CHALLENGES FACED IN TRANSFERRING ECONOMIC EVALUATIONS TO MIDDLE INCOME COUNTRIES.

BACKGROUND: Decision makers in middle-income countries are using economic evaluations (EEs) in pricing and reimbursement decisions for pharmaceuticals. However, whilst many of these jurisdictions have local submission guidelines and local expertise, the studies themselves often use economic models developed elsewhere and elements of data from countries other than the jurisdiction concerned. The objectives of this study were to describe the current situation and to assess the challenges faced by decision makers in transferring data and analyses from other jurisdictions. METHODS: Experienced health service researchers in each region conducted an interview survey of representatives of decision making bodies from jurisdictions in Asia, Central and Eastern Europe, and Latin America that had at least 1 year's experience of using EEs. RESULTS: Representatives of the relevant organizations in twelve countries were interviewed. All twelve jurisdictions had developed official guidelines for the conduct of EEs. All but one of the organizations evaluated studies submitted to them, but 9 also conducted studies and 7 commissioned them. Nine of the organizations stated that, in evaluating EEs submitted to them, they had consulted a study performed in a different jurisdiction. Data on relevant treatment effect was generally considered more transferable than those on prices/unit costs. Views on the transferability of epidemiological data, data on resource use and health state preference values were more mixed. Eight of the respondents stated that analyses submitted to them had used models developed in other jurisdictions. Four of the organizations had a policy requiring models to be adapted to reflect local circumstances. The main obstacles to transferring EEs were the different patterns of care or wealth of the developed countries from which most economic evaluations originate. CONCLUSIONS: In middle-income countries it is commonplace to deal with the issue of transferring analyses or data from other jurisdictions. Decision makers in these countries face several challenges, mainly due to differences in current standard of care, practice patterns, or gross domestic product between the developed countries where the majority of the studies are conducted and their own jurisdiction.

Factor Configurations with Governance as Conditions for Low HIV/AIDS Prevalence in HIV/AIDS Recipient Countries: Fuzzy-set Analysis.

This paper aims to investigate whether good governance of a recipient country is a necessary condition and what combinations of factors including governance factor are sufficient for low prevalence of HIV/AIDS in HIV/AIDS aid recipient countries during the period of 2002-2010. For this, Fuzzy-set Qualitative Comparative Analysis (QCA) was used. Nine potential attributes for a causal configuration for low HIV/AIDS prevalence were identified through a review of previous studies. For each factor, full membership, full non-membership, and crossover point were specified using both author's knowledge and statistical information of the variables. Calibration and conversion to a fuzzy-set score were conducted using Fs/QCA 2.0 and probabilistic tests for necessary and sufficiency were performed by STATA 11. The result suggested that governance is the necessary condition for low prevalence of HIV/AIDS in a recipient country. From sufficiency test, two pathways were resulted. The low level of governance can lead to low level of HIV/AIDS prevalence when it is combined with other favorable factors, especially, low economic inequality, high economic development and high health expenditure. However, strengthening governance is a more practical measure to keep low prevalence of HIV/AIDS because it is hard to achieve both economic development and economic quality. This study highlights that a comprehensive policy measure is the key for achieving low prevalence of HIV/AIDS in recipient country.

Japanese universal health coverage: evolution, achievements, and challenges.

Japan shows the advantages and limitations of pursuing universal health coverage by establishment of employee-based and community-based social health insurance. On the positive side, almost everyone came to be insured in 1961; the enforcement of the same fee schedule for all plans and almost all providers has maintained equity and contained costs; and the co-payment rate has become the same for all, except for elderly people and children. This equity has been achieved by provision of subsidies from general revenues to plans that enrol people with low incomes, and enforcement of cross-subsidisation among the plans to finance the costs of health care for elderly people. On the negative side, the fragmentation of enrolment into 3500 plans has led to a more than a three-times difference in the proportion of income paid as premiums, and the emerging issue of the uninsured population. We advocate consolidation of all plans within prefectures to maintain universal and equitable coverage in view of the ageing society and changes in employment patterns. Countries planning to achieve universal coverage by social health insurance based on employment and residential status should be aware of the limitations of such plans.

The societal burden of HBV-related disease: South Korea.

