A cost-utility analysis of alternative drug regimens for newly diagnosed severe lupus nephritis patients in Thailand.

OBJECTIVE: The aim of this study was to assess the value of four drug regimens for newly diagnosed severe LN from a societal perspective. METHODS: A model-based cost-utility analysis was devised to measure lifetime costs and health outcomes. Current treatment options consisting of different combinations of i.v. CYC, AZA and MMF were compared with a baseline regimen of i.v. CYC in both the induction and maintenance phases. Resource use and costs were derived from medical records reviews and databases. Event rates were elicited from randomized controlled trials. Relative treatment effects were obtained from meta-analyses. Health utilities were obtained from a real cohort of patients to estimate the outcome of quality-adjusted life years. RESULTS: It was found that a treatment regimen that combined i.v. CYC in the induction phase with AZA in the maintenance phase was cost saving compared with the baseline regimen. Treatment with i.v. CYC in the induction phase and MMF in the maintenance phase and treatment with MMF in the induction phase and a reduced dose of the same in the maintenance phase turned out to be a negatively dominated regimen. CONCLUSION: In the Thai context, the combination of i.v. CYC for the induction phase followed by AZA for the maintenance phase should be considered as the first-line therapy for newly diagnosed severe LN, as it seems to be the most cost-saving regimen.

Assessing key model parameters for economic evaluation of pandemic influenza interventions: the data source matters.

BACKGROUND: In our previous systematic review of economic evaluations of pandemic influenza interventions, five model parameters, namely probability of pandemic, duration of pandemic, severity, attack rate, and intervention efficacy, were not only consistently used in all studies but also considered important by authors. OBJECTIVES: Because these parameters originated from sources of varying quality ranging from experimental studies to expert opinion, this study aims to analyze the variation in values used according to sources of information across studies. METHODS: An analysis of estimated values of key parameters for economic modeling was performed against their different data sources, following the standard hierarchy of evidence. RESULTS: A lack of good-quality evidence to estimate pandemic duration, pandemic probability, and mortality reduction from antiviral treatment results in a large variation of values used in economic evaluations. Although there are variations in quality of evidence used for attack rate, basic reproduction number, and reduction in hospitalizations from antiviral treatment, the estimated values do not vary significantly. The use of higher-quality evidence results in better precision of estimated values compared to lower-quality sources. CONCLUSION: Hierarchies of evidence are a necessary tool to identify appropriate model parameters to populate economic evaluations and should be included in methodological guidelines. Knowledge gaps in some key parameters should be addressed, because if good-quality evidence is available, future economic evaluations will be more reliable. Some gaps may not be fulfilled by research but consensus among experts to ensure consistency in the use of these assumptions.

Multicriteria decision analysis for including health interventions in the universal health coverage benefit package in Thailand.

OBJECTIVES: Considering rising health expenditure on the one hand and increasing public expectations on the other hand, there is a need for explicit health care rationing to secure public acceptance of coverage decisions of health interventions. The National Health Security Office, the institute managing the Universal Coverage Scheme in Thailand, recently called for more rational, transparent, and fair decisions on the public reimbursement of health interventions. This article describes the application of multicriteria decision analysis (MCDA) to guide the coverage decisions on including health interventions in the Universal Coverage Scheme health benefit package in the period 2009-2010. METHODS: We described the MCDA priority-setting process through participatory observation and evaluated the rational, transparency, and fairness of the priority-setting process against the accountability for reasonableness framework. RESULTS: The MCDA was applied in four steps: 1) 17 interventions were nominated for assessment; 2) nine interventions were selected for further quantitative assessment on the basis of the following criteria: size of population affected by disease, severity of disease, effectiveness of health intervention, variation in practice, economic impact on household expenditure, and equity and social implications; 3) these interventions were then assessed in terms of cost-effectiveness and budget impact; and 4) decision makers qualitatively appraised, deliberated, and reached consensus on which interventions should be adopted in the package. CONCLUSION: This project was carried out in a real-world context and has considerably contributed to the rational, transparent, and fair priority-setting process through the application of MCDA. Although the present project has applied MCDA in the Thai context, MCDA is adaptable to other settings.

