ABSTRACT
This chapter describes the introduction of Italian Medicines Agency (AIFA) registries and management entry agreements (MEAs) for pharmaceuticals in Italy. In order to meet the challenges presented by the current economic crisis, the Italian National Health Service (I-NHS) has recently launched a range of initiatives aimed at containing healthcare expenditure while improving quality and ensuring universality of access to healthcare services. After the establishment of the Cancer Drugs Registry in 2005, which was the first drugs registry to be developed, the scope of monitoring has progressively been extended to cardiology, dermatology, diabetology, inflammatory diseases, ophthalmology, rheumatology, respiratory, and neurological diseases. Over the last decade, the Italian pricing and reimbursement system has been characterized by the introduction of both financial schemes and performance-based, risk-sharing agreements aimed at fostering access to new medicines with a high level of uncertainty at launch. Cost-sharing agreements apply a discount to the Italian NHS on the cost of first cycles of therapy for all eligible patients.
