The 2026-2028 National HTA Program for Medical Devices is awaiting final approval in Italy

On October 14, 2025, it was announced that the decree from the Ministry of Health on the HTA Program for Medical Devices (PNHTA-DM) 2026–2028 has been submitted for 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 in July 2025.

The PNHTA-DM has been fully functional since Q3 2023, with the first program covering the period from 2023 to 2025. The 2026-2028 PNHTA-DM represents an update of the Program for the next three years, adapting it to technical and scientific developments in the field of HTA, as well as the evolution of national and European legislations (such as EU HTAR).

The PNHTA-DM 2026-2028 outlines the principles, tasks, and macro-activities of all stakeholders involved, describes the integration among these activities, and explains how results are transferred into the National Health Service (SNN) decision-making process. It focuses on the following key areas of activity:

• Production of national HTA on innovative devices and technologies;
• Development of a network of collaborative centers and strengthening of regional expertise;
• Involvement of stakeholders (scientific societies, patient associations, industry, citizens);
• Generation of scientific evidence and data collection to measure clinical and economic impacts;
• Prioritization of technologies based on shared criteria;
• Appraisal procedures for validation of HTA reports by the Steering Committee;
• Training and capacity building in technology assessment;
• Communication and transparency, including online publication of all approved documents;
• Alignment with European Joint Clinical Assessment activities (EU HTAR).

The PNHTA-DM's 2026-2028 organizational and functional activities charts have been updated accordingly, as well as other Program sections.

Among other updates, the rapid evolution of digital technologies in healthcare, particularly in diagnosis and treatment, has resulted in their inclusion within the scope of EU Regulation 2017/745, which sets out the requirements for medical devices.

See the more details in Italian here and here.

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