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

Yazed Alruthia,1,2 Horiyah Alhajri,1 Omar A Almohammed,1 Bander Balkhi,1 Mai F Alsaqa’aby,2 Mohammed A Almuqbil,3– 5 Hana A Al-Abdulkarim,6 Abdulaali R Almutairi7 1Department of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia; 2Saudi Society of Pharmacoeconomics and Outcomes Research (PEOR), Riyadh, Saudi Arabia; 3College of Medicine, King Saud bin Abdulaziz University for Health Sciences (KSAU-HS), Riyadh, Saudi Arabia; 4King Abdullah International Medical Research Center (KAIMRC), Ministry of National Guard, Riyadh, Saudi Arabia; 5Division of Pediatric Neurology, Department of Pediatrics, King Abdullah Specialist Children’s Hospital (KASCH), National Guard Health Affairs (NGHA), Riyadh, Saudi Arabia; 6King Abdullah International Medical Research Center (KAIMRC), Ministry of National Guard Health Affairs, Riyadh, Saudi Arabia; 7Graduate School, Alfaisal University, Riyadh, Saudi ArabiaCorrespondence: Yazed Alruthia, Department of Clinical Pharmacy, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia, Tel +96-611-4677483, Fax +96 611-4677480, Email [email protected]: 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.Keywords: Saudi Arabia, generic drugs, biosimilars, multicriteria decision analysis, MCDA simple scoring, value-based purchasing, off-patent pharmaceuticals