Italy is a unitary parliamentary republic with a strongly decentralised public sector. Healthcare is delivered through the National Health Service, the Servizio Sanitario Nazionale (SSN), with national government setting the essential benefits that must be provided and the regions organising and funding most day-to-day service delivery. The SSN is mainly financed through national and regional taxation, with national redistribution intended to support broadly comparable per capita funding across regions.
Coverage is intended to be universal for citizens and legal residents, and access is largely free at the point of use, although co-payments apply in some areas (for example, certain outpatient services and some medicines, depending on regional rules). Private, voluntary, health insurance plays a minor supplementary role at system level.
National-level pharmaceutical pricing and reimbursement decisions are led by the Italian Medicines Agency (Agenzia italiana del farmaco, AIFA), which assesses clinical value and economic impact to inform reimbursement conditions. However, regional decision making materially affects coverage in practice, particularly for hospital use: regions and local health authorities manage medicines budgets and commonly operate regional therapeutic formularies and additional prescribing conditions, which can create differences in availability and uptake between regions.
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In this section subscribers can consult descriptions of the following stages of the national access process, with links to key sources of additional information:
- Healthcare system
- Access landscape
- Horizon scanning
- Scientific advice
- Regulatory approval
- Health technology assessment
- Price setting and rebate system
- Early access opportunities
- Additional funding opportunities
- Innovative medicines