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STANDARDIZED REPORTING FOR 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
Marc Van de Casteele
Affiliation:
Rijksinstituut voor ziekte- en invaliditeitsverzekering, Directie Farmaceutisch Beleid & KU Leuven
Bernardette Rossi
Affiliation:
Directorate for Pharmaceutical Affairs (DPA), Ministry for Energy and Health
Agnese Cangini
Affiliation:
Italian Medicines Agency
Rossella Di Bidino
Affiliation:
HTA Unit, “A.Gemelli” Teaching Hospital
Marjetka Jelenc
Affiliation:
National institute of Public Health
Payam Abrishami
Affiliation:
Zorginstituut Nederland
Ilona Autti-Rämö
Affiliation:
The Social Insurance Institution
Hans Seyfried
Affiliation:
Hauptverband der österreichischen Sozialversicherungsträger
Ingrid Wildbacher
Affiliation:
Hauptverband der österreichischen Sozialversicherungsträger
Wim G. Goettsch
Affiliation:
Zorginstituut Nederland & Division of Pharmacoepidemiology and Clinical Pharmacology, Faculty of Science, Utrecht Institute for Pharmaceutical Sciences

Abstract

Objectives: Many European countries perform rapid assessments of the relative effectiveness (RE) of pharmaceuticals as part of the reimbursement decision making process. Increased sharing of information on RE across countries may save costs and reduce duplication of work. The objective of this article is to describe the development of a tool for rapid assessment of RE of new pharmaceuticals that enter the market, the HTA Core Model® for Rapid Relative Effectiveness Assessment (REA) of Pharmaceuticals.

Methods: Eighteen member organisations of the European Network of Health Technology Assessment (EUnetHTA) participated in the development of the model. Different versions of the model were developed and piloted in this collaboration and adjusted accordingly based on feedback on the content and feasibility of the model.

Results: The final model deviates from the traditional HTA Core Model® used for assessing other types of technologies. This is due to the limited scope (strong focus on RE), the timing of the assessment (just after market authorisation), and strict timelines (e.g. 90 days) required for performing the assessment. The number of domains and assessment elements was limited and it was decided that the primary information sources should preferably be a submission file provided by the marketing authorisation holder and the European Public Assessment Report.

Conclusions: The HTA Core Model® for Rapid REA (version 3.0) was developed to produce standardised transparent RE information of pharmaceuticals. Further piloting can provide input for possible improvements, such as further refining the assessment elements and new methodological guidance on relevant areas.

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Theme Submissions
Copyright
Copyright © Cambridge University Press 2015 

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References

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Supplementary material: File

Kleijnen et al. supplementary material

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Kleijnen et al. supplementary material

Table 2

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