leave it up to parents to decide whether to pay the vaccine’s relatively modest price out of pocket, and parents, in turn, might choose to buy or not buy insurance that covered the cost of the vaccine. Since the passage of the ACA, all insurers are required to fully cover the services recommended by ACIP and the US Preventive Services Task Force regardless of cost, cost-effectiveness, or economic efficiency. Thus, in this context, information on costs or cost-effectiveness is no longer relevant to insurers’ coverage decisions.2 Moreover, because such services are fully insured, their costs are also invisible to patients, rendering the costs irrelevant.
Economic Efficiency Economic efficiency as applied to health policy decision making takes into consideration both health benefit and resource costs, and it seeks to identify those arrangements that yield the greatest net societal benefit from a given set of resources (for example, drugs, devices, and labor). Health benefits and harms are essential parts of a societal benefit calculation. Economic efficiency requires that the cost of resource use also
be considered; that benefits and costs reflect a societal perspective that takes into account all stakeholders and costs they might pay; and that recommendations be limited to those services for which benefits exceed costs. Economic efficiency does not imply that cost should be minimized, or benefit maximized, but rather that cost be compared with benefit, and that net benefit (the excess of total benefits over cost) be maximized. The fact that both ACIP and the US Preventive Services Task Force lack an economic-efficiency framework for their recommendations means that cost considerations, in the ACIP’s case, tend to be informal (for example, characterizing a vaccine as “expensive”) or, as with the US Preventive Services Task Force, wholly absent in the decision-making process.6
Health And Cost Trade-Offs ACIP is permitted to consider cost-effectiveness. Generally, “consideration” has not meant deciding against an effective vaccine on cost grounds. However, the rising price of vaccines increases the chance that advisory bodies could soon confront a trade-off between positive health benefits and high additional cost. Use of cost-effectiveness criteria by ACIP has been criticized, with Forbes contributing writer Glenn Lammi asking: “Are the 15 clinicians and academics on ACIP equipped to make decisions based on complex health economics?”7 The US Preventive Services Task Force has faced similar criticism that focused both on the organization’s lack of economic expertise (in interpreting the cost-effectiveness information provided by committee staff) and, much more importantly, on the explicit choice to ignore such information in its decision-making standards.8 It is crucial to note that the policies of ACIP and the US Preventive Services Task Force are affected by legislative and political constraints. Even with expertise and intent, and with reliance on staff to summarize information on cost-effectiveness, the two organizations are heavily restricted in their ability to incorporate costs in their decisions. Nonetheless, they are given the authority to make recommendations with potentially serious cost consequences. They are being asked to do a task that is impossible to do well. The current structure is thus unworkable as a vehicle for deciding on costly coverage. We therefore propose an alternative that could, in principle, then be implemented either by ACIP and the US Preventive Services Task Force or by some other entity. To illustrate the challenge that the ACAmandated new mission presents to ACIP and the US Preventive Services Task Force, consider N ov em b e r 2 0 1 4
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Preventive Care Jane Kim’s useful description of recent ACIP decisions about the human papillomavirus and meningococcal vaccines in an article titled “The Role of Cost-Effectiveness in U.S. Vaccination Policy.”9 Because ACIP has no identifiable cost-effectiveness strategy, Kim’s article failed to come to a definitive conclusion about that strategy. The article concludes that “public health decision makers will increasingly have to make explicit choices among health investments while keeping a vigilant eye on total expenditures. … Evidence of cost-effectiveness…can help to highlight important tradeoffs.”9(p1761) This conclusion does not, however, really apply to ACIP and the US Preventive Services Task Force because these bodies have no responsibility for a total expenditures budget for medical services that would constrain their recommendations. Thus, it is unclear what trade-offs these organizations should highlight. When they do recommend a new costly vaccine or service, that recommendation usually increases both public and private spending (including insurance premiums). However, recommending a costly vaccine or service does not impose a requirement for offsetting savings. Instead, insurance costs and, ultimately, premiums are likely to increase when these two organizations recommend new vaccines or services for coverage under the ACA requirements. The cost of the US Preventive Services Task Force recommendations for private insurance has been estimated to be about 1.5 percent in higher premiums.10 Higher insurance premiums will be reflected in lower wage rates and higher taxes for public programs. The members of ACIP and the US Preventive Services Task Force, though generally skilled and expert in making clinical judgments, balancing clinical benefits and risks, and assessing health system–wide implications of their recommendations, do not have guidelines about how they are supposed to “keep an eye” on the economywide opportunity costs of their recommendations.
An Economic Framework We take an explicitly economic approach to the question of appropriate preventive services recommendations in proposing that they satisfy criteria of economic efficiency. The strength of our proposed framework will lie, in part, in how well it is executed. There are other ways to assess the appropriateness of preventive care recommendations, ones that consider intangibles such as some concept of equity or possible differences in social views of the health of different populations. However, an economic approach explicitly 2036
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Recommending a costly vaccine or service does not impose a requirement for offsetting savings.
considers cost as representing the alternative benefits (health or not) that could have been furnished with the resources consumed in providing particular health services, and it includes all pertinent benefits of value to individuals in society. Preventive care should be made free of user cost for several reasons. The classic reason for requiring immunizations for contagious diseases is concern about the failure of consumers to consider the benefits of prevention to others who might otherwise contract the disease from them. Such use is encouraged by insurance coverage. Another reason is that considerable evidence exists suggesting that some patients do not fully appreciate the benefits from some high-value preventive services, such as the measles vaccine. Finally, future cost reduction for other services that sometimes accompany effective prevention will be overlooked by consumers insured for those services (and by insurers and employers) if there is turnover of insured people from one insurance company to another. For example, covering the chicken pox vaccine reduces an insurer’s later costs of treating chicken pox, but if the families of vaccinated children switch to other insurers, the first insurer gets no benefit from its investment. Given these possible challenges, making strong recommendations for high-value preventive care and promoting adherence through insurance coverage seem like sensible public policy. The usual economic decision model for such cases in which voluntary choices may be inefficient is simple: The efficient decision is one that compares the incremental cost-effectiveness of a given preventive service to a threshold monetary value representing society’s willingness to pay for a measure of health—for example, a qualityadjusted life year (QALY). An advisory body following this economic model would recommend use if the cost-effectiveness of the service is at or below a threshold. The threshold represents the value to “society” of a unit of benefit. So if the ratio for the intervention is below the threshold,
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The ACA establishes a statutory link between recommendations about preventive care and insurance coverage.
