The potential impact of novel tuberculosis vaccine introduction on economic growth in low- and middle-income countries: A modeling study.

BACKGROUND: Most individuals developing tuberculosis (TB) are working age adults living in low- and middle-income countries (LMICs). The resulting disability and death impact economic productivity and burden health systems. New TB vaccine products may reduce this burden. In this study, we estimated the impact of introducing novel TB vaccines on gross domestic product (GDP) growth in 105 LMICs. METHODS AND FINDINGS: We adapted an existing macroeconomic model to simulate country-level GDP trends between 2020 and 2080, comparing scenarios for introduction of hypothetical infant and adolescent/adult vaccines to a no-new-vaccine counterfactual. We parameterized each scenario using estimates of TB-related mortality, morbidity, and healthcare spending from linked epidemiological and costing models. We assumed vaccines would be introduced between 2028 and 2047 and estimated incremental changes in GDP within each country from introduction to 2080, in 2020 US dollars. We tested the robustness of results to alternative analytic specifications. Both vaccine scenarios produced greater cumulative GDP in the modeled countries over the study period, equivalent to $1.6 (95% uncertainty interval: $0.8, 3.0) trillion for the adolescent/adult vaccine and $0.2 ($0.1, 0.4) trillion for the infant vaccine. These GDP gains were substantially lagged relative to the time of vaccine introduction, particularly for the infant vaccine. GDP gains resulting from vaccine introduction were concentrated in countries with higher current TB incidence and earlier vaccine introduction. Results were sensitive to secular trends in GDP growth but relatively robust to other analytic assumptions. Uncertain projections of GDP could alter these projections and affect the conclusions drawn by this analysis. CONCLUSIONS: Under a range of assumptions, introducing novel TB vaccines would increase economic growth in LMICs.

The Macroeconomic Impact of Increasing Investments in Malaria Control in 26 High Malaria Burden Countries: An Application of the Updated EPIC Model.

BACKGROUND: Malaria remains a major public health problem. While globally malaria mortality affects predominantly young children, clinical malaria affects all age groups throughout life. Malaria not only threatens health but also child education and adult productivity while burdening government budgets and economic development. Increased investments in malaria control can contribute to reduce this burden but have an opportunity cost for the economy. Quantifying the net economic value of investing in malaria can encourage political and financial commitment. METHODS: We adapted an existing macroeconomic model to simulate the effects of reducing malaria on the gross domestic product (GDP) of 26 high burden countries while accounting for the opportunity costs of increased investments in malaria. We compared two scenarios differing in their level of malaria investment and associated burden reduction: sustaining malaria control at 2015 intervention coverage levels, time at which coverage levels reached their historic peak and scaling-up coverage to reach the 2030 global burden reduction targets. We incorporated the effects that reduced malaria in children and young adolescents may have on the productivity of working adults and on the future size of the labour force augmented by educational returns, skills, and experience. We calibrated the model using estimates from linked epidemiologic and costing models on these same scenarios and from published country-specific macroeconomic data. RESULTS: Scaling-up malaria control could produce a dividend of US$ 152 billion in the modelled countries, equivalent to 0.17% of total GDP projected over the study period across the 26 countries. Assuming a larger share of malaria investments is paid out from domestic savings, the dividend would be smaller but still significant, ranging between 0.10% and 0.14% of total projected GDP. Annual GDP gains were estimated to increase over time. Lower income and higher burden countries would experience higher gains. CONCLUSION: Intensified malaria control can produce a multiplied return despite the opportunity cost of greater investments.

The costs of improving health emergency preparedness: A systematic review and analysis of multi-country studies.