Efficiency or equity: value judgments in coverage decisions in Thailand.

PURPOSE: The purpose of this paper is to analyse the roles of social values in the reform of coverage decisions for Thailand's Universal Health Coverage (UC) plan in 2009 and 2010. DESIGN/METHODOLOGY/APPROACH: Qualitative techniques, including document review and personal communication, were employed for data collection and triangulation. All relevant data and information regarding the reform and three case study interventions were interpreted and analysed according to the thematic elements in the conceptual framework. FINDINGS: Social values determined changes in the UC plan in two steps: the development of coverage decision guidelines and the introduction of such guidelines in benefit package formulation. The former was guided by process values, while the latter was shaped by different content ideals of stakeholders and policymakers. Analysis of the three interventions suggests that in allocating its resources to subsidise particular services, the UC authority took into account not only cost-effectiveness, but also budget impacts, equity and solidarity. These social values competed with each other and, in many instances, the prioritisation of benefit candidates was not led solely by evidence, but also by value judgments, even though transparency was recognised as an ultimate goal of reform. RESEARCH LIMITATIONS/IMPLICATIONS: The study findings indicate room for improvement and for future research--the current conceptual framework is inadequate to capture all the crucial elements which influence health prioritisation, as well as their interactions with social values. ORIGINALITY/VALUE: The paper fills a gap in literature as it enhances understanding of the effects of social value judgments in real-life health prioritisation.

Systematic review of economic evaluations of preparedness strategies and interventions against influenza pandemics.

BACKGROUND: Although public health guidelines have implications for resource allocation, these issues were not explicitly considered in previous WHO pandemic preparedness and response guidance. In order to ensure a thorough and informed revision of this guidance following the H1N1 2009 pandemic, a systematic review of published and unpublished economic evaluations of preparedness strategies and interventions against influenza pandemics was conducted. METHODS: The search was performed in September 2011 using 10 electronic databases, 2 internet search engines, reference list screening, cited reference searching, and direct communication with relevant authors. Full and partial economic evaluations considering both costs and outcomes were included. Conversely, reviews, editorials, and studies on economic impact or complications were excluded. Studies were selected by 2 independent reviewers. RESULTS: 44 studies were included. Although most complied with the cost effectiveness guidelines, the quality of evidence was limited. However, the data sources used were of higher quality in economic evaluations conducted after the 2009 H1N1 pandemic. Vaccination and drug regimens were varied. Pharmaceutical plus non-pharmaceutical interventions are relatively cost effective in comparison to vaccines and/or antivirals alone. Pharmaceutical interventions vary from cost saving to high cost effectiveness ratios. According to ceiling thresholds (Gross National Income per capita), the reduction of non-essential contacts and the use of pharmaceutical prophylaxis plus the closure of schools are amongst the cost effective strategies for all countries. However, quarantine for household contacts is not cost effective even for low and middle income countries. CONCLUSION: The available evidence is generally inconclusive regarding the cost effectiveness of preparedness strategies and interventions against influenza pandemics. Studies on their effectiveness and cost effectiveness should be readily implemented in forthcoming events that also involve the developing world. Guidelines for assessing the impact of disease and interventions should be drawn up to facilitate these studies.

Impact of the introduction of government use licenses on the drug expenditure on seven medicines in Thailand.

