Hostname: page-component-cd9895bd7-mkpzs Total loading time: 0 Render date: 2024-12-23T03:18:38.970Z Has data issue: false hasContentIssue false
  • English
  • Français

STANDARDIZED REPORTING FOR RAPID RELATIVE EFFECTIVENESS ASSESSMENTS OF PHARMACEUTICALS

Published online by Cambridge University Press:  06 March 2015

Sarah Kleijnen ,
Iris Pasternack ,
Marc Van de Casteele ,
Bernardette Rossi ,
Agnese Cangini ,
Rossella Di Bidino ,
Marjetka Jelenc ,
Payam Abrishami ,
Ilona Autti-Rämö  and
Hans Seyfried
...Show all authors
Sarah Kleijnen
Affiliation:
Zorginstituut Nederland & Division of Pharmacoepidemiology and Clinical Pharmacology, Faculty of Science, Utrecht Institute for Pharmaceutical [email protected]
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
Get access Rights & Permissions [Opens in a new window]

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.

Keywords

Technology assessmentComparative effectiveness researchInternational cooperationPharmaceuticalsReimbursement
Type
Theme Submissions
Information
International Journal of Technology Assessment in Health Care , Volume 30 , Issue 5 , November 2014 , pp. 488 - 496
Copyright
Copyright © Cambridge University Press 2015 

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

REFERENCES

1. Eichler, HG, Bloechl-Daum, B, Abadie, E, et al. Relative efficacy of drugs: An emerging issue between regulatory agencies and third-party payers. Nat Rev Drug Discov. 2010;9:277–291.Google Scholar
2. Franken, M, Nilsson, F, Sandmann, F, de Boer, A, Koopmanschap, M. Unravelling Drug reimbursement outcomes: A comparative study of the role of pharmacoeconomic evidence in Dutch and Swedish reimbursement decision making. Pharmacoeconomics. 2013;31:781–797.Google Scholar
3. Kleijnen, S, George, E, Goulden, S, et al. Relative effectiveness assessment of pharmaceuticals: Similarities and differences in 29 jurisdictions. Value Health. 2012;15:954–960.Google Scholar
4. Kleijnen, S, Goettsch, W, d’Andon, A, et al. EUnetHTA JA WP5/JA1: Relative Effectiveness Assessment (RE assessment) 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
5. 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):9–20.Google Scholar
6. Pavlovic M, Teljeur C, Wieseler B, Klemp M, Cleemput I, Neyt M. Endpoints for relative effectiveness assessment (REA) of pharmaceuticals. Int J Technol Assess Heath Care. 2014;30:508-513. CrossRefGoogle Scholar
7. 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).Google Scholar
8. 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).Google Scholar
9. Kleijnen, S, Pasternack, I, Rannanheimo, P, et al. Piloting international production of rapid relative effectiveness assessments of pharmaceuticals. Int J Technol Assess Health Care. 2014; In process.Google Scholar
10. Henshall, C, Mardhani-Bayne, L, Frønsdal, KB, Klemp, M. Interactions between health technology assessment, coverage, and regulatory processes: Emerging issues, goals, and opportunities. Int J Technol Assess Health Care. 2011;27:253–260.CrossRefGoogle ScholarPubMed
11. The European Medicines Agency. Benefit-Risk Methodology Project. Doc. Ref. EMEA/108979/2009. London, 12 March 2009. http://www.ema.europa.eu/docs/en_GB/document_library/Report/2011/07/WC500109477.pdf (accessed September 19, 2013).Google Scholar
12. Committee for Medicinal Products for Human Use. Reflection paper on benefit-risk assessment methods in the context of the evaluation of marketing authorisation applications of medicinal products for human use. Doc. Ref. EMEA/CHMP/15404/2007. London, 19 March 2008. http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2010/01/WC500069634.pdf (accessed September 19, 2013).Google Scholar
13. Public Law No: 111–5. H.R. 1. American Recovery and Reinvestment Act of 2009 signed by President Barack Obama on 2/17/2009.Google Scholar
14. Biskupiak, JE, Dunn, JD, Holtorf, AP. Implementing CER: What will it take? J Manag Care Pharm. 2012;18 (Supp A):S19–S29.Google Scholar
Supplementary material: File

Kleijnen et al. supplementary material

Table 1

Download Kleijnen et al. supplementary material(File)
File 62 KB
Supplementary material: File

Kleijnen et al. supplementary material

Table 2

Download Kleijnen et al. supplementary material(File)
File 89.6 KB