The Importance of a Methodological Manual for Economic Evaluations in Healthcare Decision-Making in Ecuador

Abstract

This article provides an overview of Ecuador’s Methodological Manual for Economic Evaluations of Health Technologies, emphasizing its importance, key methodological aspects, and relevance within the country’s health technology assessment (HTA) framework. The manual establishes standardized guidelines for conducting economic evaluations, incorporating international best practices while adapting them to the national context. It outlines essential methodological components, including decision problem definition, economic evaluation types, cost estimation, use of decision models, and sensitivity analysis. Additionally, it highlights the role of quality-adjusted life years (QALYs) and cost-effectiveness thresholds in supporting evidence-based decision-making. Beyond its methodological contributions, the manual plays a crucial role in institutionalizing economic evaluations in Ecuador’s healthcare system. By promoting transparency, consistency, and technical rigor, it strengthens the integration of economic evidence into policy decisions, ensuring efficient resource allocation. However, challenges persist, including limitations in technical capacity, data availability, and the need for further refinement of local cost-effectiveness thresholds and indirect cost valuation. This article also explores the broader policy implications of adopting the manual within Ecuador’s HTA framework. Strengthening institutional capacity, improving data infrastructure, and fostering international collaboration will be essential to its successful implementation. By embedding economic evaluations into healthcare decision-making, Ecuador can enhance the sustainability of its health system, optimize expenditures, and improve access to cost-effective health technologies.

Key Points for Decision Makers

Countries increasingly use cost-effectiveness and cost-utility analyses to guide resource allocation and ensure the efficient use of health budgets. This approach supports health systems in managing rising costs and prioritizing high-value health interventions.

The paper introduces Ecuador’s new Methodological Manual for Economic Evaluations of Health Technologies, which aligns with international best practices. It sets a structured framework for conducting economic evaluations, specifically tailored to Ecuador’s healthcare context, and incorporates tools such as QALYs to optimize health resource use.

By integrating economic evaluations into Ecuador’s healthcare decision-making processes, the manual promotes evidence-based policy, transparency, and accountability. It strengthens the country’s capacity for HTA, encouraging the use of objective, data-driven methods to ensure the sustainability and efficiency of the national healthcare system.

Introduction

In recent decades, a robust set of technical tools has been developed to enhance the rigor of methodologies for health technology assessment (HTA) and improve the selection of healthcare interventions. These advancements have been documented in manuals and guidelines that promote standardized and consistent economic evaluations across different countries [1]. Ecuador’s Methodological Manual for Economic Evaluations of Health Technologies is a product of this evolving field. It draws on academic literature, international guidelines, and practical manuals relevant to the national context, aiming to establish a solid methodological foundation for conducting economic evaluations in the healthcare sector [2].

The development of the Ecuadorian Economic Evaluation Manual followed the official methodology for the creation of health normative documents established by the Ministry of Public Health (MSP by its acronym in Spanish). This methodology involves a structured process comprising three main stages: a preliminary phase, a drafting phase, and a final validation and officialization phase [3]. The manual was developed over 2 years (2021–2022) and involved a multidisciplinary group of 14 stakeholders, including members of the Ministry of Public Health, representatives from the pharmaceutical industry, academic experts, and delegates from social security institutes. The preliminary stage included the identification and prioritization of the need for an economic evaluation manual, guided by national health policies and strategic planning instruments. This stage also involved the elaboration of a technical report justifying the manual’s necessity and its inclusion in MSP’s regulatory agenda [3].

The drafting stage included the formation of an interdisciplinary team of authors and methodologists, who adapted international methodological standards for economic evaluations (such as those from Canadian Agency for Drugs and Technologies in Health (CADTH), National Institute for Health and Care Excellence (NICE), and International Society for Pharmacoeconomics and Outcomes Research (ISPOR)) to ensure methodological rigor. For example, the manual recommends the use of generic health outcome measures such as quality-adjusted life years (QALYs), aligning with international best practices, while promoting the use of Ecuador-specific EQ-5D-3L value sets when available [2].