this implies that benefits exceed costs. This rule is appropriate for interventions that are not mutually exclusive, and most preventive care services are not: An annual flu shot does not preclude immunization against measles. Sometimes, however, interventions can take several forms, but only one can be selected. For example, a screening program can start either earlier or later in life. Then the efficient decision for society says to compare the two interventions in terms of both additional cost (it will cost more to begin screening at age thirty than at forty) and additional benefits (screening earlier may well detect more cases earlier and save lives). Under current ACIP and US Preventive Services Task Force practices, advisory bodies usually settle the question of what to recommend based on a comparison of health benefits and risks alone, as the US Preventive Services Task Force did for its guidelines on breast cancer screening.11 But a rigorous economic analysis would compare the additional cost of the more expensive and effective screening program with the additional benefits, calculate the cost per unit of additional benefit, and compare the incremental cost-effectiveness ratio to the benchmark value. That would determine which of the two is more economically efficient. For example, if screening women younger than age fifty would pick up only half as many breast cancers as screening older women at the same cost per person, the cost for cancer discovered or death prevented would be twice as high. The relevant comparison is with other options such as an alternative screening program for other age groups.12 Efficiency is not the only criterion that society may wish to use for judging a desirable outcome—equity or justice or even political transparency also are important. But whatever further adjustments are made to achieve other goals (for example, subsidies to achieve distributional objectives), the final outcome should be efficient.
Shorn of technical language and complex mathematics, the fundamental goal of economic efficiency is to provide all services worth more than their cost to users and others who value receipt of these services. In contrast, services should not be provided if they improve health but not by enough to justify their costs. The benchmark case favoring adopting treatments based on a uniform threshold value of $100,000 per QALY gained is commonly used as a standard for good value in US health care analyses. This criterion would be appropriate for a public health decision maker who believes that society is willing to pay $100,000 for increments in health measured by quality-adjusted survival.13
Categories Of Evaluation And Advice We outline a simple set of recommendations for which we then provide suggested procedures and content. What guidance would an economic framework provide about two logically linked resource allocation questions: Which services should patients use in what circumstances? How should recommendations of such professional quasi-public bodies be designed to lead closer to ideal patterns of use? Here is a way to consider possible policies. A highly desirable service may be “strongly” recommended, with the expectation that physicians will routinely offer and encourage the use of such services and insurance or public subsidies will reduce the user price to zero. Most recommended pediatric immunizations fall into this category. The word routine is important here: These are situations in which the expected outcome is highly net beneficial and fairly uniform, at least for those prespecified groups at risk. This would be considered a strong recommendation. But what should be the appropriate policy for services that do not have high and uniform net benefit for a broad target population? Which stance is appropriate for the large class of situations for which it is impossible for external observers to distinguish subpopulations that would receive high or low net benefits? Back pain patients may know how bad their pain is, and oncologists may know how much benefit their cancer patients are likely to obtain from a costly treatment, but the insurer often has much less information with which to judge benefits. In these situations, the options and how they should best be characterized are less clear. There are effective preventive services that might be of limited benefit to most people’s health but are sufficiently beneficial for some people to prefer them. We suggest that recommendations in this case be “permissive.” They would emphasize to N ov e m b e r 201 4
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Preventive Care consumers the positive health benefits of the care and the need to alert them about its availability and cost. Those who attach personal value to the benefit in excess of the societal threshold would be permitted to use them or insure them, but neither subsidies nor insurance would be required. Finally, there could be a “discouraging” recommendation. In such cases, the service may be effective but insufficiently effective to justify its cost for the great majority of people. This multilevel recommendation structure appeals to common sense. But in contrast to current practice, recommendations would be based on evidence of both effectiveness and cost-effectiveness of interventions as they apply in different applications and reflect explicit criteria for deciding on which services to recommend or to discourage. An economic framework should be helpful. In our view, there ought to be such an explicit choice, instead of allowing resource allocation and cost-effects to just happen as a result of judgments made primarily on clinical grounds, without rigorous economic analysis.
Which Kind Of Recommendation When? The ACA establishes a statutory link between recommendations about preventive care and insurance coverage. What kinds of recommendations for treatment and coverage should be made? Strong Recommendation If there is positive net benefit for everyone in the target population, the service (and coverage) should be fully insured. If there are substantial external benefits (as for vaccination for contagious disease), there is an even stronger case for requiring insurance coverage. Here a value of $100,000 per QALY gained might be proposed as a threshold. Permissive Recommendation When some people receive positive and others negative net benefits, everyone should be informed about effectiveness and cost but with the choices about use and insurance coverage left to them. Insurance plans could offer coverage of the services, presumably at higher premiums, and people could choose whether or not to select an insurance plan that provided coverage. If consumers were to choose a plan that did not cover or fully cover the service, those people who valued the service at more than its user price could pay for the service out of pocket. Interventions with cost-effectiveness greater than $100,000 per QALY gained but less than some large number (such as $400,000) might fall into this category. Our use of the concept permissive differs from 2038
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Effectively requiring coverage for one moderately low-value vaccine and not for another is evidence of an ad hoc process that is inconsistent in logic.
how ACIP has used this category in discussions about recent practices. Discouraging Recommendation For some services, evidence might indicate very small benefits relative to cost for almost everyone or a negative net benefit for most but with a minority obtaining positive net benefit. These services would, for example, have cost-effectiveness ratios above $400,000 per QALY gained. Instead of encouraging provision of information that would only result in a decision not to use such care, the alternative would simply indicate that the service will not yield benefits that exceed costs.
