Access of medicines to the market: three years' experience of Sicily's regional drug formulary

BACKGROUND: In Italy, pharmaceutical market access depends on European Medicines Agency (EMA), Italian national drug agency (AIFA) and regional regulatory procedures (Sicilian Drug Formulary Committee). The regulatory and economic outcomes of the Sicilian Regional Drug Formulary Committee have not yet been described. The objective of this study was to quantify: 1) the number of drugs approved regionally; 2) the drug review time by European, national and regional competent authorities; 3) regional healthcare expenditure associated with the approved drugs. METHODS: All drugs approved by the Sicilian Drug Formulary Committee between 1st January 2013 to 1st April 2016 were identified. For these drugs, the median (with interquartile range, IQR) approval time taken by the European, national and regional competent authorities were estimated for all drugs and innovative drugs separately. Finally, the economic impact of regional regulatory decisions was estimated one year after drug approval. RESULTS: In total 117 drugs were approved. Median (IQR) time between EMA and AIFA approval was 1.17 years (0.93-1.66), while between AIFA and the Sicilian regional approval this was 0.35 years (0.27-0.94). The time elapsed for innovative drugs was 0.91 years (IQR: 0.66-1.75) between EMA and AIFA and 0.13 years (IQR: 0.02-0.25) between AIFA and Sicilian regional approval. Regional drug approvals were associated with a yearly cost of 525,489,586. CONCLUSIONS: The approval of 117 drugs over 3 years was associated with a 525 million pharmaceutical expenditure yearly. The total median time for pharmaceutical market access in Sicily was 1.52 years, and 1.04 years for innovative drugs.