Outcomes in Economic Evaluations of Public Health Interventions in Low- and Middle-Income Countries: Health, Capabilities and Subjective Wellbeing.

Public health programmes tend to be complex and may combine social strategies with aspects of empowerment, capacity building and knowledge across sectors. The nature of the programmes means that some effects are likely to occur outside the healthcare sector; this breadth impacts on the choice of health and non-health outcomes to measure and value in an economic evaluation. Employing conventional outcome measures in evaluations of public health has been questioned. There are concerns that such measures are too narrow, overlook important dimensions of programme effect and, thus, lead to such interventions being undervalued. This issue is of particular importance for low-income and middle-income countries, which face considerable budget constraints, yet deliver a large proportion of health activities within public health programmes. The need to develop outcome measures, which include broader measures of quality of life, has given impetus to the development of a variety of new, holistic approaches, including Sen's capability framework and measures of subjective wellbeing. Despite their promise, these approaches have not yet been widely applied, perhaps because they present significant methodological challenges. This paper outlines the methodological challenges for the identification and measurement of broader outcomes of public health interventions in economic evaluation in low-income and middle-income countries.

Maternal and child health voucher scheme in Myanmar: a review of early stage implementation.

BACKGROUND: The Maternal and Child Health Voucher Scheme (MCHVS) was introduced in Myanmar to address the high rate of maternal and infant mortalities. It aimed to increase access to maternal and child health (MCH) services by skilled birth attendants (SBAs) and improve the health of pregnant women and their babies. A study to pilot a voucher scheme was implemented in May 2013 in Yedarshey Township. This paper provides a report on a mid-term review of the programme after 7 months of implementation to determine the outcomes of the programme and its impediments. METHODS: Quantitative and qualitative approaches were used. Secondary quantitative data were analysed in order to measure the coverage and utilisation of the programme. Semi-structured interviews were conducted in groups and individually with 79 key informants to explore qualitative information on voucher communication, beneficiary's identification, voucher distribution, and challenges for beneficiaries and providers under the MCHVS. RESULTS: The results showed that 63 % of eligible pregnant women who registered to the programme received voucher booklets, while the utilisation of most of the MCH services increased over time; in particular, delivery by SBAs increased significantly (P < 0.01) after implementing MCHVS. Overall, the programme was implemented well in terms of promoting and communicating the programme to people in Yedarshey Township. Although a number of targeted poor pregnant women were included in the programme, some beneficiaries were overlooked for a variety of reasons. Nevertheless, both providers and beneficiaries who experienced the MCHVS service utilisation were satisfied with the programme. The evaluation indicated several programme challenges, i.e. external and internal programme communication, voluntary voucher distributor recruitment, incentive and support for voucher distributors, beneficiary screening criteria, and approaches to increase access of services for pregnant women living in remote areas. CONCLUSIONS: Generally, the MCHVS pilot programme is a promising initiative to increase access to and utilisation of the MCH services for pregnant women and their babies in Myanmar. However, increasing coverage of the programme and overcoming the barriers should be considered as high-priority issues that need to be addressed.

The influence of cost-per-DALY information in health prioritisation and desirable features for a registry: a survey of health policy experts in Vietnam, India and Bangladesh.

BACKGROUND: Economic evaluation has been implemented to inform policy in many areas, including coverage decisions, technology pricing, and the development of clinical practice guidelines. However, there are barriers to evidence-based policy in low- and middle-income countries (LMICs) that include limited stakeholder awareness, resources and data availability, as well as the lack of capacity to conduct country-specific economic evaluations. This study aims to survey health policy experts' opinions on barriers to use of cost-effectiveness data in these settings and to obtain their advice on how to make a new cost-per-DALY database being developed by Tufts Medical Center more relevant to LMICs. It also identifies the factors influencing transferability. METHODS: In-depth interviews were conducted with 32 participants, including policymakers, technical advisors, and researchers in Health Ministries, universities and non-governmental organisations in Bangladesh, India (New Delhi, Tamil Nadu and Karnataka) and Vietnam. RESULTS: The survey revealed that, in all settings, the use of cost-effectiveness information in policy development is lacking, owing to limited knowledge among policymakers and inadequate human resources with health economics expertise in the government sector. Furthermore, researchers in universities do not have close connections with health authorities. In India and Vietnam, the demand for evidence to inform coverage decisions tends to increase as the countries are moving towards universal health coverage. The informants in all countries argue that cost-effectiveness data are useful for decision-makers; however, most of them do not perform data searches by themselves but rely on the information provided by the technical advisor counterparts. Most interviewees were familiar with using evidence from other countries and were also aware of the influences of contextual elements as a limitation of transferability. Finally, strategies to promote the newly developed database include training on basic economic evaluation for policymakers and researchers, and effective communication programs, with support from reputable global agencies. CONCLUSIONS: Although cost-effectiveness information is recognised as essential in resource allocation, there are several impediments in the generation and use of such evidence to inform priority setting in LMICs. As such, the Cost-per-DALY database should be well-designed and introduced with appropriate promotion strategies so that it will be helpful in real-world policymaking.

