OBJECTIVES: To present recent experiences about the Italian model for granting initial reimbursability of innovative therapies. This model is based on a Register whose aim is to warrant appropriate prescribing, and on a conditional agreements (risk-sharing) until drug effectiveness/tolerability is confirmed in clinical practice. METHODS: As an example of implementation of the Italian method, we report the re-negotiation process of pirfenidone in the treatment of idiopathic pulmonary fibrosis. The first reimbursement authorization (2013) was granted along with a risk-sharing agreement (Success Fee) and pirfenidone inclusion in the AIFA Register. The aim of these tools was to assure from the initial access a proper cost-benefit profile also when evidence from clinical practice was limited. RESULTS: The Register warranted pirfenidone appropriate utilization according to clinical trials eligibility criteria. This made it possible to achieve adherence and persistence rates with therapy greater than EU values (80%ITA vs. 72%EU and 73%ITA vs. 50%EU, respectively). When the agreement had to be renegotiated, new clinical data from Phase III randomized trials and clinical practice, supporting pirfenidone value, were submitted in order to reassess the cost-benefit profile. Due to this evidence, AIFA overcame the initial uncertainty about the benefit in clinical practice and agreed to remove the risk-sharing mechanism; the drug, however, is still present in the Register in order to evaluate appropriateness of prescribing patterns. CONCLUSIONS: This approach, based on an initial risk-sharing agreement, to minimize effectiveness uncertainties, allows post-marketing reassessment of health technologies, consistent with current health policies. It is expected that in the future there will be an increased utilization of data collected through AIFA Registers for reassessment of innovative therapies. REFERENCES