Submitted by Patrizia Berto, SVP Value & Access, Regulatory Pharma Net (RPN), Pisa, Italy
The 8th Annual Conference of the ISPOR Italy Rome Chapter was successfully held in Rome, November 28-29, 2022 with about 180 in-presence participants from national and regional authorities, health care organizations, academic institutions, consulting agencies and manufacturers of drugs and medical devices. It was held as a plenary meeting, articulated over 5 sessions, each of them structured around lectures, discussions and round-tables.
The Conference was endorsed by AIES (Italian Association of Health Economists), CEIS (Centre for Economic Studies, Tor Vergata University), SiHTA (Italian HTA Society) and UPO (Piemonte Orientale University) and hosted experts and governmental officials from national agencies including the National Institute of Health (ISS), the AIFA (National Regulatory Agency), regional agencies (Regione Toscana, Regione Veneto) and speakers from the Italian Pharma-Industry Association.
The first session, was focused on the “State of the art on the use of economic evaluations in P&R Dossiers, in Italy”, after about 18 months from the enforcement of the new Dossier structure and Guidelines issued in late 2020 by AIFA. It triggered a very interesting discussion on how economic analyses contribute to the approval of pharmaceuticals, how this contribution is valued by the Italian Regulatory Agency and how it could evolve and could be improved in the future.
During the Meeting, the results of 3 different ISPOR Rome Chapter Working Group projects were presented and discussed.
- “PRICE AND REIMBURSEMENT IN THE CASE OF INDICATION EXTENSION”, coordinated by Prof C Jommi, which included contributions from the Industry, Academia and Authorities as well as the results of a survey among ISPOR Rome Chapter members on the topic. A Report on the WG conclusion will soon be published on our website.
- “GOOD PRACTICES FOR THE DEVELOPMENT OF BUDGET IMPACT MODELS AT REGIONAL LEVEL” [https://www.isporitaly.org/index.php/documenti]. The document was coordinated by A. Marcellusi, and supported by a Steering Committee composed of representatives from government institutions, academia, consulting agencies and manufacturers.
- “REAL WORLD EVIDENCE TO SUPPORT PRICE AND REIMBURSEMENT EVALUATION PROCESSES IN ITALY” [https://www.isporitaly.org/index.php/documenti], coordinated by Dr A. Pierini, and supported by a Steering Committee composed of AIFA members which investigated the main challenges inherently related to the identification of sources and potential uses of RWE an its contribution to the P&R process in Italy.
The final session was dedicated to the recently founded GIRF (ISPOR ROMA FOR FUTURE GROUP), a group of young ISPOR members (age<35yr). with a presentation of the Group’s activities in 2022 and launch of the 2nd GIRF Congress to be held in Milano in May 2023. This session also included 5 Podium Presentations from young ISPOR/GIRF members: all of them were extremely focused and well-presented and were applauded by the large audience.