BACKGROUND: Investing in health emergency preparedness is critical to the safety, welfare and stability of communities and countries worldwide. Despite the global push to increase investments, questions remain around how much should be spent and what to focus on. We conducted a systematic review and analysis of studies that costed improvements to health emergency preparedness to help to answer these questions. METHODS: We searched for studies that estimated the costs of improving health emergency preparedness and that were published between 1 January 2000 and 14 May 2021, using PubMed, Web of Science, Google Scholar, EconLit, and National Health Service Economic Evaluation Databases (PROSPERO CRD42021254428). We also searched grey literature repositories and contacted subject experts. We included studies that estimated the costs of improving preparedness at the global level and/or at the national level across at least ten countries, covered two or more technical areas in the WHO Benchmarks for International Health Regulations (IHR) Capacities, and included activities focused on human health. We mapped costs across technical areas in the WHO Benchmarks for IHR Capacities. FINDINGS: Ten studies met our inclusion criteria. Costing methods varied substantially across included studies and cost estimates ranged from US$1·6 billion per year to improve capacities across 139 low- and middle-income countries (LMICs) to US$43 billion per year to support national-level activities worldwide and implement global-level initiatives, such as research and development for health technologies (diagnostics, therapeutics, and vaccines). Two recent studies estimated costs by drawing on IHR Monitoring and Evaluation Framework country capacity data, with one study estimating costs across 67 LMICs of US$15·4 billion per year (US$29·1 billion including upfront capital costs) and the other calculating costs for the 196 States Parties to the IHR of US$24·8 billion per year. Differences in included studies' methods, and the characteristics of countries considered, mean it is difficult to make like-for-like comparisons of the absolute costs or per-capita costs estimated by studies. INTERPRETATION: Improving health emergency preparedness worldwide will require substantial and sustained increases in investments. Further guidance on estimating the size of those investments can help to standardise methods, allowing greater interpretation and comparison across studies/countries. As well as greater transparency and detail in the reporting of methods by studies focused on this topic, this can help support estimates of global resource requirements and facilitate investments towards improving preparedness for future pandemics. FUNDING: None.

Costs and Cost-Effectiveness of Malaria Control Interventions: A Systematic Literature Review.

OBJECTIVES: To systematically review the literature on the unit cost and cost-effectiveness of malaria control. METHODS: Ten databases and gray literature sources were searched to identify evidence relevant to the period 2005 to 2018. Studies with primary financial or economic cost data from malaria endemic countries that took a provider, provider and household, or societal perspective were included. RESULTS: We identified 103 costing studies. The majority of studies focused on individual rather than combined interventions, notably insecticide-treated bed nets and treatment, and commonly took a provider perspective. A third of all studies took place in 3 countries. The median provider economic cost of protecting 1 person per year ranged from $1.18 to $5.70 with vector control and from $0.53 to $5.97 with chemoprevention. The median provider economic cost per case diagnosed with rapid diagnostic tests was $6.06 and per case treated $9.31 or $89.93 depending on clinical severity. Other interventions did not share enough similarities to be summarized. Cost drivers were rarely reported. Cost-effectiveness of malaria control was reiterated, but care in methodological and reporting standards is required to enhance data transferability. CONCLUSIONS: Important information that can support resource allocation was reviewed. Given the variability in methods and reporting, global efforts to follow existing standards are required for the evidence to be most useful outside their study context, supplemented by guidance on options for transferring existing data across settings.

Priority Setting in HIV, Tuberculosis, and Malaria - New Cost-Effectiveness Results From WHO-CHOICE.

BACKGROUND: This paper forms part of an update of the World Health Organization Choosing Interventions that are Cost-Effective (WHO-CHOICE) programmes. It provides an assessment of global health system performance during the first decade of the 21st century (2000-2010) with respect to allocative efficiency in HIV, tuberculosis (TB) and malaria control, thereby shining a spotlight on programme development and scale up in these Millennium Development Goal (MDG) priority areas; and examining the cost-effectiveness of selected best-practice interventions and intervention packages commonly in use during that period. METHODS: Generalized cost-effectiveness analysis (GCEA) was used to determine the cost-effectiveness of the selected interventions. Impact modelling was performed using the OpenMalaria platform for malaria and using the Goals and TIME (TB Impact Model and Estimates) models in Spectrum for HIV and TB. All health system costs, regardless of payer, were included and reported in international dollars. Health outcomes are estimated and reported as the gain in healthy life years (HLYs) due to the specific intervention or combination. Analysis was restricted to eastern sub-Saharan Africa and Southeast Asia. RESULTS: At the reference year of 2010, commonly used interventions for HIV, TB and malaria were cost-effective, with cost-effectiveness ratios less than I$ 100/HLY saved for virtually all interventions included. HIV, TB and malaria prevention and treatment interventions are highly cost-effective and can be implemented through a phased approach to full coverage to achieve maximum health benefits and contribute to the progressive elimination of these diseases. CONCLUSION: During the first decade of the 21st century (2000-2010), the global community has done well overall for HIV, TB, and malaria programmes as regards both economic efficiency and programmatic selection criteria. The role of international assistance, financial and technical, arguably was critical to these successes. As the global community now tackles the challenge of universal health coverage, this analysis can reinforce commitment to Sustainable Development Goal targets but also the importance of continued focus on these critical programme areas.

