Market access and assessment of post marketing use and cost of biological drugs in oncology

Access of medicines to the market: Three Years’ Experience of the Sicilian Regional Drug Formulary Abstract Objective To describe the approval timing and regional economic impactof the Sicilian Drug Formulary Committee approval process. Data Sources European public assessment reports, administrative acts published in the Italian government bulletin, Sicilian regional health department website, national electronic compendium, dossiers submitted to the Sicilian Drug Formulary Committee and Italian drug agency (AIFA) website were used. Study Design Newly approved drugs for which a dossier was presented to the Sicilian Drug Formulary Committee to authorize drug use in the Sicilian hospitals were identifiedfrom 1st January 2013 to 1st April 2016. The lag time between European Medicines Agency (EMA) and AIFA approval, and AIFA and Sicilian Drug Formulary Committee approval dates was calculated. The budget impact analysis (BIA) of approved drugs on the Sicilian region oneyearafter their approval was performed. Principal Findings Median (IQR) lag time between EMA and AIFA approval and between AIFA and Sicilian Drug Formulary Committee approval was 15.1 (IQR: 10.9-21.5) and 3.6 months (IQR: 0.2-7.1), respectively. The BIA showed that all the drugs were associated with a total annual cost of € 525,489,586. Conclusion Drug approvallag times may lead to disparity in health services access. In Italy, this largely depends on national procedures.