OBJECTIVES: To assess the budget impact of the government use licenses policy, a form of compulsory licensing used by the government, on seven patented drugs, namely, efavirenz, lopinavir/ritonavir combination, clopidogrel, letrozole, docetaxel, erlotinib, and imatinib, in Thailand between 2006 and 2008. METHODS: By using government's perspective, budget impact was estimated within a 5-year period after the introduction of the policy. The number of patients who need treatment with each drug and the costs of treatments by both original and generic versions were obtained from Thai government agencies. Probabilistic sensitivity analysis was used to determine the impact of uncertainty surrounding parameters such as the numbers of patients and the health-care costs. RESULTS: The study indicated that the use of generic drugs under the policy could save the government budget approximately $370 million over 5 years. It was also found that each drug had a different effect on budget saving depending on the number of patients treated, the difference in drug costs between original and generic drugs, and the lag time from the introduction of the policy to the availability of the generic drugs on the market. CONCLUSION: The study showed that the introduction of the government use licenses policy in Thailand would provide significant benefits for the study timeframe; however, there are several issues that should be taken into account when the government use licenses policy is adopted.

Using health technology assessment for informing coverage decisions in Thailand.

This article aims to illustrate and critically analyze the results from the 1-year experience of using health technology assessment (HTA) in the development of the Thai Universal Coverage health benefit package. We review the relevant documents and give a descriptive analysis of outcomes resulting from the development process in 2009-2010. Out of 30 topics nominated by stakeholders for prioritization, 12 were selected for further assessment. A total of five new interventions were recommended for inclusion in the benefit package based on value for money, budget impact, feasibility and equity reasons. Different stakeholders have diverse interests and capabilities to participate in the process. In conclusion, HTA is helpful for informing coverage decisions for health benefit packages because it enhances the legitimacy of policy decisions by increasing the transparency, inclusiveness and accountability of the process. There is room for improvement of the current use of HTA, including providing technical support for patient representatives and civic groups, better communication between health professionals, and focusing more on health promotion and disease prevention.

Government use licenses in Thailand: an assessment of the health and economic impacts.

BACKGROUND: Between 2006 and 2008, Thailand's Ministry of Public Health (MOPH) granted government use licenses for seven patented drugs in order to improve access to these essential treatments. The decision to grant the government use licenses was contentious both within and beyond the country. In particular, concerns were highlighted that the negative consequences might outweigh the expected benefits of the policy. This study conducted assessments of the health and economic implications of these government use licenses. METHODS: The health and health-related economic impacts were quantified in terms of i) Quality Adjusted Life Years (QALYs) gained and ii) increased productivity in US dollars (USD) as a result of the increased access to drugs. The study adopted a five-year timeframe for the assessment, commencing from the time of the grant of the government use licenses. Empirical evidence gathered from national databases was used to assess the changes in volume of exports after US Generalized System of Preferences (GSP) withdrawal and level of foreign direct investment (FDI). RESULTS: As a result of the granting of the government use licenses, an additional 84,158 patients were estimated to have received access to the seven drugs over five years. Health gains from the use of the seven drugs compared to their best alternative accounted for 12,493 QALYs gained, which translates into quantifiable incremental benefits to society of USD132.4 million. The government use license on efavirenze was found to have the greatest benefit. In respect of the country's economy, the study found that Thailand's overall exports increased overtime, although exports of the three US GSP withdrawal products to the US did decline. There was also found to be no relationship between the government use licenses and the level of foreign investment over the period 2002 to 2008. CONCLUSIONS: The public health benefits of the government use licenses were generally positive. Specifically, the policy helped to increase access to patented drugs, while the impact of the US GSP withdrawal did not adversely affect the overall export status. Because the levels of benefit gained from the government use licenses varied widely between the seven drugs, depending on several factors, this study makes recommendations for the future implementation of the policy in order to maximise benefits.

Measurement of clinical effects.

The measurement and valuation of clinical effects is a significant component of economic evaluation. Decision makers are commonly interested in how a particular health intervention works in everyday practice; therefore, the resulting outcome under this circumstance is called the effectiveness. Clinical effects usually measure final intended effects of a proposed health technology in terms of the ultimate change in health state brought about by the technology. The systematic review and meta-analysis of high quality RCTs is the most favorable method to synthesize evidence because they are disciplined and transparent methods. The present chapter focuses on how to make a valid measure of clinical effects for use in cost-effectiveness analysis and how clinical effect is to be appropriately defined and measured.