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ETHICAL CONSIDERATIONS FOR PRIORITY-SETTING IN HEALTH CARE
Fair distribution is an increasingly important issue in healthcare due to factors such as the scarcity of resources associated with "high tech" medicine, longer life expectancies, and the increasing prevalence of chronic diseases. One way to cope with the scarcity of healthcare resources is to apply cost-effective analysis (CEA) in priority setting. Disability adjusted life years (DALYs) have been used to measure the global burden of disease since they were first launched by the World Bank (1). It is a specific version of the person trade-off technique that uses "disability weights" to reflect the burden of the same health state (2). However, even though the DALY concept enables one to compare different interventions and individuals on a single quantitative scale, it has been criticized for some drawbacks (3). For example, the method implicitly presupposes that the lives of disabled people have less value than the lives of people without disabilities (4). Moreover, the DALY approach discriminates against disabled or older individuals by assuming that they are less entitled to health benefits that would extend their lives (3). Even though this tool is necessary in priority setting, it is still insufficient in assisting decision makers (5).
According to the Institute of Medical Panels on Cost-Effectiveness in Health and Medicine (6), a CEA should be used to aid a decision maker who must weigh the information in the context of other values. Without a consensus on the ethical values that underlie health policies, priority setting in healthcare is insufficient to handle "what should be done" (5). This paper aims to provide a discussion on the ethical considerations involved in priority setting for the fair allocation of resources. We present a health technology assessment (HTA) of European network for Health Technology Assessment (EUnetHTA) project as an example of an ethical approach to health policy, and we discuss the necessity for a consensus on a fair procedure to reach an agreement regarding healthy policy in South Korea.
STATUS OF PRIORITY SETTING IN KOREA
A remarkable aspect of healthcare in South Korea is the universal coverage of its population. After the introduction of social health insurance in 1977, the National Health Insurance (NHI) system was extended to the "entire population" in only 12 years (78). Because South Korea only spends approximately 6% of its gross domestic product on healthcare, which is the third lowest level for health care expenditures in the Organisation for Economic Co-operation and Development (OECD) area (8), expanding access to healthcare puts a "heavy financial burden" on the system (9). Furthermore, South Korea has been facing the largest increase in life expectancy among OECD countries (8). Thus, there have been multiple efforts by the Korean government to reduce the financial burden. In 2006, the government introduced the positive listing system (PLS) to slow the growth of expenditures on pharmaceuticals (8). Rules addressing generic drugs were also adjusted by the government. Testing the cost-effectiveness of healthcare was introduced into the system at that time (9).
Currently, inconsistent processes for priority setting in healthcare may be the biggest challenge in Korea. Several government bodies participate in the decision-making system in Korea (Fig. 1). First, the National Evidence-based Healthcare Collaborating Agency (NECA) specializes in health technology assessments (HTAs) in Korea (9). Decision-making for the approval of drugs, medical devices, and diagnostic procedures is handled by separate bodies such as the Korean Food and Drug Administration (KFDA) and the Committee for New Health Technology Assessment (CNHTA). After approval by the KFDA or the CNHTA, the Health Insurance Review and Assessment Service (HIRA) assesses the appropriateness of the budget impact of drugs, medical devices, and diagnostic procedures. The Ministry of Health and Welfare (MOHW) has the authority to approve final decision-making. In the case of approval of a new drug for tuberculosis treatment, for instance, the KFDA investigates safety as well as the efficacy of the drug, and HIRA evaluates the cost-effectiveness. Then, the National Health Insurance Corporation (NHIC) negotiates the price of the drug with the manufacturer (910). The out-of-pocket payments are determined according to economic efficiency and health insurance benefits, in a broad sense, but specific standards for assessment are different between "diagnostics and procedures" and "drugs." In terms of ethical values in healthcare priority setting in Korea, there is no reliable rationale for the judgment used in decision-making. This challenge introduced essential or discretionary benefits to cover most of the previously non-covered medical services. HIRA's website states the evaluation criteria for discretionary benefits are as follows: 1) clinical efficacy, 2) cost-effectiveness, and 3) social demands for coverage (11). The term "social demands" includes social value judgments. Social value judgments are defined as "judgments made on the basis of the moral or ethical values of a particular society" (12). The particular form of social values might be made from purely moral values and be refined by the cultural, social, and institutional features of a given society (12). However, in HIRA's statement, there is no clear moral vision that underpins these social values. For social demands, they only include the vulnerable, emergent diseases, or direct correlations between a disease and a disability (Table 1). Even though some ethical considerations and value judgments such as "vulnerability" are embedded in these criteria, there is no information available to pass judgment on these values in decision-making. Another problem is that each body in the Korean healthcare decision-making system may have different priorities in its policy making (9). An important question, therefore, is which ethical values guiding the practice of decision-making should be reconciled with the economic evidence found in Korean healthcare.