To highlight the societal burden of HBV infection in South Korea, we estimated the annual societal costs of HBV-related diseases for the year 2005. For the economic costs of HBV-infection-related diseases estimate, baseline data was collected from the Health Insurance Review and Assessment Service (HIRA) database. To complement data from the HIRA database, hospital charts from sample hospitals was reviewed and patient surveys were conducted. In 2005, the societal cost of HBV infection was 1.937 trillion KRW, including 474,642 million KRW of direct costs and 1.463 trillion KRW of indirect costs. The cost breakdown by disease was CHB at 465,167 million KRW, cirrhosis at 533,449 million KRW, hepatocellular carcinoma at 863,940 million KRW, and liver transplantation at 74,635 million KRW. The estimated amount is equivalent to 0.24% of the 2005 Korean GDP. This analysis emphasizes how important the prevention and treatment of these diseases are from the perspectives of the Korean society.

Who pays for health care in Asia?

We estimate the distributional incidence of health care financing in 13 Asian territories that account for 55% of the Asian population. In all territories, higher-income households contribute more to the financing of health care. The better-off contribute more as a proportion of ability to pay in most low- and lower-middle-income territories. Health care financing is slightly regressive in three high-income economies with universal social insurance. Direct taxation is the most progressive source of finance and is most so in poorer economies. In universal systems, social insurance is proportional to regressive. In high-income economies, the out-of-pocket (OOP) payments are proportional or regressive while in low-income economies the better-off spend relatively more OOP. But in most low-/middle-income countries, the better-off not only pay more, they also get more health care.

Health Expenditure Growth under Single-Payer Systems: Comparing South Korea and Taiwan.

OBJECTIVE: Achieving universal health coverage has been an important goal for many countries worldwide. However, the rapid growth of health expenditures has challenged all nations, both those with and without such universal coverage. Single-payer systems are considered more efficient for administrative affairs and may be more effective for containing costs than multipayer systems. However, South Korea, which has a typical single-payer scheme, has almost the highest growth rate in health expenditures among industrialized countries. The aim of the present study is to explicate this situation by comparing South Korea with Taiwan. METHODS: This study analyzed statistical reports published by government departments in South Korea and Taiwan from 2001 to 2015, including population and economic statistics, health statistics, health expenditures, and social health insurance reports. RESULTS: Between 2001 and 2015, the per capita national health expenditure (NHE) in South Korea grew 292%, whereas the corresponding growth of per capita NHE in Taiwan was only 83%. We find that the national health insurance (NHI) global budget cap in Taiwan may have restricted the growth of health expenditures. Less comprehensive benefit coverage for essential diagnosis/treatment services under the South Korean NHI program may have contributed to the growth of out-of-pocket payments. The expansion of insurance coverage for vulnerable individuals may also contribute to higher growth in NHE in South Korea. Explicit regulation of health care resource distribution may also lead to more limited provisioning and utilization of health services in Taiwan. CONCLUSION: Under analogous single-payer systems, South Korea had a much higher growth in health spending than Taiwan. The annual budget cap for total reimbursement, more comprehensive coverage for essential diagnosis and treatment services, and the regulation of health care resource distribution are important factors associated with the growth of health expenditures.

Role of economic evidence in coverage decision-making in South Korea.

OBJECTIVES: The South Korean government required the submission of economic evidence when it implemented the Positive-List System in December 2006. This study investigates the key factors that influenced actual public insurance reimbursement decisions, including the role of economic evidence, after 10 years of decision practice under compulsory health technology assessment (HTA) for new drugs. METHOD: Logistic regression analysis was used to estimate the impact of the variables involved, including cost-effectiveness ratio as a key variable, on reimbursement decisions. The latter were defined as "yes" or "no" at a submitted price and indication. Only cases (n = 91) that present a cost-effectiveness ratio, and that have been reviewed based on this ratio from January 2007 to December 2016, were included in the analysis. RESULTS: Cases with higher cost-effectiveness ratios were less likely to be accepted. In addition, drugs that were used to treat severe diseases and drugs with no substitute were more likely to be recommended. The probability of acceptance declined along with the level of uncertainty in the submitted evidence. The acceptance rate for severe-disease drugs has increased since 2013, when the government introduced several policies that lowered the existing barriers to positive reimbursement. However, such an increase was not statistically significant. CONCLUSIONS: Cost-effectiveness is one of the most influential factors in drug-reimbursement decisions. However, inclusion of other explanatory variables, in addition to the cost-effectiveness ratio, predicted the results of decisions more accurately.