Comparison With Recent Practices How does this ideal scheme compare with what advisory bodies, and especially ACIP, currently do? Contrast, for example, ACIP’s initial statements on the rotavirus vaccine for young children versus the vaccine for Lyme disease. Both had cost-effectiveness ratios of between $100,000 and $300,000 per QALY gained when administered to target populations at risk. Lyme disease can have serious health consequences, and there is an effective vaccine to prevent it, but one that has a relatively high cost per QALY added. ACIP’s recommendation here was permissive rather than mandatory, which meant that it was not added to the list of recommended childhood vaccinations. The recommendation would have allowed consumers to choose insurance plans that did or did not cover it. ACIP’s statement was not to recommend use (and hence coverage) but rather advised that patient decision be based on how often the patient expected to be exposed to the risk of a bite from an infected tick. Insurance that did not
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Following current law and practice undercuts the recommendation process by making it more arbitrary than it need be.
cover this vaccine was presumably less costly than insurance that did, even if in the latter case the vaccine was primarily used by those who felt they were at increased risk.14 In contrast, rotavirus vaccination was recommended for all oneyear-olds,15 despite a similarly adverse cost-effectiveness ratio. The effect is to increase premiums and insurer claims processing costs, regardless of the value a family places on this type of care or insurance coverage for it. Our argument here is not that either recommendation was mistaken on clinical grounds. There are nuances and variations in both risk and preferences that should be taken into account in any person’s decision to use care and in any policy for offering vaccination to a population. Our argument is that effectively requiring coverage for one moderately low-value vaccine and not for another is evidence of an ad hoc process that is inconsistent in logic. (Indeed, in a pioneering article published in Pediatrics on the cost-effectiveness of rotavirus vaccine, Marc-Alain Widdowson and colleagues advocate “willingness to pay” studies, another method of quantification, to better estimate the vaccine’s value—and offering the option of buying insurance or vaccination to patients advised by informed physicians would directly reveal their willingness to pay.)16 Another example involves the hepatitis B vaccine. One of ACIP’s most recent decisions is that the hepatitis B vaccine be recommended for routine use by adults diagnosed with diabetes mellitus but only up to age fifty-nine. For all such people, the cost-effectiveness of the vaccine, based on a very well done study, is about $75,000 per QALY.17 But the recommendation ignores the finding that the cost-effectiveness ratio for persons ages 50–59 is nearly
$300,000 per QALY. The age cutoff, set at fiftynine because of declining efficacy of the vaccine in older people, also allows for a recommendation that yields a reasonable average ratio. In ignoring the unattractive cost-effectiveness ratio for the older age group, the recommendation sacrifices efficient discrimination in favor of hitting a particular target.
Conclusion With the new link between clinical recommendations and mandated insurance coverage, national advisory bodies are faced with a task impossible to perform or explain unless the system is changed to permit considerations of value (and, of necessity, cost) in a way similar to what we have proposed. Fortunately, until now many services considered by these advisory bodies did have low enough cost-effectiveness ratios that the resulting mandates for coverage were intuitively reasonable and efficient. But if pharmaceutical and vaccine firms have pricing power because of patent exclusivity, there are bound to be more problems and more need for a consistent and transparent rationale for recommending services or mandating coverage of them. Failure to recommend an effective but high-cost treatment is likely to be controversial because the current strong political sensitivity about cost considerations will clash with a similarly strong sensitivity to imposing government requirements that raise private insurance premiums. Following current law and practice not only leads to poor choices but also undercuts the recommendation process by making it more arbitrary than it need be. Given that higher premiums can be a consequence of a recommendation, it seems illogical not to explicitly consider the higher costs compared to the benefit but to be explicit about both benefits and the need to consider the options, as we have recommended. This is a comparison, we admit, that clinical decision makers are reluctant or unable to make because it requires something beyond clinical considerations, and there is no alternative under current law and policies other than inconsistent or undesirable behavior. We have instead recommended a three-tier approach based on cost-effectiveness ratios. The precise dollar values that divide tiers is a political and ultimately a societal judgment. Getting the political process to make the judgment about monetary value may be the greatest challenge. ▪
This research was supported by Novartis Inc.
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NOTES 1 A recommendation is grade A if the US Preventive Services Task Force concludes that there is high certainty of substantial net benefit. It is grade B if the treatment has high certainty of moderate benefit or moderate certainty of high-to-moderate benefit. Grade C recommendations, which do not trigger coverage, also do not consider costs and simply refer to small or uncertain net benefits. US Preventive Services Task Force. Grade definitions [Internet]. Rockville (MD): USPSTF; 2013 Feb [cited 2014 Sep 4]. Available from: http://www.uspreventiveservices taskforce.org/uspstf/grades.htm 2 Internal Revenue Service, Department of the Treasury; Employee Benefits Security Administration, Department of Labor; Office of Consumer Information and Insurance Oversight, Department of Health and Human Services. Interim final rules for group health plans and health insurance issuers relating to coverage of preventive services under the Patient Protection and Affordable Care Act. Fed Regist. 2010 Jul 19;75(137):41726–60. 3 Centers for Disease Control and Prevention. Recommendations on the use of quadrivalent human papillomavirus vaccine in males— Advisory Committee on Immunization Practices (ACIP), 2011. MMWR Morb Mortal Wkly Rep. 2011;60(50): 1705–8. 4 “The USPSTF does not consider the costs of providing a service in this assessment.” US Preventive Services Task Force. Screening for and management of obesity in adults [Internet]. Rockville (MD): USPSTF; 2012 Jun [cited 2014 Sep 4]. Available from: http://www.uspreventive servicestaskforce.org/uspstf11/ obeseadult/obesers.htm 5 Smith JC, Snider DE, Pickering LK. Immunization policy development in the United States: the role of the Advisory Committee on Immunization Practices. Ann Intern Med.
