OBJECTIVES: Managed entry agreements (MEAs) are arrangements between manufacturers and healthcare payers/providers that facilitate the health technology assessment of innovative medicines, typically for oncology and rare diseases, that present financial and/or clinical uncertainties. MEAs aim to provide early access with broader coverage while minimizing the impact on healthcare budgets. MEAs are widely utilized, particularly in Central and Eastern Europe, with sporadic implementation in Asia (specifically South Korea and Taiwan), but not in Southeast Asia (SEA). This research aims to investigate the feasibility of implementing MEAs in SEA to enhance access to high-cost innovative medicines.

METHODS: Qualitative surveys were conducted with eight experts, comprising payers and policymakers from six countries, namely Italy, the UK, Australia, Hong Kong, Taiwan, and South Korea. Nine questions were administered to gain insights into the drivers and barriers encountered during the implementation of innovative funding models in their respective countries, along with recommendations for SEA. Common themes that could inform the implementation of MEAs in SEA were identified.

RESULTS: Key success factors for implementing MEAs in these countries included having strong political support, engaging relevant stakeholders, establishing robust data infrastructure, employing formal and comprehensive health technology assessment processes, ideally within a single-payer system. Experts emphasized the significance of formal appraisal mechanisms with clearly defined contractual terms, supplemented by additional alternative funding sources, to ensure the sustainability of access to high-cost drugs. Regarding the implementation of MEAs in SEA, experts suggested the following: 1) fostering intersectoral collaboration with stakeholder engagement and clear policy direction to cultivate expertise in MEAs, overcome bureaucratic hurdles, and address stakeholder capacity limitations; and 2) developing robust and standardized data infrastructure to enhance evidence generation for outcomes evaluation.

CONCLUSIONS: By leveraging global and regional experiences, SEA can explore MEAs as valuable tools to facilitate patient access to effective innovative medicines while maintaining adequate control over healthcare budgets.