Launching healthcare products in Italy

Discover key facts about the healthcare market in Italy and learn about our latest market research for our pharmaceutical, medical device, and healthcare sector clients.

Key facts about the Italian health market:

Funding in the Italian healthcare system

Italy’s National Health Service (NHS) automatically covers all citizens. It is funded by corporate and value added tax revenues collected by the central government. These are distributed to the regional governments, which are responsible for delivering care.

The central government defines a national statutory benefits package offered to all residents in every region. Regions can offer services not included in the national statutory benefits but must finance those services themselves.

Health technology assessment in the Italy

Agenzia Italiana del Farmaco (AIFA) is the national public body that regulates medicines for human use in Italy. Prescription drugs are divided into three tiers according to clinical effectiveness and, in part, cost effectiveness:

  • Tier 1 (Class A) includes life-saving drugs and treatments for chronic conditions and is covered in all cases
  • Tier 2 (Class C) includes drugs for all other conditions and is not covered by Italy’s NHS
  • Tier 3 (Class H) comprises drugs that can be delivered only in a hospital setting

New medical devices are reimbursed following the advice of clinicians; hospitals and regions may then decide to reimburse based on their assessment and expert advice.

Italian payers’ primary focus:

The Italian market is clinically focused.

To discuss your launch strategy for Italy with our experts, or to enquire about market research services, get in touch using the form below.

    Keep me up to date with the latest news and events.

    Market access in Italy: Reforms at AIFA

    For our Global Whispers webinar in October, Clare Foy (Director – Global Market Access, Mtech Access) spoke to Italian market access expert Prof. Fabrizio Gianfrate (Professor of Health Economics and Outcomes Research [HEOR] and Ex-Payer) about the market access landscape in Italy, particularly regarding changes at the AIFA.

    EU Joint Clinical Assessment (JCA) – implications for Pharma and Medtech cover

    EU Joint Clinical Assessment (JCA) – implications for Pharma and Medtech

    Our health technology assessment experts provide an overview of the EU Joint Clinical Assessment (JCA) and what it means for Pharma and Medical Device manufacturers launching new technologies from 2025

    Market access and reimbursement in key European markets

    Market access and reimbursement in key European markets

    In this introductory guide, our Global market access experts present an overview of the reimbursement landscape in key European healthcare systems, including Germany.