Regular working meetings, technical reviews, and adherence to the Vancouver referencing system ensured technical and editorial rigor. During the final stage, the manual underwent internal peer review, validation workshops with national and regional experts, and legal verification to ensure regulatory coherence. Official approval was granted through a ministerial agreement, following the established procedures [3].

The intended audience of the manual includes decision-makers involved in health policy and resource allocation, health economists, academic researchers, and analysts conducting economic evaluations to inform the adoption, coverage, and reimbursement of health technologies in Ecuador. Clarifying the target audience aims to ensure that the manual serves both technical users and policymakers who require clear, standardized methodologies for evaluating health interventions.

The development of the manual addressed several methodological challenges through a structured and participatory process. Among the key issues tackled were the definition and contextualization of cost-effectiveness thresholds, the adaptation of international methodological standards, and the alignment with national health policy priorities​. Regarding cost-effectiveness thresholds, the manual reviewed international practices, including the World Health Organization (WHO) recommendations and the opportunity cost-based approaches, to propose a provisional threshold based on Ecuador’s estimated marginal productivity of healthcare spending. However, recognizing the ongoing debate and lack of official adoption, the manual recommends that analysts specify and justify the threshold employed in each evaluation, thus allowing flexibility while promoting transparency [2]. The manual represents a significant milestone in Ecuador’s effort to institutionalize health economic evaluations and improve healthcare decision-making.

The manual serves as a critical tool for the design, analysis, and interpretation of economic evaluations in Ecuador’s health system. It is designed to be applicable to a wide range of health technologies, including pharmaceuticals, medical devices, public health interventions, and healthcare procedures [2]. While the guidelines have a broad scope, certain methodological aspects are tailored to specific types of technologies, ensuring relevance and flexibility across different sectors of health [2]. Economic evaluations provide quantitative insights that are crucial for decision-making processes, particularly in ensuring the efficient use of resources without compromising access to essential health technologies [4]. The results from such evaluations support policy decisions that balance healthcare access with the sustainability of the health system [3].

Ecuador’s 2008 Constitution underscores this approach by mandating, in Article 367, Section 7, that the state guarantees the availability of safe, effective, and high-quality medicines, while also promoting the national production and use of generics to meet the population’s epidemiological needs [5]. The Organic Health Law reinforces this responsibility, assigning the Ministry of Public Health the leadership role in healthcare policy formulation and implementation [5]. Specifically, Article 6, Section 20 mandates the creation of policies to ensure access to quality medicines at the lowest cost [5].

As part of the institutionalization of HTA in Ecuador, the National Directorate of Health Technology Assessment (Dirección Nacional de Evaluación de Tecnologías en Salud, DNETS) was established within the Ministry of Public Health in 2022. This directorate develops studies that contribute to the decision-making process for formulating health policies and regulations through health technology assessment. The DNETS aims to enhance transparency and efficiency in adopting new technologies by providing systematic evaluations based on clinical, social, ethical, economic, and financial criteria.

Building on these provisions, in 2020, the Constitutional Court of Ecuador issued Ruling No. 679-18-JP/20, reaffirming the right to access high-quality, safe, and effective medicines. The court directed the MSP to update its regulations and procedures, particularly concerning the acquisition of medicines not included in the national formulary, for both emergency and nonemergency scenarios [6]. Subsequently, the MSP issued Ministerial Agreement No. 00018 in 2021, which established the “Regulation for the Authorization of the Acquisition and Use of Medicines Not Listed in the National Basic Medicines List.” The practical utility of the manual aligns with this Ministerial Agreement, requiring economic evaluations to serve as technical inputs for decision-making processes by competent authorities. Additionally, this agreement allowed for the creation of the Institutional Technical Commission for the Evaluation of Medicines not included in the essential medicines list (COTIEM, its acronym in Spanish). The COTIEM is a group of individuals responsible for analyzing and evaluating the information and requests from healthcare establishments that require authorization to purchase medicines not included in the essential medicines list. Each COTIEM has an HTA unit to prepare reports on efficacy, safety, cost-effectiveness, and budget impact [7].

