OBJECTIVES: The purpose of this study was to evaluate the reduction in average market entry timelines for oncology agents in Italy if approved by AIFA as “C(nn)” class (non-negotiated class under the 189/2012 law) as compared to “A”  (fully reimbursed) / “H” (hospital reimbursement). METHODS: For the purpose of this study, only the approval of the agents’ first indications were taken into consideration. Included in this study were C(nn) oncology agents approved between May 27, 2013 and February 27, 2014 (aflibercept, pertuzumab, bosutinib, enzalutamide, vismodegib, pomalidomide, regorafenib, dabrafenib, infliximab, afatinib, radium Ra223 dichloride, trastuzumab emtansine) and class “A” / “H” agents approved between May 27, 2010 and December 2, 2013 (everolimus®, denosumab, pazopanib, cabazitaxel, denosumab, abiraterone, vemurafenib, vandetanib, axitinib). The average time to approval was calculated as the average difference between the date of issue of EMA marketing authorization and the determination date (“determina”) in the Italian “Gazzetta Ufficiale”.  RESULTS: The average time to reimbursement for oncology agents from EMA marketing authorization to AIFA approval as “C(nn)” class was estimated as 111.3±39.9 days (n=12), while the average time to reimbursement as either “A” or “H” class was estimated as 428.3±109.0 days (n=9). This represents a significantly faster approval process (unpaired t-test, p<0.01), where on average, the C(nn) approval process is faster by 317 days. CONCLUSIONS: This study shows that time to reimbursement for oncology agents from EMA marketing authorization to AIFA approval is significantly expedited through the use of “C(nn)” classification, reducing market entry timelines by nearly a full year (317 days) compared to the regular “A” or “H” class approval process. Pharmaceutical companies seeking expeditious market entry into Italy for a newly approved oncology therapy targeting an area of high unmet need should therefore consider applying for C(nn) class.