Health Economics Approach Research Articles

Defining Elements of Value in Health Care—A Health Economics Approach: An ISPOR Special Task Force Report [3

The third section of our Special Task Force report identifies and defines a series of elements that warrant consideration in value assessments of medical technologies. We aim to broaden the view of what constitutes value in health care and to spur new research on incorporating additional elements of value into cost-effectiveness analysis (CEA). Twelve potential elements of value are considered. Four of them—quality-adjusted life-years, net costs, productivity, and adherence-improving factors—are conventionally included or considered in value assessments. Eight others, which would be more novel in economic assessments, are defined and discussed: reduction in uncertainty, fear of contagion, insurance value, severity of disease, value of hope, real option value, equity, and scientific spillovers. Most of these are theoretically well understood and available for inclusion in value assessments. The two exceptions are equity and scientific spillover effects, which require more theoretical development and consensus. A number of regulatory authorities around the globe have shown interest in some of these novel elements. Augmenting CEA to consider these additional elements would result in a more comprehensive CEA in line with the “impact inventory” of the Second Panel on Cost-Effectiveness in Health and Medicine. Possible approaches for valuation and inclusion of these elements include integrating them as part of a net monetary benefit calculation, including elements as attributes in health state descriptions, or using them as criteria in a multicriteria decision analysis. Further research is needed on how best to measure and include them in decision making.

Review of Recent US Value Frameworks—A Health Economics Approach: An ISPOR Special Task Force Report [6

The sixth section of our Special Task Force (STF) report reviews and comments on recent US-oriented value assessment frameworks, specifically those published by the American College of Cardiology/American Heart Association, the Institute for Clinical and Economic Research, the American Society of Clinical Oncology, the National Comprehensive Cancer Network, and the Memorial Sloan Kettering Cancer Center. We review published commentaries that address the validity, reliability, and conceptual underpinnings of these frameworks. We find common themes of critique regarding the strengths and limitations across frameworks. Particular shortcomings of some frameworks pose greater threats to their face validity and utility compared with others. The most significant limitations include lack of clear perspective (e.g., patient vs. health plan) and poor transparency in accounting for costs and benefits. We then review how each framework adheres to core STF recommendations, with particular emphasis on whether the framework can be used to support coverage decisions by health insurers, and whether it adheres to core principles of cost-effectiveness analysis. The Institute for Clinical and Economic Research framework most closely adheres to core STF recommendations. Others have significant limitations that vary widely from framework to framework. We also review how the frameworks follow STF recommendations for addressing potentially relevant issues beyond cost-effectiveness analysis - for example, equity in resource allocation and patient heterogeneity. Finally, we review whether and how each framework uses value thresholds and addresses affordability concerns. We conclude with suggestions for further research, particularly in the areas of testing the measurement and use of novel elements of value and deliberative processes.

An Overview of Value, Perspective, and Decision Context—A Health Economics Approach: An ISPOR Special Task Force Report [2

The second section of our Special Task Force builds on the discussion of value and perspective in the previous article of the report by 1) defining a health economics approach to the concept of value in health care systems; 2) discussing the relationship of value to perspective and decision context, that is, how recently proposed value frameworks vary by the types of decisions being made and by the stakeholders involved; 3) describing the patient perspective on value because the patient is a key stakeholder, but one also wearing the hat of a health insurance purchaser; and 4) discussing how value is relevant in the market-based US system of mixed private and public insurance, and differs from its use in single-payer systems. The five recent value frameworks that motivated this report vary in the types of decisions they intend to inform, ranging from coverage, access, and pricing decisions to those defining appropriate clinical pathways and to supporting provider-clinician shared decision making. Each of these value frameworks must be evaluated in its own decision context for its own objectives. Existing guidelines for cost-effectiveness analysis emphasize the importance of clearly specifying the perspective from which the analysis is undertaken. Relevant perspectives may include, among others, 1) the health plan enrollee, 2) the patient, 3) the health plan manager, 4) the provider, 5) the technology manufacturer, 6) the specialty society, 7) government regulators, or 8) society as a whole. A valid and informative cost-effectiveness analysis could be conducted from the perspective of any of these stakeholders, depending on the decision context.