At the international level, economic evaluations are recognized as the fourth critical criterion in the adoption of health technologies, alongside safety, efficacy, and quality [8]. These evaluations provide vital information for guiding healthcare decisions. Another key component of HTA in Ecuador is the National Essential Medicines List (CNMB), which is currently guided primarily by criteria related to safety, efficacy, and convenience. Although efficiency is mentioned as a consideration, it has yet to be given sufficient weight in the decision-making process. Strengthening the emphasis on efficiency is particularly important for Ecuador, given its status as a lower-middle-income country (LMIC) with a highly constrained health budget. The development of the Manual for Economic Evaluations of Health Technologies represents a significant step toward addressing this gap. It underscores the critical need to ensure that evidence from economic evaluations is applicable within local healthcare settings, taking into account the specific epidemiological and economic challenges faced by the nation [10, 11].

Despite the progress in institutionalizing HTA and economic evaluations in Ecuador, several challenges remain. The heterogeneity of existing studies, limited technical capacity, and restricted access to quality data pose significant obstacles to conducting robust evaluations [12]. To mitigate these limitations, Ecuador has increasingly relied on international and Latin American guidelines to standardize methodologies and enhance the credibility of assessments. The development of the manual seeks to address these gaps by providing a clear, standardized framework tailored to the national context.

This article aims to provide an overview of Ecuador’s methodological manual for economic evaluations, highlighting its importance and key methodological aspects. Additionally, it explores its relevance to decision-making and policy implications within the Ecuadorian HTA framework.

Methodological Framework

The development and methodological context for conducting economic evaluations of health technologies, as proposed by Ecuador’s Ministry of Public Health, outlines the principles, procedures, and techniques that must be followed to make informed decisions within the Public Integrated Health Network (RPIS by its acronym in Spanish). This framework aligns with international best practices and is designed to ensure transparency, consistency, and efficiency in resource allocation in the healthcare system [2]. Below are the key components that define this framework.

Decision Problem

The decision problem defines the core question that the economic evaluation seeks to answer. This question must articulate the uncertainty surrounding the efficiency of two or more healthcare alternatives. It is essential that the research question is formulated clearly, specifying the health interventions to be compared, the target population, and the analytical perspective (such as the health system, society, or patient perspective). The framework recommends using the Population, Intervention, Comparator, and Outcomes (PICO) strategy to ensure relevance and clarity [11–13].

Target Population

The target population of the economic evaluation must be described according to its demographic, epidemiological, and clinical characteristics. It can also be categorized on the basis of the healthcare system affiliation (i.e., Ministry of Public Health, Ecuadorian Institute of Social Security, Social Security Institute of the Armed Forces and the National Police, or Private Complementary Network) and health system utilization patterns. The target population may be subdivided into specific groups if the objective is to differentiate the effectiveness or costs of healthcare interventions, especially in cases of heterogeneous populations [11, 12].

Evaluated Technologies

Intervention Technology

This is the technology under evaluation, which may include treatments, medical devices, diagnostic tools, or public health programs. It must address a specific health problem, indicating whether it is intended for prevention, screening, diagnosis, treatment, or rehabilitation [12].

Comparator Technology

The comparator typically represents the current standard of care in the healthcare system. It refers to the healthcare technologies that are included in authorized coverage or are being publicly funded. This allows for an assessment of whether the intervention technology provides a meaningful improvement over existing practices [12].

Type of Economic Evaluation

The type of economic evaluation to be conducted depends on the nature of the problem being addressed. In addition to the nature of the problem, the selection of an economic evaluation method also depends on the decision-making level. Cost-effectiveness analysis (CEA) is typically used for decisions within a single disease area, as it provides comparisons based on natural health units. When broader health sector decisions are required, cost–utility analysis (CUA) is more appropriate due to its ability to incorporate quality-of-life adjustments through quality-adjusted life years (QALYs). Additionally, the manual acknowledges the possible use of disability-adjusted life years (DALYs) as an alternative health outcome measure, particularly in public health interventions or evaluations aligned with the global burden of disease framework [2].

