OBJECTIVES. This study aims to assess the impact of the performance-based schemes (PBS) in Italy, in the last 5 years, based on last updated data available. METHODS. A review of the existing risk-sharing agreement in Italy has been performed by checking the data published on the annual Osservatorio Nazionale per l’Impiego dei Medicinali (Osmed) National Report (2013-2017). Data about Registries active at May 2019 has been also performed in order to observe the most recent evolution of Managed Entry Agreements in Italy. RESULTS. In the considered timeframe, the number of Registries gradually increased from 90 Registries in 2013 to 167 in 2017 (including also 16 web-based Therapeutic Plans; + 85%). A similar tendency can be observed by looking at the number of patients (from 149.447 in 2013 to 1.463.548 in 2017; +1.064%) and treatments (from 143.012 in 2013 to 1.644.119 in 2017; +880%). The estimate reimbursement amounts increased from the estimated 41 MIO Euro in 2013-2014, to 204,6 MIO in 2015, until 693 MIO in 2016. In 2017 the estimate savings were 531,8 MIO. Despite the the efficiency of spending (pay only when work, top of allocative efficiency), it is interesting to note how the percentage of performance-based schemes in Italy on the total of the new Registries introduced in the last few years and still active at May 2019, significantly decreased: 30% (4/13) in 2013, 39% (11/28) in 2014, 24% (5/21) in 2015, 19% (3/16) in 2016, 19% (4/21) in 2017 and none neither in 2018 nor in 2019.Further analysis (both qualitative and quantitative) was conducted. CONCLUSIONS. PBS showed to be an efficacious cost-containment measure with a very positive impact in terms of savings for the Italian NHS. Their role could become essential in the next few months/years considering the next arrival in the Italian market of the first ATMPs.