Economic evaluation guidelines in the Middle East and North Africa (MENA) region: a comparative analysis

The increasing cost of healthcare resource utilization and pharmaceuticals strongly affects healthcare systems worldwide. Therefore, health economics evaluations have become an essential strategy to inform a cost-effective decision for pharmaceutical and healthcare service delivery. Economic evaluation is conducted to compare two interventions based on their costs and health outcomes.^1,2 These analyses play an essential role in efficient and transparent health resource allocation.

To enhance the quality and comparability of economic evaluations, the Consolidated Health Economic Evaluation Reporting Standards (CHEERS) were established.^3,4 The 2022 update of CHEERS emphasizes transparency and broader applicability across diverse health interventions, including pharmaceuticals.³ These standards provide a common frameworkfor guide researchers and decision-makers alike.

The adaptation of economic evaluation across MENA region remains variable and heterogenous. Whereas some countries have made significant progress in establishing a health technology assessment (HTA), which depends on economic evaluations, other low-middle-income countries (LMICs) continue to face challenges, such as limited accessibility to data, a fragmented information system, and inadequate stakeholder awareness. These barriers may hinder the implementation of economics evaluations to inform policymaking.⁵

Global health authorities, such as the world health organization (WHO)⁶ and the International Society of Pharmacoeconomics and Outcomes Research (ISPOR),^7,8 have prioritized the importance and advancement of HTAs and economic evaluation in LMICs.

Platforms such as the Guide to Health Economic Analysis and Research (GEAR) support these priorities.⁹ Despite these efforts, significant limitations in establishing, implementing, and updating EEGs in these regions remain notable.⁸

MENA countries are at different phases of development and implementation of EEGs. Countries have adapted them from well-recognized frameworks or developed their own national guidelines. These countries are recognizing the value of integrating economic evidence into reimbursement decisions for optimal resource allocation.⁸

Given that economic evaluation guidelines are published periodically, this review is intended to identify existing published EEGs in the MENA region and to compare and assess these guidelines using the CHEERS criteria.⁴

METHODS

Study Design and Search Strategy

A systematic search was conducted to identify EEGs in MENA countries. Multiple sources for searching have been used till august 2025 to ensure comprehensive coverage of published guidelines in formally recognized repositories and additional guidelines in gray literature.

The ISPOR and the GEAR databases served as the primary sources for identifying EEGs.^10,11 The ISPOR database was systematically searched to identify any published EEG guidelines from MENA countries. Countries included in the MENA region search were Kuwait, Lebanon, Libya, Morocco, Oman, Palestine, Qatar, Saudi Arabia, Sudan, Syria, Tunisia, Turkey, the United Arab Emirates, Algeria, Bahrain, Egypt, Iran, Iraq, Israel, Jordan, and Yemen. Each country was individually searched for in the ISPOR database to identify published guidelines or HTA frameworks. The GEAR database was also explored to extract

relevant EEGs.¹¹This database offers a standardized comparative framework with 33 key features for each guideline, including type, policy objectives, analytical techniques, perspective, comparator choice, time horizon, cost considerations, modeling approaches, and sensitivity analysis requirements.

In addition, systematic searches were conducted in PubMed and Google Scholar using combinations of the following search terms: individual MENA country names and regional terms, such as “Middle East,” “North Africa,” “Arab countries,” and “Gulf Cooperation Council”; “pharmacoeconomic guidelines,” and “health economic evaluation guidelines.”

To complement the ISPOR and GEAR and PubMed search, a comprehensive gray literature search was conducted across multiple databases and sources. This search strategy was important given that some guidelines might be published in their local language and in official government websites or some specialized regional publications that are not indexed in global databases. Governmental authorities include ministries of health, health insurance organizations, and food and drug authorities.

Moreover, an inclusive search of regional organizations and publications was conducted, which included the regional office for the Eastern Mediterranean region under the WHO. Finally, regional experts in health economics and outcomes were contacted to identify additional or unpublished guidelines that may be part of the development process at the time of the search. Detailed search strategy in Supplementary 1.

