The Saudi Food and Drug Authority (SFDA) has released the final version of the “Economic Evaluations Studies Guideline (INS40043)”, establishing a comprehensive framework for the conduct, submission, and review of Economic Evaluation Studies (EES) for pharmaceutical (medicinal) products in Saudi Arabia.
The guideline aims to ensure that drug pricing and reimbursement decisions are supported by robust pharmacoeconomic evidence, focusing on cost-effectiveness, safety, and clinical value.
Key Highlights:
- Defines the types of economic evaluations accepted — Cost-Effectiveness (CEA), Cost-Utility (CUA), Cost-Benefit (CBA), and Cost-Minimization (CMA).
- Mandatory for innovative and biological products; optional for generics and biosimilars.
- Exemptions include OTCs, generics, and biosimilars with registered alternatives.
- Studies must adopt a healthcare payer perspective, using Saudi-specific cost and epidemiological data.
- Cost-effectiveness thresholds estimated between SAR 50,000–75,000 per QALY.
- Requires submission of epidemiological data, market plan, HTA evidence, and pharmacoeconomic forms.
This final version updates the earlier draft (July 2025) with clarified exemption criteria, minor editorial changes, and submission timelines.
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