Table 2.

Decision rules for the definition of risk-sharing arrangements

Uncertainty type	Objectives	Proposed model
Uncertainty concerning health outcomes	Limit and share the risk over short-term, medium-term, and long-term health outcomes	PBRSA (e.g., PLRS or coverage with evidence development)
Uncertainty concerning financial outcomes	Limit and share the risk of unexpected growth of estimated BI due to variations in posology or treatment duration	CSA (e.g., price volume, budget and/or utilization capping) or conventional payment with simple discount based on clinical outcomes
	Limit and share the risk of unexpected growth of estimated BI due to unforeseen use extensions and the patient population	CSA (e.g., price volume, budget or/and utilization capping), conventional payment with simple discount based on clinical outcomes and/or access restriction concerning patient subgroups

BI budgetary impact, CSA cost-sharing arrangement, PLRS performance-linked reimbursement scheme, PBRSA performance-based risk-sharing arrangement