The Economic Burden of Malaria: Revisiting the Evidence.

A portion of the economics literature has long debated about the relative importance of historical, institutional, geographical, and health determinants of economic growth. In 2001, Gallup and Sachs quantified the association between malaria and the level and growth of per capita income over the period 1965-1995 in a cross-country regression framework. We took a contemporary look at Gallup and Sachs' seminal work in the context of significant progress in malaria control achieved globally since 2000. Focusing on the period 2000-2017, we used the latest data available on malaria case incidence and other determinants of economic growth, as well as macro-econometric methods that are now the professional norm. In our preferred specification using a fixed-effects model, a 10% decrease in malaria incidence was associated with an increase in income per capita of nearly 0.3% on average and a 0.11 percentage point faster per capita growth per annum. Greater average income gains were expected among higher burden countries and those with lower income. Growth of industries with the same level of labor intensity was found to be significantly slower in countries with higher malaria incidence. To analyze the causal impact of malaria on economic outcomes, we used malaria treatment failure and pyrethroid-only insecticide resistance as exogeneous instruments in two-stage least squares estimations. Despite several methodological challenges, as expected in these types of analyses, our findings confirm the intrinsic link between malaria and economic growth and underscore the importance of malaria control in the agenda for sustainable development.

Costs and Cost-Effectiveness of Plasmodium vivax Control.

The continued success of efforts to reduce the global malaria burden will require sustained funding for interventions specifically targeting Plasmodium vivax The optimal use of limited financial resources necessitates cost and cost-effectiveness analyses of strategies for diagnosing and treating P. vivax and vector control tools. Herein, we review the existing published evidence on the costs and cost-effectiveness of interventions for controlling P. vivax, identifying nine studies focused on diagnosis and treatment and seven studies focused on vector control. Although many of the results from the much more extensive P. falciparum literature can be applied to P. vivax, it is not always possible to extrapolate results from P. falciparum-specific cost-effectiveness analyses. Notably, there is a need for additional studies to evaluate the potential cost-effectiveness of radical cure with primaquine for the prevention of P. vivax relapses with glucose-6-phosphate dehydrogenase testing.

Malaria: Global progress 2000 - 2015 and future challenges.

BACKGROUND: 2015 was the target year for malaria goals set by the World Health Assembly and other international institutions to reduce malaria incidence and mortality. A review of progress indicates that malaria programme financing and coverage have been transformed since the beginning of the millennium, and have contributed to substantial reductions in the burden of disease. FINDINGS: Investments in malaria programmes increased by more than 2.5 times between 2005 and 2014 from US$ 960 million to US$ 2.5 billion, allowing an expansion in malaria prevention, diagnostic testing and treatment programmes. In 2015 more than half of the population of sub-Saharan Africa slept under insecticide-treated mosquito nets, compared to just 2 % in 2000. Increased availability of rapid diagnostic tests and antimalarial medicines has allowed many more people to access timely and appropriate treatment. Malaria incidence rates have decreased by 37 % globally and mortality rates by 60 % since 2000. It is estimated that 70 % of the reductions in numbers of cases in sub-Saharan Africa can be attributed to malaria interventions. CONCLUSIONS: Reductions in malaria incidence and mortality rates have been made in every WHO region and almost every country. However, decreases in malaria case incidence and mortality rates were slowest in countries that had the largest numbers of malaria cases and deaths in 2000; reductions in incidence need to be greatly accelerated in these countries to achieve future malaria targets. Progress is made challenging because malaria is concentrated in countries and areas with the least resourced health systems and the least ability to pay for system improvements. Malaria interventions are nevertheless highly cost-effective and have not only led to significant reductions in the incidence of the disease but are estimated to have saved about US$ 900 million in malaria case management costs to public providers in sub-Saharan Africa between 2000 and 2014. Investments in malaria programmes can not only reduce malaria morbidity and mortality, thereby contributing to the health targets of the Sustainable Development Goals, but they can also transform the well-being and livelihood of some of the poorest communities across the globe.

Prices and mark-ups on antimalarials: evidence from nationally representative studies in six malaria-endemic countries.

