The first report released within the national HTA program for medical devices in Italy

The national HTA program (Programma Nazionale di Health Technology Assessment, PNHTA) was established in Italy in 2017. However, it became fully operational only in 2023, when the Ministry of Health published the Decree on the adoption of PNHTA 2023-2025. 

PNHTA 2023-2025 is focused on medical devices. It is led by a national steering committee for HTA (Cabina di Regia) created by the Ministry of Health, and coordinated by the National Agency for Regional Health Services (AGENAS). The program aims to develop national HTAs and integrate their recommendations into decision-making on reimbursement and procurement within the national healthcare system at all levels (national, regional, and healthcare provider). The PNHTA is expected to be updated every three years. 

The first assessment within PNHTA 2023-2025 was initiated in 2024 and completed in July 2025. It concerns robotic surgery systems in general surgery, gynecology, and urology. The report analyzes the current state of robotic surgery in Italy, evaluating its safety, effectiveness, economic, organizational, and ethical impacts compared to laparoscopic and open surgery approaches. 

Assessment covered 22 surgical procedures across three approaches (robotic, laparoscopic, open), including gastrointestinal (e.g., cholecystectomy, Nissen fundoplication, gastrectomy), general (e.g., splenectomy), gynecology (e.g., hysterectomy), and urology (e.g., nephroureterectomy, radical prostatectomy, kidney transplantation). 

The evaluation compared three robotic systems: Da Vinci (Xi, X, SP, MP), Hugo RAS, and Versius. Economic evaluation included both a Cost Minimization Analysis (CMA) and a Budget Impact Analysis (BIA), considering two perspectives: the National Health Service and societal.

It was concluded that further evaluation of robotic surgery's safety and effectiveness is needed compared to traditional approaches and between commercial systems to support the economic profile. The current results serve as an initial reference for future evaluations, aiming to determine the actual impact of robotic surgery and support evidence-based national health planning. Efficient implementation requires careful resource management, team coordination, and specialized training.

See the details in Italian here (completed HTA) and here (PNHTA 2023-2025).

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