ESTABLISHING A MULTI-STAKEHOLDER CONSENSUS FRAMEWORK FOR INNOVATIVE MEDICAL DEVICE MARKET ACCESS AND HTA INTEGRATION IN THE MENA REGION
Author(s)
Mina Wadih, MSc, PharmD1, Abdulrazak Aljazairy, PhD2, Emily Woodward, PhD3, Guvenc Kockaya, MSc, PhD, MD4, Haider Shamsi, BSc, MSc5, Khalil Dashti, BSc, MSc6, Manal Alansari, BSc, MSc7, Mohammad Naser Fargaly, PhD8, Mohamed Tannira, BSc, MSc9, Mahmoud M. Tolba, BSc, MSc10, Murtada Alsaif, BSc, MSc11, Mutaz Ahmed, BSc, MSc12, Nadia Al Mazrouei, PhD13, Sahar Fahmy, PhD5, Sahar Hassan, BSc, MSc10, Samar Mansour, PhD9, Sara Mohibullah Al Balushi, III, BA14, Serhan Acar, BSc; MS15, Suha Al Lawati, BSc, MSc16, Inna Nadelwais, MBA, MSc, MD17.
1ISPOR Lebanon Chapter, Beirut, Lebanon, 2Clinical Trials Transformation Initiative Division, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia, 3Health Economics and Market Access EMEA Department, Boston Scientific, Dubai, United Arab Emirates, 4ECONiX Research, Tallinn, Estonia, 5Department of Health, Abu Dhabi, United Arab Emirates, 6Central Medical Stores, Kuwait City, Kuwait, 7Ministry of Health, Muscar, Oman, 8Dubai Medical College, Dubai, United Arab Emirates, 9ISPOR UAE Chapter, Dubai, United Arab Emirates, 10Health Evidence & HEOR Department, Stellar Consulting MEA, Dubai, United Arab Emirates, 11Boston Scientific, Riyadh, Saudi Arabia, 12M42 Health, Abu Dhabi, United Arab Emirates, 13Department of Pharmacy Practice and Pharmacotherapeutics, College of Pharmacy, University of Sharjah, Sharjah, United Arab Emirates, 14Pharmaceutical Care Department, Ministry of Health, Muscat, Oman, 15Boston Scientific, Istanbul, Turkey, 16Clinical Pharmacy & Clinical Audit Department, Ministry of Health, Muscat, Oman, 17MedTech Industry and Trade Association, Dubai, United Arab Emirates.
1ISPOR Lebanon Chapter, Beirut, Lebanon, 2Clinical Trials Transformation Initiative Division, King Faisal Specialist Hospital and Research Centre, Riyadh, Saudi Arabia, 3Health Economics and Market Access EMEA Department, Boston Scientific, Dubai, United Arab Emirates, 4ECONiX Research, Tallinn, Estonia, 5Department of Health, Abu Dhabi, United Arab Emirates, 6Central Medical Stores, Kuwait City, Kuwait, 7Ministry of Health, Muscar, Oman, 8Dubai Medical College, Dubai, United Arab Emirates, 9ISPOR UAE Chapter, Dubai, United Arab Emirates, 10Health Evidence & HEOR Department, Stellar Consulting MEA, Dubai, United Arab Emirates, 11Boston Scientific, Riyadh, Saudi Arabia, 12M42 Health, Abu Dhabi, United Arab Emirates, 13Department of Pharmacy Practice and Pharmacotherapeutics, College of Pharmacy, University of Sharjah, Sharjah, United Arab Emirates, 14Pharmaceutical Care Department, Ministry of Health, Muscat, Oman, 15Boston Scientific, Istanbul, Turkey, 16Clinical Pharmacy & Clinical Audit Department, Ministry of Health, Muscat, Oman, 17MedTech Industry and Trade Association, Dubai, United Arab Emirates.
OBJECTIVES: To identify key barriers to patient access for innovative medical devices and establish an expert-vetted policy framework integrating HTA and value-based reimbursement considerations.
METHODS: A multi-stage, mixed-methods consensus study was conducted during the ISPOR UAE 2026 Conference using a modified Nominal Group Technique. The expert panel included policymakers, payers, providers, industry representatives, and HTA experts. Discussions were structured around six domains: HTA, DRGs, private health insurance, reimbursement, digitization, and stakeholder collaboration. Quantitative polling and qualitative insights were synthesized through thematic analysis. Consensus was predefined as ≥80% agreement.
RESULTS: Private insurance stratification (≥80% agreement): Although baseline coverage has expanded across the region, access to innovative medical devices remains dependent on insurance benefit design. Stakeholder fragmentation (≥80% agreement): Suboptimal communication is a barrier to access, thus the need for stronger collaboration and locally relevant clinical and economic evidence informing coverage decisions. Medical billing obstacles (≥80% agreement): DRG systems, built on retrospective data, may create financial disincentives for hospitals, limiting the use of innovative technologies, despite value. Policy framework (≥80% agreement): Participants supported an integrated framework that includes device-specific HTA approaches, longitudinal outcome monitoring, flexible reimbursement pathways, value-based DRG considerations, and exploration of managed entry agreements.
CONCLUSIONS: Improving access to innovative medical devices in MENA requires localized HTA capacity, value-based reimbursement models, adaptive DRG frameworks, and stronger stakeholder collaboration. The proposed practical framework could support evidence-based adoption and sustainable patient access across the region.
METHODS: A multi-stage, mixed-methods consensus study was conducted during the ISPOR UAE 2026 Conference using a modified Nominal Group Technique. The expert panel included policymakers, payers, providers, industry representatives, and HTA experts. Discussions were structured around six domains: HTA, DRGs, private health insurance, reimbursement, digitization, and stakeholder collaboration. Quantitative polling and qualitative insights were synthesized through thematic analysis. Consensus was predefined as ≥80% agreement.
RESULTS: Private insurance stratification (≥80% agreement): Although baseline coverage has expanded across the region, access to innovative medical devices remains dependent on insurance benefit design. Stakeholder fragmentation (≥80% agreement): Suboptimal communication is a barrier to access, thus the need for stronger collaboration and locally relevant clinical and economic evidence informing coverage decisions. Medical billing obstacles (≥80% agreement): DRG systems, built on retrospective data, may create financial disincentives for hospitals, limiting the use of innovative technologies, despite value. Policy framework (≥80% agreement): Participants supported an integrated framework that includes device-specific HTA approaches, longitudinal outcome monitoring, flexible reimbursement pathways, value-based DRG considerations, and exploration of managed entry agreements.
CONCLUSIONS: Improving access to innovative medical devices in MENA requires localized HTA capacity, value-based reimbursement models, adaptive DRG frameworks, and stronger stakeholder collaboration. The proposed practical framework could support evidence-based adoption and sustainable patient access across the region.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
HTA148
Topic
Health Policy & Regulatory, Health Technology Assessment, Organizational Practices
Topic Subcategory
Decision & Deliberative Processes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas