A Strategic National Framework for Managed Entry Agreements to Access Innovative and Breakthrough Medications in Saudi Arabia
Author(s)
Hussain Abdulrahman Al-Omar, MSc, PhD1, Asma Abdulaziz Al-Muhsin, MSc, PharmD2, Lolwa Almudaiyan, MSc3, AMAL Hassan AL-NAJJAR, DPhil3, Laila Carolina Abu Esba, MSc4, Hind Almodaimegh, BSc, PharmD5, ESRAA ALTAWIL, MSc6, Consuela Yousef, BSc7, MANSOOR KHAN8, Khalid AlYahya, PhD9, Jehan Alamre, PhD10, Fatma Maraiki, MSc, PharmD11, Bernadette Poellinger, PhD12, Ghadah Albassam, MSc, PharmD13, Jaime Espin, MSc, PhD14, Rosanna Tarricone, PhD15, Panos Kanavos, BSc, MSc, PhD16.
1College of Pharmacy, King Saud University, Riyadh, Saudi Arabia, 2Ministry of Health, Riyadh, Saudi Arabia, 3Center for Health Technology Assessment, Riyadh, Saudi Arabia, 4King Abdulaziz Medical City, Ministry of National Guard, Health Affairs, Riyadh, Saudi Arabia, 5Ministry of National Guard – Health Affairs, Riyadh, Saudi Arabia, 6Corporate Pharmacy Service, King Saud University Medical City, Riyadh, Saudi Arabia, 7Ministry of National Guard – Health affairs, Dammam, Saudi Arabia, 8National Guard Hospital, Jeddah, Saudi Arabia, 9Department of Pharmaceutical Service, Prince Sultan Military Medical City, Riyadh, Saudi Arabia, 10Drug Policy and Economic Center, King Abdulaziz Medical City, Riyadh, Saudi Arabia, 11Alfaisal University, Riyadh, Saudi Arabia, 12MSD, München, Germany, 13MSD KSA GmbH, Riyadh, Saudi Arabia, 14EASP, Granada, Spain, 15Bocconi University, ROMA, Italy, 16London School of Economics and Political Science, London, United Kingdom.
1College of Pharmacy, King Saud University, Riyadh, Saudi Arabia, 2Ministry of Health, Riyadh, Saudi Arabia, 3Center for Health Technology Assessment, Riyadh, Saudi Arabia, 4King Abdulaziz Medical City, Ministry of National Guard, Health Affairs, Riyadh, Saudi Arabia, 5Ministry of National Guard – Health Affairs, Riyadh, Saudi Arabia, 6Corporate Pharmacy Service, King Saud University Medical City, Riyadh, Saudi Arabia, 7Ministry of National Guard – Health affairs, Dammam, Saudi Arabia, 8National Guard Hospital, Jeddah, Saudi Arabia, 9Department of Pharmaceutical Service, Prince Sultan Military Medical City, Riyadh, Saudi Arabia, 10Drug Policy and Economic Center, King Abdulaziz Medical City, Riyadh, Saudi Arabia, 11Alfaisal University, Riyadh, Saudi Arabia, 12MSD, München, Germany, 13MSD KSA GmbH, Riyadh, Saudi Arabia, 14EASP, Granada, Spain, 15Bocconi University, ROMA, Italy, 16London School of Economics and Political Science, London, United Kingdom.
OBJECTIVES: Recently, there has been increased interest in adopting managed entry agreements (MEAs) as a tool to overcome access paradoxes for innovative and breakthrough therapies. However, efficient implementation requires integrating MEAs into a country’s formal pricing, reimbursement, and market access policies. This research proposes a national MEA framework for innovative and breakthrough therapies and identifies strategic enablers for optimal MEAs implementation in Saudi Arabia.
METHODS: A half-day multi-stakeholder workshop was convened in Riyadh, Saudi Arabia, with official representatives from governmental, semi-governmental, and private sectors (including pharmaceutical manufacturers), all holding roles in pharmaceutical pricing, reimbursement, or market access. A predefined and validated set of questions was used to guide the discussion, supplemented by follow-up props and prompts to elicit more insights from the participants. Thematic analysis was applied to identify strategic enablers for MEAs implementation and to inform the framework design.
RESULTS: Ten themes emerged from the analysis, crucially informing the framework design. These themes included: access to innovative medications; stakeholder views about MEAs; early dialogue; prioritization of MEAs for pharmaceutical products; the regulatory landscape; designing a technical framework for MEAs; innovative pharmaceutical payment models; health system governance; challenges for successful implementation; and stakeholder engagement. Two models were developed under the national framework, namely a price reduction model and an uncertainty mitigation model.
CONCLUSIONS: MEAs are considered strategic levers that enable Saudi Arabia’s health system to overcome access paradoxes for innovative and breakthrough therapies, including advanced therapeutic medicinal products and oncology medications; workshop participants prioritized these therapies for outcome-based agreements. While more complex innovative and breakthrough medications emerge, adopting agile and evidence-adaptive MEAs is essential to remain fit-for-purpose and maintain health system sustainability in Saudi Arabia.
METHODS: A half-day multi-stakeholder workshop was convened in Riyadh, Saudi Arabia, with official representatives from governmental, semi-governmental, and private sectors (including pharmaceutical manufacturers), all holding roles in pharmaceutical pricing, reimbursement, or market access. A predefined and validated set of questions was used to guide the discussion, supplemented by follow-up props and prompts to elicit more insights from the participants. Thematic analysis was applied to identify strategic enablers for MEAs implementation and to inform the framework design.
RESULTS: Ten themes emerged from the analysis, crucially informing the framework design. These themes included: access to innovative medications; stakeholder views about MEAs; early dialogue; prioritization of MEAs for pharmaceutical products; the regulatory landscape; designing a technical framework for MEAs; innovative pharmaceutical payment models; health system governance; challenges for successful implementation; and stakeholder engagement. Two models were developed under the national framework, namely a price reduction model and an uncertainty mitigation model.
CONCLUSIONS: MEAs are considered strategic levers that enable Saudi Arabia’s health system to overcome access paradoxes for innovative and breakthrough therapies, including advanced therapeutic medicinal products and oncology medications; workshop participants prioritized these therapies for outcome-based agreements. While more complex innovative and breakthrough medications emerge, adopting agile and evidence-adaptive MEAs is essential to remain fit-for-purpose and maintain health system sustainability in Saudi Arabia.
Conference/Value in Health Info
2025-11, ISPOR Europe 2025, Glasgow, Scotland
Value in Health, Volume 28, Issue S2
Code
HPR10
Topic
Health Policy & Regulatory, Health Technology Assessment
Topic Subcategory
Coverage with Evidence Development & Adaptive Pathways, Reimbursement & Access Policy, Risk-sharing Approaches
Disease
Oncology, Rare & Orphan Diseases