Inclusion and Exclusion Criteria

EEGs were included if they were published by governmental authorities or regulatory bodies and focused on pharmaceutical, medical device, or medical technologies. Moreover, the guidelines should provide detailed methodologies for the economic evaluation assessment framework. Finally, the guidelines had to published since 2000 to ensure relevance. Excluded guidelines include academic papers not representing a governmental entity, preliminary documents, drafts without official endorsement, and old versions of newly published guidelines

Data Extraction and synthesis

A standardized data extraction form was developed using Excel sheets. Extracted data was organized into two sections, the overall characteristics of EEGs (guideline title, organization, publication year, implementation status and timeline) and the required items based on the CHEERS 2013 checklist.⁴

CHEERS consists of a 24-item checklist for reporting health economic evaluations, which includes title, abstract, background, methods (target, population, setting, perspective, comparators, time horizon, discount rate, choice of health outcomes, measurement of effectiveness, measurement and valuation of preference, estimating resources and costs, currency, price date, conversion, choice of model, assumptions, and analytical methods). The results section includes study parameters, incremental costs and outcomes, characterizations of uncertainty, and characterizations of heterogeneity. The discussion section includes study findings, limitations, and generalizability. Final remarks include funding sources and conflicts of interest.

The results were synthesized using narrative and tabular approaches. Comparison tables for each guideline based on characteristics and CHEERs items were developed to present key features of each identified EEG. For the narrative format, three domains were discussed in the results: cost, effectiveness, and modeling domains.

RESULTS

Overview of Guideline Development and Implementation Status

A total of four EEGs were retrieved and were published in Lebanon,¹² Saudi Arabia,¹³ Tunisia,¹⁴ and Egypt¹⁵ (Table 1). Among these, the Egyptian guideline is relatively outdated, having been published in 2013,¹⁵ whereas the remaining three are more recent, with publication years of 2021,¹⁴ 2024,¹³ and 2025,¹² respectively.

Each EEG was developed by a different organization, The Saudi EEG was published by the Saudi Food and Drug Authority,¹³ the Tunisian EEG was published by Tunisia’s National Authority for Health Evaluation and Accreditation (Instance Nationale de l’Évaluation et del’Accréditation en Santé),¹⁴ and the Egyptian EEG was published by the Pharmacoeconomic unit in the Ministry of Health and Population (MOHP).¹⁵ Finally, the Lebanese EEG was developed through collaboration among multiple institutions.¹²

In terms of implementation status, in the Saudi EEG, phased implementation was undertaken according to specific dates and types of requirements as follows: from July to December 2024, it was voluntary for general requirements and economic evaluation requirements; from January to June 2025, it was mandatory for general requirements and remains voluntary for economic evaluation requirements; and starting July 2025, it was mandatory for both requirements.¹³ For the Tunisian EEG, it was a mandatory guideline since publication and fully implemented.¹⁴ The Egyptian MOHP’s guideline is recommended (nonmandatory).¹⁵ The Lebanese EEG is under development and not currently implemented; however, it is mandatory.¹²

Comparative analysis

Based on the CHEERs 24-item checklist, all EEGs included required reporting of the title; an abstract section; an introduction section; and other sections, including the source of funding and conflict of interest. A detailed comparison of remaining items is presented below as domains for cost, outcomes, and modeling.

Cost Domain

The analysis of cost-related requirements revealed discrepancy across the four EEGs.Lebanon prefers a societal perspective as the primary viewpoint.¹² Saudi Arabia demonstrated a differentiated approach to cost perspectives, explicitly requiring a healthcare payer perspective while encouraging a societal perspective for broader economic impact assessment.¹³ This inclusive approach aligns with the Tunisian approach, which mandates the public payer perspective through the National Health Insurance Fund and public healthcare structures as the primary perspective. The societal perspective can be used as a supplementary analysis.¹⁴

Egypt embraced a more adaptable approach, emphasizing the healthcare payer perspective while maintaining flexibility to include additional costs if data accessibility is feasible.¹⁵ Setting and location was not mentioned in all EEGs.

