Presentation (CTI)

OBJECTIVES: Risk-sharing agreements (RSAs) are being used globally to help facilitate the reimbursement of high-cost drugs, particularly orphan drugs. This analysis considers the evolution of RSAs for orphan drugs around the world over the last decade based on the number of agreements made, geographic distribution, and agreement type.
METHODS: All available RSAs between 2015 and 2024 were identified from GlobalData’s Risk Sharing Database. To evaluate the five-year growth rate by market for orphan drug related RSAs, the dataset was divided into two timeframes: arrangements made from 2015-2018 and 2019-2024.
RESULTS: Between 2015-2024, the highest RSA activity was in the UK (812), followed by Australia (145). Orphan drug RSAs accounted for 62% and 59% of the arrangements in these two markets, respectively. Across all drug types, 90% of agreements made were finance-based, with only 10% performance-based. For orphan drugs specifically, performance-based RSAs were higher at 13%, while 87% of RSAs were finance-based. In 2019-2024, orphan drug related RSAs surged in Ireland (450%), followed by Australia (205%) and the UK (44%), compared to 2015-2018. In contrast, Sweden and the Netherlands experienced declines of 83% and 63%, respectively. Asian markets, in particular China and South Korea, demonstrated increased interest in RSAs and have signed their first orphan drug related RSAs in the last decade.
CONCLUSIONS: RSA activity remains high in established markets such as the UK and Australia. The higher proportion of performance-based RSAs for orphan drugs reflects the need for outcome-based models to address the clinical and economic uncertainty. Ireland demonstrated growth in the last decade, establishing itself as an evolving market. The entry of Asian markets suggests a shift in their stance towards RSAs, particularly for orphan drugs, thereby improving access. However, declines in some European markets may reflect concerns around the financial sustainability of RSAs.