AUTHOR=Gozzo Lucia , Paterson Kenneth , Wong Olivier , Megerlin Francis , Geldmacher Jan , Popoli Patrizia , Jommi Claudio , Fricke Frank-Ulrich , De Solà-Morales Oriol , Kamae Isao , Rasi Guido , Drago Filippo TITLE=Towards a European harmonization of health technology assessment recommendations executive paper of European regulatory conference focused on the EU commission proposal to harmonize HTA JOURNAL=Frontiers in Drug Safety and Regulation VOLUME=2 YEAR=2022 URL=https://www.frontiersin.org/journals/drug-safety-and-regulation/articles/10.3389/fdsfr.2022.970661 DOI=10.3389/fdsfr.2022.970661 ISSN=2674-0869 ABSTRACT=

Health Technology Assessment (HTA) is a multidisciplinary process which supports policy “decision-making”, including those related to drug reimbursement and price negotiation based on comprehensive clinical and non-clinical evaluations. The discrepancies in HTA recommendations among European countries are related to the differences in health care systems and willingness to invest in health care, differences in assessment methodologies and appraisal practices, and variations in economic constraints, and may produce disparities in terms of patient access to medicines. The political discussion about the adoption of the European Regulation on HTA lasted for years due to concerns about its feasibility and its implications for national health care systems In this paper we highlighted the importance to harmonize HTA process in Europe and some critical issues emerged during the discussion among experts in the field carried out at the European Regulatory Conference.