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2009;150(1):45–9. 6 Wilensky GR. The policies and politics of creating a comparative clinical effectiveness research center. Health Aff (Millwood). 2009;28(4):w719– 29. DOI: 10.1377/hlthaff.28.4.w719. 7 Lammi GG. Will little-known federal advisory panel deprive infants of meningitis vaccine? Forbes [serial on the Internet]; 2011 May 27 [cited 2014 Sep 4]. Available from: http:// www.forbes.com/sites/docket/ 2011/05/27/will-little-knownfederal-advisory-panel-depriveinfants-of-meningitis-vaccine/ 8 Gottlieb S. The bleeding edge of rationing: Obama’s health plan and the new power of the United States Preventive Services Task Force [Internet]. Washington (DC): American Enterprise Institute for Public Policy Research; 2011 Nov [cited 2014 Sep 4]. Available from: http://www .aei.org/article/health/healthcarereform/the-bleeding-edge-ofrationing 9 Kim JJ. The role of cost-effectiveness in U.S. vaccination policy. N Engl J Med. 2011;365(19):1760–1. 10 Cassidy A. Health Policy Brief: preventive services without cost sharing. Health Affairs [serial on the Internet]. 2010 Dec 28 [cited 2014 Sep 4]. Available from: http:// healthaffairs.org/healthpolicy briefs/brief.php?brief_id=37 11 US Preventive Services Task Force. Screening for breast cancer [Internet]. Rockville (MD): USPSTF; 2013 Nov [cited 2014 Sep 4]. Available from: http://www.uspreventive servicestaskforce.org/breastcancer .htm 12 Here is an example to show how the incremental cost-effectiveness ratio (ICER) is calculated and how it differs from comparison of stand-alone cost-effectiveness ratios. Suppose starting screening a population very late would cost $90,000 compared to usual care and add one additional quality-adjusted life-year (QALY) worth $100,000 per year. In con-
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trast, starting much earlier would cost $910,000 and add ten years. The ICER is ð$910; 000–90; 000Þ=ð10–1Þ, or $820,000/9, or $91,111, which is less than $100,000—so the earlier start strategy would be more efficient. This is true even though, compared with doing nothing (or usual care), the ICER is lower (more favorable) for the late start than for the early start. Ubel PA, Hirth RA, Chernew ME, Fendrick AM. What is the price of life and why doesn’t it increase at the rate of inflation? Arch Intern Med. 2003;163(14):1637–41. After selling several million doses of Lyme disease vaccine, its manufacturer eventually withdrew it, in part because of reports of adverse reactions and class-action lawsuits. Some observers speculated that the generic “permissive” recommendation was not persuasive for many consumers. College of Physicians of Philadelphia. The history of the Lyme disease vaccine [Internet]. Philadelphia (PA): The College; 2014 Jul 31 [cited 2014 Sep 4]. Available from: http://www.historyofvaccines .org/content/articles/history-lymedisease-vaccine Cortese MM, Parashar UD. Prevention of rotavirus gastroenteritis among infants and children: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2009;58(RR-2):1–25. Widdowson MA, Meltzer ML, Zhang X, Bresee JS, Parashar UD, Glass RL. Cost-effectiveness and potential impact of rotavirus vaccine in the United States. Pediatrics. 2007; 119(4):684–97. Hoerger TJ, Schille S, Wittenborn JS, Bradley CL, Zhou F, Byrd K, et al. Cost-effectiveness of hepatitis B vaccination in adults with diagnosed diabetes. Diabetes Care. 2013;36(1): 63–9.
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The online version of this article, along with updated information and services, is available at: http://content.healthaffairs.org/content/33/11/2034.full.html
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Health Affairs is published monthly by Project HOPE at 7500 Old Georgetown Road, Suite 600, Bethesda, MD 20814-6133. Copyright © 2014 by Project HOPE - The People-to-People Health Foundation. As provided by United States copyright law (Title 17, U.S. Code), no part of Health Affairs may be reproduced, displayed, or transmitted in any form or by any means, electronic or mechanical, including photocopying or by information storage or retrieval systems, without prior written permission from the Publisher. All rights reserved.
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Preventive Care By Mark V. Pauly, Frank A. Sloan, and Sean D. Sullivan 10.1377/hlthaff.2013.0873 HEALTH AFFAIRS 33, NO. 11 (2014): 2034–2040 ©2014 Project HOPE— The People-to-People Health Foundation, Inc.
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Mark V. Pauly (pauly@wharton .upenn.edu) is the Bendheim Professor and a professor in the Health Care Management Department at the Wharton School, University of Pennsylvania, in Philadelphia. Frank A. Sloan is the J. Alexander McMahon Professor of Health Policy and Management and a professor in the Department of Economics at Duke University, in Durham, North Carolina. Sean D. Sullivan is the Stergachis Family Professor and Dean, School of Pharmacy, at the University of Washington, in Seattle.