Regarding cost categories and data requirements, the Saudi Arabia guidelines require direct healthcare costs while encouraging inclusion of long-term care, intangible costs, and productivity loss costs if the societal perspective is used. The methods used to calculat productivity loss are required. The guidelines also require cost presentation in Saudi riyals and US dollars, allowing for regional and international comparisons.¹³

Tunisia follows a similar approach in terms of cost inclusions; however, the Tunisian dinar (TND) is used to present costs. Explicit requirements for local cost data are required to ensure national-context relevance.¹⁴

Egypt demonstrated balanced flexibility by requiring direct medical costs as the minimum standard while permitting indirect costs and other types of costs if the data are available. Cost data are presented in Egyptian pounds.¹⁵

Lebanon uses the Lebanese national reference prices for costing. The reference cost index includes indices for drugs, devices, and hospitalization. If these indices are not available, either a top-down or a bottom-up costing approach is used. The Lebanese EEG requires reporting of the price year, currency used, and year of conversion.¹² Discounting for costs was required in the four EEGs with different rates: 3% in the Lebanon EEG,¹² 3-5% in the Saudi EEG,¹³ 5% in the Tunisia EEG,¹⁴ and 3.5% in the Egyptian EEG.¹⁵ Additional details in supplementary 2.

Effectiveness Domain

The Saudi Arabian EEG includes natural units as outcomes for cost-effectiveness analysis and the QALY (quality-adjusted life year) for cost-utility analysis¹³ whereas in the Tunisian guidelines, the prefer life years and QALY, other outcomes must be justified.¹⁴ Lebanon prefers QALY as the primary outcome. Other outcomes presented in natural units can be added when important.¹² Finally, the Egyptian guidelines favor generic, disease-specific, or preference-based health-related quality of life (HRQOL) measures.¹⁵ As for the source of the effectiveness data, Saudi Arabia required the most extensive evidence requirements, preferring randomized controlled trials (RCTs), real-world evidence, and network meta-analyses.¹³ The Tunisian EEG requires systematic reviews and the best available effectiveness data.¹⁴ Lebanon’s EEG stated a preference for systematic reviews and meta-analyses¹² whereas meta-analyses of RCTs were the preferred source of evidence in the Egyptian EEG.¹⁵

Regarding measurement and valuation of preferences, for the Lebanon EEG, EQ-5D-5L is the preferred measure, and the SF-6Dv1 is preferred for Lebanon or international sets.¹² Egypt recommends the use of the EQ-5D or SF-6D.¹⁵ Generic preference-based measures were recommended in the Tunisian EEG¹⁴ whereas the Saudi HHG, a specification for a utility measure, was not clearly mentioned.¹³

Modelling Domain

The Saudi Arabian EEG demonstrates the need for justifying the model selection and encouraged model validation. It also requires parameterization of global models to meet local requirements when no local economic model exists.¹³

Meanwhile, the Tunisian EEG recommends using a recognized model in the disease area, preferably published or assessed by HTA institutions. Various types of model validation are also required.¹⁴ The Lebanese EEG encourages using the modeling approach when clinical studies are not sufficient to cover the time horizon. In addition, the guideline do not specify particular modeling approaches but require that models should be appropriate for the research question. Model validation and transparency are also required.¹²

Egypt’s EEG requires the use of decision trees and Markov modeling techniques reflecting the real practice. External and internal validation is needed.¹⁵

In the sensitivity analysis domain, the Saudi Arabian EEG established a comprehensive uncertainty analysis requirement, mandating probabilistic sensitivity analyses (PSAs) with an illustration of the cost-effectiveness plane and cost-effectiveness acceptability curves. One-way sensitivity analysis and scenario analysis are preferred if feasible. Budget impact analysis should be presented in separate tables.¹³ The Tunisian and Lebanese EEGs mandate deterministic analyses and PSAs^12,14

The Egyptian EEG requires deterministic sensitivity analysis while making PSA optional due to interpretation difficulties for decision-makers.¹⁵

