PCN265 - Timeline of Authorization and Reimbursement for Oncological Drugs in Italy: An Integrated Analysis, Across Legislation’s Leverage

Abstract

Italian reimbursement process is regulated by dense legislation. In this scenario the 537/93 law, the 189/2012 law and 648/96 law.We assessed final timeline needed to gain the reimbursed status for oncological drugs, passing over the application of mentioned laws. We assessed how these regulations interact each other, fostering or disfavouring the reimbursement process, considering various factors: orphan designation, route of administration, use of monitoring registries and MEAs applied. We reviewed oncological drugs list published by CR from January 2013 to December 2015 (CHMP date). These data interpolated with data from Italian authorization decrees OG, and with data from Monitoring Registries. Out of 35 oncological drugs authorized by CHMP in selected years and afterward valuated by AIFA, only 20 (57%) have obtained the reimbursement in Italy, in a medium time of 502 days. Most of the reimbursed drugs are protein kinase inhibitors (8; 20%) and monoclonal antibodies (6; 30%), with a different timeline to obtain reimbursement status (555 days and 372 days, respectively). The access, the evaluation and the non-request of compassionate use have influenced the time. Furthermore, drugs’ monitoring agreements, related to monitoring registries (18; 52%), conducted to a more pulverized scenario. Not ever, orphan designated drugs (12; 35%) achieved a faster access. Additional analyses provide data about the role of administration route and an intramoenia use. This analysis shows the importance of the Italian legislation in the authorization and reimbursement pathway, to ensure the market access to oncological drugs. This process ensure an expenditure monitoring of NHS, to collect additional effectiveness clinical data and to guarantee use of the right drug for the right patient.