The private for-profit sector is an important source of treatment for malaria. However, private patients face high prices for the recommended treatment for uncomplicated malaria, artemisinin combination therapies (ACTs), which makes them more likely to receive cheaper, less effective non-artemisinin therapies (nATs). This study seeks to better understand consumer antimalarial prices by documenting and exploring the pricing behaviour of retailers and wholesalers. Using data collected in 2009-10, we present survey estimates of antimalarial retail prices, and wholesale- and retail-level price mark-ups from six countries (Benin, Cambodia, the Democratic Republic of Congo, Nigeria, Uganda and Zambia), along with qualitative findings on factors affecting pricing decisions. Retail prices were lowest for nATs, followed by ACTs and artemisinin monotherapies (AMTs). Retailers applied the highest percentage mark-ups on nATs (range: 40% in Nigeria to 100% in Cambodia and Zambia), whereas mark-ups on ACTs (range: 22% in Nigeria to 71% in Zambia) and AMTs (range: 22% in Nigeria to 50% in Uganda) were similar in magnitude, but lower than those applied to nATs. Wholesale mark-ups were generally lower than those at retail level, and were similar across antimalarial categories in most countries. When setting prices wholesalers and retailers commonly considered supplier prices, prevailing market prices, product availability, product characteristics and the costs related to transporting goods, staff salaries and maintaining a property. Price discounts were regularly used to encourage sales and were sometimes used by wholesalers to reward long-term customers. Pricing constraints existed only in Benin where wholesaler and retailer mark-ups are regulated; however, unlicensed drug vendors based in open-air markets did not adhere to the pricing regime. These findings indicate that mark-ups on antimalarials are reasonable. Therefore, improving ACT affordability would be most readily achieved by interventions that reduce commodity prices for retailers, such as ACT subsidies, pooled purchasing mechanisms and cost-effective strategies to increase the distribution coverage area of wholesalers.

Effect of Paying for Performance on Utilisation, Quality, and User Costs of Health Services in Tanzania: A Controlled Before and After Study.

BACKGROUND: Despite widespread implementation across Africa, there is limited evidence of the effect of payment for performance (P4P) schemes in low income countries on the coverage of quality services and affordability, consistent with universal health coverage objectives. We examined the effect of a government P4P scheme on utilisation, quality, and user costs of health services in Tanzania. METHODS: We evaluated the effects of a P4P scheme on utilisation of all maternal and child immunization services targeted by the scheme, and non-targeted general outpatient service use. We also evaluated effects on patient satisfaction with care and clinical content of antenatal care, and user costs. The evaluation was done in 150 facilities across all 7 intervention districts and 4 comparison districts with two rounds of data collection over 13-months in January 2012 and February 2013. We sampled 3000 households of women who had delivered in the 12 months prior to interview; 1500 patients attending health facilities for targeted and non-targeted services at each round of data collection. Difference-in-difference regression analysis was employed. FINDINGS: We estimated a significant positive effect on two out of eight targeted indicators. There was an 8.2% (95% CI: 3.6% to 12.8%) increase in coverage of institutional deliveries among women in the intervention area, and a 10.3% (95% CI: 4.4% to 16.1%) increase in the provision of anti-malarials during pregnancy. Use of non-targeted services reduced at dispensaries by 57.5 visits per month among children under five (95% CI: -110.2 to -4.9) and by 90.8 visits per month for those aged over five (95% CI: -156.5 to -25.2). There was no evidence of an effect of P4P on patient experience of care for targeted services. There was a 0.05 (95% CI: 0.01 to 0.10) increase in the patient satisfaction score for non-targeted services. P4P was associated with a 5.0% reduction in those paying out of pocket for deliveries (95% CI: -9.3% to -0.7%) but there was no evidence of an effect on the average amount paid. CONCLUSION: This study adds to the very limited evidence on the effects of P4P at scale and highlights the potential risks of such schemes in relation to non-targeted service use. Further consideration of the design of P4P schemes is required to enhance progress towards universal health coverage, and close monitoring of effects on non-targeted services and user costs should be encouraged.

Protocol for the evaluation of a free health insurance card scheme for poor pregnant women in Mbeya region in Tanzania: a controlled-before and after study.

