Advanced therapy medicinal products and health technology assessment principles and practices for value-based and sustainable healthcare

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Jönsson, B.; Hampson, G.; Michaels, J.; Towse, A.; von der Schulenburg, J.-M.G. et al.: Advanced therapy medicinal products and health technology assessment principles and practices for value-based and sustainable healthcare. In: European Journal of Health Economics 20 (2019), Nr. 3, S. 427-438. DOI: https://doi.org/10.1007/s10198-018-1007-x

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To cite the version in the repository, please use this identifier: https://doi.org/10.15488/3900

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Sum total of downloads: 55




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Abstract: 
Background: Advanced therapy medicinal products (ATMPs) are beginning to reach European markets, and questions are being asked about their value for patients and how healthcare systems should pay for them. Objectives: To identify and discuss potential challenges of ATMPs in view of current health technology assessment (HTA) methodology—specifically economic evaluation methods—in Europe as it relates to ATMPs, and to suggest potential solutions to these challenges. Methods: An Expert Panel reviewed current HTA principles and practices in relation to the specific characteristics of ATMPs. Results: Three key topics were identified and prioritised for discussion—uncertainty, discounting, and health outcomes and value. The panel discussed that evidence challenges linked to increased uncertainty may be mitigated by collection of follow-on data, use of value of information analysis, and/or outcomes-based contracts. For discount rates, an international, multi-disciplinary forum should be established to consider the economic, social and ethical implications of the choice of rate. Finally, consideration of the feasibility of assessing the value of ATMPs beyond health gain may also be key for decision-making. Conclusions: ATMPs face a challenge in demonstrating their value within current HTA frameworks. Consideration of current HTA principles and practices with regards to the specific characteristics of ATMPs and continued dialogue will be key to ensuring appropriate market access. Classification code: I.
License of this version: CC BY 4.0
Document Type: article
Publishing status: publishedVersion
Issue Date: 2018
Appears in Collections:Wirtschaftswissenschaftliche Fakultät

distribution of downloads over the selected time period:

downloads by country:

pos. country downloads
total perc.
1 image of flag of Germany Germany 42 76.36%
2 image of flag of United States United States 3 5.45%
3 image of flag of Canada Canada 2 3.64%
4 image of flag of Russian Federation Russian Federation 1 1.82%
5 image of flag of Portugal Portugal 1 1.82%
6 image of flag of Poland Poland 1 1.82%
7 image of flag of Japan Japan 1 1.82%
8 image of flag of Greece Greece 1 1.82%
9 image of flag of United Kingdom United Kingdom 1 1.82%
10 image of flag of France France 1 1.82%
    other countries 1 1.82%

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