A strategic framework for synergizing managed entry agreement efforts to access pharmaceutical products in Saudi Arabia-results from a multi-stakeholder workshop.

Abstract

Background: Managed entry agreements (MEAs) between manufacturers and healthcare payers allow health systems to maximize patients' access to treatments while maintaining financial sustainability. However, to work efficiently, MEAs need to be integrated into a country's formal pricing, reimbursement, and market access processes. This study proposes a country-specific MEA framework for pharmaceutical products and sheds light on the key enablers of optimal implementation of MEAs in Saudi Arabia.

Methods: This mixed-methods study was conducted through secondary data collection derived from systematic literature search followed by a half-day multi-stakeholder workshop hosted in Riyadh, Saudi Arabia including representatives from different governmental, quasi-governmental, and private sectors, all of whom had a job role related to pharmaceutical pricing, reimbursement, and market access. A predefined and validated set of questions was used to guide the workshop discussion with props and prompts to elicit more insights on MEAs design and framework from the participants. The workshop discussion and interactions were digitally recorded to enable verbatim transcription, followed by a thematic analysis.

Results: Ten themes emerged from the workshop discussion with majority guided the framework design: (1) access to innovative medications; (2) stakeholder views about MEAs; (3) early dialogue; (4) prioritization of MEAs for pharmaceutical products; (5) the regulatory landscape; (6) designing a technical framework for MEAs; (7) innovative payment models; (8) health system governance; (9) challenges for successful implementation; and (10) stakeholder engagement.

Conclusions: In Saudi Arabia, MEAs are perceived as strategic levers to enable health system to navigate the access paradox, particularly for innovative and high-cost therapies. Nevertheless, having in place a robust Saudi-specific framework and anchored regulations and policies is essential to ensure that MEAs enhance-rather than compromise-access, sustainability, and equity. As therapies grow more complex, Saudi Arabia must adopt agile, evidence-adaptive MEAs policy and structure to remain fit for purpose.