OBJECTIVES: Standard Monitoring Registries (SMRs), which were introduced for the first time in the Italian market in June 2005, have become a fundamental tool for Italian Medicine Agency (AIFA) in monitoring Managed Entry Agreements (MEAs) and the appropriateness of prescriptions. MEAs are differentiated in outcome-based and financial-based agreements. The main purpose of this research was to investigate the adoption of SMRs in Italy and their evolution throughout the last 10 years.

METHODS: The study was a desk research conducted by integrating different information sources, which included AIFA’s public and updated information about SMRs and Official Gazette RESULTS: Out of 176 products/indications analyzed, 102 were included in a SMR for “Appropriateness of Prescription”, whilst 74 were associated to a SMR with MEA. Overall, for the 74 products/indications, 50 (68%) were managed by an outcome-based MEA, 23 (31%) by a financial-based MEA and only 1 (1%) by a mixed MEAs approach. The majority of drugs with MEAs belonged to three main therapeutic areas: oncology (77%), virology (7%) and ophthalmology (7%). Since 2016, a sharp reduction in the outcome-based MEAs’ adoption was noticed, while SMRs linked to “Appropriateness of Prescription” remained steady.

CONCLUSIONS: SMRs are considered a strategic method to evaluate the appropriateness of prescriptions and the real-world efficacy of a drug. Nevertheless, the tendency to negotiate outcome-based MEAs decreased during the last two years, probably due to difficulties in monitoring clinical outcomes. However, MEAs can facilitate the access to the market of expensive molecules such as oncologic therapies, representing a win strategy for stakeholders involved.