BACKGROUND: The use of demand-side financing mechanisms to increase health service utilisation among target groups and enhance service quality is gaining momentum in many low- and middle-income countries. However, there is limited evidence on the effects of such schemes on equity, financial protection, quality of care, and cost-effectiveness. A scheme providing free health insurance cards to poor pregnant women and their households was first introduced in two regions of Tanzania in 2011 and gradually expanded in 2012. METHODS: A controlled before and after study will examine in one district the effect of the scheme on utilization, quality, and cost of healthcare services accessed by poor pregnant women and their households in Tanzania. Data will be collected 4 months before implementation of the scheme and 17 months after the start of implementation from a survey of 24 health facilities, 288 patients exiting consultations and 1500 households of women who delivered in the previous year in one intervention district (Mbarali). 288 observations of provider-client interactions will also be carried out. The same data will be collected from a comparison district in a nearby region. A process evaluation will ascertain how the scheme is implemented in practice and the level of implementation fidelity and potential moderators. The process evaluation will draw from impact evaluation data and from three rounds of data collection at the national, regional, district, facility and community levels. An economic evaluation will measure the cost-effectiveness of the scheme relative to current practice from a societal perspective. DISCUSSION: This evaluation will generate evidence on the impact and cost-effectiveness of targeted health insurance for pregnant women in a low income setting, as well as building a better understanding of the implementation process and challenges for programs of this nature.

Determinants of price setting decisions on anti-malarial drugs at retail shops in Cambodia.

BACKGROUND: In many low-income countries, the private commercial sector plays an important role in the provision of malaria treatment. However, the quality of care it provides is often poor, with artemisinin combination therapy (ACT) generally being too costly for consumers. Decreasing ACT prices is critical for improving private sector treatment outcomes and reducing the spread of artemisinin resistance. Yet limited evidence exists on the factors influencing retailers' pricing decisions. This study investigates the determinants of price mark-ups on anti-malarial drugs in retail outlets in Cambodia. METHODS: Taking an economics perspective, the study tests the hypothesis that the structure of the anti-malarial market determines the way providers set their prices. Providers facing weak competition are hypothesized to apply high mark-ups and set prices above the competitive level. To analyse the relationship between market competition and provider pricing, the study used cross-sectional data from retail outlets selling anti-malarial drugs, including outlet characteristics data (e.g. outlet type, anti-malarial sales volumes), range of anti-malarial drugs stocked (e.g. dosage form, brand status) and purchase and selling prices. Market concentration, a measure of the level of market competition, was estimated using sales volume data. Market accessibility was defined based on travel time to the closest main commercial area. Percent mark-ups were calculated using price data. The relationship between mark-ups and market concentration was explored using regression analysis. RESULTS: The anti-malarial market was on average highly concentrated, suggesting weak competition. Higher concentration was positively associated with higher mark-ups in moderately accessible markets only, with no significant relationship or a negative relationship in other markets. Other determinants of pricing included anti-malarial brand status and generic type, with higher mark-ups on cheaper products. CONCLUSIONS: The results indicate that provider pricing as well as other key elements of anti-malarial supply and demand may have played an important role in the limited access to appropriate malaria treatment in Cambodia. The potential for an ACT price subsidy at manufacturer level combined with effective communications directed at consumers and supportive private sector regulation should be explored to improve access to quality malaria treatment in Cambodia.

In Tanzania, the many costs of pay-for-performance leave open to debate whether the strategy is cost-effective.

Pay-for-performance programs in health care are widespread in low- and middle-income countries. However, there are no studies of these programs' costs or cost-effectiveness. We conducted a cost-effectiveness analysis of a pay-for-performance pilot program in Tanzania and modeled costs of its national expansion. We reviewed project accounts and reports, interviewed key stakeholders, and derived outcomes from a controlled before-and-after study. In 2012 US dollars, the financial cost of the pay-for-performance pilot was $1.2 million, and the economic cost was $2.3 million. The incremental cost per additional facility-based birth ranged from $540 to $907 in the pilot and from $94 to $261 for a national program. In a low-income setting, the costs of managing the program and generating and verifying performance data were substantial. Pay-for-performance programs can stimulate the generation and use of health information by health workers and managers for strategic planning purposes, but the time involved could divert attention from service delivery. Pay-for-performance programs may become more cost-effective when integrated into routine systems over time.

Pay for performance: an analysis of the context of implementation in a pilot project in Tanzania.

