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Review
. 2021 Apr 28:3:629750.
doi: 10.3389/fmedt.2021.629750. eCollection 2021.

Efficacy, Safety, and Economics of Innovative Medicines: The Role of Multi-Criteria Decision Analysis and Managed Entry Agreements in Practice and Policy

Tanja Fens  1   2   3 , Eugène P van Puijenbroek  3   4 , Maarten J Postma  1   2   3   5   6   7
Affiliations
Review

Efficacy, Safety, and Economics of Innovative Medicines: The Role of Multi-Criteria Decision Analysis and Managed Entry Agreements in Practice and Policy

Tanja Fens et al. Front Med Technol. .

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 bodies' point of view, we bring the question of whether multi-criteria decision analysis (MCDA) is an adequate tool for further improvement of health technology assessment (HTA) of innovative medicines. Second, we ask if managed entry agreements (MEAs) pose solutions for facilitating the access to innovative medicines and further strengthening the evidence base concerning efficacy and effectiveness, as well as safety. Elaborating on such challenges brought us to conclude that increasing the attention to safety in MCDAs and MEAs will increase the trust of the authorities and improve the access for the manufacturers and the early availability of safe and effective medicines for the patients.

Keywords: health technology assessment; health-economics; innovative medicines; managed entry agreements; monitoring systems; multi-criteria decision analysis; regulatory policy.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Figures

Figure 1
Figure 1
Type of managed entry agreements across countries. MEA, managed entry agreement.
See this image and copyright information in PMC

References

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