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Market access for medical technologies in Italy

A brief overview of key market access pathways and challenges for medical devices, in-vitro diagnostic tests in Italy

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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
     
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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 27. 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 (ICD-9-CM from the 2007 year) and a diagnosis code (ICD-9). 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. 

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Health technology assessment

HTAs are performed at the national level by AGENAS and in several regions. A National Program for HTA is emerging (expected in 2024). 

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Specifics for IVD tests

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

MTRC has experience with more than 226 projects in Italy

News and insights

Public consultation on the telemonitoring guidelines open in Italy

On June 10, 2024, the National Agency for Regional Health Services (AGENAS) announced an online public consultation on the draft of the “Guidelines on the Evolutionary Pathway of Medical Systems for Telemonitoring”.

Rapid HTAs of three medical devices released in Tuscany

The HTA body of the Tuscany Regional Healthcare issues three types of documents: full HTA reports, rapid HTA reports, and motivational forms. With regional decree 8521 of April 19, 2024, Tuscany Regional Healthcare published three reassessments of medical devices in the cardiovascular, peripheral vascular, and e-health areas.

Rapid HTAs of four medical devices released in Tuscany

The HTA body of the Tuscany Regional Healthcare issues three types of documents: full HTA reports, rapid HTA reports, and motivational forms. With regional decree 6700 of March 27, 2024, Tuscany Regional Healthcare published three new assessments and one re-assessment of medical devices in the cardiovascular, men’s health, nephrology and urology, and surgical procedures areas.

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