Review of Relative Effectiveness Assessments (REAs) of Pharmaceuticals at the European Network for Health Technology Assessment(EUnetHTA):A first step towards a consolidated European Perspective on Comparative Effectiveness & Safety?

Abstract Objectives REAs from Joint Action (JA1-3) were reviewed and compared versus Health Technology Assessments (HTA) in France, Germany, UK, Italy. Methods EUnetHTA REAs published until end of 2019 were identified. Leveraging information derived from the HTA bodies’ website key process (population; timing; national HTA bodies involved) and content characteristics (evidence base; comparative therapy, endpoints, subgroups) were determined and compared against national appraisals. Results All twelve pharmaceutical EUnetHTA assessment finalized until end of 2019 were included with Ustekinumab being the most recent (October 2019) and Pazopanib the first assessment (September 2012). In all but three assessments EUnetHTA’s assessment did not cover the full EMA indication. Since JA3 time intervals between EMA approval and EUnetHTA assessment were 10 (Pazopanib). EUnetHTA did consider non – RCT evidence in 7 procedures; take a rather inclusive approach regarding appropriate comparative treatments; approach endpoints less restrictively than e.g. the German IQWiG/G-BA; not apply a predetermined set of subgroups analyses. In seven REAs, national appraisal showed inhomogeneities across the 4 countries. National appraisals for Sotagliflozin and Ustekinumab were not yet available. Conclusions A joint European HTA assessment has the potential to address the challenge of heterogeneity across the various national European HTA bodies and to determine joint European clinical development data standards that are aligned with regulatory requirements.