A Health Economics Approach to US Value Assessment Frameworks—Introduction: An ISPOR Special Task Force Report [1

Concerns about rising spending on prescription drugs and other areas of health care have led to multiple initiatives in the United States designed to measure and communicate the value of pharmaceuticals and other technologies for decision making. In this section we introduce the work of the International Society for Pharmacoeconomics and Outcomes Research Special Task Force on US Value Assessment Frameworks formed to review relevant perspectives and appropriate approaches and methods to support the definition and use of high-quality value frameworks. The Special Task Force was part of the International Society for Pharmacoeconomics and Outcomes Research Initiative on US Value Assessment Frameworks, which enlisted the expertise of leading health economists, concentrating on what the field of health economics can provide to help inform the development and use of value assessment frameworks. We focus on five value framework initiatives: the American College of Cardiology/American Heart Association, the American Society of Clinical Oncology, the Institute for Clinical and Economic Review, the Memorial Sloan Kettering Cancer Center, and the National Comprehensive Cancer Network. These entities differ in their missions, scope of activities, and methodological approaches. Because they are gaining visibility and some traction in the United States, it is essential to scrutinize whether the frameworks use approaches that are transparent as well as conceptually and methodologically sound. Our objectives were to describe the conceptual bases for value and its use in decision making, critically examine existing value frameworks, discuss the importance of sound conceptual underpinning, identify key elements of value relevant to specific decision contexts, and recommend good practice in value definition and implementation as well as areas for further research.

A Health Economics Approach to US Value Assessment Frameworks—Summary and Recommendations of the ISPOR Special Task Force Report [7

This summary section first lists key points from each of the six sections of the report, followed by six key recommendations. The Special Task Force chose to take a health economics approach to the question of whether a health plan should cover and reimburse a specific technology, beginning with the view that the conventional cost-per-quality-adjusted life-year metric has both strengths as a starting point and recognized limitations. This report calls for the development of a more comprehensive economic evaluation that could include novel elements of value (e.g., insurance value and equity) as part of either an “augmented” cost-effectiveness analysis or a multicriteria decision analysis. Given an aggregation of elements to a measure of value, consistent use of a cost-effectiveness threshold can help ensure the maximization of health gain and well-being for a given budget. These decisions can benefit from the use of deliberative processes. The six recommendations are to: 1) be explicit about decision context and perspective in value assessment frameworks; 2) base health plan coverage and reimbursement decisions on an evaluation of the incremental costs and benefits of health care technologies as is provided by cost-effectiveness analysis; 3) develop value thresholds to serve as one important input to help guide coverage and reimbursement decisions; 4) manage budget constraints and affordability on the basis of cost-effectiveness principles; 5) test and consider using structured deliberative processes for health plan coverage and reimbursement decisions; and 6) explore and test novel elements of benefit to improve value measures that reflect the perspectives of both plan members and patients.

The challenges of proprotein convertase subtilisin-kexin-9 inhibitors for lipid guidelines and models of care.

The article reviews the challenges facing cardiovascular disease (CVD) guidelines committees. Clinical trials in high-risk populations have shown additional CVD event reduction with ezetimibe and proprotein convertase subtilisin-kexin-9 inhibitors. These trials recruit middle-aged secondary prevention populations, whereas increasingly the population at risk of CVD comprises the elderly in primary prevention. Some major guidelines have moved from a lipid-target to a risk-based approach. Some guidelines wish to preserve treatment targets to optimize the risk profile of individual patients as opposed to using population-based approaches. A numbers needed to treat approach has been suggested as a way of prioritizing patients for treatment, while retaining an individual's LDL cholesterol risk. However, the main barrier to implementation of some novel therapies in medicine is not their efficacy or safety but their cost. Health economic approaches that consider both benefits and costs can help guideline committees to define populations mostly likely to benefit. The efficacy and expense of novel treatments is challenging traditional guideline development. Previously guideline committees used only to review clinical efficacy and safety endpoints but now they also have to consider costs to derive recommendations that are practical to implement.

