Spending on pharmaceuticals in Italy: macro constraints with local autonomy.

Italy has a national health service (SSN) that is moving toward decentralization and empowerment of local health enterprises (LHEs)-the arms of the regions for delivering health services. Drug policy and spending decisions are both influenced by central government and local authorities. At the "macro" level, the government holds the power to decide the amount of drug expenditure, currently at 13% of total SSN expenditure; the pricing policy, price negotiation, reference price, and price cuts; criteria for reimbursement, inclusion in the positive list, and restrictive notes; and the copayments and exemptions. So far, the government concern has been predominantly on cost containment, and its approach in selecting drugs for reimbursement has been cost minimization. Italy has no centralized office for health technology assessment and this hinders the search for an efficient use of drugs. At the "micro" level, however, the LHEs are showing a great vitality in fostering a better use of drugs by general practitioners. One of the tools employed is local voluntary agreements between LHEs and general practitioners (GPs) that may be supported by economic incentives, in cash or in kind. In 2000 there were 61 agreements in place, 31% of total LHEs, which concerned the respect of drug expenditure ceilings and the local development and implementation of clinical guidelines (47% of LHEs). A traditional and widespread tool for controlling drug expenditure is providing GPs with regular reports on their drug prescriptions (59% of LHEs). Monitoring, moral suasion, and clinical guidelines are the main incentives for efficiency at local level, but focus on health outcomes is limited. The cost-containment mentality still prevails and the use of drug budget for purchasing better health is at its very early stage.