2021
DOI: 10.3389/fmedt.2021.629750
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Efficacy, Safety, and Economics of Innovative Medicines: The Role of Multi-Criteria Decision Analysis and Managed Entry Agreements in Practice and Policy

Abstract: Through the years, solutions for accelerated access to innovative treatments are implemented in models of regulatory approvals, yet with limited data. Besides efficacy data, providing adequate safety data is key to transferring conditional marketing authorization to final marketing authorization. However, this remains a challenge because of the restricted availability and transferability of such data. Within this study, we set up a challenge to analyze the answers of two questions. First, from regulatory bodie… Show more

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Cited by 4 publications
(6 citation statements)
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“…Health technology assessments use a broad spectrum of elements to inform decision makers 14 . This decision process can cover issues of acquisition, finance, or adequate use of technologies, as well as disinvestment in ineffective or old alternatives 31,32 .…”
Section: Discussionmentioning
confidence: 99%
See 4 more Smart Citations
“…Health technology assessments use a broad spectrum of elements to inform decision makers 14 . This decision process can cover issues of acquisition, finance, or adequate use of technologies, as well as disinvestment in ineffective or old alternatives 31,32 .…”
Section: Discussionmentioning
confidence: 99%
“…Health technology assessments use a broad spectrum of elements to inform decision makers. 14 This decision process can cover issues of acquisition, finance, or adequate use of technologies, as well as disinvestment in ineffective or old alternatives. 31,32 To support health decisions, it is important that managers have access to technology information, such as advantages (benefits), disadvantages (risks), uncertainties, and costs.…”
Section: Treatment Phasementioning
confidence: 99%
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