An Economic Framework For Preventive Care Advice
Under the Affordable Care Act, preventive care measures, including vaccinations and screenings, recommended by the Advisory Committee on Immunization Practices and the US Preventive Services Task Force must be covered in full by insurance. These recommendations affect the cost of medical care. Yet neither organization explicitly incorporates measures of efficiency or cost-effectiveness in making its recommendations. To redress this shortcoming, we propose a decisionmaking framework for these two organizations based on the principles of economic efficiency. Our analysis suggests that routine use of a preventive service should be recommended for full insurance coverage if the service’s cost-effectiveness exceeds a socially determined threshold. For less costeffective services, we suggest that information about effectiveness and cost should be provided to consumers by physicians or government, but the choice of care and insurance coverage for care should be made by individuals. For the least cost-effective services, the two organizations should discourage public and private insurers from covering such services and report their unfavorable cost-effectiveness. ABSTRACT
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nder the Affordable Care Act (ACA), all vaccinations recommended by the Advisory Committee on Immunization Practices (ACIP) must be covered in full by public and private insurance. In addition, insurance must also cover all non-immunizationrelated preventive care services (such as screening tests) receiving a grade of A (strongly recommended) or B (recommended) by the US Preventive Services Task Force.1,2 Recommendations of these advisory bodies (both created by federal legislation before 1994, with fifteen or sixteen physician and health professional members) affect both health outcomes and medical spending. Yet neither organization is explicitly mandated to give cost or cost-effectiveness information an important role in making its recommendations. They are asked to advise on policies that affect cost without being given specific guid2034
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ance in considering those costs. ACIP was established to make general recommendations on immunization practices and recommend specific vaccinations for routine use. It is not required to base advice on any specific criteria; it is only instructed by law to offer advice on the most appropriate use of vaccines for the control of disease. Federal regulations permit ACIP to include “consideration of vaccine efficacy, as well as cost-benefit and risk-benefit analyses” in making its recommendations, but there is no specific guidance in these regulations or in the organization’s standard procedures as to how such analyses should be used, and ACIP recommendations do not incorporate cost-effectiveness analysis in an explicit, systematic, or rigorous fashion.3 In contrast, the US Preventive Services Task Force explicitly refrains from any consideration of cost or cost-effectiveness in developing its recommendations.4
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While all services or immunizations these bodies recommend must be approved by the Food and Drug Administration (FDA) if subject to FDA scrutiny as involving new drugs or devices, they recommend neither all FDA-approved vaccines nor all preventive care measures commonly rendered by physicians. So cost-effectiveness is not a regular part of the process by which either organization decides to impose costs on insurers and premium payers. Either it is ignored by the US Preventive Services Task Force or it is considered only in an ad hoc way by ACIP. Our intent in this article is to offer a decisionmaking framework based on the principles of economic efficiency as a starting point for the public conversation that ought to occur about how consideration of costs should factor into binding recommendations about insurance coverage. Our target audience includes policy makers setting guidelines for these advisory committees or, in cases such as ACIP, where discretion is permitted, the committee members themselves. Before the ACA, one function of these advisory bodies was to provide information on the economic implications of recommendations to users, including both insurers and consumers, who could use that information if they saw a need to do so in deciding whether to cover or comply.5 For example, the varicella (chicken pox) vaccine, which received an ACIP recommendation in 1995, represented an increased cost to insurers and consumers but was considered cost-effective. An insurer might decide to leave it up to parents to decide whether to pay the vaccine’s relatively modest price out of pocket, and parents, in turn, might choose to buy or not buy insurance that covered the cost of the vaccine. Since the passage of the ACA, all insurers are required to fully cover the services recommended by ACIP and the US Preventive Services Task Force regardless of cost, cost-effectiveness, or economic efficiency. Thus, in this context, information on costs or cost-effectiveness is no longer relevant to insurers’ coverage decisions.2 Moreover, because such services are fully insured, their costs are also invisible to patients, rendering the costs irrelevant.
Economic Efficiency Economic efficiency as applied to health policy decision making takes into consideration both health benefit and resource costs, and it seeks to identify those arrangements that yield the greatest net societal benefit from a given set of resources (for example, drugs, devices, and labor). Health benefits and harms are essential parts of a societal benefit calculation. Economic efficiency requires that the cost of resource use also
be considered; that benefits and costs reflect a societal perspective that takes into account all stakeholders and costs they might pay; and that recommendations be limited to those services for which benefits exceed costs. Economic efficiency does not imply that cost should be minimized, or benefit maximized, but rather that cost be compared with benefit, and that net benefit (the excess of total benefits over cost) be maximized. The fact that both ACIP and the US Preventive Services Task Force lack an economic-efficiency framework for their recommendations means that cost considerations, in the ACIP’s case, tend to be informal (for example, characterizing a vaccine as “expensive”) or, as with the US Preventive Services Task Force, wholly absent in the decision-making process.6
Health And Cost Trade-Offs ACIP is permitted to consider cost-effectiveness. Generally, “consideration” has not meant deciding against an effective vaccine on cost grounds. However, the rising price of vaccines increases the chance that advisory bodies could soon confront a trade-off between positive health benefits and high additional cost. Use of cost-effectiveness criteria by ACIP has been criticized, with Forbes contributing writer Glenn Lammi asking: “Are the 15 clinicians and academics on ACIP equipped to make decisions based on complex health economics?”7 The US Preventive Services Task Force has faced similar criticism that focused both on the organization’s lack of economic expertise (in interpreting the cost-effectiveness information provided by committee staff) and, much more importantly, on the explicit choice to ignore such information in its decision-making standards.8 It is crucial to note that the policies of ACIP and the US Preventive Services Task Force are affected by legislative and political constraints. Even with expertise and intent, and with reliance on staff to summarize information on cost-effectiveness, the two organizations are heavily restricted in their ability to incorporate costs in their decisions. Nonetheless, they are given the authority to make recommendations with potentially serious cost consequences. They are being asked to do a task that is impossible to do well. The current structure is thus unworkable as a vehicle for deciding on costly coverage. We therefore propose an alternative that could, in principle, then be implemented either by ACIP and the US Preventive Services Task Force or by some other entity. To illustrate the challenge that the ACAmandated new mission presents to ACIP and the US Preventive Services Task Force, consider N ov em b e r 2 0 1 4
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Preventive Care Jane Kim’s useful description of recent ACIP decisions about the human papillomavirus and meningococcal vaccines in an article titled “The Role of Cost-Effectiveness in U.S. Vaccination Policy.”9 Because ACIP has no identifiable cost-effectiveness strategy, Kim’s article failed to come to a definitive conclusion about that strategy. The article concludes that “public health decision makers will increasingly have to make explicit choices among health investments while keeping a vigilant eye on total expenditures. … Evidence of cost-effectiveness…can help to highlight important tradeoffs.”9(p1761) This conclusion does not, however, really apply to ACIP and the US Preventive Services Task Force because these bodies have no responsibility for a total expenditures budget for medical services that would constrain their recommendations. Thus, it is unclear what trade-offs these organizations should highlight. When they do recommend a new costly vaccine or service, that recommendation usually increases both public and private spending (including insurance premiums). However, recommending a costly vaccine or service does not impose a requirement for offsetting savings. Instead, insurance costs and, ultimately, premiums are likely to increase when these two organizations recommend new vaccines or services for coverage under the ACA requirements. The cost of the US Preventive Services Task Force recommendations for private insurance has been estimated to be about 1.5 percent in higher premiums.10 Higher insurance premiums will be reflected in lower wage rates and higher taxes for public programs. The members of ACIP and the US Preventive Services Task Force, though generally skilled and expert in making clinical judgments, balancing clinical benefits and risks, and assessing health system–wide implications of their recommendations, do not have guidelines about how they are supposed to “keep an eye” on the economywide opportunity costs of their recommendations.