Core values for vaccine evaluation

Currently, most health economic modelling approaches tend to inadequately incorporate crucial disease-specific criteria and other attributes of benefit resulting from vaccination, which limits their utility for evaluating vaccines and, in consequence, for optimally guiding vaccine decision-making. Additionally, vaccine evaluation methods are frequently poorly standardised and non-transparent, leading to a potentially low level of accountability that can hinder acceptance of resulting decisions. To address these issues, we have considered whether it is possible to identify a set of universal vaccine-disease considerations, which we have called Core Values. To begin to identify such a set of criteria, and to establish whether strong agreement around such core values exists, we conducted two studies based on the Delphi technique. Both studies surveyed a cohort consisting of expert members of the global vaccine community with diverse professional backgrounds. Formal statistical analysis of both studies identified four attributes with strong agreement: 1. Incidence disease cases prevented per year, 2. Cost-effectiveness (including cost-benefit and cost-utility analysis), 3. High mortality disease (case-fatality-rate), and 4. Severity of target disease (risk of morbidity and mortality). These results suggest the feasibility of identifying a clear consensus on a specific set of Core Values for Vaccine Evaluation.

SELFIE, a novel Horizon2020 project on integrated care for multi-morbidity

Introduction: SELFIE is a new EU-Horizon2020 funded project, which started on September 1st 2015 and is entitled “Sustainable intEgrated care modeLs for multi-morbidity: delivery, FInancing and performance”. SELFIE stands out from other EU-funded projects on integrated care by adopting a broad health economic approach. SELFIE will perform empirical research of promising integrated care models which specifically target individuals with multi-morbidity. It will conduct policy evaluations of financing/payments schemes with different incentives to support integration of care within and across the health care, long-term care and social care sectors. It will develop methods for price-setting, tools for performance monitoring, and strategies for implementation of integrated care in different healthcare systems and contexts including Central and Eastern European Countries. But the first stream of research in SELFIE consists of the development of a conceptual framework on integrated care for multi-morbidity, the identification of specific programs in developed countries, and qualitative research on these programs.Methods: To inform the conceptual framework, scientific literature was searched in online databases (i.e. Pubmed, Embase, Scopus, Web of Science, Cochrane, PsycInfo, and sociological & Social Services Abstracts via ProQuest) and combined with grey literature from OECD, WHO and EU. Studies and reports concerning frameworks/models, integrated care, and multi-morbidity were selected. These sources were also used to identify implemented integrated care programs in the EU. In later phases of SELFIE, these programs will be scored and rank-ordered on a number of criteria in order to select the most promising ones. The latter will be included in the qualitative and quantitative empirical evaluation using Multi-Criteria Decision Analyses (MCDA). MCDA assesses the performance of different integrated care programs on a number of criteria related to the Triple Aim of integrated care (i.e. patient experience, health/wellbeing and costs) and combines them with relative weights that Patients, their Partners, the Professionals, the Payers and the Policy makers (5 Ps) assign to the importance of the criteria. Weights will be obtained o.a. via Discrete Choice Experiments. As little is known about the dynamics, success factors and obstacles for ICC programs dealing with multi-morbidity, a research approach from the qualitative paradigm, the thick description, is used to gain more insight in their social fabric.Results: The literature search resulted in x unique studies of which y were included in our selection. At the time this abstract was written, information from the studies was being retrieved and the identification of implemented integrated care programs for multi-morbidity was in progress. At the conference we will present the first results, including the conceptual framework, the approach for the qualitative in-depth study of specific programs and the methods developed for the MCDA. The focus of the results will be on elements of integrated care particularly relevant for individuals with multi-morbidity. Examples of such elements are a holistic assessment of an individual’s needs, preferences, skills, life-style and illness-perceptions across the entire spectrum of diseases that the individual has, and person-centred care that accounts for overlap and interaction between clinical guidelines/protocols for different diseases and avoids polypharmacy.Discussion and conclusion: The ICIC-16 will be an ideal conference to present the SELFIE study for the first time to a large and broad audience and the results will be interesting to many attendees. The discussion will include the need to develop integrated care approaches for multi-morbidity, the elements that constitute integrated care suitable for people with multi-morbidity and the potential of using MCDA to facilitate a broad evaluation of integrated care.This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 634288. The content of this abstract reflects only the SELFIE groups’ views and the European Commission is not liable for any use that may be made of the information contained herein.

Health-Economic Researches in Perioperative Medicine

Purpose of Review Since healthcare costs have continued to rise, health-economic approaches in perioperative medicine tend to create potential benefits. However, a review of the perioperative literature reveals that there are only few published economic analyses. The aim of the present review is to explore the health-economic researches in the field of perioperative medicine.

A health economic approach to promote active travel – does it work and what can we do better?