For cross-sectoral decisions that compare healthcare investments with other public sector allocations, cost–benefit analysis (CBA) is preferred, as it translates both costs and benefits into monetary terms, facilitating comparisons across different policy areas [1]. The authors of the manual have not included the cost–consequences analysis, as this type of study does not combine them into a single summary measure, such as what occurs in the rest of economic evaluations.

The manual placed greater emphasis on the use of CEA and CUA, although it does not specify which type of evaluation is preferred. The manual recommends employing QALYs as an outcome measure in CUA [2]. In Ecuador, the Ministry of Public Health recognized the need for indicators that measure individuals’ social preferences regarding health states and the impact of healthcare interventions. As a result, the EQ-5D-3L questionnaire, translated and validated for the country, was applied, leading to the publication of the results of the social valuation survey of EQ-5D health states in Ecuador [14]. This document is recommended as a local resource for obtaining health outcomes in the development of CEA or CUA. In the absence of local data, the manual recommends using data from literature [2].

Perspective of the Analysis

The perspective of the evaluation is critical as it determines which costs and outcomes to include. The manual suggests that the National Health System or RPIS’s third-party payer perspective be prioritized for most evaluations. However, researchers have the flexibility to explore other perspectives in a scenario analysis, such as those of patients or society, as appropriate for the decision-making context [2].

Time Horizon

The time horizon should be sufficient to capture all relevant clinical and economic outcomes associated with the technology under evaluation. For chronic diseases, a longer time horizon may be necessary, while for acute conditions, a shorter one may suffice. The manual emphasizes the importance of justifying the selected time horizon on the basis of the expected duration of the intervention’s effects [2, 11]​.

Discount Rate

Both costs and outcomes should be discounted to reflect their present value, as healthcare benefits and expenses often occur at different times. The manual suggests a default discount rate of 5%, with sensitivity analyses recommended using rates of 0%, 3.5%, 7%, and 12% [2].

This recommendation was proposed by the authors and validated by the reviewers of the manual. However, a review conducted in Australia on discount rates could have been a valuable reference for the manual. This report not only discussed methodological considerations but also recommended the adoption of a lower discount rate, closer to 3.5%, aligned with practices in other high-income countries [17]. One of its main findings was the concern that using relatively high discount rates, such as 5%, can disproportionately reduce the present value of future health benefits, potentially disadvantaging long-term health interventions [17].

In the context of Latin America, discount rates used in economic evaluations vary. For instance, Chile’s health economic evaluation guidelines recommend a 3% discount rate for both costs and outcomes [13], whereas Mexico and Colombia commonly use a 5% rate. Brazil also applies a 5% discount rate in its official methodological guidance [18–20]. Compared with global best practices, where lower discount rates are increasingly favored to better capture long-term benefits, especially in preventive and public health interventions, Ecuador’s default rate of 5% may be considered relatively high. However, it is consistent with the rates currently applied in countries such as Colombia, Brazil, and Mexico, indicating regional alignment in methodological approaches [18–21].

A higher discount rate implies that future health gains and costs are given less weight in present value terms. In economic evaluations, this can lead to underestimating the value of interventions whose benefits accrue over long periods, such as vaccination programs, chronic disease prevention, or early life interventions. Therefore, the choice of discount rate has direct implications for decision-making. Using a high rate may bias decisions against long-term investments in health and reduce the likelihood that such interventions are deemed cost-effective. Reflecting more deeply on this issue could improve the alignment of Ecuador’s economic evaluation framework with evolving international standards and support more balanced and forward-looking health policy decisions [17, 21, 22].

Health Outcomes Estimation

Health outcome measures should reflect changes in quality of life, survival rates, or other clinical endpoints relevant to the population under study. For instance, the evaluation may include measures such as QALYs or DALYs, which offer a comprehensive way to assess both the duration and quality of life following a healthcare intervention [1]. These generic utility measures are often preferred, as they enable comparability across different health programs and diseases [2].