An Economic Framework We take an explicitly economic approach to the question of appropriate preventive services recommendations in proposing that they satisfy criteria of economic efficiency. The strength of our proposed framework will lie, in part, in how well it is executed. There are other ways to assess the appropriateness of preventive care recommendations, ones that consider intangibles such as some concept of equity or possible differences in social views of the health of different populations. However, an economic approach explicitly 2036
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Recommending a costly vaccine or service does not impose a requirement for offsetting savings.
considers cost as representing the alternative benefits (health or not) that could have been furnished with the resources consumed in providing particular health services, and it includes all pertinent benefits of value to individuals in society. Preventive care should be made free of user cost for several reasons. The classic reason for requiring immunizations for contagious diseases is concern about the failure of consumers to consider the benefits of prevention to others who might otherwise contract the disease from them. Such use is encouraged by insurance coverage. Another reason is that considerable evidence exists suggesting that some patients do not fully appreciate the benefits from some high-value preventive services, such as the measles vaccine. Finally, future cost reduction for other services that sometimes accompany effective prevention will be overlooked by consumers insured for those services (and by insurers and employers) if there is turnover of insured people from one insurance company to another. For example, covering the chicken pox vaccine reduces an insurer’s later costs of treating chicken pox, but if the families of vaccinated children switch to other insurers, the first insurer gets no benefit from its investment. Given these possible challenges, making strong recommendations for high-value preventive care and promoting adherence through insurance coverage seem like sensible public policy. The usual economic decision model for such cases in which voluntary choices may be inefficient is simple: The efficient decision is one that compares the incremental cost-effectiveness of a given preventive service to a threshold monetary value representing society’s willingness to pay for a measure of health—for example, a qualityadjusted life year (QALY). An advisory body following this economic model would recommend use if the cost-effectiveness of the service is at or below a threshold. The threshold represents the value to “society” of a unit of benefit. So if the ratio for the intervention is below the threshold,
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The ACA establishes a statutory link between recommendations about preventive care and insurance coverage.
this implies that benefits exceed costs. This rule is appropriate for interventions that are not mutually exclusive, and most preventive care services are not: An annual flu shot does not preclude immunization against measles. Sometimes, however, interventions can take several forms, but only one can be selected. For example, a screening program can start either earlier or later in life. Then the efficient decision for society says to compare the two interventions in terms of both additional cost (it will cost more to begin screening at age thirty than at forty) and additional benefits (screening earlier may well detect more cases earlier and save lives). Under current ACIP and US Preventive Services Task Force practices, advisory bodies usually settle the question of what to recommend based on a comparison of health benefits and risks alone, as the US Preventive Services Task Force did for its guidelines on breast cancer screening.11 But a rigorous economic analysis would compare the additional cost of the more expensive and effective screening program with the additional benefits, calculate the cost per unit of additional benefit, and compare the incremental cost-effectiveness ratio to the benchmark value. That would determine which of the two is more economically efficient. For example, if screening women younger than age fifty would pick up only half as many breast cancers as screening older women at the same cost per person, the cost for cancer discovered or death prevented would be twice as high. The relevant comparison is with other options such as an alternative screening program for other age groups.12 Efficiency is not the only criterion that society may wish to use for judging a desirable outcome—equity or justice or even political transparency also are important. But whatever further adjustments are made to achieve other goals (for example, subsidies to achieve distributional objectives), the final outcome should be efficient.
Shorn of technical language and complex mathematics, the fundamental goal of economic efficiency is to provide all services worth more than their cost to users and others who value receipt of these services. In contrast, services should not be provided if they improve health but not by enough to justify their costs. The benchmark case favoring adopting treatments based on a uniform threshold value of $100,000 per QALY gained is commonly used as a standard for good value in US health care analyses. This criterion would be appropriate for a public health decision maker who believes that society is willing to pay $100,000 for increments in health measured by quality-adjusted survival.13
Categories Of Evaluation And Advice We outline a simple set of recommendations for which we then provide suggested procedures and content. What guidance would an economic framework provide about two logically linked resource allocation questions: Which services should patients use in what circumstances? How should recommendations of such professional quasi-public bodies be designed to lead closer to ideal patterns of use? Here is a way to consider possible policies. A highly desirable service may be “strongly” recommended, with the expectation that physicians will routinely offer and encourage the use of such services and insurance or public subsidies will reduce the user price to zero. Most recommended pediatric immunizations fall into this category. The word routine is important here: These are situations in which the expected outcome is highly net beneficial and fairly uniform, at least for those prespecified groups at risk. This would be considered a strong recommendation. But what should be the appropriate policy for services that do not have high and uniform net benefit for a broad target population? Which stance is appropriate for the large class of situations for which it is impossible for external observers to distinguish subpopulations that would receive high or low net benefits? Back pain patients may know how bad their pain is, and oncologists may know how much benefit their cancer patients are likely to obtain from a costly treatment, but the insurer often has much less information with which to judge benefits. In these situations, the options and how they should best be characterized are less clear. There are effective preventive services that might be of limited benefit to most people’s health but are sufficiently beneficial for some people to prefer them. We suggest that recommendations in this case be “permissive.” They would emphasize to N ov e m b e r 201 4
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Preventive Care consumers the positive health benefits of the care and the need to alert them about its availability and cost. Those who attach personal value to the benefit in excess of the societal threshold would be permitted to use them or insure them, but neither subsidies nor insurance would be required. Finally, there could be a “discouraging” recommendation. In such cases, the service may be effective but insufficiently effective to justify its cost for the great majority of people. This multilevel recommendation structure appeals to common sense. But in contrast to current practice, recommendations would be based on evidence of both effectiveness and cost-effectiveness of interventions as they apply in different applications and reflect explicit criteria for deciding on which services to recommend or to discourage. An economic framework should be helpful. In our view, there ought to be such an explicit choice, instead of allowing resource allocation and cost-effects to just happen as a result of judgments made primarily on clinical grounds, without rigorous economic analysis.
