Market access for medical technologies in Italy

Key topics

There are two key themes describing market access for medical technologies in Italy:

Reimbursement: payment mechanism via DRG system, add-on reimbursement
Health technology assessment: assessments by national and regional HTA organizations

Reimbursement

Reimbursement of hospital care in Italy depends on the “ownership” status of hospitals and includes diagnosis-related group (DRG) and global budget mechanisms.

Reimbursement of the hospital activity is made solely through a diagnosis-related group (DRG) system. Italy does not have its own system and adopted the CMS DRG version 24. The system is very rigid at the national level, with no updates made since the adoption of the DRG system.

DRGs are determined by the combination of a procedure code and a diagnosis code (ICD-9-CM from the 2007 year). Procedure codes have not been updated since 2007, and many innovative technologies cannot be appropriately coded in the Italian system.

Regions can establish their own tariffs and can innovate on the structure of the DRG system. This includes the creation of DRG sub-categories (DRG split mechanism) or add-on reimbursement for expensive procedures or devices.

Health technology assessment

HTAs are performed at the national level by AGENAS and in several regions. In early 2024, the National HTA Program for Medical Devices became fully functional with the initiation of the first evaluations of technologies.

Specifics for IVD tests

In-vitro diagnostic tests are reimbursed using a fee-for-service mechanism via the regional reimbursement catalogs (using an adaptation of ICD-9-CM classification) in outpatient settings.

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