BACKGROUND: Pay for performance schemes are increasingly being implemented in low income countries to improve health service coverage and quality. This paper describes the context within which a pay for performance programme was introduced in Tanzania and discusses the potential for pay for performance to address health system constraints to meeting targets. METHOD: 40 in-depth interviews and four focus group discussions were undertaken with health workers, and regional, district and facility managers. Data was collected on work environment characteristics and staff attitudes towards work in the first phase of the implementation of the pilot. A survey of 75 facilities and 101 health workers were carried out to examine facility resourcing, and health worker employment conditions and job satisfaction. RESULTS: Five contextual factors which affect the implementation of P4P were identified by health workers: salary and employment benefits; resource availability, including staff, medicines and functioning equipment; supervision; facility access to utilities; and community preferences. The results suggest that it is important to consider contextual issues when implementing pay for performance schemes in low income settings. It highlights the importance of basic infrastructures being in place, a minimum number of staff with appropriate education and skills as well as sufficient resources before implementing pay for performance. CONCLUSION: Health professionals working within a pay for performance scheme in Tanzania were concerned about challenges related to shortages of resources, limited supplies and unfavourable community preferences. The P4P scheme may provide the incentive and means to address certain constraints, in so far as they are within the control of providers and managers, however, other constraints will be harder to address.

Understanding private sector antimalarial distribution chains: a cross-sectional mixed methods study in six malaria-endemic countries.

BACKGROUND: Private for-profit outlets are important treatment sources for malaria in most endemic countries. However, these outlets constitute only the last link in a chain of businesses that includes manufacturers, importers and wholesalers, all of which influence the availability, price and quality of antimalarials patients can access. We present evidence on the composition, characteristics and operation of these distribution chains and of the businesses that comprise them in six endemic countries (Benin, Cambodia, Democratic Republic of Congo, Nigeria, Uganda and Zambia). METHODS AND FINDINGS: We conducted nationally representative surveys of antimalarial wholesalers during 2009-2010 using an innovative sampling approach that captured registered and unregistered distribution channels, complemented by in-depth interviews with a range of stakeholders. Antimalarial distribution chains were pyramidal in shape, with antimalarials passing through a maximum of 4-6 steps between manufacturer and retailer; however, most likely pass through 2-3 steps. Less efficacious non-artemisinin therapies (e.g. chloroquine) dominated weekly sales volumes among African wholesalers, while volumes for more efficacious artemisinin-based combination therapies (ACTs) were many times smaller. ACT sales predominated only in Cambodia. In all countries, consumer demand was the principal consideration when selecting products to stock. Selling prices and reputation were key considerations regarding supplier choice. Business practices varied across countries, with large differences in the proportions of wholesalers offering credit and delivery services to customers, and the types of distribution models adopted by businesses. Regulatory compliance also varied across countries, particularly with respect to licensing. The proportion of wholesalers possessing any up-to-date licence from national regulators was lowest in Benin and Nigeria, where vendors in traditional markets are important antimalarial supply sources. CONCLUSIONS: The structure and characteristics of antimalarial distribution chains vary across countries; therefore, understanding the wholesalers that comprise them should inform efforts aiming to improve access to quality treatment through the private sector.

Protocol for the evaluation of a pay for performance programme in Pwani region in Tanzania: a controlled before and after study.

BACKGROUND: The use of supply-side incentives to increase health service utilisation and enhance service quality is gaining momentum in many low- and middle-income countries. However, there is a paucity of evidence on the impact of such schemes, their cost-effectiveness, and the process of implementation and potential unintended consequences in these settings. A pay for performance (P4P) programme was introduced in Pwani region of Tanzania in 2011. METHODS/DESIGN: An evaluation of the programme will be carried out to inform a potential national rollout. A controlled before and after study will examine the effect of the P4P programme on quality, coverage, and cost of targeted maternal and newborn healthcare services and selected non-targeted services at facilities in Tanzania. Data will be collected from a survey of 75 facilities, 750 patients exiting consultations, over 75 health workers, and 1,500 households of women who delivered in the previous year, in all seven intervention districts. Data will be collected from the same number of respondents in four control districts. A process evaluation will examine: whether the P4P programme was implemented as planned; stakeholder response to the programme and its acceptability; and implementation bottlenecks and facilitating factors. Three rounds of process data collection will be conducted including a review of available P4P documents, individual interviews and focus group discussions with key informants working at facility and district level in five of the intervention districts, and at the regional and national levels. An economic evaluation will measure the cost-effectiveness of P4P relative to current practice from a societal perspective. DISCUSSION: This evaluation will contribute robust evidence on the impact and cost-effectiveness of P4P in a low income setting, as well as generate a better understanding of the feasibility of integrating complex intervention packages like P4P within health systems in resource poor settings.