Which Kind Of Recommendation When? The ACA establishes a statutory link between recommendations about preventive care and insurance coverage. What kinds of recommendations for treatment and coverage should be made? Strong Recommendation If there is positive net benefit for everyone in the target population, the service (and coverage) should be fully insured. If there are substantial external benefits (as for vaccination for contagious disease), there is an even stronger case for requiring insurance coverage. Here a value of $100,000 per QALY gained might be proposed as a threshold. Permissive Recommendation When some people receive positive and others negative net benefits, everyone should be informed about effectiveness and cost but with the choices about use and insurance coverage left to them. Insurance plans could offer coverage of the services, presumably at higher premiums, and people could choose whether or not to select an insurance plan that provided coverage. If consumers were to choose a plan that did not cover or fully cover the service, those people who valued the service at more than its user price could pay for the service out of pocket. Interventions with cost-effectiveness greater than $100,000 per QALY gained but less than some large number (such as $400,000) might fall into this category. Our use of the concept permissive differs from 2038
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Effectively requiring coverage for one moderately low-value vaccine and not for another is evidence of an ad hoc process that is inconsistent in logic.
how ACIP has used this category in discussions about recent practices. Discouraging Recommendation For some services, evidence might indicate very small benefits relative to cost for almost everyone or a negative net benefit for most but with a minority obtaining positive net benefit. These services would, for example, have cost-effectiveness ratios above $400,000 per QALY gained. Instead of encouraging provision of information that would only result in a decision not to use such care, the alternative would simply indicate that the service will not yield benefits that exceed costs.
Comparison With Recent Practices How does this ideal scheme compare with what advisory bodies, and especially ACIP, currently do? Contrast, for example, ACIP’s initial statements on the rotavirus vaccine for young children versus the vaccine for Lyme disease. Both had cost-effectiveness ratios of between $100,000 and $300,000 per QALY gained when administered to target populations at risk. Lyme disease can have serious health consequences, and there is an effective vaccine to prevent it, but one that has a relatively high cost per QALY added. ACIP’s recommendation here was permissive rather than mandatory, which meant that it was not added to the list of recommended childhood vaccinations. The recommendation would have allowed consumers to choose insurance plans that did or did not cover it. ACIP’s statement was not to recommend use (and hence coverage) but rather advised that patient decision be based on how often the patient expected to be exposed to the risk of a bite from an infected tick. Insurance that did not
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Following current law and practice undercuts the recommendation process by making it more arbitrary than it need be.
cover this vaccine was presumably less costly than insurance that did, even if in the latter case the vaccine was primarily used by those who felt they were at increased risk.14 In contrast, rotavirus vaccination was recommended for all oneyear-olds,15 despite a similarly adverse cost-effectiveness ratio. The effect is to increase premiums and insurer claims processing costs, regardless of the value a family places on this type of care or insurance coverage for it. Our argument here is not that either recommendation was mistaken on clinical grounds. There are nuances and variations in both risk and preferences that should be taken into account in any person’s decision to use care and in any policy for offering vaccination to a population. Our argument is that effectively requiring coverage for one moderately low-value vaccine and not for another is evidence of an ad hoc process that is inconsistent in logic. (Indeed, in a pioneering article published in Pediatrics on the cost-effectiveness of rotavirus vaccine, Marc-Alain Widdowson and colleagues advocate “willingness to pay” studies, another method of quantification, to better estimate the vaccine’s value—and offering the option of buying insurance or vaccination to patients advised by informed physicians would directly reveal their willingness to pay.)16 Another example involves the hepatitis B vaccine. One of ACIP’s most recent decisions is that the hepatitis B vaccine be recommended for routine use by adults diagnosed with diabetes mellitus but only up to age fifty-nine. For all such people, the cost-effectiveness of the vaccine, based on a very well done study, is about $75,000 per QALY.17 But the recommendation ignores the finding that the cost-effectiveness ratio for persons ages 50–59 is nearly
$300,000 per QALY. The age cutoff, set at fiftynine because of declining efficacy of the vaccine in older people, also allows for a recommendation that yields a reasonable average ratio. In ignoring the unattractive cost-effectiveness ratio for the older age group, the recommendation sacrifices efficient discrimination in favor of hitting a particular target.
Conclusion With the new link between clinical recommendations and mandated insurance coverage, national advisory bodies are faced with a task impossible to perform or explain unless the system is changed to permit considerations of value (and, of necessity, cost) in a way similar to what we have proposed. Fortunately, until now many services considered by these advisory bodies did have low enough cost-effectiveness ratios that the resulting mandates for coverage were intuitively reasonable and efficient. But if pharmaceutical and vaccine firms have pricing power because of patent exclusivity, there are bound to be more problems and more need for a consistent and transparent rationale for recommending services or mandating coverage of them. Failure to recommend an effective but high-cost treatment is likely to be controversial because the current strong political sensitivity about cost considerations will clash with a similarly strong sensitivity to imposing government requirements that raise private insurance premiums. Following current law and practice not only leads to poor choices but also undercuts the recommendation process by making it more arbitrary than it need be. Given that higher premiums can be a consequence of a recommendation, it seems illogical not to explicitly consider the higher costs compared to the benefit but to be explicit about both benefits and the need to consider the options, as we have recommended. This is a comparison, we admit, that clinical decision makers are reluctant or unable to make because it requires something beyond clinical considerations, and there is no alternative under current law and policies other than inconsistent or undesirable behavior. We have instead recommended a three-tier approach based on cost-effectiveness ratios. The precise dollar values that divide tiers is a political and ultimately a societal judgment. Getting the political process to make the judgment about monetary value may be the greatest challenge. ▪
This research was supported by Novartis Inc.