Purpose Cycling and walking is a promising approach to counteract some of the leading risk factors for Europe’s health, including physical inactivity, air pollution and climate change. The Health E...

The economic burden of breakfast skipping in Mexico

Background and objectivesRecent data from the 2012 National Health and Nutrition Survey in Mexico showed that 18% of 5 to 14 year old children skipped breakfast. Breakfast skipping is associated with higher odds of overweight and obesity, lower nutrient adequacy, lower cognitive performance (such as memory and attention), and lower academic achievement (such as school performance). These outcomes are, in turn, directly linked to social economic losses; however, no previous study has assessed the economic impact of breakfast skipping in Mexico. The aim of this study was to estimate the economic burden of breakfast skipping related to lower cognitive performance and academic achievement.MethodsThe following data were used: the 2012 National Health and Nutrition Survey (prevalence of breakfast skipping and school attendance), literature review of published peer‐reviewed articles examining the effect of breakfast skipping on cognition and school performance, in addition to economic data (local wages, expected economic growth, and returns on education in Mexico). A mathematical model was developed following a health economic approach in school‐aged children through human capital accumulation to estimate the losses of breakfast skipping. Lower school performance and cognitive outcomes were assumed to impact future child wages throughout their adult working life. The future production losses were discounted to estimate the net present value.ResultsPreliminary results showed that the annual economic burden from breakfast skipping in Mexico in children 5 to 14 years old in 2015 was 4 billion US dollars or 6.7 billon purchasing power parity US dollars. This figure is equivalent to 0.3% of the Mexican Gross Domestic Product. On average each child who regularly skipped breakfast had an estimated loss of 1’150 USD; 987 USD due to lower school performance and 163 USD due to years of school lost. A reduction of the breakfast skipping rate of 1% in children aged 5 to 14 years old would bring an annual economic social benefit of 240 million USD due to its impact on cognitive outcomes and academic achievement.ConclusionThe model shows that small reductions of breakfast skipping rates could have a positive economic impact for society. These results only represent a partial benefit as reduction of breakfast skipping could also be associated with higher micronutrient adequacy and lower overweight rates in both childhood and adulthood which could bring additional economic and health benefits.Support or Funding InformationNestlé Research Center

Health care utilization and cost-effectiveness analyses in prevention studies in the mental health care field

Current literature reports a serious lack of research on the cost-effectiveness of health promotion and prevention programs in the mental health care field. This article gives an overview of the general health economic approach in mental health promotion and describes the methodology of analyzing the budget consequences and cost-utility of innovative stress prevention programs. The programs were implemented and tested in four studies aiming for stress-reduction at the workplace, in educational settings and relapse prevention.

Communicating the Parameter Uncertainty in the IQWiG Efficiency Frontier to Decision‐Makers

The Institute for Quality and Efficiency in Health Care (IQWiG) developed—in a consultation process with an international expert panel—the efficiency frontier (EF) approach to satisfy a range of legal requirements for economic evaluation in Germany's statutory health insurance system. The EF approach is distinctly different from other health economic approaches. Here, we evaluate established tools for assessing and communicating parameter uncertainty in terms of their applicability to the EF approach. Among these are tools that perform the following: (i) graphically display overall uncertainty within the IQWiG EF (scatter plots, confidence bands, and contour plots) and (ii) communicate the uncertainty around the reimbursable price. We found that, within the EF approach, most established plots were not always easy to interpret. Hence, we propose the use of price reimbursement acceptability curves—a modification of the well-known cost-effectiveness acceptability curves. Furthermore, it emerges that the net monetary benefit allows an intuitive interpretation of parameter uncertainty within the EF approach. This research closes a gap for handling uncertainty in the economic evaluation approach of the IQWiG methods when using the EF. However, the precise consequences of uncertainty when determining prices are yet to be defined. © 2014 The Authors. Health Economics published by John Wiley & Sons Ltd.