Table 1
Assessment elements in discretionary benefits by Health Insurance Review and Assessment Services
MORE ROOM FOR ETHICS
Previous studies agree that value judgments must be made "somewhere in the process" of creating guidelines for decision-making, but it is difficult to clearly state "how these judgments should be made" (13141516). In this article, we take the EUnetHTA project to put forth a model for incorporating ethical values into decision-making (16). Implementing health technologies can lead to moral consequences and technology itself carries values that justify integrating an ethical analysis into the "traditional assessment" of cost-effectiveness (17). The key contents of the model are presented below.
The EUnetHTA project
In 2006, the EUnetHTA project was launched as a response to the need for a practical transnational collaboration between the European Commission (EC) and European Union (EU) Member States (16). The objective of the EUnetHTA is to provide reliable, timely, transferable, and transparent information and to support policy decisions (17). Fig. 2 shows the relation between the HTA and policy processes. Fifty-nine partner organizations from 31 countries joined this project and 10 international teams developed a generic "HTA core model" to guide the assessment. The basic idea of the HTA core model is to divide information contained in an HTA into standardized pieces of information, the "assessment elements" (18). The assessment elements are described in detail in element cards and formulated as several questions (e.g., Do drug-eluting stents decrease symptoms such as chest pain in patients with angina pectoris?). This process establishes a methodological framework for an HTA, allowing users to obtain relevant and high quality information (16).
Fig. 2
The processes of Health technology assessment and policy making in EUnetHTA. *Adapted from Practical tools and methods for health technology assessment in Europe: structures, methodologies, and tools developed by the European network for Health Technology Assessment, EUnetHTA by Kristensen et al. (16).
Ethical analysis in the EUnetHTA
The ethics model is one part of nine domains in the core model (Fig. 3). The ethical analysis aims to "provide a thorough understanding of norms and values that need to be taken into account during the HTA and in the decision-making process" (19). In this model, the ethical domain examines social values and moral norms and considers the consequences of adopting or not adopting a particular type of healthcare technology, for example, the domain considers the values that the technology itself constructs. It also considers the impacts of cultural, legal, socio-political, and economic differences on moral values. In the EUnetHTA, the ethical domain contains six different topics: 1) beneficence/nonmaleficence, 2) autonomy, 3) respect for persons involved, 4) justice and equity, 5) legislation, and 6) ethical consequences of the HTA. Table 2 presents ethical domains and 19 issues that are covered by these domains.
Table 2
The structure of the ethical domain and the assessment elements of EUnetHTA
EUnetHTA, European network for Health Technology Assessment.
*Adapted from EUnetHTA Joint Action 2, Work Package 8. HTA Core Model® version 2.1 (19).
Description of the methodology for ethical analysis: an example of a core HTA on drug-eluting stents for coronary artery disease
An example of the model on drug eluting stents (DES), which was developed as a pilot assessment by Work Package 4 of the EUnetHTA project in 2008, is presented below (20). To conduct a successful ethical analysis, it is important to identify all stakeholder perspectives. In this analysis, a literature search (regarding existing HTA reports, articles on ethical topics relating to DES, etc.) was performed and 88 references from journals were examined. The principle questions of the analysis are as follows:
1) "Is the utilization of DES intended to be an innovative mode of care, an 'add on' to a standard mode of care, or a replacement of a standard?", 2) "Can DES challenge religious, cultural, or moral convictions, the beliefs of some groups, or can they change current social arrangements?", and 3) "What are the hidden or unintended consequences of DES and their application to different stakeholders?" (20).
The ethical domain was developed and the model had 14 other questions addressing the core issues regarding DES (Table 3). To integrate an ethical analysis into an HTA, it is important to consider the technology in the context of the given healthcare system, and there are several methods for users to conduct a discrete analysis (17). Table 4 presents several methods identified by the International Network of Agencies for Health Technology Assessment (INAHTA) working group to conduct an ethical analysis (1719).
Table 3
The frame of ethical analysis on drug eluting stents
DES, drug eluting stents; BMS, bare metal stents.
*Adapted from EUnetHTA Work Package 4, Core HTA on drug eluting stents, pilot assessment (20).
