HPR10 A strategic national framework for managed entry agreements to access innovative and breakthrough medications in Saudi Arabia

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.