Managing pharmaceutical innovation in Italy: which regional governance tools can be adopted?

Abstract

Managing pharmaceutical innovation in Italy: which regional governance tools can be adopted? Within the Italian federalist framework, national and regional governance tools for pharmaceutical care have been developed in recent years. From a financial perspective, the pharmaceutical outpatient expenditure has already been put under control and this has markedly contributed to reducing the overall costs. The hospital pharmaceutical expenses instead have grown. On this last element bears how innovative and expensive drugs are introduced and managed; among these drugs, cancer drugs have a decisive role.

In the last years the AIFA (Agenzia Italiana del Farmaco – Italian Drugs Agency) policies regarding the adoption process of new drugs have stressed the concept of value for money: any innovative and expensive drug is linked to a webbased control register in order to monitor outcomes. The aim is to relate the drug price to the obtained results (payment by result and risk-sharing) or at least to institute simple financial agreements (cost-sharing) that can be defined as managed entry agreements (MEA). The critical point that can cause equity problems is the way these national governance tools are applied in different regional contexts. There are in fact marked differences among Italian regions. Most regions are aware that the only way to rule the system, and in particular the use of innovative drugs, is to have stronger evidence-based management tools able to connect different systems of oncological prescriptions. The aim is to follow patients in different care settings in order to measure the pathway phases in terms of consumption, costs and quality outcomes and therefore evaluate in actual practice the value for money of innovative drugs.