PNS59 Italian Regional Access for Drugs: 20 Regions VS 21 Procedures

Abstract

This study aims to assess the similarities and differences of drugs’ access for the 19 regions and the 2 autonomous provinces (APs) in Italy. We conducted targeted literature searches, including relevant regional websites and national laws, in order to find information and details about drugs’ regional access. The regional drugs’ access is a fragmented and complex process with different procedures. To data (April 2020), 17 of 21 Italian regions/APs adopt regional formularies of reimbursed drugs, but 3 of them are no more updated for at least 2 years. The remaining 4 regions/APs without regional formularies, have different local formularies instead of a regional single one. In all the regions that adopt a formulary except one, the inclusion of a drug/therapeutic indication in the regional formulary is mandatory for the inclusion in the subordinated local formularies. The prescription of drugs not included in regional formularies have to be limited to single and exceptional clinical cases, only in case no valid therapeutic alternative is available. The request for the submission of new drugs in regional formularies can be made by clinicians (70%), often following a bottom-up procedure, or by pharmaceutical companies with a top-down procedure (24%), or automatically after obtaining the reimbursement (6%). Out of 17 regions/APs with formularies, 12 (71%) have a template for the submission of the request of inclusion of a new drug/therapeutic indication in the formulary, 23% have not a regional template and for 1 region a letter of notification is enough for the inclusion in the formulary. This study allows to observe how various and multifaced is the process for regional drugs’ access. Due to these different procedures and to regional decision-making autonomy, discrepancies and inequalities between different regions/APs in the timing of patient access are created.