The choice between QALYs and DALYs depends on the decision context. According to the Ecuadorian Economic Evaluation Manual, generic measures such as QALYs or DALYs should be used when the objective is to inform decisions related to resource allocation and priority setting across multiple diseases or population groups. In such cases, these metrics allow for comparability across interventions, helping to identify the most efficient options within a constrained budget [2].

QALYs are especially suitable when quality of life is a critical component of the evaluation and when utility weights can be obtained, either directly from the target population or from validated social preferences using instruments such as the EQ-5D-3L. The manual highlights that Ecuador has developed its own EQ-5D-3L value set, making QALYs a practical and locally grounded option [2, 16]. Moreover, the use of QALYs is widely adopted in health technology assessment guidelines and is increasingly recommended by international reference cases [21].

DALYs, on the other hand, may be more appropriate in evaluations focused on global burden of disease comparisons or when considering population-level public health interventions where disability and mortality burdens are central, particularly in low- and middle-income settings [23]. DALYs are often used in global health research owing to their alignment with metrics produced by the global burden of disease (GBD) studies and their focus on population health loss rather than individual utility gains [23].

However, the Ecuadorian manual does not provide specific examples or decision rules to guide the choice between QALYs and DALYs in particular scenarios. This represents a potential gap in operational guidance that could be addressed in future methodological updates to support more consistent and transparent decision-making.

Therefore, while the manual acknowledges the importance of selecting outcome measures based on the decision objective and theoretical framework, it could benefit from more concrete guidance or illustrative examples to support users in selecting the most appropriate metric for each evaluation context. Clarifying these situations would enhance consistency in the application of health outcome measures in economic evaluations.

Cost Estimation

Cost estimation requires identifying, quantifying, and valuing both direct and indirect costs. In Ecuador, the current Tariff of Benefits for the National Health System (TPSNS by its acronym in Spanish) can be used as a cost information source for medical procedures. If the necessary information is not available in the TPSNS, other external sources (such as academic studies, price catalogs from healthcare institutions, etc.) can be used, provided that their inclusion and source are justified [2].

For drugs, it is recommended to use official price databases, such as the consolidated ceiling prices from the Price Setting Technical Secretariat of the Ministry of Public Health. When analyzing medications or medical devices, a 15% discount on the unit price should be applied according to Article 163 of the Organic Health Law, provided the analysis is conducted from the payer’s perspective as a member of the RPIS. The source of the information used must be specified.

Indirect costs, such as productivity losses due to morbidity or mortality and caregiver time, may also be considered if relevant data are available and depending on the perspective of the study [2]. However, the manual does not provide specific guidance or methodological recommendations on how to estimate or value these costs. This omission can lead to variability in how analysts incorporate indirect costs into economic evaluations, potentially affecting the comparability and transparency of results.

Common methods for estimating productivity losses include the human capital approach and the friction cost method, each with different theoretical underpinnings and implications for cost estimates. The absence of guidance on the preferred method may result in inconsistencies across studies and hinder the use of economic evaluations for policy-making or cross-study comparisons [1, 24]. Additionally, the valuation of unpaid work, such as informal caregiving, is a critical component of indirect costs in public health interventions, particularly those targeting chronic diseases or aging populations, but remains unaddressed in the manual.

Decision Model

Decision models simplify real-life complexity and are commonly used in economic evaluations to predict clinical outcomes on the basis of theoretical frameworks that integrate data from multiple sources. They help assess the effectiveness and costs of health interventions, with decision trees and Markov models being the most frequently used [10, 15]. These models also allow for the analysis of uncertainty and variability in assumptions and parameters [16].

In Ecuador, decision models should account for the availability of local information on the target population, costs, and clinical aspects of the disease. Economic evaluations must clearly describe the type of model, assumptions, limitations, and data sources [17]. Local or validated international models can be used, but justification is required when applying foreign models to the Ecuadorian context, ensuring national data calibration [2].

