OBJECTIVES: Implemented by the Italian Medicines Agency (AIFA) in 2013, Class C-nn (C – non negotiated) was created to make all drugs approved by the European Medicines Agency (EMA) available to patients at prices set by manufacturer before AIFA’s pricing & reimbursement (P&R) decision. The study’s objective is to challenge the intended purpose of Class C-nn and its impact on the time to market. METHODS: Drugs assigned to Class C-nn between January 2013 and April 2015 were considered for the analysis. Nine official dates, representing key milestones in the national market access process, from EMA approval to the P&R decision were identified; the period from AIFA’s Technical-Scientific Committee’s (CTS) opinion to the P&R decision was the main focus. The negotiation lengths were compared to those prior to the introduction of Class C-nn. Moreover, the relationship between drug-specific variables (e.g., therapeutic area, presence of registry, orphan/innovative status) and the negotiation length was analyzed. RESULTS:  Out of 137 products assigned to Class C-nn, 43 completed the P&R process. The average time from EMA approval and CTS’s opinion to the P&R decision totaled 393 days (95% CI 353-432) and 159 days (95% CI 137-181) respectively. The analysis revealed longer negotiations for oncology and diabetes drugs versus drugs targeting other therapeutic areas. Negotiations for drugs included in the AIFA monitoring system were almost twice as long as products not monitored. It is worth noting that orphan drugs as well as drugs with an innovative status did not result in shorter negotiation processes. Furthermore, a negligible number of drugs accessed the market with C-nn status at freely set prices. CONCLUSIONS:  Implementing Class C-nn has not significantly impacted the time to reimbursement in Italy. Most companies prefer to not submit freely set prices prior to the P&R decision, thus neglecting the possibility of early market access.