Medical costs in patients with heart failure after acute heart failure events: one-year follow-up study.

AIMS: This study investigated annual medical costs using real-world data focusing on acute heart failure. METHODS: The data were retrospectively collected from six tertiary hospitals in South Korea. Overall, 330 patients who were hospitalized for acute heart failure between January 2011 and July 2012 were selected. Data were collected on their follow-up medical visits for 1 year, including medical costs incurred toward treatment. Those who died within the observational period or who had no records of follow-up visits were excluded. Annual per patient medical costs were estimated according to the type of medical services, and factors contributing to the costs using Gamma Generalized Linear Models (GLM) with log link were analyzed. RESULTS: On average, total annual medical costs for each patient were USD 6,199 (±9,675), with hospitalization accounting for 95% of the total expenses. Hospitalization cost USD 5,904 (±9,666) per patient. Those who are re-admitted have 88.5% higher medical expenditure than those who have not been re-admitted in 1 year, and patients using intensive care units have 19.6% higher expenditure than those who do not. When the number of hospital days increased by 1 day, medical expenses increased by 6.7%. LIMITATIONS: Outpatient drug costs were not included. There is a possibility that medical expenses for AHF may have been under-estimated. CONCLUSION: It was found that hospitalization resulted in substantial costs for treatment of heart failure in South Korea, especially in patients with an acute heart failure event. Prevention strategies and appropriate management programs that would reduce both frequency of hospitalization and length of stay for patients with the underlying risk of heart failure are needed.

Time dependent factors affecting the duration of work disability after compensated low-back pain in South Korea.

The purpose of this study was to investigate the time dependent effects among factors affecting duration of work disability after compensated low-back pain. A postal survey involving 238 compensated workers at 39 companies was performed between January 5, 2004, and March 23, 2004. Cox proportional hazard regression analysis was used to model the effect of demographic, work-related, and injury factors affecting the duration of work disability. The variables that significantly affected the duration of work disability were age, company size, compensation benefit, pain radiation, and diagnosis. In addition, company size and pain radiation showed statistically significant time dependent effect. Consequently, this study found that there were time dependent factors affecting the duration of work disability. A phase-specific analysis would be useful to make policy for the prevention of long-term disability after back injury.

Eight-year experience of using HTA in drug reimbursement: South Korea.

This study describes the process and results of drug reimbursement decision-making in South Korea and evaluates its performance from the perspectives of the various stakeholders involved. Data were retrieved from the evaluation report posted on the Health Insurance Review and Assessment Service (HIRA) website. As of 2014, 253 new drugs had been submitted to the HIRA for appraisal. Of these, 175 (69.2%) were recommended in favor of listing and 78 (30.8%) were rejected. Furthermore, 68 of these drugs were deemed clinically improved relative to existing drugs. For those drugs that did not demonstrate clinical superiority (which was most of them), a simple price comparison to the existing drug was utilized as a gate toward listing. On top of the base-line analysis, 104 stakeholders from the industry, academia, public office, and civic society responded to a questionnaire designed to obtain their opinions on the South Korean positive list system (PLS). Stakeholders agreed that the consistency of reimbursement decision-making has improved since 2007, while accessibility to new drugs has apparently decreased. Respondents also indicated a preference toward improved public access to decision-making information. This examination of reimbursement decisions in South Korea will illuminate critical issues for countries that are considering the introduction of similar policies.

Cost-effectiveness of long-term care services in South Korea.

This study examines the economic validity of home health-care and nursing-home care with the aim of providing guidelines for efficient use of limited health-care resources. Data collection took place over 8 months in 2001 (from May to December) at six institutions: two home health-care service providers and four nursing homes. A total of 99 stroke patients (49 from home health-care service providers and 50 from nursing homes) participated in the study. The findings indicate that patients with a lower level of physical/cognitive dependency (activities of daily living (ADL) >or= 9.3, cognitive performance scale (CPS) >or= 3.3) tend to benefit more from home health-care service, while those with a high dependency level (ADL < 9.3, CPS < 3.3) receive more suitable care at nursing homes. The study confirms that the economic value of health-care providers varies with the level of physical/cognitive function of the patients. That is, higher efficiency is achieved when those with a lower and higher levels of dependency are provided with home health-care services and nursing-home care, respectively. When assigning long-term care services, it is suggested that the level of physical/cognitive function of patients should be taken into consideration.