When local data is insufficient, information on intervention effects or transition probabilities can be sourced from international literature, with the source clearly stated. Modeling is necessary to extend outcomes beyond the time horizon of clinical trials or to adapt results to different contexts, enhancing decision-making and optimizing health resource allocation [17, 18].

Sensitivity Analysis

Sensitivity analysis measures the uncertainty in assumptions and parameters used in economic evaluations. It can involve estimations from decision models or scientific judgments. A univariate deterministic sensitivity analysis is recommended, particularly for discount rates, technology effectiveness (including quality of life weights or utilities), and costs. A tornado diagram may be included to highlight variables with the greatest impact [1, 2]. Additionally, multivariate analyses can be conducted when necessary [1, 2].

Probabilistic sensitivity analysis (PSA) is also recommended in the manual to quantify the variability in cost-effectiveness and cost-utility results [2]. PSA involves running the model multiple times (typically 1000 to 10,000) using random sampling of parameter distributions to generate a range of outcomes. A key result of PSA is the cost-effectiveness acceptability curve (CEAC), which shows the probability that an intervention is cost-effective at various thresholds [1]. CEAC is recommended to include in the analysis since this helps decision-makers understand the uncertainty involved [2].

Results Presentation and Interpretation

The results of economic evaluations, such as CEA and CUA, are presented through the incremental cost-effectiveness ratio (ICER). Standardizing the reporting of results is essential for transparency, comparability, and reproducibility. The Consolidated Health Economic Evaluation Reporting Standards (CHEERS) 2022 guidelines are recommended for presenting results [30].

To guide decision-making, ICERs should be interpreted using cost-effectiveness thresholds, which reflect the opportunity cost in health. Although early recommendations from the WHO used gross domestic product (GDP) per capita multiples, current perspectives favor thresholds based on opportunity costs, particularly in resource-limited health systems [31, 32]. For Ecuador, a 2016 estimate suggests an opportunity cost-based threshold of USD 4923 per QALY gained, with a suggested variation range of ± 33% to reflect uncertainty and potential variability in health system marginal productivity. This results in a range of approximately USD 3282 to USD 6564 [32].

This range is not a distribution of thresholds but a sensitivity interval around a central estimate, used to account for uncertainty in the estimation of opportunity cost. It does not represent a formal threshold adopted by national authorities; however, it has been referenced in academic literature and could serve as a temporary benchmark for economic evaluations in the absence of an official Ecuadorian threshold [32].

Compared with other Latin American countries, Ecuador’s proposed threshold appears aligned with regional practices, although it remains on the more conservative side. For instance, Peru has adopted a cost-effectiveness threshold ranging between Peruvian sol (S/) 9500 and S/ 19,300 per year of healthy life gained, equivalent to approximately USD 2500 to USD 5100 (based on 2021 exchange rates), and corresponding to 2.2–4.4 times the Peruvian tax unit (UIT) [33]. Similarly, Colombia has estimated a threshold of approximately USD 4487.5 per year of life lost avoided and USD 5180.8 per QALY gained, which is roughly equivalent to one GDP per capita [34]. These examples suggest that Ecuador’s reference value of USD 4923 per QALY falls within the expected regional range, though it leans toward the lower end, potentially reflecting a cautious approach aimed at maximizing health gains per unit of investment.

The implications of using a lower threshold in Ecuador’s drug reimbursement or technology adoption processes are significant. While it ensures that only highly efficient interventions are considered cost-effective, it may also result in the exclusion of many new health technologies, especially those with higher initial costs or marginal gains in quality of life. This could limit access to innovative treatments unless additional criteria (such as severity, rarity, or equity) are integrated into the decision-making framework.

Given that the Ecuadorian Ministry of Health currently mandates no explicit threshold, researchers must justify the choice of threshold used in each study. A formal adoption of a threshold, accompanied by guidance on when and how it may be adjusted (e.g., for severity or equity considerations), would improve consistency and transparency in economic evaluations supporting public health decisions.