Regarding the time horizon, the Saudi Arabia EEG showed flexibility, specifying 2-5 years for cost minimization analysis or lifetime for cost-utility and cost-effective analysis.¹³ The Egyptian, Lebanese, and Tunisian EEGs require a time horizon sufficient to capture outcomes and costs incurred for a given disease.^12,14,15 All guidelines emphasize the importance of equirty and generalizability to the local context. Finally, only the Saudi Arabia and Tunisia EEGs require funding and conflict of interest disclosures.^13,14

These findings suggest that although all the guidelines demonstrate alignment with

international standards and the CHEERS checklist, some domains were more extensively detailed than others, such as uncertainty, sensitivity, and presentation of economic evaluation results, favoring the Saudi EEG. Other items, such as the valuation of utilities, were limited in all guidelines, especially in Saudi Arabia’s.

DISCUSSION

The EEGs from Saudi Arabia, Tunisia, Egypt, and Lebanon demonstrate varying degrees of alignment with CHEERS. This misalignment either comes from not reporting the element at all or reporting with minimal description.

The time frame for developing EEGs in the MENA region reflects the global interest in health technology assessment, for which economic evaluation is part of this process. According to a systematic review by Sharma et al., 74% of EEGs were published after 2010, with updated version published years afterward.¹⁶ The development of EEGs in the region started a few years later, in 2015, in Egypt, followed by Tunisia, Saudi Arabia, and finally Lebanon.

There is distinction in implementation status (mandatory versus recommendary) directly affects guideline uptake: mandatory approaches standardize decision-making, phased implementation allows gradual capacity building, and recommendatory approaches improve feasibility at the cost of heterogeneity.¹⁶

Guideline implementability depends critically on alignment between guideline specifications and organizational capacity, including available resources, expertise, and data infrastructure.

Our findings suggest that optimal guideline development should establish mandatory requirements for core methodological elements (discount rate, perspective) while allowing flexibility in implementation details—balancing standardization with contextual feasibility and improving guideline uptake and HTA decision-making quality across the region.¹⁷

According to Sharma et al., approximately 31% of national guidelines are mandatory, 42% are recommended, and 16% are voluntary.¹⁶ The mandatory guidelines are usually published by governmental authorities, reflecting the governmental support for using economic evaluation in decision-making.

The EEGs in the MENA region demonstrate adherence to CHEERS guidelines regarding preferred analytical methods. All four EEGs emphasize that cost-effectiveness analysis and cost utility analysis are the preferred analytical methods. This was consistent with global practice, in which most international and regional EEGs recommend these analytical approaches.¹⁶ In Saudi Arabia and Egypt, cost minimization analysis was also listed as a potential approach for generics and biosimilars, allowing for more flexible and inclusive approaches to most product types.

Regarding the outcome measures, QALY is widely recognized as the preferred outcome measure in EEGs. According to Sharma et al., 39% of global guidelines specify QALY as the solely preferred health outcome measure.¹⁶

However, in the MENA EEGs, QALYs were combined with either natural unit or life years gained. The inclusive approach is also admired. A national representative tariff value set for utility valuations is still immature in the MENA region; a recent systematic review showed that only Tunisia and Egypt have a national representative tariff for utility valuation. Most countries in the MENA region were using national tariffs from the UK, the US, and other countries, which significantly affect the calculation of QALYs¹⁸

The perspective recommendations in the MENA EEGs reveal interesting patterns when compared to international practice. Globally, 48% of national guidelines recommend the payer perspective, and 26% recommend the societal perspective for primary analysis.¹⁶

Our EEGs reveal mixed approaches: Saudi Arabia’s and Egypt’s accept both perspectives, depending on the research questions,^13,15 whereas Tunisia’s focuses on the public payer perspective (CNAM and SSP),¹⁴ with the societal perspective as supplementary analysis. In Lebanon, the preferred perspective is the social perspective.¹² This aligns with the global trend of 26% of countries recommending a societal perspective.¹⁶

Although the societal perspective gives a comprehensive view of an intervention’s impact on all types of costs, calculating indirect costs is widely recognized as one of the challenging areas in health economics,¹⁶ and the MENA region faces similar challenges. Given these limitations, allowing for the payer perspective seems reasonable for the time being.