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NOTES 1 A recommendation is grade A if the US Preventive Services Task Force concludes that there is high certainty of substantial net benefit. It is grade B if the treatment has high certainty of moderate benefit or moderate certainty of high-to-moderate benefit. Grade C recommendations, which do not trigger coverage, also do not consider costs and simply refer to small or uncertain net benefits. US Preventive Services Task Force. Grade definitions [Internet]. Rockville (MD): USPSTF; 2013 Feb [cited 2014 Sep 4]. Available from: http://www.uspreventiveservices taskforce.org/uspstf/grades.htm 2 Internal Revenue Service, Department of the Treasury; Employee Benefits Security Administration, Department of Labor; Office of Consumer Information and Insurance Oversight, Department of Health and Human Services. Interim final rules for group health plans and health insurance issuers relating to coverage of preventive services under the Patient Protection and Affordable Care Act. Fed Regist. 2010 Jul 19;75(137):41726–60. 3 Centers for Disease Control and Prevention. Recommendations on the use of quadrivalent human papillomavirus vaccine in males— Advisory Committee on Immunization Practices (ACIP), 2011. MMWR Morb Mortal Wkly Rep. 2011;60(50): 1705–8. 4 “The USPSTF does not consider the costs of providing a service in this assessment.” US Preventive Services Task Force. Screening for and management of obesity in adults [Internet]. Rockville (MD): USPSTF; 2012 Jun [cited 2014 Sep 4]. Available from: http://www.uspreventive servicestaskforce.org/uspstf11/ obeseadult/obesers.htm 5 Smith JC, Snider DE, Pickering LK. Immunization policy development in the United States: the role of the Advisory Committee on Immunization Practices. Ann Intern Med.
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2009;150(1):45–9. 6 Wilensky GR. The policies and politics of creating a comparative clinical effectiveness research center. Health Aff (Millwood). 2009;28(4):w719– 29. DOI: 10.1377/hlthaff.28.4.w719. 7 Lammi GG. Will little-known federal advisory panel deprive infants of meningitis vaccine? Forbes [serial on the Internet]; 2011 May 27 [cited 2014 Sep 4]. Available from: http:// www.forbes.com/sites/docket/ 2011/05/27/will-little-knownfederal-advisory-panel-depriveinfants-of-meningitis-vaccine/ 8 Gottlieb S. The bleeding edge of rationing: Obama’s health plan and the new power of the United States Preventive Services Task Force [Internet]. Washington (DC): American Enterprise Institute for Public Policy Research; 2011 Nov [cited 2014 Sep 4]. Available from: http://www .aei.org/article/health/healthcarereform/the-bleeding-edge-ofrationing 9 Kim JJ. The role of cost-effectiveness in U.S. vaccination policy. N Engl J Med. 2011;365(19):1760–1. 10 Cassidy A. Health Policy Brief: preventive services without cost sharing. Health Affairs [serial on the Internet]. 2010 Dec 28 [cited 2014 Sep 4]. Available from: http:// healthaffairs.org/healthpolicy briefs/brief.php?brief_id=37 11 US Preventive Services Task Force. Screening for breast cancer [Internet]. Rockville (MD): USPSTF; 2013 Nov [cited 2014 Sep 4]. Available from: http://www.uspreventive servicestaskforce.org/breastcancer .htm 12 Here is an example to show how the incremental cost-effectiveness ratio (ICER) is calculated and how it differs from comparison of stand-alone cost-effectiveness ratios. Suppose starting screening a population very late would cost $90,000 compared to usual care and add one additional quality-adjusted life-year (QALY) worth $100,000 per year. In con-
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trast, starting much earlier would cost $910,000 and add ten years. The ICER is ð$910; 000–90; 000Þ=ð10–1Þ, or $820,000/9, or $91,111, which is less than $100,000—so the earlier start strategy would be more efficient. This is true even though, compared with doing nothing (or usual care), the ICER is lower (more favorable) for the late start than for the early start. Ubel PA, Hirth RA, Chernew ME, Fendrick AM. What is the price of life and why doesn’t it increase at the rate of inflation? Arch Intern Med. 2003;163(14):1637–41. After selling several million doses of Lyme disease vaccine, its manufacturer eventually withdrew it, in part because of reports of adverse reactions and class-action lawsuits. Some observers speculated that the generic “permissive” recommendation was not persuasive for many consumers. College of Physicians of Philadelphia. The history of the Lyme disease vaccine [Internet]. Philadelphia (PA): The College; 2014 Jul 31 [cited 2014 Sep 4]. Available from: http://www.historyofvaccines .org/content/articles/history-lymedisease-vaccine Cortese MM, Parashar UD. Prevention of rotavirus gastroenteritis among infants and children: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2009;58(RR-2):1–25. Widdowson MA, Meltzer ML, Zhang X, Bresee JS, Parashar UD, Glass RL. Cost-effectiveness and potential impact of rotavirus vaccine in the United States. Pediatrics. 2007; 119(4):684–97. Hoerger TJ, Schille S, Wittenborn JS, Bradley CL, Zhou F, Byrd K, et al. Cost-effectiveness of hepatitis B vaccination in adults with diagnosed diabetes. Diabetes Care. 2013;36(1): 63–9.
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