Presentation (CTI)

OBJECTIVES: Chile faces significant financial challenges due to the rising costs of innovative therapies. Although the Ricarte Soto Law provides a dedicated fund for high-cost treatments, expanding coverage has outpaced budgets, causing variable access and fiscal pressure. With real-world effectiveness often uncertain post-trial, risk-sharing agreements (RSAs) offer a mechanism to balance cost containment and clinical uncertainty. We evaluate RSA feasibility by identifying key barriers, facilitators, and provide recommendations for decision-makers.
METHODS: International literature review was conducted together with a comprehensive assessment of Chile’s legal, regulatory, procurement, and HTA frameworks. In-depth interviews were conducted with key decision-makers and private institutions to identify principal barriers and enabling conditions in order to inform targeted policy recommendations to support the implementation of RSAs.
RESULTS: Stakeholder interviews and literature review revealed several key barriers to implementing RSAs in Chile: absence of a standardized negotiation framework; institutional inefficiencies; procurement and payment regulations that lack flexibility for extended or outcome-linked agreements; data gaps in epidemiology and patient registries; and mandatory public pricing disclosures. These factors impede the scalability of RSA models in high-need areas such as oncology and rare diseases. In terms of policy options, by systematically linking payment to measurable outcomes, RSAs can incentivize ongoing data collection and strengthen collaboration, enhancing health system resilience. A focused implementation of RSA pilots in areas with high unmet need can generate operational insights on aligning evidence generation, stakeholder incentives, and regulatory processes. These learnings will support the development of a flexible, evidence-driven reimbursement framework that balances clinical benefit with economic sustainability
CONCLUSIONS: Adopting RSAs in Chile could create a more responsive reimbursement environment by embedding risk-adjusted contracts into standard practice. RSAs enable continuous policy adjustments informed by emerging real-world data and promote collaborative decision-making among payers, providers, and manufacturers.