GOVERNANCE AND PRIORITIZATION FRAMEWORKS FOR EQUITABLE ACCESS TO INNOVATIVE HEALTH TECHNOLOGIES IN THE MENA REGION: A CONSENSUS-DRIVEN APPROACH
Author(s)
Abdulrahman Aloumi, PhD1, Abdulrazak Aljazairy, PhD2, Ibrahim Alabbadi, MBA, RPh, PhD3, Ibrahim ElJabour, Sr., BSc, MSc4, Hugh McGuire, BSc, MSc5, Lina Wahba, PhD6, Jessica Davis, PhD7, Mohamed Farghaly, MD8, Mohamed Tannira, BSc, MSc9, Mahmoud M. Tolba, BSc, MSc10, Sahar Hassan, BSc, MSc11, Nadia Al Mazrouei, PhD12, Sahar Fahmy, PhD13, Samar Mansour, PhD9, Khalil Dashti, PhD14.
1Pricing Department, Pharmaceutical and Herbal Medicine Registration and Control Administration, Ministry of Health, Kuwait City, Kuwait, 2Clinical Trials Transformation Initiative Division, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia, 3Department of Biopharmaceutics and Clinical Pharmacy, The University of Jordan, Amman, Jordan, 4Pharmalink Drug Store & Medicina Group, Dubai, United Arab Emirates, 5National Institute of Health and Care Excellence, London, United Kingdom, 6Adult Oncology Unit and Pharmacy Department, Tawam Hospital, Abu Dhabi, United Arab Emirates, 7National Institute for Health and Care Excellence (NICE), London, United Kingdom, 8Dubai Medical College, Dubai, United Arab Emirates, 9ISPOR UAE Chapter, Dubai, United Arab Emirates, 10Health Evidence & HEOR Department, Stellar Consulting MEA, Dubai, Egypt, 11Health Evidence & HEOR Department, Stellar Consulting MEA, Dubai, United Arab Emirates, 12Department of Pharmacy Practice and Pharmacotherapeutics, College of Pharmacy, University of Sharjah, Sharjah, United Arab Emirates, 13Department of Health, Abu Dhabi, United Arab Emirates, 14Oncology and Hematology Drug Utilization Committee, Kuwait City, Kuwait.
1Pricing Department, Pharmaceutical and Herbal Medicine Registration and Control Administration, Ministry of Health, Kuwait City, Kuwait, 2Clinical Trials Transformation Initiative Division, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia, 3Department of Biopharmaceutics and Clinical Pharmacy, The University of Jordan, Amman, Jordan, 4Pharmalink Drug Store & Medicina Group, Dubai, United Arab Emirates, 5National Institute of Health and Care Excellence, London, United Kingdom, 6Adult Oncology Unit and Pharmacy Department, Tawam Hospital, Abu Dhabi, United Arab Emirates, 7National Institute for Health and Care Excellence (NICE), London, United Kingdom, 8Dubai Medical College, Dubai, United Arab Emirates, 9ISPOR UAE Chapter, Dubai, United Arab Emirates, 10Health Evidence & HEOR Department, Stellar Consulting MEA, Dubai, Egypt, 11Health Evidence & HEOR Department, Stellar Consulting MEA, Dubai, United Arab Emirates, 12Department of Pharmacy Practice and Pharmacotherapeutics, College of Pharmacy, University of Sharjah, Sharjah, United Arab Emirates, 13Department of Health, Abu Dhabi, United Arab Emirates, 14Oncology and Hematology Drug Utilization Committee, Kuwait City, Kuwait.
OBJECTIVES: This study aimed to evaluate the governance, ethical, evidentiary, and operational mechanisms required to ensure equitable access to the innovative technologies - including biologics, gene therapies, and
precision medicines - under evolving regulatory frameworks in the MENA region.
METHODS: A multidisciplinary expert panel, comprising 12 HTA specialists, clinicians, payer representatives, regulatory experts, and industry leaders was convened to identify regional priorities. A structured consensus methodology was employed via facilitated discussions and iterative review. Qualitative content analysis was used to synthesize findings into recommendations across five domains: governance, ethics, patient engagement, managed access, and data infrastructure. Consensus was predefined as ≥85% agreement.
RESULTS: The panel reached the following levels of consensus on strategic imperatives: Unified HTA Frameworks: Establishing a unified HTA body across hospitals, regions, and payers to reduce fragmentation 100% consensus. Evidence-Based Funding: Mandatory application of cost-effectiveness analysis and budget impact assessments prior to funding, with independent audits 95% consensus. Ethical Legitimacy: Prioritizing patient inclusion, public documentation, and defensible managed-access criteria 90% consensus. Data Infrastructure: Strengthening national disease registries, EMR integration, and cross-country data sharing 95% consensus. Benchmarking: Adopting international models (e.g., NICE) adapted to local realities 90% consensus.
CONCLUSIONS: Equitable access depends on centralized governance, transparent prioritization, patient representation, and digital monitoring. Economic evaluation must be paired with ethical safeguards and independent oversight to preserve legitimacy.
precision medicines - under evolving regulatory frameworks in the MENA region.
METHODS: A multidisciplinary expert panel, comprising 12 HTA specialists, clinicians, payer representatives, regulatory experts, and industry leaders was convened to identify regional priorities. A structured consensus methodology was employed via facilitated discussions and iterative review. Qualitative content analysis was used to synthesize findings into recommendations across five domains: governance, ethics, patient engagement, managed access, and data infrastructure. Consensus was predefined as ≥85% agreement.
RESULTS: The panel reached the following levels of consensus on strategic imperatives: Unified HTA Frameworks: Establishing a unified HTA body across hospitals, regions, and payers to reduce fragmentation 100% consensus. Evidence-Based Funding: Mandatory application of cost-effectiveness analysis and budget impact assessments prior to funding, with independent audits 95% consensus. Ethical Legitimacy: Prioritizing patient inclusion, public documentation, and defensible managed-access criteria 90% consensus. Data Infrastructure: Strengthening national disease registries, EMR integration, and cross-country data sharing 95% consensus. Benchmarking: Adopting international models (e.g., NICE) adapted to local realities 90% consensus.
CONCLUSIONS: Equitable access depends on centralized governance, transparent prioritization, patient representation, and digital monitoring. Economic evaluation must be paired with ethical safeguards and independent oversight to preserve legitimacy.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA7
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Systems & Structure
Disease
Genetic, Regenerative & Curative Therapies, No Additional Disease & Conditions/Specialized Treatment Areas