OBJECTIVES: Managed Entry Agreements (MEAs) aim to share the risk of uncertainties of new drugs, whose clinical effectiveness and economic impact are still unknown. MEAs are differentiated in outcome-based and non outcome-based agreements. The main purpose of this research is to analyze the impact of MEAs on the drug time to market (TTM), from the EMA approval to the regional patient access.

METHODS: A desk research was conducted on institutional websites, integrating different sources (EMA; AIFA; Italian Official Journal). The sample included 23 branded drugs belonging to different therapeutic areas, commercialized in Italy from 2011 to 2016. The analysis focused on products with a negotiated MEA (12 drugs with outcome-based MEA and 11 with non outcome-based MEA). The dates of first regional dispensation were obtained through the QuintilesIMS Hospital database, which gathers data on hospital and local healthcare unit distribution.

RESULTS: Negotiated MEAs were mainly observed for oncologic, innovative and orphan drugs. The analysis of all drugs with MEAs showed a National TTM of 14.1 months and a regional TTM of 6.1 months. The sub-analysis for different types of MEA evidenced an increase in TTM both at National (16.4 months) and at regional level (7.2 months) for drugs with outcome-based MEAs. On the contrary, non outcome-based MEAs seemed to reduce the TTM especially at National level (11.5 months).

CONCLUSIONS: MEAs have become a fundamental step toward a successful drug access to the Italian Pharmaceutical Market, to evaluate drug effectiveness and to ensure prescriptions are appropriate according to the drug label. Financial agreements (outcome-based MEAs) guarantee a faster drug access; hence, non outcome-based MEAs require a more flexible administrative framework, in order to achieve successful agreements and to reduce TTM with faster patient access to drugs.