The Saudi Food and Drug Authority (SFDA) has released a comprehensive guideline for Economic Evaluation Studies (EES), introducing a standardized framework for evaluating pharmaceutical products’ economic and therapeutic value in Saudi Arabia. As healthcare budgets expand and the demand for cost-effective solutions increases, this new framework supports more informed decision-making for manufacturers and healthcare providers.
The SFDA now requires EES submission in the drug registration application. Also, in other types of submissions that require drug pricing, such as renewals, price appeals, and re-pricing requests.
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Understanding Economic Evaluation Studies (EES)
Economic Evaluation Studies are essential for assessing healthcare interventions’ costs and benefits. According to the SFDA guideline, EES compares various treatment options based on their financial impact and outcomes to evaluate a new product’s added value against existing standards. The SFDA categorizes EES into two main types:
- Partial Economic Studies – Focuses on independent cost or consequence analyses, such as Budget Impact Analysis (BIA), which evaluates the financial feasibility of a new intervention.
- Full Economic Studies – Known as Pharmacoeconomic Evaluation Studies (PES), this category assesses both costs and outcomes, including:
- Cost-Effectiveness Analysis (CEA)
- Cost-Minimization Analysis (CMA)
- Cost-Utility Analysis (CUA)
- Cost-Benefit Analysis (CBA)
Mandatory Requirements
The SFDA mandates that manufacturers and marketing authorization holders submit EES for innovative pharmaceutical products by July 2025. To facilitate evaluation, submissions must include detailed documentation on various factors, such as:
- Epidemiological Data: Information about disease prevalence, incidence, and targeted populations in Saudi Arabia.
- Market Share Projections: Current and anticipated market share for new products.
- Drug Marketing Plan: Detailed strategies for product distribution within Saudi healthcare sectors.
- Access Agreements: Agreements that ensure accessibility of medications, such as entry agreements, localization initiatives, and patient support programs.
- Health Technology Assessment (HTA): Information on comparable HTA decisions from agencies like NICE, CADTH, and others.
Economic Evaluation Methodology
The SFDA emphasizes using validated models tailored to the Saudi healthcare landscape to achieve accurate economic assessments. Cost assessments must reflect direct and indirect healthcare costs, including long-term care and productivity loss. When reporting results, SFDA recommends employing sensitivity analysis to address uncertainties in economic models, with graphical representations like cost-effectiveness acceptability curves and scatter plots enhancing clarity.
Implications for Manufacturers and Healthcare Providers
The SFDA guideline empowers manufacturers to present the economic value of their products transparently, assisting the SFDA in making informed pricing and reimbursement decisions. Healthcare providers will benefit from a clearer understanding of the cost-effectiveness of available treatments, promoting a more sustainable healthcare system that balances innovation with economic responsibility.
Implementation Timeline
Below is a summary table for application time for each data requirement:
Years | General Requirements | Economic Evaluation Requirements |
July– December 2024 | Voluntary | Voluntary |
January – June 2025 | Mandatory | Voluntary |
July 2025 | Mandatory | Mandatory |
How PharmaKnowl Can Help?
We develop the general requirements or complete economic evaluation studies (EES) for your product accurately and quickly. You may contact us to please your request or discuss further.
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