At the ISPOR Congress 2023 in Copenhagen, Denmark, the two ISPOR Italian Chapters (ISPOR Milan and ISPOR Rome) presented a joint forum titled “EU HTA Regulation (HTA-R): How Is Italy Moving?” Professor Pier Luigi Canonico (President of ISPOR Italy Rome Chapter) and Dr. Paolo Angelo Cortesi (President of ISPOR Italy Milan Chapter) moderated the session, and Dr. Francesco Conti F (Treasurer of the Milan Chapter) and Dr. Patrizia Berto (Director of the Rome Chapter) presented at the session.
The purpose of the Forum is to present the Italian regulatory framework of Medicinal Products (MPs) and Medical Devices (MDs) and the changes that we are observing, also considering the new Regulation (EU) 2021/2282 on health technology assessment (HTAR). Dr. Paolo Cortesi and Prof. Pier Luigi Canonico introduced the forum and highlighted that Italy has a highly regulated pricing, reimbursement, and access environment for MPs, that is lacking for MDs. Further, implementation of the EU HTAR will begin on 12 January 2025, which will require significant changes and bring new challenges for the assessment and access of both MPs and MDs in Italy as well as in all EU-27 countries. The EU HTA Regulation (HTA-R) on Joint Clinical Consultation (JCC) and Joint Clinical Assessment (JCA), from January 2025 requires health technology developers to submit a comprehensive clinical dossier to the EU Commission, for a selection of MP and MD, to be extended to much larger groups of technologies in 2028 and 2030; however, as in many other EU countries, the impact of this new regulation in Italy is still to be defined.
The Forum addressed current and future interactions between the EMA process, the HTA-R and the local Italian agency, pricing, and reimbursement process for pharmaceuticals as well as between the HTA-R process and local Italian agency, funding and access environment for devices.
Dr. Conti presented an overview of the new Italian National HTA Program for medical devices 2023 - 2025 and how this program does affect the activities of medical device companies. The Italian National HTA Program - Medical Devices is intended to be aligned and integrated with the requirements of the EU New HTA Regulation. The Program is designed to promote successful collaboration between the Ministry of Health, the Italian National Agency for Regional Healthcare Services (Agenas), and the Italian Regions and Autonomous Provinces to develop and implement HTA-based tools for more comprehensive and effective governance of medical devices.
Dr. Berto illustrated the challenges facing drug manufacturers in dealing with EMA-HTAR-AIFA submissions, provided statistics on approval timings of pharmaceuticals in the past 3 years and presented an update of the most recent changes in the Italian Regulatory agency, AIFA, in terms of organization and governance. Dr. Berto presented the new AIFA Regulation, which introduces major changes to the organization and operation of the Italian Agency. These changes include the creation of a new single Scientific and Economic Commission for Pharmaceuticals (CSE) in place of the current Technical and Scientific Commission (CTS) and Price and Reimbursement Committee (CPR). The CSE, composed of ten members, carries out the activities previously assigned to the CTS and the CPR, with the responsibility of evaluating the efficacy and safety of drugs, as well as setting prices and reimbursement rates.
Prof. Canonico and Dr. Cortesi provided comments from a regulatory authority perspective and facilitated the session and the intense interaction with the highly attentive and participating audience which was composed of industry HTA professionals, their colleagues in value & access strategy and management roles and HTA agency staffs. A series of questions related to the impact of the Italian National HTA Program - Medical Devices and the AIFA reform remained open, waiting for their application in 2024. Further, the use and impact of Joint Clinical Assessment (JCA) by AIFA and AGENA assessment procedure is unclear and it will be part of the chapters’ activities in the next couple of years.