Methods for implementing a medicine outlet survey: lessons from the anti-malarial market.

BACKGROUND: In recent years an increasing number of public investments and policy changes have been made to improve the availability, affordability and quality of medicines available to consumers in developing countries, including anti-malarials. It is important to monitor the extent to which these interventions are successful in achieving their aims using quantitative data on the supply side of the market. There are a number of challenges related to studying supply, including outlet sampling, gaining provider cooperation and collecting accurate data on medicines. This paper provides guidance on key steps to address these issues when conducting a medicine outlet survey in a developing country context. While the basic principles of good survey design and implementation are important for all surveys, there are a set of specific issues that should be considered when conducting a medicine outlet survey. METHODS: This paper draws on the authors' experience of designing and implementing outlet surveys, including the lessons learnt from ACTwatch outlet surveys on anti-malarial retail supply, and other key studies in the field. Key lessons and points of debate are distilled around the following areas: selecting a sample of outlets; techniques for collecting and analysing data on medicine availability, price and sales volumes; and methods for ensuring high quality data in general. RESULTS AND CONCLUSIONS: The authors first consider the inclusion criteria for outlets, contrasting comprehensive versus more focused approaches. Methods for developing a reliable sampling frame of outlets are then presented, including use of existing lists, key informants and an outlet census. Specific issues in the collection of data on medicine prices and sales volumes are discussed; and approaches for generating comparable price and sales volume data across products using the adult equivalent treatment dose (AETD) are explored. The paper concludes with advice on practical considerations, including questionnaire design, field worker training, and data collection. Survey materials developed by ACTwatch for investigating anti-malarial markets in sub-Saharan Africa and Asia provide a helpful resource for future studies in this area.

Coverage, adherence and costs of intermittent preventive treatment of malaria in children employing different delivery strategies in Jasikan, Ghana.

BACKGROUND: Intermittent preventive treatment of malaria in children (IPTc) involves the administration of a course of anti-malarial drugs at specified time intervals to children at risk of malaria regardless of whether or not they are known to be infected. IPTc provides a high level of protection against uncomplicated and severe malaria, with monthly sulphadoxine-pyrimethamine plus amodiaquine (SP&AQ) and sulphadoxine-pyrimethamine plus piperaquine being the most efficacious regimens. A key challenge is the identification of a cost-effective delivery strategy. METHODS: A community randomized trial was undertaken in Jasikan district, Ghana to assess IPTc effectiveness and costs using SP&AQ delivered in three different ways. Twelve villages were randomly selected to receive IPTc from village health workers (VHWs) or facility-based nurses working at health centres' outpatient departments (OPD) or EPI outreach clinics. Children aged 3 to 59 months-old received one IPT course (three doses) in May, June, September and October. Effectiveness was measured in terms of children covered and adherent to a course and delivery costs were calculated in financial and economic terms using an ingredient approach from the provider perspective. RESULTS: The economic cost per child receiving at least the first dose of all 4 courses was US$4.58 when IPTc was delivered by VHWs, US$4.93 by OPD nurses and US$ 5.65 by EPI nurses. The unit economic cost of receiving all 3 doses of all 4 courses was US$7.56 and US$8.51 when IPTc was delivered by VHWs or facility-based nurses respectively. The main cost driver for the VHW delivery was supervision, reflecting resources used for travelling to more remote communities rather than more intense supervision, and for OPD and EPI delivery, it was the opportunity cost of the time spent by nurses in dispensing IPTc. CONCLUSIONS: VHWs achieve higher IPTc coverage and adherence at lower costs than facility-based nurses in Jasikan district, Ghana. TRIAL REGISTRATION: ClinicalTrials.gov NCT00119132.

Socially-marketed rapid diagnostic tests and ACT in the private sector: ten years of experience in Cambodia.

