Accessing the Italian market

Italy has a national health care system with central, regional and local levels, providing free and universal healthcare. Pricing and reimbursement is set by the Italian Medicines Agency (Agenzia Italiana del Farmaco; AIFA), via the Technical and Scientific Committee and the Prices and Reimbursement Committee. The levels of reimbursement are based on product effectiveness, and value to patients and to the healthcare system. Costs are a major market access driver, and payers rely on international therapeutic reference prices to set reimbursement levels.

Once AIFA has approved a drug, it can be acquired by hospitals or physicians, but is paid for from their budget.

Risk-sharing agreements, providing payers with a 'money back' guarantee, are set at national and regional levels, and are becoming increasingly common.

For all these reasons, market access in Italy is a very fragmented and complex environment for companies to navigate, and the process is time-consuming.

  • During both pre-launch and peri-launch, work towards:
    • Understanding the federalized system – decision-makers and decisions can differ region by region
    • Creating relationships with key stakeholders and decision-makers at national, regional and local level
    • Understanding the timelines at national, regional and local level

To guide you through your market access journey in Italy, visit our Italy Value, Access and Outcomes Planner.

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