EU HTA Regulations (HTA-R) in Motion: Italy’s Path Forward

Italy has a highly regulated pricing, reimbursement, and access environment for Medicinal Products (MPs) and a rather de-regulated environment for Medical Devices (MDs). However, the current situation required significant changes to face the new challenges for the assessment and access of MPs and MDs, not only in Italy but also in all EU countries. The EU HTA Regulation (HTA-R) joint clinical assessment (JCA) requires health technology developers to submit a comprehensive clinical dossier to the EU Commission, from January 2025, for a selection of MP and MD, to be extended to larger groups of technologies in 2028 and 2030.

The Forum will address the interactions between the EMA process, the HTA-R and the local Italian pricing and reimbursement process for pharmaceuticals as well as the interactions between the HTA-R process and local Italian funding and access environment for devices.

Conti will present an overview of the Italian National HTA Program for medical devices 2023 2025 and how this program might affect the activities of medical device companies (10 min.); Berto will illustrate the challenges for drug manufacturers in dealing with EMA-HTAR-AIFA submissions as well as an update of the AIFA organization and governance (10 min.); Canonico and Cortesi will provide an Italian regulatory authority perspective (20 min.) and will facilitate the session and the interaction with the audience.

Audience participation will include identifying challenges in managing the EU HTA and Italian process interplay (20 min). The interactive element can be digitally enabled (app-based question & suggestion submission) and/or facilitated live by the moderators, as preferred by ISPOR and informed by venue and estimated attendee numbers.

This interactive and creative workshop will be valuable to industry HTA professionals, their colleagues in value & access strategy and management roles and to HTA agency staff.