Developing a medical-device formulary for council of health insurance beneficiaries in Saudi Arabia: stakeholder challenges and policy recommendations.

Ensuring equitable access to dispensed-to-patient (DTP) medical devices is an important policy priority for health insurance systems. This mixed-method study examined stakeholder perspectives on barriers and policy priorities for developing a DTP medical-device formulary for health insurance beneficiaries in Saudi Arabia. An exploratory online survey was distributed to 58 purposively selected stakeholders, and 17 responded (29.3%). Survey findings were summarized descriptively as n/N (%) with 95% confidence intervals. A subsequent stakeholder consultation workshop with 42 stakeholders was used to explore survey themes and identify policy-relevant recommendations. Survey respondents identified several recurring barriers, including lack of standardized evaluation criteria for including new devices (15/17, 88.2%; 95% CI 65.7-96.7), lack of clarity on reimbursement policies (13/17, 76.5%; 95% CI 52.7-90.4), limited reimbursement coverage for certain devices (10/17, 58.8%; 95% CI 36.0-78.4), and fragmented coding and categorization systems. Qualitative findings highlighted the need for explicit eligibility criteria, transparent pricing, risk-based assessment pathways, and coding systems that support claims processing and post-market evidence generation. The findings support an evidence-informed, stakeholder-informed formulary process with clear governance, standardized assessment criteria, transparent reimbursement rules, and improved coding infrastructure. Given the small exploratory survey sample, the quantitative findings should be interpreted as preliminary and validated in larger stakeholder studies.