OBJECTIVES: Drugs centrally approved by the European Medicine Agency (EMA) are automatically granted marketing authorization by Italian Drug Agency (AIFA), which is responsible for pricing and reimbursement (P&R) negotiation at national level. In most Italian regions, a Drug Formulary Committee (DFC) must admit those drugs in the Regional Hospital Formulary before use at regional level. Some authors have argued that the timing from National to Regional formularies inclusion may lead to important disparities in patients’ access to new drugs. The aim of this work is to present data on the timeframe/lag time between EMA, AIFA and Sicilian DFC (SDFC) for newly approved drugs in Europe.

METHODS: Newly approved drugs, for which dossiers were presented to SDFC, were identified from 1^st January 2013 to 1^st April 2016. Publicly available sources were used to retrieve relevant information on approval decisions. Both median and mean values were used in the analysis to estimate the timeframe/lag time.

RESULTS: On 117 drugs, 100 newly approved medicines were included in the analysis while 17 were excluded due to missing data. The median lag time from EMA to AIFA (LTEA) was