The Health Technology Assessment Environment in Mainland China, Japan, South Korea, and Taiwan-Implications for the Evaluation of Diabetes Mellitus Therapies.

BACKGROUND: Diabetes mellitus (DM) is associated with a significant global economic and humanistic burden. The condition presents a real challenge in Asia, which accounts for more than 60% of individuals with DM globally. Health technology assessment (HTA) is a field of scientific research used to inform policy and clinical decision making relating to the introduction and diffusion of health technologies. OBJECTIVES: This article, examines the present use and predicted evolution of HTA with respect to pricing and reimbursement of drugs in mainland China, Japan, South Korea, and Taiwan. It makes specific reference to important assessment considerations for DM therapies, which should assist key stakeholders in choosing which data to capture, and what approaches to use, to help quantify the value of treatment. METHODS: The findings are informed by two Advisory Board discussions, a literature review, and the authors' personal experience. RESULTS: HTA already has a key role in South Korea and Taiwan, with current systems undergoing important changes. In contrast, in mainland China and Japan, HTA is not yet formally utilized, although this appears likely to change. Several elements are important for HTA to be meaningful and impactful for DM therapies, including a clear, transparent analytical framework for HTA that includes all relevant costs and outcomes; availability of local DM epidemiologic, economic, and quality-of-life data; acceptance of modeling as a core methodology; availability of real-life patient data; and recognition of specific evidence requirements associated with biosimilars. HTA has the potential to assist payors in making informed decisions about the coverage of DM medications.

New anti-rebate legislation in South Korea.

The South Korean Government recently announced a reform in the drug anti-rebate law, with the purpose of eradicating pervasive, unethical, and illegal rebate practices in pharmaceutical marketing. The main objective of this reform is to have the ability to bring criminal charges against doctors and pharmacists for receiving illegal kickbacks from drug companies. Previously, provision of illegal kickbacks by drug companies led to criminal punishment of the drug companies alone, leaving doctors and pharmacists unpunished as the recipients. With the introduction of the "Dual Punishment System (DPS)" reform, criminal punishment for illegal rebates is extended to those receiving illegal kickbacks. Although bitter controversy erupted among stakeholders when the reform was first drafted, a civic group participated in the reform process and effectively influenced the legislative process to a successful end. Some interim outcomes from the DPS in terms of bringing illegal practices to account have already been reported since the policy's implementation in November 2010. The reform background, goals, potential issues, and policy implications are explored in this study with the objective of providing further insight into drug policy for other countries that face similar challenges in the area of drug marketing.

Implication of high-body-fat percentage on cardiometabolic risk in middle-aged, healthy, normal-weight adults.

OBJECTIVE: This study investigated the number of Korean adults who had a normal body mass index (BMI) but high body-fat percentage (BF%) and determined their increased risk factors for cardiovascular diseases, including high blood pressure, hyperglycemia, and dyslipidemia. DESIGN AND METHODS: This cross-sectional study was based on 12,386 subjects (6,534 men and 5,852 women), with a normal BMI, between 30 and 49 years of age. Subjects were categorized into two groups by BF% (normal BF% group, BF% <25 for men, and BF% <30 for women; high BF(%) group, BF% ≥25 for men, and BF% ≥30 for women). RESULTS: The proportion of subjects with a normal BMI and high BF% was 12.7% (n = 1,572; 291 [4.5%] men and 1,281 [21.9%] women). Subjects with a high BF% had a significantly higher prevalence of high blood pressure (men only), hyperglycemia, and dyslipidemia. Multiple logistic regression analyses revealed that subjects with a normal BMI and high BF% had a 1.63 (adjusted odds ratio, 95% confidence interval: 1.21-2.19) in men and 1.56 (adjusted odds ratio, 95% confidence interval: 1.36-1.80) in women increased risk of one or more cardiovascular risk factors compared to subjects in the normal BMI and normal BF% group, even after adjusting for abdominal obesity. CONCLUSION: High BF% is associated with a high cardiometabolic risks, regardless of abdominal obesity, in normal-weight Korean adults. Thus, follow-up screening of those with a high BF% may be necessary to detect and prevent cardiometabolic diseases, particularly for women with a normal BMI.

Price cuts and drug spending in South Korea: the case of antihyperlipidemic agents.

