Importance of Local Clinical Data in the Kingdom of Saudi Arabia

Viewpoints

Importance of Local Clinical Data in the Kingdom of Saudi Arabia

For many years, healthcare payers within Saudi Arabia primarily based their decision-making concerning coverage and reimbursement on clinical data, cost-effectiveness models, and established benchmarks from the United States (US) and the European Union (EU). This reliance was often a practical necessity due to a perceived lack of robust, locally generated evidence. However, the previous assumption that US/EU data offered a sufficiently accurate foundation for local policy is being critically re-evaluated.

The emerging consensus is that while data from these international sources can provide a useful approximation or theoretical starting point, it fails to capture the full truth of the local healthcare ecosystem. Payers are recognizing the imperative need to generate, prioritize, and utilize data specific to their own population and market to ensure equitable, effective, and financially sustainable healthcare decisions.

Genetic differences in the Saudi population:

The Middle East and particularly the Arab population possesses a unique genetic architecture shaped by distinct historical and cultural patterns. The Saudi population is characterized by a high degree of consanguinity (50-55%) increasing the probability of offspring inheriting identical copies of rare recessive genes. This leads to a higher prevalence of individuals lacking certain genes which can fundamentally lead to rare genetic disorders.¹

Most global clinical data is benchmarked against a European reference genome. Tayoun et. al (2025) captured the genetic variation in the Middle East highlighting 53% of high impact gene variants found in Middle Eastern individuals are absent from global databases like gnomAD. Marking a clear difference in the genetic expressions of patients in Middle East.²

This genetic gap is the key economic and clinical bottleneck for healthcare payers in Saudi Arabia. When global pharmaceutical companies submit data derived from largely US/EU populations, they are presenting a biological mismatch that often results in lower drug efficacy or higher adverse event rates for local patients.

Chronic Epidemics

Unique genetic expressions of the Middle East population are fueling a “silent epidemic” of chronic diseases that manifest differently than in the US/EU. Key examples of this variance are:

1. Early-Onset of Chronic Diseases: Average age of presentation of coronary artery disease (CAD) is one decade younger in the Saudi population relative to other patients worldwide.³ Saudi Arabia is in the top ten countries with the highest prevalence of diabetes (20-79 years) in the world.⁴
2. Burden of Hemoglobinopathies: Saudi Arabia has the highest burden of hemoglobinopathies, such as Sickle Cell Disease and Thalassemia compared to other gulf countries requiring lifelong, high-cost transfusion and chelation therapies.⁵

Studies indicate that certain drugs may require different doses due to influence of genetic variations drug metabolism and response in the Saudi population. The distinct genetic characteristics of the Saudi population requires customized methods for managing anticoagulant treatment.⁶

The disparity between the local population genome in the Middle East and that of the US/EU populations, combined with observed variances in drug efficacy and safety profiles, has become a critical consideration for healthcare payers in Saudi Arabia to re-evaluate their evidence requirements for market access and reimbursement decisions impacting how medications are tested and approved based on global clinical trials.

There is a distinct and growing preference to consider local clinical data as evidence required to demonstrate a drug’s efficacy and safety. This is particularly crucial in the domain of rare diseases, where genetic variation often plays an outsized role in disease presentation, progression, and therapeutic response.

The change is fueled by the need to ensure approved treatments are safe and optimized for the diverse Saudi patient population, rather than relying solely on global data. Here is a breakdown of how local data has become a non-negotiable requirement in Saudi Arabia:

1. Tailoring Efficacy to the Target Recipient:

The Saudi Food and Drug Authority (SFDA) draft of clinical considerations for efficacy and safety (2023) increasingly emphasizes the importance of local clinical data to move beyond “one-size-fits-all” global averages.⁷

Local data is essential to establish Pharmacokinetic (PK) and Pharmacodynamic (PD) parameters specifically for the Saudi population. Factors such as genetic variations, local comorbidities (e.g., high prevalence of diabetes), and even lifestyle/dietary habits can influence how a drug is metabolized.
By requiring data on the target recipient, the SFDA ensures that the dose-response relationship and safety profile are validated for the people actually living in the Kingdom, rather than relying solely on foreign demographics that may not react identically.

Several therapies for rare diseases have been registered but faced “reimbursement delays” by payers due to lack of sufficient and robust clinical data, uncertainties related to their real-world efficacy, and added value in local population.⁸

2. The Mandate for Local Cost-Effectiveness ⁹
With the implementation of the Economic Evaluation Studies (EES) Guidelines in July 2025, the “value” of a drug is now measured strictly through a local perception.

Payers now require local adaptation because global models often use cost structures (e.g., UK or US hospital costs) that don’t reflect the reality of the Saudi healthcare system.
Manufacturers must now provide data reflecting local epidemiological trends, Saudi-specific resource utilization, and local pricing. If a drug is “cost-effective” in Europe, payers will still demand proof that it provides a similar value-to-cost ratio within the Saudi budgetary framework.

3. Need for Local Clinical Trials:

While global clinical trials provide the scientific foundation for drug safety and efficacy, they under-represent the Middle Eastern genotype. Hence SFDA requires local trials to ensure a drug’s performance in the Saudi population. These local trails identify unique safety signals or efficacy plateaus that global trials might miss.

SFDA may also request for additional bridging studies (a supplementary trial to extrapolate existing foreign clinical data to a new population, minimizing the need to repeat full, large-scale studies) where needed.¹⁰

The Future Outlook

The transition from US/EU benchmarks to a “Saudi-first” data model is the signal of transforming into a new stepping stone for public safety. As the Kingdom of Saudi Arabia moves toward vision 2030, two key transformations will define the regional healthcare landscape:

1. Global R&D and Clinical Trials in the Region

With the SFDA reporting a staggering 83% growth in clinical trial applications for biotechnology products in 2025,¹¹ the Kingdom is becoming the primary destination for evidence hubs in the Middle East.

The Impact: We expect Saudi Arabia to emerge as the regional hub for Bridging Studies. Global pharmaceutical companies will increasingly view a Saudi-based clinical trial as the mandatory gateway for the Middle East region, using the local population as the gold standard reference genome for the Arab population.

2. Risk-Sharing through Outcome-Based Agreements (OBAs)

The implementation of the Economic Evaluation Studies (EES) Guidelines in July 2025 marks the transformative change into value-based healthcare.

The Shift: Payers are moving toward Outcome-Based Agreements (OBAs) shifting financial risk back to the manufacturer: the full price of a drug is only paid if it achieves predefined clinical milestones within the local Saudi population. This ensures that the high cost of innovation particularly in rare diseases is justified by real-world efficacy.

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