ABSTRACT
Agencia Italiana del Farmaco is controlled by the Ministry of Health and the Ministry of Economics. Hospitals maintain a formulary of drugs for use in its institutions and reimbursed by the Department of Health. Hospital formulary drug choices must be compliant with the Hospital Pharmaceutical Formulary. Hospitals get a mandatory 50% discount off the approved public price. Many high-cost retail drugs are managed through the hospital budget in Italy. Health economic evaluations in Italy have only limited impact on pricing and reimbursement decision-making at a national level and are mainly included in dossiers at the initiative of pharmaceutical companies. The Italian healthcare system has always been characterized by continual change, although many of the underlying philosophies of cost management remain the same. The Italian Medicines Agency has responsibility for market authorization, pharmaco-vigilance, pricing and reimbursement for all pharmaceuticals for human use since July 2004.
