Italy

On October 14, 2025, it was announced that the decree from the Ministry of Health for the National HTA Program for Medical Devices (PNHTA-DM) 2026–2028 has been submitted to the State–Regions Conference opinion. The Program was developed by the National Agency for Regional Health Services (AGENAS) and approved by the HTA Steering Committee.

On October 14, 2025, the National Agency for Regional Health Services (AGENAS) published the list of technologies prioritized for evaluation within the National HTA Program for Medical Devices in 2025. Technologies from the fields of endocrinology, men’s health, neurology/neurosurgery, and radiotherapy have been identified as priorities and are currently undergoing health technology assessment.

In July 2025, the HTA body of Tuscany Regional Healthcare published nine rapid HTA reports (eight new assessments and one reassessment) of medical devices in the ENT, neurosurgery, ophthalmology, orthopedics, peripheral vascular, and surgical procedures fields.

At the end of July 2025, the Ministry of Health published the first report within the national HTA program for medical devices. The program was established in 2017; however, it became fully functional only in late 2023, and the first assessment was launched in 2024 concerning robotic surgery in general (gastrointestinal) surgery, gynecology, and urology areas.

In May 2025, the HTA body of Tuscany Regional Healthcare published seven rapid HTA reports (six new assessments and one reassessment) of medical devices in the cardiovascular, e-health, intensive care and operating room, neuromodulation, ophthalmology, and orthopedics fields.

In April 2025, the HTA body of Tuscany Regional Healthcare published six rapid HTA reports (five new assessments and one reassessment) of medical devices in the cardiovascular, peripheral vascular, endoscopy, and dermatology fields.

In February 2025, the HTA body of Tuscany Regional Healthcare published four new rapid HTA reports on medical devices used in cardiovascular, endoscopy, pulmonology, and general surgical fields.

In January 2025, the HTA body of Tuscany Regional Healthcare published four new rapid HTA reports on medical devices used in surgical procedures, ophthalmology, men’s health, and orthopedics.

In November 2024, the HTA body of the Tuscany Regional Healthcare published five rapid HTA reports (four new assessments and one reassessment) of medical devices in the cardiovascular, ophthalmology, ENT, and dermatology areas.

On November 14, 2024, the State-Regions Conference approved the Decree with the new national LEA tariffs for outpatient specialist care and prosthetic care presented by the Italian Ministry of Health. The effective date of new tariffs is December 30, 2024.

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 20315 of September 9, 2024, Tuscany Regional Healthcare published two new rapid HTA reports of medical devices in the orthopedics and surgical procedures areas.

On August 7, 2024, the National Agency for Regional Health Services (AGENAS) announced a call for applications for Health Technology Assessment (HTA) for robotic surgery systems with intended use in the following surgical specialties: general surgery, gynecology and obstetrics, and urology, as part of the 2023-2025 National Health Technology Assessment Program for Medical Devices.