Discussion and Conclusion

The final section should include a critical analysis of the results, comparing the base case and sensitivity analysis, while also mentioning the limitations in terms of clinical and economic information, the use of decision models and the implications for health policy [2]. Finally, a summary table with the main parameters and results of the economic evaluation should be provided [2].

Discussion

Relevance to Decision-Making and Policy Implications

The Manual for Economic Evaluations of Health Technologies represents a crucial step in aligning Ecuador’s healthcare policies with global best practices, particularly in ensuring the efficient use of limited healthcare resources. Economic evaluations have long been recognized as an essential tool for prioritizing health interventions, and their integration into decision-making frameworks has demonstrated positive impacts in various settings [17]. The manual directly contributes to achieving these objectives by providing clear guidance on the elaboration of economic evaluations, ensuring that decision-makers are equipped to make evidence-based choices aligned with national health goals.

Efficient Resource Allocation

As healthcare systems worldwide grapple with escalating costs, economic evaluations provide a way to ensure that resources are allocated to interventions offering the highest value for money. This approach is especially important for resource-limited settings such as Ecuador, where maximizing health outcomes with constrained budgets is a priority [22]. Studies have shown that economic evaluations can improve resource allocation, reduce unnecessary spending, and guide policymakers toward more efficient investment strategies [1].

For instance, in Latin American countries such as Brazil, Mexico, Chile, and Argentina, integrating CEA into HTA has led to more targeted spending on interventions that provide significant health benefits relative to their costs [9]. Ecuador’s manual similarly emphasizes the role of CEA and CUA in assessing new health technologies to ensure that health gains are maximized, aligning with Ecuador’s national healthcare objectives [2].

Health Intervention Prioritization

One of the primary goals of embedding economic evaluations into health policy is to support the prioritization of interventions that address the most significant health needs. For Ecuador, with its dual burden of communicable and noncommunicable diseases, prioritizing high-impact interventions becomes critical for achieving national health goals [23]. The manual provides a framework for comparing the cost-effectiveness of interventions across diverse health sectors, enabling decision-makers to allocate resources toward interventions that deliver the greatest impact [2].

The use of QALYs and DALYs as outcome measures is a well-established method for quantifying health outcomes in economic evaluations [24]. Evidence from countries such as the UK, where QALYs are routinely used in HTAs, shows that this approach can inform better healthcare decisions by comparing interventions across different disease areas and populations [25].

Transparency and Accountability in Decision-Making

Economic evaluations, when applied rigorously and consistently, promote transparency and accountability in health system decision-making. By requiring all new technologies to undergo a standardized evaluation process, Ecuador’s healthcare system can reduce the influence of external pressures and other vested interest [27]. The use of objective criteria, such as cost-effectiveness ratios, ensures that technology adoption decisions are based on evidence, improving trust and equity in the allocation of healthcare resources [28].

Research has shown that greater transparency in health technology assessments leads to better public trust and acceptance of healthcare policies. European countries that have adopted HTA frameworks have seen improvements in the public’s perception of healthcare decision-making due to the open and evidence-based processes used to evaluate new interventions [29].

Strengthening HTA Capacity

Another key implication is the institutionalization of HTA within Ecuador’s healthcare system. As seen in countries such as Brazil and Colombia, where HTA agencies have been instrumental in healthcare decision-making, and being a member of International Network of Agencies for Health Technology Assessment (INAHTA), Ecuador stands to benefit significantly from strengthening its HTA infrastructure [26]. The manual encourages the formal integration of economic evaluations into RPIS, thus fostering evidence-based policy decisions that consider both clinical effectiveness and efficiency [2].

However, gaps in capacity, such as the availability of trained professionals, data infrastructure, and funding for HTA, must be addressed to ensure the manual’s recommendations are effectively implemented. Specific efforts to enhance the technical capacity of health economists and decision analysts, along with investments in robust data collection systems and funding for HTA initiatives, will be critical for the sustainable elaboration of economic evaluations. Additionally, fostering collaboration with international bodies and regional HTA agencies can provide further support in capacity-building.

