Leveraging EUnetHTA's conceptual framework to compare HTA decision drivers in France, Italy, and Germany from a manufacturer's point of view

Health Economics Review
Giovanni GiulianiJörg Ruof

Abstract

Health Technology Assessments (HTA) procedures differ substantially across the various European countries. We reviewed recent appraisals of a pharmaceutical manufacturer in three major European markets (France; Italy; Germany) and identified and categorized related decision drivers. New marketing authorisation between January 2011 and August 2017, and Roche being the Marketing Authorization Holder, were included. Outcome of HTA appraisals by the Haute Autorité de Santé (HAS), Agenzia Italiana del Farmaco (AIFA), and Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) were reviewed. Respective decision drivers were identified and commonalities and differences across the three countries were determined leveraging the EUnetHTA conceptual taxonomy (i.e. the 9 domains of the EUnetHTA core model). Within that time period Roche received European marketing authorization for eight new molecular entities (10 indications, respectively). Outcome of HTA appraisals was heterogeneous across the three countries. However, the four clinical domains of the EUnetHTA core model were driving the national HTA appraisals, with the clinical effectiveness domain being of most importance. Important drivers related to the other three clinical doma...Continue Reading

References

Jun 21, 2008·The European Journal of Health Economics : HEPAC : Health Economics in Prevention and Care·Pietro Folino-GalloNello Martini
May 15, 2013·Health Policy·Patrick MaisonUNKNOWN ISPEP group of the French National Authority for Health
Jun 19, 2013·The European Journal of Health Economics : HEPAC : Health Economics in Prevention and Care·Jörg RuofCharalabos-Markos Dintsios
Aug 17, 2014·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Michael BerntgenFinn Børlum Kristensen
Jan 1, 2013·Journal of Market Access & Health Policy·Cécile RémuzatBruno Falissard
Feb 27, 2017·Value in Health : the Journal of the International Society for Pharmacoeconomics and Outcomes Research·Finn Børlum KristensenLidia Becla
Oct 20, 2018·International Journal of Technology Assessment in Health Care·Marlene GyldmarkFinn Børlum Kristensen

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Software Mentioned

InterMune
EUnetHTA
AIFA

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