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PILOTING INTERNATIONAL PRODUCTION OF RAPID RELATIVE EFFECTIVENESS ASSESSMENTS OF PHARMACEUTICALS

Published online by Cambridge University Press:  06 March 2015

Sarah Kleijnen
Affiliation:
Zorginstituut Nederland & Division of Pharmacoepidemiology and Clinical Pharmacology, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences skleijnen@zinl.nl
Iris Pasternack
Affiliation:
Zorginstituut Nederland & Summaryx Ltd
Piia Rannanheimo
Affiliation:
Finnish Medicines Agency
Jenni M Vuola
Affiliation:
GlaxoSmithKline
Marc Van de Casteele
Affiliation:
Rijksinstituut voor ziekte- en invaliditeitsverzekering, Directie Farmaceutisch Beleid & KU Leuven
Anna Bucsics
Affiliation:
Hauptverband der Österreichischen Sozialversicherungsträger and University of Vienna
Isabelle Zahra Pulis
Affiliation:
Directorate for Pharmaceutical Affairs, Ministry for Energy and Health
Rossella Di Bidino
Affiliation:
HTA Unit, “A.Gemelli” Teaching Hospital
Dario Sacchini
Affiliation:
Institute of Bioethics, “Agostino Gemelli” School of Medicine” School of Medicine
Simona Montilla
Affiliation:
Italian Medicines Agency
Payam Abrishami
Affiliation:
Zorginstituut Nederland
Sylvana Magrin Sammut
Affiliation:
Directorate for Pharmaceutical Affairs, Ministry for Energy and Health
Luisa Anna Adele Muscolo
Affiliation:
Italian Medicines Agency
Pertti Happonen
Affiliation:
Finnish Medicines Agency
Wim G. Goettsch
Affiliation:
Zorginstituut Nederland & Division of Pharmacoepidemiology and Clinical Pharmacology, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences

Abstract

Background: This article describes the lessons learned from an international pilot assessment using the first version of the HTA Core Model® and Guidelines for rapid Relative Effectiveness Assessment (REA) of pharmaceuticals based on input from three different perspectives: the assessors, the users (health technology assessment organisations) and the marketing authorisation holder.

Methods: A pilot assessment was performed of pazopanib for the treatment of advanced or metastatic renal cell carcinoma for which 54 individuals from 22 EUnetHTA member organisations from 16 European countries gave their contribution. The work was divided in eight domain teams. Subsequently, results of these domain teams were synthesised in one pilot report. Feedback on the outcomes of the pilot was gathered throughout the project and through structured surveys.

Results: The first version of the assessment was produced in six months and consisted of 55 question and answer pairs, 8 domain reports and a synthesis section that combined the results from the different domains. The organisation of the pilot required intense coordination. Main points of criticism on the assessment were the lengthiness of the document and overlap of information throughout the assessment.

Conclusions: A reduction in the number of authoring organisations and individuals participating is necessary to avoid information overlap and increase efficiency in undertaking the assessment. Involving several organisations (e.g. five) in an in-depth review could still ensure the benefit of broad participation from various countries. The focus of a rapid REA should be on the first four domains of the Model.

Type
Theme Submissions
Copyright
Copyright © Cambridge University Press 2015 

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References

1. Kleijnen, S, Goettsch, W, d’Andon, A, et al. EUnetHTA JA WP5: Relative Effectiveness Assessment (REA) of Pharmaceuticals. Background review. July 2011. http://eunethta.fedimbo.belgium.be/sites/5026.fedimbo.belgium.be/files/Final%20version%20of%20Background%20Review%20on%20Relative%20Effectiveness%20Assessment%2Bappendix.pdf (accessed September 19, 2013).Google Scholar
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7. EUnetHTA Joint Action 1 WP5. Pazopanib for the treatment of advanced renal cell carcinoma Pilot assessment using the draft HTA Core Model for Rapid Relative Effectiveness Assessment model. December 2012 http://eunethta.fedimbo.belgium.be/sites/5026.fedimbo.belgium.be/files/Final%20version%20of%20Background%20Review%20on%20Relative%20Effectiveness%20Assessment%2Bappendix.pdf (accessed September 19, 2013).Google Scholar
8. Pasternack, I, Anttila, H, Mäkelä, M, et al. Testing the HTA core model: Experiences from two pilot projects. Int J Technol Assess Health Care. 2009;25 (Suppl 2):2127.CrossRefGoogle ScholarPubMed
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