Whilst some populations have recently experienced dramatic declines in malaria, the majority of those most at risk of Plasmodium falciparum malaria still lack access to effective treatment with artemisinin combination therapy (ACT) and others are already facing parasites resistant to artemisinins.In this context, there is a crucial need to improve both access to and targeting of ACT through greater availability of good quality ACT and parasitological diagnosis. This is an issue of increasing urgency notably in the private commercial sector, which, in many countries, plays an important role in the provision of malaria treatment. The Affordable Medicines Facility for malaria (AMFm) is a recent initiative that aims to increase the provision of affordable ACT in public, private and NGO sectors through a manufacturer-level subsidy. However, to date, there is little documented experience in the programmatic implementation of subsidized ACT in the private sector. Cambodia is in the unique position of having more than 10 years of experience not only in implementing subsidized ACT, but also rapid diagnostic tests (RDT) as part of a nationwide social marketing programme. The programme includes behaviour change communication and the training of private providers as well as the sale and distribution of Malarine, the recommended ACT, and Malacheck, the RDT. This paper describes and evaluates this experience by drawing on the results of household and provider surveys conducted since the start of the programme. The available evidence suggests that providers' and consumers' awareness of Malarine increased rapidly, but that of Malacheck much less so. In addition, improvements in ACT and RDT availability and uptake were relatively slow, particularly in more remote areas.The lack of standardization in the survey methods and the gaps in the data highlight the importance of establishing a clear system for monitoring and evaluation for similar initiatives. Despite these limitations, a number of important lessons can still be learnt. These include the importance of a comprehensive communications strategy and of a sustained and reliable supply of products, with attention to the geographical reach of both. Other important challenges relate to the difficulty in incentivising providers and consumers not only to choose the recommended drug, but to precede this with a confirmatory blood test and ensure that providers adhere to the test results and patients to the treatment regime. In Cambodia, this is particularly complicated due to problems inherent to the drug itself and the emergence of artemisinin resistance.

Cost effectiveness of seasonal intermittent preventive treatment using amodiaquine & artesunate or sulphadoxine-pyrimethamine in Ghanaian children.

BACKGROUND: Intermittent preventive treatment for malaria in children (IPTc) involves the administration of a full course of an anti-malarial treatment to children under 5 years old at specified time points regardless of whether or not they are known to be infected, in areas where malaria transmission is seasonal. It is important to determine the costs associated with IPTc delivery via community based volunteers and also the potential savings to health care providers and caretakers due to malaria episodes averted as a consequence of IPTc. METHODS: Two thousand four hundred and fifty-one children aged 3-59 months were randomly allocated to four groups to receive: three days of artesunate plus amodiaquine (AS+AQ) monthly, three days of AS+AQ bimonthly, one dose of sulphadoxine-pyrimethamine (SP) bi-monthly or placebo. This paper focuses on incremental cost effectiveness ratios (ICERs) of the three IPTc drug regimens as delivered by community based volunteers (CBV) in Hohoe, Ghana compared to current practice, i.e. case management in the absence of IPTc. Financial and economic costs from the publicly funded health system perspective are presented. Treatment costs borne by patients and their caretakers are also estimated to present societal costs. The costs and effects of IPTc during the intervention period were considered with and without a one year follow up. Probabilistic sensitivity analysis was undertaken to account for uncertainty. RESULTS: Economic costs per child receiving at least the first dose of each course of IPTc show SP bimonthly, at US$8.19, is the cheapest to deliver, followed by AS+AQ bimonthly at US$10.67 and then by AS+AQ monthly at US$14.79. Training, drug delivery and supervision accounted for approximately 20-30% each of total unit costs. During the intervention period AS & AQ monthly was the most cost effective IPTc drug regimen at US$67.77 (61.71-74.75, CI 95%) per malaria case averted based on intervention costs only, US$64.93 (58.92-71.92, CI 95%) per malaria case averted once the provider cost savings are included and US$61.00 (54.98, 67.99, CI 95%) when direct household cost savings are also taken into account. SP bimonthly was US$105.35 (75.01-157.31, CI 95%) and AS & AQ bimonthly US$211.80 (127.05-399.14, CI 95%) per malaria case averted based on intervention costs only. The incidence of malaria in the post intervention period was higher in children who were <1 year old when they received AS+AQ monthly compared to the placebo group leading to higher cost effectiveness ratios when one year follow up is included. The cost per child enrolled fell considerably when modelled to district level as compared to those encountered under trial conditions. CONCLUSIONS: We demonstrate how cost-effective IPTc is using three different drug regimens and the possibilities for reducing costs further if the intervention was to be scaled up to the district level. The need for effective training, drug delivery channels and supervision to support a strong network of community based volunteers is emphasised.