Conditional Agreements For Innovative Therapies In Italy: The Case Of Pirfenidone.

● In 2005, AIFA (Italian Drug Agency) implemented drug registries to ensure appropriate use of the treatment and enabling conditional agreements (i.e., risk-sharing) until the risk/benefit ratio of the drug is confirmed in clinical practice. ● Strong collaboration between AIFA, Clinicians, Hospital Pharmacists, Pharmacologists, Payers (Regional and Local) and pharmaceutical companies is needed through the Registries management (i.e., prescription, purchasing process, effectiveness evaluation) ● Registries permit to collect real world data to re-assess the clinical value in clinical practice (i.e., effectiveness) enabling a value-based pricing approach. ● For all stakeholders, registries represent an opportunity to work together in the light of partnership and sustainability. ● As an example of implementation of conditional agreement based on AIFA registries, we report the re-negotiation process of pirfenidone in the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF). ● Pirfenidone had its first reimbursement authorization in 2013 with a risk-sharing agreement (Success Fee) and drug inclusion in the AIFA Registry.