Creating A Multi-Criteria Decision Analysis Tool to Enhance Value-Based Purchasing of Generic and Biosimilar Medications in Saudi Arabia: A Pilot Study.

Background: Saudi Arabia is reforming its healthcare system to promote the use of generic and biosimilar medications to improve spending efficiency. However, concerns regarding therapeutic equivalence persist. This study aims to establish a stakeholder-driven, value-based procurement framework for off-patent pharmaceuticals (OPPs). Methods: The Saudi chapter of the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) convened stakeholders to define procurement criteria. Participants reviewed 29 potential criteria during a workshop, followed by a multi-criteria decision analysis (MCDA) simple scoring exercise and conjoint analysis to determine the relative weight of essential factors. Results: Forty-nine stakeholders participated, primarily pharmacists (57%) and regulators (27%). Sixteen criteria were identified as important: published effectiveness data, drug delivery systems, bioequivalence, real-world data generation, drug stability, direct costs, supply track record, labeled indications, drug safety profile, quality assurance of production, interchangeability, contribution to national healthcare priorities, availability in reference countries, manufacturing site quality certification, pharmaceutical equivalence, and pharmacovigilance. Effectiveness data received the highest weight (11.56%), while pharmacovigilance received the lowest (3.23%). Conclusion: This pilot study establishes the first consensus-based MCDA criteria for Saudi Arabia, prioritizing effectiveness and drug stability over costs. It emphasizes scientific validity over price, serving as a foundation for a national value-based procurement system, though further research is needed to test the framework in healthcare tenders.