Understanding the Saudi Food & Drug Authority’s Guidelines for Economic Evaluation Studies: Key Recommendations for Pharmaceutical Companies 

Written by Johann Sanseáu, Senior Analyst

Saudi Arabia has been progressively integrating pharmacoeconomic evaluation methods into the decision-making processes concerning the pricing and reimbursement of novel health technologies. This has resulted in the recent publication by the Saudi Food & Drug Authority (SFDA) of guidelines for Economic Evaluation Studies (EES). The aim being to ensure that pharmaceutical products are evaluated effectively for their added value to the healthcare system. As these guidelines will become mandatory in the next year, it is crucial for manufacturers, marketing authorization holders, and agents involved in pricing and marketing pharmaceutical products in Saudi Arabia to be aware of, and plan for these requirements. This blog post will provide an overview of the SFDA guidelines and offer three essential recommendations for pharmaceutical companies to successfully navigate these regulations. 

Introduction to Economic Evaluation Studies 

EES are critical for assessing the value of pharmaceutical products by comparing alternative courses of action based on their costs and consequences. These evaluations help in decision-making processes regarding the adoption and utilization of new health technologies. The SFDA classifies EES into two main categories: 

1. 1. Partial Economic Studies: Analyze either cost or consequence independently, such as budget impact analysis (BIA) 

2. 2. Full Economic Studies: Compare difference interventions in terms of both costs and outcomes, including cost-effectiveness analysis (CEA), cost minimization analysis (CMA), cost utility analysis (CUA), and cost-benefit analysis (CBA) 

The guidelines are designed to standardize the methodology for performing, submitting, or publishing EES to ensure consistency and reliability in the evaluation process. 

General Requirements 

The guidelines detail the requirements for submitting EES, including epidemiological data, market share information, drug marketing plans, and access agreements. Key aspects include: 

• • Documenting disease prevalence, incidence, and the number of patients both globally and in Saudi Arabia 

• • Providing market share data for the product in Saudi Arabia and estimates for the next five years for new products 

• • Presenting a comprehensive drug marketing plan targeting specific healthcare segments within Saudi Arabia 

• • Detailing any access agreements, such as entry agreements, localization efforts, or patient support programs, to facilitate market entry and product distribution 

• • Documenting any published EES in addition to health technology assessment (HTA) summaries from any of the following agencies: the National Institute for Health and Care excellence (NICE), Institute for Clinical and Economic Review (ICER), Canadian Agency for Drugs and Technologies in Health (CADTH), Haute Autorité de santé (HAS), and the Pharmaceutical Benefits Advisory Committee (PBAC) 

Economic Evaluation Studies Requirements  

It is mandatory to provide at least one of the best-suited EES based on product type: 

Various information is required in each EES, of note is the current estimated cost-effectiveness threshold published in Saudi Arabia ranges between SAR 50,000 – 75,000 per quality-adjusted life year (QALY). However, consideration will be taken for specific products.  

Implementation Dates 

These changes to data requirements for HTA will be implemented in a phased process, with all requirements becoming mandatory by July 2025. 

Three Key Recommendations for Pharmaceutical Companies 

1. 1. Thorough preparation and documentation  

Pharmaceutical companies must ensure that all required data, including epidemiological statistics, market share projections, and detailed drug marketing plans, are meticulously documented and presented. For example: 

• • Gathering comprehensive data on local disease prevalence and patient demographics 

• • Providing accurate and detailed market share information 

• • Clearly outlining the drug marketing strategy, specifying the targeted healthcare segments and distribution channels 

2. 2. Strategic use of access agreements 

Access agreements can play a vital role in facilitating the market entry and acceptance of new pharmaceutical products in Saudi Arabia. Companies should: 

• • Develop and present clear entry agreements that outline how the product will be made accessible within the Saudi healthcare system 

• • Consider localization efforts and patient support programs to facilitate patient access 

• • Ensure compliance with all access agreement requirements and promptly notify the SFDA of any changes or updates 

3. 3. Rigorous economic evaluation studies 

Conducting comprehensive and accurate economic evaluation studies is crucial for demonstrating the value of pharmaceutical products to the healthcare system. Companies should: 

• • Utilize appropriate economic evaluation methods, such as CEA, CMA, CUE, or CBA, based on the product type and the evaluation’s objectives 

• • Ensure that all relevant costs and outcomes are included in the evaluation, with data sourced from the Saudi healthcare system whenever possible 

• • Perform sensitivity analyses to address uncertainties and present the results in a clear and standardized format 

Conclusion 

Despite the evolving HTA landscape, consideration should be given to prioritizing the Saudi market to enable patients with rare diseases to have sustainable access to new therapies.  Therefore, adhering to the SFDA’s guidelines for EES will be essential for pharmaceutical companies seeking to introduce new products into the Saudi market. By thoroughly preparing and documenting all required data, strategically utilizing access agreements, and conducting rigorous economic evaluations, companies can effectively demonstrate the value of their products and navigate the regulatory landscape successfully. These efforts will ultimately contribute to the improved health and well-being of the Saudi population, aligning with the SFDA’s mission to protect and promote public health through effective regulation and oversight. 

At Partners4Access, we are constantly monitoring policy changes to the market access landscape to continue to provide up-to-date strategies for our clients. For more information on how we can support your market access and pricing strategy, feel free to reach out to Partners4Access.  

For more detailed information, please refer to the full SFDA guidelines available here: https://www.sfda.gov.sa/sites/default/files/2024-07/EconomicEvaluationStudies.pdf