Drug Commercialization Before The Pricing And Reimbursement In Italy: The Non Negotiated C Class (C-NN)

Abstract

Since 2012, all drugs receiving Marketing Authorization have been firstly included in the non-negotiated (C-nn) class, waiting for the decision on the reimbursement status by the Italian Medicine Agency (AIFA). Before Pricing & Reimbursement (P&R) resolution, Regions are nonetheless autonomous to allow the commercialization of these drugs, even without the reimbursement of the National Healthcare System. The research aims to understand the purchasing behavior of Italian Regions on the C-nn class, considering policies, therapeutic areas and trends. A desk research gathered national and regional C-nn policies. Twenty-seven drugs registered in C-nn class from 2013 to 2016, were considered. Ten of them resulted commercialized before the P&R negotiation. Drugs in scope belonged to different therapeutic areas and categories. Information on first regional dispensation date were extracted from a QuintilesIMS Hospital database, which gathers data on hospital and local healthcare unit distribution. Thirty-seven percent of products registered in C-nn class were commercialized before the P&R negotiation and the majority of them were oncologic drugs. Among these, 67% and 22% were innovative and orphan drugs, respectively. Puglia was the only Region that bought all the 10 drugs in C-nn class, followed by Lombardy, Veneto and Tuscany. On the contrary, Emilia Romagna purchased only two products. AIFA’s C-nn approval guaranteed a fast access to the therapy in those Regions buying in C-nn, with a national first sale on average 7.2 months before the P&R negotiation. The research underlines a low adoption of drugs under the C-nn class, before the P&R resolution. The tendency is mainly observed for innovative drugs, especially with oncologic indications, supporting the crucial role of these treatments to meet patient’s care needs. On the other hand, it is worth noting that the scenario is highly fragmented, causing disparities to the patient access across Italian regions.