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

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dc.identifier.uri http://dx.doi.org/10.15488/3900
dc.identifier.uri https://www.repo.uni-hannover.de/handle/123456789/3934
dc.contributor.author Jönsson, Bengt
dc.contributor.author Hampson, Grace
dc.contributor.author Michaels, Jonathan
dc.contributor.author Towse, Adrian
dc.contributor.author Schulenburg, Johann-Matthias Graf von der
dc.contributor.author Wong, Olivier
dc.date.accessioned 2018-11-01T09:00:43Z
dc.date.available 2018-11-01T09:00:43Z
dc.date.issued 2018
dc.identifier.citation 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
dc.description.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. eng
dc.language.iso eng
dc.publisher Heidelberg : Springer Verlag
dc.relation.ispartofseries European Journal of Health Economics 20 (2019), Nr. 3
dc.rights CC BY 4.0
dc.rights.uri https://creativecommons.org/licenses/by/4.0/
dc.subject Advanced therapy medicinal products eng
dc.subject Cell therapy eng
dc.subject Gene therapy eng
dc.subject Health technology assessment eng
dc.subject Regenerative medicine eng
dc.subject Value eng
dc.subject biomedical technology assessment eng
dc.subject cell therapy eng
dc.subject decision making eng
dc.subject feasibility study eng
dc.subject gene therapy eng
dc.subject human eng
dc.subject market eng
dc.subject regenerative medicine eng
dc.subject uncertainty eng
dc.subject.ddc 610 | Medizin, Gesundheit ger
dc.title Advanced therapy medicinal products and health technology assessment principles and practices for value-based and sustainable healthcare
dc.type article
dc.type Text
dc.relation.issn 1618-7598
dc.relation.doi https://doi.org/10.1007/s10198-018-1007-x
dc.description.version publishedVersion
tib.accessRights frei zug�nglich


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