How to meet the demand for good quality renal dialysis as part of universal health coverage in resource-limited settings?

BACKGROUND: It is very challenging for resource-limited settings to introduce universal health coverage (UHC), particularly regarding the inclusion of high-cost renal dialysis as part of the UHC benefit package. This paper addresses three issues: (1) whether a setting commits to include renal dialysis in its UHC benefit package and if so, why and how; (2) how to ensure quality of renal dialysis services; and (3) how to improve the quality of life of patients using psychosocial and community interventions. DISCUSSION: This article reviews experiences of renal dialysis programs in seven settings based on presentations and discussions during the International Forum on Peritoneal Dialysis as a Priority Health Policy in Asia. A literature review was conducted to verify and validate the data as well as to fill information gaps presented in the forum. Five out of the seven settings implemented renal dialysis as part of their benefits package, while the other two have pilots or programs in their nascent stage. Renal replacement therapy has become part of the universal access package because these governments recognize the rising number of chronic kidney disease (CKD) cases, the catastrophically high costs of treatment, and that this is the only life-saving treatment available to patients. The recommendations are as follows: Governments should have a holistic approach to CKD interventions, including primary prevention as well as psychosocial interventions. Governments should consider subsidizing CKD treatment costs depending on their resources. Multi-stakeholder cooperation should be facilitated to enact these policies and conduct research and development for all aspects of interventions. International collaboration should be initiated to share experiences, good practices, and joint activities (e.g. capacity building and multinational procurement of medical supplies). CONCLUSION: This study provides practical recommendations to country governments as well as the international community on how to meet the demand for good quality renal dialysis as part of UHC in resource-limited settings.

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.

A review of the health and economic implications of patent protection, with a specific focus on Thailand.

BACKGROUND: Although it has been two decades since the Thai Patent Act was amended to comply with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), there has been little emphasis given to assessing the implications of this amendment. The purpose of this review is to summarize the health and economic impact of patent protection, with a focus on the experience of Thailand. METHODS: A review of national and international empirical evidence on the health and economic implications of patents from 1980 to 2009 was undertaken. RESULTS: The findings illustrate the role of patent protection in four areas: price, present access, future access, and international trade and investment. Forty-three empirical studies were found, three of which were from Thai databases. Patenting does increase price, although the size of effect differs according to the methodology and country. Although weakening patent rights could increase present access, evidence suggests that strengthening patenting may benefit future access; although this is based on complex assumptions and estimations. Moreover, while patent protection appears to have a positive impact on trade flow, the implication for foreign direct investment (FDI) is equivocal. CONCLUSIONS: Empirical studies in Thailand, and other similar countries, are rare, compromising the robustness and generalizability of conclusions. However, evidence does suggest that patenting presents a significant inter-temporal challenge in balancing aspects of current versus future access to technologies. This underlines the urgent need to prioritize health research resources to assess the wider implications of patent protection.

Government use licenses in Thailand: The power of evidence, civil movement and political leadership.

This paper attempts to describe and analyse the policy processes that led to the granting and implementation of the government use licenses to enable the import and production of generic versions of medicines patented in Thailand. The decision to grant the series of government use licenses was taken despite much domestic and international controversy. The paper demonstrates that the policy processes leading to the granting of government use licenses are a successful application of the concept of "the triangle that moves the mountain". This is a well-known conceptualisation of a philosophical and strategic approach to public policy advocacy in Thailand, which propounds that the effective bridging of three powers; a.) Knowledge and evidence generated by research and analysis, b.) Civil society movements and public support, and c.) Leadership of policy makers and politicians; in a synergistic "triangle" can move "mountains", meaning the resolution of seemingly insurmountable problems. The paper provides insights into the policy context for the decision and analyses the roles of key actors, their motivations and the policy processes in the country.

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.