医薬品・医療機器を対象とした社会経済評価ガイドラインのエキスパート・コンセンサス案とその活用への提言

The interest has been officially growing in introducing health economics approach to the issues of pricing and reimbursement for new drugs and medical devices. In the Social Security Reform Plan of the Cabinet Office, the Ministry of Health, Labor, and Welfare proposed an idea for further investigating a role of socio-economic evaluation to assess the innovation of medical technology. To address this new circumstance, the government must develop and implement an official guideline for economic evaluation of medical technology. Responding to the emerging need for a socio-economic evaluation guideline, we illuminate an outline of the socio-economic evaluation guideline drafted by experts' consensus and proposed to Ministry of Health, Labor, and Welfare in March 2007. Also the potentials and the issues to substantiate the guideline by government were identified for future discussions between government, academics and industry.

Pharmaceutical interventions for mitigating an influenza pandemic: modeling the risks and health-economic impacts

Model-based analyses built on burden-of-disease and cost–effectiveness theory predict that pharmaceutical interventions may efficiently mitigate both the epidemiologic and economic impact of an influenza pandemic. Pharmaceutical interventions typically encompass the application of (pre)pandemic influenza vaccines, other vaccines (notably pneumococcal), antiviral treatments and other drug treatment (e.g., antibiotics to target potential complications of influenza). However, these models may be too limited to capture the full macro-economic impact of pandemic influenza. The aim of this article is to summarize current health-economic modeling approaches to recognize the strengths and weaknesses of these approaches, and to compare these with more recently proposed alternative methods. We conclude that it is useful, particularly for policy and planning purposes, to extend modeling concepts through the application of alternative approaches, including insurers’ risk theories, human capital approaches and sectoral and full macro-economic modeling. This article builds on a roundtable meeting of the Pandemic Influenza Economic Impact Group that was held in Boston, MA, USA, in December 2008.

鍼灸に対する医療経済学的アプローチの検討

鍼灸に対する医療経済学的アプローチの検討

Quality of life in severe mental illness

Studies of quality of life (QOL) in severe mental illness have investigated objective life circumstances, the individual's subjective appraisal of their life, health status and a variety of health-economic approaches. A selective review of the literature published in English is provided. Multiple meanings and multiple measures have been employed in the QOL literature. Numerous correlates and predictors of QOL have been identified, of which by far the most consistently powerful is mood state. Subjective QOL appears to be less amenable to change than measures of health status. The authors conclude that more attention should be paid to the assessment of the impact of service interventions on service users' objective life circumstances and to obtaining narrative accounts of the issues that affect users' experience of quality of life.

Measuring costs in multisite randomized controlled trials: lessons from the VA Cooperative Studies Program.

The interest in the economic impact of new health care interventions has increased dramatically over recent years; however, the results can be highly variable depending upon the economic assumptions made and the approaches taken in collecting the data and in conducting the analyses. This paper describes experiences from the VA Cooperative Studies Program in measuring health care utilization and costs for studies that evaluate clinical interventions. Experiences from two multisite randomized clinical trials (RCTs) are highlighted to illustrate strategies used to measure costs by directly measuring health care utilization and economic data within the context of the trials. Despite the substantial resources required to gather evidence about the cost of care for health care innovations, future VA multisite studies should include accepted health economic approaches to make important contributions to health planning and health policy within and outside the VA health care system.

Pricing and reimbursement of pharmaceuticals in Belgium.

The Belgian healthcare system has a tradition of access and equity at affordable prices. As in other countries, the system becomes pressured by increasing healthcare costs. This paper describes the actual situation in Belgium with special focus on pharmaceutical products and the potential role of pharmacoeconomics in decision making on price and reimbursement. Nearly all people in Belgium are covered by compulsory health insurance. The system is paid for by social security, the patients and the federal and regional authorities. The part of the consumption of pharmaceuticals that is charged to insurance was about 62.1 billion Belgian francs (BeF), i.e. about 50% of the pharmaceutical market in 1994. Price setting in Belgium has been rather low due to the positive reimbursement list, where the price of a new drug is compared to existing drugs in a comparable therapeutic class (so-called reimbursement criteria). The expenditure on pharmaceuticals is increasing faster than global funding for public health. In order to control drug budgets, different cost-containment measures have been or are being taken, i.e. a mix of price, reimbursement and volume controls. These cost-containment measures are not necessarily in accordance with a health economic approach. This paper suggests the scope for better implementation of pharmacoeconomic evaluation, which can lead to more flexible reimbursement systems in specific indications. Therefore, a formal recognition of the role of objective economic evaluations is needed for both hospital and ambulatory care. This process should be proceeded by improving the understanding and robustness of pharmacoeconomic evaluations.