OBJECTIVES: The Italian National Health Service (INHS) is highly decentralized and Regions are responsible for planning healthcare services and allocating financial resources. Local autonomy implies stronger financial accountability leading to different economic strategies across regions. The Sicilian Drug Formulary Committee (SDFC) must approve drugs before hospital use at regional level and drug companies must present a specific dossier for the approval. Budget impact is a critical information for decision makers, therefore the aim of this study is to perform a pharmaceutical budget impact analysis (BIA) of drugs dispensed by the Sicilian Healthcare System (SHS) after one year from their approval.

METHODS: From 1st January 2013 to 1st April 2016, all approved 117-drugs, for which dossiers were presented to SDFC, were identified and stratified according to the Anatomical Therapeutic Chemical (ATC) classification. To perform the BIA, the following data were considered: the main indication of use for an average adult patient (i.e. average body weight of 70kg or body surface of 1.8m), treatment duration of 12 months, the highest drugs’ strength, ex-factory prices. The average annual cost per patient was then multiplied for the eligible cohort as estimated in the drug dossier presented by the manufacturers.

RESULTS: The BIA showed that in the first year from approval, drugs were associated with a total estimated annual pharmaceutical cost of € 500.9 million in charge of the SHS. The highest total expenditures were observed in three drug classes: respiratory system (ATC R) = €215,021,396 (494,782 patients), antineoplastic and immunomodulating agents (ATC L) = €177,185,744 (7,028 patients) and alimentary tract and metabolism (ATC A) = €47,335,649 (68,360 patients).

CONCLUSIONS: In the past three years, the SDFC approved drugs accounted for €500 million for one year treatment at steady state. Further analyses and monitoring are needed to validate the estimation.