F Chassagnol1, G Marcelli2, J Wagle3, G Giuliani2, D Traub3, V Schaub4, J Ruof5. 1. Roche SAS, France. 2. Roche S.p.A. Italy. 3. Roche Pharma AG, Germany. 4. F. Hoffmann La Roche, Switzerland. 5. Medical School of Hanover, Germany; r-connect GmbH, Switzerland. Electronic address: joerg.ruof@r-connect.org.
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 < 80 days. Number of (co-)authoring HTA bodies ranged between 2 (in 6 REAs) and > 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/GBA; 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.
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 < 80 days. Number of (co-)authoring HTA bodies ranged between 2 (in 6 REAs) and > 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/GBA; 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.
Authors: Agnes Kisser; Joschua Knieriemen; Annette Fasan; Karolin Eberle; Sara Hogger; Sebastian Werner; Tina Taube; Andrej Rasch Journal: Eur J Health Econ Date: 2021-11-12
Authors: Ting Wang; Neil McAuslane; Wim G Goettsch; Hubert G M Leufkens; Marie L De Bruin Journal: Front Pharmacol Date: 2022-07-18 Impact factor: 5.988