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EVIDENCE REQUIREMENTS FOR REIMBURSEMENT OF PHARMACEUTICALS ACROSS EUROPE

  • Oyinlola Oyebode (a1), Zoe Garrett (a2), Elizabeth George (a2), Agnese Cangini (a3), Luisa Anna Adele Muscolo (a3), Simone Warren (a4), Bertalan Nemeth (a5), Csenge Földesi (a5), Marcela Heislerová (a6) and Eva Gajdošová (a7)...
Abstract

Objectives: The objective of this study was to compare evidence requirements for health technology assessment of pharmaceuticals by national agencies across Europe responsible for reimbursement decisions focusing specifically on relative effectiveness assessment.

Methods: Evidence requirements from thirty-three European countries were requested and twenty-nine national agencies provided documents to review. Data were extracted from national documents (manufacturer's submission templates and associated guidance) into a purpose-made framework with categories covering information about the health condition, the technology, clinical effectiveness and safety.

Results: The level of detail in the required evidence varies considerably across countries. Some countries include specific questions while others request information under general headings. Some countries include all information in a single document, which may or may not include guidance on how to complete the template. Others have specific guidance documents or methods and process manuals that help with the completion of the submission templates. Despite differences in quantity and detail, the content of the evidence requirements is broadly similar. All countries ask for information on the health technology, target disease, and clinical effectiveness and safety. However, one country only requests clinical effectiveness information as part of cost-effectiveness analyses. We found twenty-six evidence requirements for which generic answers may apply across borders and nineteen in which countries requested nationally specific information.

Conclusions: This work suggests that it would be possible to put together a minimum set of evidence requirements for HTA to support reimbursement decisions across Europe which could facilitate collaboration between jurisdictions.

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References
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1. Jonsson, E. Health technology assessment and comparative effectiveness in Sweden. Value Health. 2010;13 (Suppl 1):S6S7.
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;24:511551.
3. Hailey, D. Development of the International Network of Agencies for Health Technology Assessment. Int J Technol Assess Health Care. 2009;25 (Suppl 1):2427.
4. Mathes, T, Jacobs, E, Morfeld, JCC, Pieper, D. Methods of international health technology assessment agencies for economic evaluations–A comparative analysis. BMC Health Serv Res. 2013;13:371.
5. Asua Batarrita, J. [The International Network of Agencies for Health Technology Assessment (INAHTA) or the need for collaboration in evaluating health technologies]. Med Clín (Barc). 1999;112 (Suppl 1):8689.
6. Kristensen, FBB, Lampe, K, Chase, DL, et al. Practical tools and methods for health technology assessment in Europe: Structures, methodologies, and tools developed by the European Network for Health Technology Assessment, EUnetHTA. Int J Technol Assess Health Care. 2009;25 (Suppl 2):18.
7. Kristensen, FBB, Mäkelä, M, Neikter, SAA, etal. European network for health technology assessment, EUnetHTA: Planning, development, and implementation of a sustainable European network for health technology assessment. Int J Technol Assess Health Care. 2009;25 (Suppl 2):107116.
8. Kleijnen, S, George, E, Goulden, S, et al. Relative effectiveness assessment of pharmaceuticals: Similarities and differences in 29 jurisdictions. Value Health. 2012;15:954960.
9. 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.
10. Lampe, K, Mäkelä, M, Garrido, MVV, 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.
11. UnetHTA website. http://www.eunethta.eu/ (accessed April 7, 2014).
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International Journal of Technology Assessment in Health Care
  • ISSN: 0266-4623
  • EISSN: 1471-6348
  • URL: /core/journals/international-journal-of-technology-assessment-in-health-care
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