Italy - Briefings

Additional national funding for medicines in Italy is used mainly to support timely and consistent uptake of medicines that have been designated as ‘innovative’ for a specific indication, rather than to create a separate route that bypasses routine national pricing and reimbursement.

Italy’s main national early access routes for medicines are designed to allow treatment before marketing authorisation is granted or standard reimbursement is available, when clinical need is high and alternatives are limited.

Health technology assessment for medicines in Italy is carried out by the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) and combines a comparative clinical appraisal with an assessment of economic value and financial impact.

Italy provides universal healthcare through a tax-funded national health service. Central government sets the national benefits package and the main rules for eligibility, entitlements, and patient charges, while regions and autonomous provinces plan and deliver services and manage budgets.

Italy’s main nationally defined mechanism to support access to innovative medicines is the innovativeness framework administered by the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA).

Managed entry agreements are used to enable National Health Service reimbursement for medicines where there is residual uncertainty at launch, most commonly uncertainty about outcomes in routine practice, the size of the eligible population, or the budget impact.

Italy manages medicines utilisation and public expenditure through national monitoring, ceiling-based expenditure governance, and nationally defined conditions for reimbursement.

Italy sets ex factory prices for reimbursed medicines through a national pricing and reimbursement procedure led by the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA).

Italy reduces net public expenditure on reimbursed medicines through statutory payback mechanisms and negotiated financial arrangements.

Italy uses a combination of nationally set list prices and distribution remuneration rules for medicines reimbursed through community pharmacies and hospital procurement.

Italy regulates medicines within the European Union framework. Marketing authorisation is often obtained through EU procedures that are valid in Italy, while national authorities remain responsible for significant lifecycle supervision.

Italy provides near-universal healthcare coverage through a tax-funded national health service, with most planning, delivery and spending decisions taken at regional level.