Table 4
The methodological approaches used for ethical analysis in health technology assessment
Based on these methods, ethical arguments related to the topics listed in Table 3 were discussed. For example, regarding the topic beneficence/non-maleficence, the answer to the question "What are the potential benefits and harms of implementing DES rather than bare metal stents (BMS) for other stakeholders?" was recorded in a result card from the perspective of various stakeholders such as care providers, professions, payers, society, and industry (19). For care providers, an attractive goal is to gain the reputation of providing the most advanced care in their facilities. Furthermore, if the system supports a fee for service reimbursement, this technology may provide an opportunity for an additional financial gain for care providers. On the other hand, if a provider lives in a country where a flat rate reimbursement system does not cover the costs of the procedure, DES can bring additional costs to this provider.
From the societal point of view, the working group took notice that guaranteeing equal access to adequate care service is one of the basic principles for the provision of healthcare. They also considered that there are strong beliefs among patients and the public regarding the possibility of obtaining optimal results through advanced technologies (21). Previous studies and media responses concerning DES illustrated the belief that the implementation of DES is the treatment of choice for coronary artery diseases. Thus, a society with a private healthcare market might experience "two class healthcare" when they accept the implementation of DES. The extra costs for the procedure are another adverse consequence of the implementation of DES. Meanwhile, implementing DES can earn that society a reputation for providing the most innovative care. There are several companies manufacturing DES and a number of trials, as well as most of the data, are supported by these companies. Implementing DES provides financial gains to these manufactures, and as a result, the industry is able to support further data collection on the "real life use" of DES. However, ongoing competition for market shares is a predictable adverse consequence when proceeding with implementation.
Going through the 14 questions in Table 3, the working group identified related areas that are ethically problematic when using DES. Questions for ethical analysis were answered based on valuation through different types of stakeholder perspectives. For example, for the question "What are the hidden or unintended consequences of DES and their application to different stakeholders?", the working group revealed that at least 50% of the devices were used for "off-label" purposes in patients who suffered from more severe coronary artery diseases, rather than for the "intended purposes" (20). They also expressed doubt regarding the autonomy of patients that are especially vulnerable (who are in an emergency situation such as acute cardiac syndrome) in understanding the differences between the risk/benefit profile of DES and that of BMS. The question-based structure of this model is open to contextual interpretation and has flexibility for broader use (17).
Application of the new selective reimbursement system in Korea
How, then, can the ethical analysis suggested by the EUnetHTA guide decision-making in Korea? Consider the selective reimbursement system that applies to four major conditions. When an item is determined to be a selective reimbursement item, the NHI will cover it with differentiated patient payments (22). As we explained in Table 1, each determination of coverage has three components: clinical efficacy, cost-effectiveness, and social demands for coverage. Even though there are elements for decision-making, there are still issues with the definition and application of "social demands." The elements used to make a final determination should attempt to avoid ambiguities. Furthermore, it is easy to ignore some items that are difficult to quantify. The lack of consistency in the decision-making process might be another issue. If the decision-making committee is to provide judgment about social demands, they should utilize an ethical analysis of the assessment elements. For example, a set of questions can be used for capsule endoscopy, which is included on the 2015 list for selective reimbursement by the HIRA. Some of the questions are as follows. Does the use of capsule endoscopy add a new mode of care or is it intended to replace a standard care mode? What are the potential unintended consequences of capsule endoscopy for different stakeholders? Is capsule endoscopy used for patients who are especially vulnerable? Can capsule endoscopy entail special risks of which the person should be informed? Does the implementation of capsule endoscopy affect other diseases? The information elicited may support the generation of evidence and successful implementation of the policy.
CONCLUSION
In this article, we present ethical issues of priority setting in access to healthcare resources. What is needed for fair distribution is a moral vision underpinning healthcare policy. This vision calls for a reasonable consensus on what is the best for the public good (3). An ethical analysis from the planning stage through the entire decision-making process can provide insight into achieving healthcare goals and resource allocation. As discussed above, the ethical analysis in the EUnetHTA can be a useful tool to provide a balance between values and norms through discussions on several issues including the political, cultural, economic, legal, and other social aspects that are affected by the application of new technologies.
It is true that this model does not represent all the ethical content for decision-making processes in healthcare. Actually, there are some limitations to the model, such as the fact that it highlights an "individualistic perspective" that is suitable for only "certain types" of healthcare organizations (17). Establishing a transparent process in collecting and reporting evidence is also a critical prerequisite for maintaining the balanced views of different stakeholders. However, considering the fact that priority setting in healthcare policy requires value-laden judgments and that few policy analyses in Korea have explicitly attempted these assessments, this effort can be a turning point in integrating ethical analyses into decision-making in the Korean healthcare system.
Ethical analyses challenge traditional priority setting methods in Korea. When applying the results of the Korean Burden of Disease Study to healthcare decisions, ethical principles and transparent processes may be essential features of a fair healthcare system. An ethical framework in harmony with a cost-effectiveness analysis is the key to increasing policy relevance.
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