OBJECTIVE: To identify the effect of price control policies on drug expenditure in South Korea. METHODS: We retrospectively examined the effects of price-reduction policies on drug expenditures, in particular regarding anti-hyperlipidemic drugs. The National Health Insurance claims data for a 60-month period between 2006 and 2010 were analysed. A segmented regression analysis was conducted with three intervention variables: July 2008, April 2009, and January 2010. RESULTS: Despite three rounds of price cuts, monthly drug expenditures increased by KRW 599.67 million (USD 523,726) after the third intervention (p=0.0781). The trend in volume increased consistently, but not significantly. The unit prices showed a steady downward trend over time, but rebounded after the third price cut. The number of patients with hyperlipidemia more than doubled to 3729 (p=0.0801) per month after the entry of generics for atorvastatin in July 2008. CONCLUSION: Extensive price controls did not effectively suppress the growth of pharmaceutical expenditures. The increased number of patients, attributable to the newly launched generic drug atorvastatin, and the increased use of expensive drugs were major factors affecting the increase in drug spending. Policies that regulate both drug prices and utilisation, and that reduce financial burdens via enhanced use of generics need to be introduced.

Cost-utility analysis for platinum-sensitive recurrent ovarian cancer therapy in South Korea: results of the polyethylene glycolated liposomal doxorubicin/carboplatin sequencing model.

OBJECTIVE: We performed a cost-utility analysis to assess the cost-effectiveness of a chemotherapy sequence including a combination of polyethylene glycolated liposomal doxorubicin (PLD)/carboplatin versus paclitaxel/carboplatin as a second-line treatment in women with platinum-sensitive ovarian cancer. METHODS: A Markov model was constructed with a 10-year time horizon. The treatment sequence consisted of first- to sixth-line chemotherapies and best supportive care (BSC) before death. Cycle length, a time interval for efficacy evaluation of chemotherapy, was 9 weeks. The model consisted of four health states: responsive, progressive, clinical remission, and death. At any given time, a patient may have remained on a current therapy or made a transition to the next therapy or death. Median time to progressions and overall survivals data were obtained through a systematic literature review and were pooled using a meta-analytical approach. If unavailable, this was elicited from an expert panel (eg, BSC). These outcomes were converted to transition probabilities using an appropriate formula. Direct costs included drug-acquisition costs for chemotherapies, premedication, adverse-event treatment and monitoring, efficacy evaluation, BSC, drug administration, and follow-up tests during remission. Indirect costs were transportation expenses. Utilities were also derived from the literature. Costs and utilities were discounted at an annual rate of 5% per cycle. RESULTS: PLD/carboplatin combination as the second line in the sequence is more effective and costly than paclitaxel/carboplatin combination, showing an additional US$21,658 per quality-adjusted life years. This result was robust in a deterministic sensitivity analysis except when median time to progression of second-line therapies and administration cost of PLD/carboplatin per administration cycle were varied. The probability of cost-effectiveness for PLD/carboplatin combination was 49.4% at a willingness to pay $20,000. CONCLUSION: A PLD/carboplatin combination is an economically valuable option as second-line chemotherapy for the treatment of platinum-sensitive ovarian cancer in South Korea.

Interview: Health technology assessment in Asia: an emerging trend.

Bong-min Yang, PhD (in economics), is Professor and former Dean of the School of Public Health at the Seoul National University, South Korea. Professor Yang has led research and written many papers in health economics and healthcare systems in Korea and Asia. His recent research and publications focus on the field of economic evaluation and outcomes research. He played a key role in the introduction of a formal health technology assessment system within Korean healthcare. He is currently serving as Executive Director, Institute of Health and Environment, Seoul National University. In addition to his research and publications, Professor Yang is Associate Editor for Journal of Comparative Effectiveness Research, is co-editor-in-chief for Value in Health Regional Issues, and is currently chair of the Management Advisory Board of Value in Health and a member of the editorial board of the Journal of Medical Economics. He has been a policy consultant to China, Japan, Indonesia, Hong Kong, Malaysia, Taiwan, Thailand and India. He has also worked as a short-term consultant at the WHO, ADB, UNDP and the World Bank. For the Korean government, he served as Chairperson of the Health Insurance Reform Committee, and Chairperson of the Drug Pricing and Reimbursement Committee. He is currently serving as Chair of the International Society of Pharmacoeconomics and Outcomes Research-Asia Consortium, and a member of the Board of Directors of the International Society of Pharmacoeconomics and Outcomes Research.