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.
Our work in the Italian market
At Mtech Access, we have a global network of Associates, including experts across Italy. Their insights inform our primary research and validate our secondary research.
Here are just a few examples of how we have supported clients looking to understand and influence the healthcare market in Italy:
View Case StudyExploring funding and reimbursement routes for digital health technologies across EU4, UK and US
View Case StudyResearching market access pathways, reimbursement requirements and implications of orphan drug designation for a rare disease product
View Case StudyModelling pricing and market dynamics in a competitive therapeutic landscape across the EU4 and UK markets
View Case StudyReviewing HTA decisions in key markets across the globe
More Italian market insights and research
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
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
In this introductory guide, our Global market access experts present an overview of the reimbursement landscape in key European healthcare systems, including Germany.