Globally, discount rates vary considerably among national guidelines, reflecting differing economic contexts and policy preferences.¹⁶

In this study, the EEGs demonstrate alignment with and deviation from international standards. Saudi Arabia’s 3-5% range and Egypt’s 3.5% rate align closely with common international practice^13,15 whereas Tunisia’s 5% rate represents the higher end of typical ranges.¹⁴ In all MENA EEGs, the time horizon emphasizes capturing all relevant costs and effects by applying a lifetime horizon to avoid incurred costs and change in outcomes, especially for diseases with a chronic nature.¹⁶ In the Saudi EEGs, a time horizon of 2.5 years was specially assigned to cost minimization analysis.

A systematic review published in 2021 concerned the status of EEGs in LMICs.⁸ In that review, only Egyptian EEGs were published; this demonstrates great growth and awareness in MENA countries to advance in this field.

One fact worth noting is that Saudi Arabia’s EEG explicitly states a cost-effectiveness threshold of SAR 50,000-75,000 per QALY. According to Daccache et al., few LMIC EEGs (6 out of 13) specify explicit thresholds.⁸

The modeling requirements across the MENA EEGs show varying levels of complexity. The Saudi and Tunisian EEGs detailed modeling specifications, including validation requirements and parameterization guidance, and approach the comprehensiveness found in established international guidelines^13,14 whereas Egypt’s emphasis on model simplicity and understandability demonstrates practical consideration for decision-maker capacity.¹⁵ It was likely a reasonable approach at the date of publication, 2013, for the experts’ knowledge and readiness were limited. The same concept applies to the uncertainty: whereas Saudi Arabia and Tunisia mandate a PSA,^13,14 the Egyptian guidelines require a deterministic sensitivity analysis, and the PSA was optional.¹⁵ This was also due to the limited number of experts and decision-makers’ limited awareness at the time.

One of the additional features not required by CHEERS but worth mentioning is the development of standardized submission formats, particularly in Saudi Arabia’s and Tunisia’s comprehensive forms, which reflects understanding of the importance of consistent evaluation processes.^13,14 This standardization facilitates quality assurance and capacity building in the respective countries.

The emphasis on local cost and outcomes data requirements across all EEGs highlights the critical need for health economics research infrastructure development in the region.^19,20 Investment in unified electronic medical records, for example, will enhance future economic evaluations’ relevance and applicability.

A critical limitation in conducting comparative research on economic evaluation guidelines is these documents’ accessibility and long-term availability. EEG guidelines are typically published by governmental bodies, regulatory agencies, or national health authorities, and their availability is subject to several challenges that can significantly impact research reproducibility and knowledge continuity. Efforts in establishing an international repository to archive these EEGs allows for research reproducibility and evaluation of the guidelines over years, also allowing researchers to observe changes and providing equitable access to information.

CONCLUSIONS

In all, the MENA region’s EEGs collectively represent a significant advancement in regional HTA capacity, demonstrating international alignment and local adaptation. The variation in implementation approaches (mandatory versus recommendatory) and methodological sophistication reflects various stages of the HTA system’s maturation, providing valuable lessons for other developing regions.

Funding

The study was not funded.

Authorship contributions

Saja H. Almazrou: Conceptualization and writing – original draft. Huda T. Alshahrani: Data and information extraction. Wafi A. Alshahrani: Data and information extraction. Ziyad S. Almalki: Writing – review & editing. Shiekha S. Alaujan: Writing – review & editing.

Disclosure of interest

The authors completed the ICMJE Disclosure of Interest Form (available upon request from the corresponding author) and disclose no relevant interests.

Additional material

Additional material is available as an Online Supplementary Document.

Correspondence to:

Saja H. Almazrou
Department of Clinical Pharmacy, College of Pharmacy, King Saud University.
Riyadh, Saudi Arabia
salmazrou@ksu.edu.sa