The Fund, established to support the development and operation of a national system for the governance of medical devices, of which HTA is a core component, is financed annually by a contribution equal to 0.75% of net (VAT-excluded) turnover generated from the sale of medical devices and large equipment to the National Health Service (SSN), pursuant to Article 15 of Law No. 53/2021 and Articles 28 of Legislative Decree No. 137/2022 and24 of Legislative Decree No. 138/2022. One third of the resources is earmarked for activities assigned to AGENAS, which plays a central role in the implementation of the Programme.

The launch of the PNHTA 2023-2025 experienced delays compared with the original timeline due to the actual availability of resources, which became accessible only at the end of the 2025 fiscal year following administrative appeals lodged against the interministerial decree implementing the Fund. In the meantime, AGENAS completed all preparatory activities, enabling the immediate start of the PNHTA-DM 2026-2028, which received formal approval at the State-Regions Conference in December 2025.

The Programme includes a comprehensive set of strategic actions, including:

• the production of 50-100 HTA assessments during 2026 on medical devices with high clinical, organisational, and economic impact, also through the expansion of the Register of Collaborative Centres and the activation of Framework Agreements. Particular attention will be given to artificial intelligence platforms and digital therapeutics, which are increasingly present on the market;

• the systematic implementation of appraisal processes and the formulation of recommendations to support policy and procurement decisions;

• basic training for users of HTA assessments, with the nationwide rollout of training programmes,following pilot experiences involving 60 participants over two editions—and the objective of engaging up to 1,500 professionals each year;

• advanced training and capacity building through the funding of selected university programmes, with the allocation of approximately 250 scholarships for advanced training courses and50 scholarships for second - level (postgraduate) university master's programmes;

• the development and deployment of the national IT platform supporting the PNHTA;

• the launch of research projects aimed at evidence generation, with particular focus on real-world data, clinical outcomes, and value-based procurement models;

• the strengthening of communication, information, and stakeholder engagement activities, including through the PNHTA Stakeholder Network and the organisation of territorial InfoDays for Regions, healthcare organisations, and other system actors, to support the operational implementation of the Programme at regional and organisational levels;

• the consolidation of transparency and communication actions to support the adoption of recommendations arising from HTA reports.