Strengths and Limitations

The manual provides a comprehensive approach to the integration of economic evaluations in health policy, offering valuable guidelines for decision-makers in Ecuador. Its emphasis on CEA and CUA, the use of QALYs, and a systematic approach to resource allocation represent strengths in ensuring that healthcare investments are guided by evidence and focused on achieving maximum health impact.

However, the manual does not fully address challenges related to the implementation of these evaluations, particularly in terms of existing gaps in human resources, data infrastructure, and funding. Additionally, the manual does not address indirect comparisons, which represents a significant methodological gap. Including guidelines for indirect comparisons would enhance the comprehensiveness of economic evaluations in Ecuador, particularly in contexts where direct head-to-head clinical trials between relevant comparators are unavailable. This is especially important in therapeutic areas such as oncology, rare diseases, and new high-cost technologies, where decision-makers increasingly rely on network meta-analyses (NMA) or other adjusted indirect comparisons to estimate relative effectiveness. International HTA agencies, including NICE in the UK and CADTH in Canada, have long recognized the role of indirect comparisons in supporting evidence-based decisions when direct evidence is limited or absent [36, 37].

Incorporating such approaches would enable more robust estimates of incremental effectiveness and cost-effectiveness, reduce uncertainty in economic evaluations, and strengthen the relevance of evidence for resource allocation decisions in Ecuador [38]. Further research and policy development will be needed to address these gaps and ensure that the manual’s strategies are fully realized. In future revisions, the manual could include more detailed recommendations on overcoming these challenges, as well as practical steps for establishing a sustainable HTA process in Ecuador.

Conclusions

The establishment of a standardized methodology for the development of economic evaluations, as outlined in the Manual for Economic Evaluations of Health Technologies, represents a major advancement in Ecuador’s healthcare decision-making processes. A key milestone has been the incorporation of cost-effectiveness criteria into the Regulation for the Authorization of the Acquisition and Use of Medicines Not Listed in the National Basic Medicines List, thereby strengthening COTIEM processes by ensuring that decisions regarding nonlisted medicines are grounded in economic value assessments. Furthermore, the availability of a standardized methodology paves the way for the National Essential Medicines List (CNMB) process to conduct more detailed cost-effectiveness analyses and to assign greater weight to efficiency, complementing its traditional focus on safety, efficacy, and convenience [10, 11].

By aligning with international best practices and implementing methodologies such as cost-effectiveness and cost–utility analyses, Ecuador is enhancing the transparency, efficiency, and sustainability of its healthcare system [2]. The manual also emphasizes the importance of adapting economic evaluations to local epidemiological and economic contexts, thereby ensuring that decision-making remains relevant and applicable to the country’s specific challenges [35].

In the broader global context, rising healthcare expenditures driven by technological innovation and demographic changes highlight the critical need to promote sustainable healthcare financing [35]. Ecuador’s commitment to the systematic use of economic evaluations positions the country to address future healthcare challenges more effectively. Sustained investment in institutional capacity, professional training, and the consistent application of internationally validated methodologies will be essential to ensure the long-term success of this initiative and to maintain alignment with global best practices [39].

Declarations

Funding

No funding was received for conducting this article.

Conflicts of Interest

The author has no relevant financial or nonfinancial interests to disclose.

Availability of Data and Material

The data supporting the findings of this study are publicly available. The methodology for conducting economic evaluations in Ecuador was based on the publicly accessible manual, which can be found at https://www.salud.gob.ec/manuales-metodologicos/. This manual was used as the primary source for the framework and guidelines applied in the study.

Ethics Approval

Not applicable.

Consent to Participate

Not applicable.

Consent for Publication

Not applicable.

Code Availability

Not applicable.

Author Contributions

Ricardo Yajamín-Villamarín: concept and design, acquisition of data, analysis and interpretation of data, drafting of the manuscript, critical revision of the paper for important intellectual content, administrative, technical, or logistic support, and supervision.