Medical Device Reimbursement in Italy

Italian Medical Device Reimbursement Landscape & Decision Makers

We analyze the Italian reimbursement environment relevant to your medical device, focusing on national frameworks and regional implementation.

• Assessment of eligibility under the national statutory benefits package (Livelli Essenziali di Assistenza, LEA), applicable DRG tariffs, and nationally defined coverage frameworks.
• Analysis of regional implementation and funding mechanisms managed by Regional Health Agencies (Agenzia Sanitaria Regionale, ASR) and Local Health Authorities (Azienda Sanitaria Locale, ASL).
• Identification of key national and regional decision makers, including the National Agency for Regional Health Services (AGENAS), and definition of a tailored reimbursement and market access strategy for Italy.

Evidence Requirements & Reimbursement Planning for Medical Devices in Italy

Based on the reimbursement landscape, we develop the evidence strategy required by Italian national and regional decision makers, including regional health authorities, AGENAS, and advisory bodies such as the National Health Council (Consiglio Superiore di Sanità, CSS) and the National Institute of Health (Istituto Superiore di Sanità, ISS).

• Value Story: A clinical and economic value narrative aligned with LEA inclusion criteria and regional healthcare priorities.
• Economic Model: Budget impact and cost-effectiveness analyses adapted to DRG-based reimbursement and regional funding decisions.
• Clinical Evidence: Recommendations to align clinical studies with scientific and policy guidance from ISS, CSS, and regional health authorities.
• Decision Maker Feedback: Structured engagement with ASR, ASL, and other stakeholders to validate reimbursement assumptions.

Market Access & Reimbursement Implementation Strategy in Italy

Depending on the reimbursement pathway, we support execution through:

• Billing & Coding Guidance for hospitals and providers.
• Reimbursement Applications at regional or national levels.
• Pilot Programs with selected regions or hospitals.
• Interim Funding Strategies where applicable.

FAQ: Medical Device Reimbursement in Italy

How long does medical device reimbursement take in Italy?

Typically between 12 and 36 months, depending on device category, regional requirements, and evidence needs.

How are medical devices reimbursed in Italy?

Primarily through DRG-based hospital payments and regionally administered funding mechanisms.

Which institutions are involved in medical device reimbursement decisions in Italy?

Medical device reimbursement in Italy involves both national and regional bodies. National frameworks such as the LEA are complemented by regional decision making through ASR and ASL. Evidence and policy guidance may also involve AGENAS, the National Health Council (CSS), and the National Institute of Health (ISS).

Can reimbursement planning begin before regulatory approval?

Yes. Early planning helps align clinical studies and pilot programs, but formal reimbursement requires CE marking and regulatory approval.

Are regional differences significant in Italian reimbursement?

Yes. Each region may have specific DRG tariffs, funding programs, or application requirements, so a tailored regional strategy is essential.

What evidence is required for DRG tariff or LEA inclusion?

Decision makers typically require clinical effectiveness data, economic analyses, and alignment with regional healthcare priorities.

View all FAQs or explore our reimbursement consulting services.

Why Choose Mediclever for Medical Device Reimbursement in Italy

Mediclever supports medical device manufacturers with end-to-end reimbursement strategy and execution across Italy and Europe.

Medical Device Reimbursement Services Across Countries