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PILOTING INTERNATIONAL PRODUCTION OF RAPID RELATIVE EFFECTIVENESS ASSESSMENTS OF PHARMACEUTICALS

  • Sarah Kleijnen (a1), Iris Pasternack (a2), Piia Rannanheimo (a3), Jenni M Vuola (a4), Marc Van de Casteele (a5), Anna Bucsics (a6), Isabelle Zahra Pulis (a7), Rossella Di Bidino (a8), Dario Sacchini (a9), Simona Montilla (a10), Payam Abrishami (a11), Sylvana Magrin Sammut (a7), Luisa Anna Adele Muscolo (a10), Pertti Happonen (a12) and Wim G. Goettsch (a13)...

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.

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References

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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).
2. Hutton, J, Trueman, P, Facey, K. Harmonization of evidence requirements for health technology assessment in reimbursement decision making. Int J Technol Assess Health Care. 2008;24:511517.
3. High Level Pharmaceutical Forum 2005–2008. Conclusions and recommendations. 2008 http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/pharmaforum_final_conclusions_brochure_en.pdf (accessed September 19, 2013).
4. Kleijnen, S, George, E, Goulden, S, et al. Relative effectiveness assessment of pharmaceuticals: Similarities and differences in 29 jurisdictions. Value Health. 2012;15 (6):954960.
5. Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems. Official Journal L 040, 11/02/1989 P. 0008–0011.
6. Lampe, K, Mäkelä, M, Garrido, MV, et al. The HTA core model: A novel method for producing and reporting health technology assessments. Int J Technol Assess Health Care. 2009;25 (Suppl 2):920.
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).
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.
9. EUnetHTA Joint Action 2 WP8. HTA Core Model® Online Handbook. Version 1.4. 17 Sep 2012 http://meka.thl.fi/htacore/ViewHandbook.aspx (accessed February 10, 2014).
10. High Level Pharmaceutical Forum. Core principles on relative effectiveness. 2008 http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/rea_principles_en.pdf (accessed September 19, 2013).

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PILOTING INTERNATIONAL PRODUCTION OF RAPID RELATIVE EFFECTIVENESS ASSESSMENTS OF PHARMACEUTICALS

  • Sarah Kleijnen (a1), Iris Pasternack (a2), Piia Rannanheimo (a3), Jenni M Vuola (a4), Marc Van de Casteele (a5), Anna Bucsics (a6), Isabelle Zahra Pulis (a7), Rossella Di Bidino (a8), Dario Sacchini (a9), Simona Montilla (a10), Payam Abrishami (a11), Sylvana Magrin Sammut (a7), Luisa Anna Adele Muscolo (a10), Pertti Happonen (a12) and Wim G. Goettsch (a13)...

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