Adaptive pathways: possible next steps for payers in preparation for their potential implementation
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Published version
Author(s)
Type
Journal Article
Abstract
Medicines receiving a conditional marketing authorization through Medicines Adaptive Pathways to Patients (MAPPs) will be a challenge for payers. The “introduction” of MAPPs is already seen by the European Medicines Agency (EMA) as a fait accompli, with payers not consulted or involved. However, once medicines are approved through MAPPs, they will be evaluated for funding by payers through different activities. These include Health Technology Assessment (HTA) with often immature clinical data and high uncertainty, financial considerations, and negotiations through different types of agreements, which can require monitoring post launch. Payers have experience with new medicines approved through conditional approval, and the fact that MAPPs present additional challenges is a concern from their perspective. There may be some activities where payers can collaborate. The final decisions on whether to reimburse a new medicine via MAPPs will have more variation than for medicines licensed via conventional processes. This is due not only to increasing uncertainty associated with medicines authorized through MAPPs but also differences in legal frameworks between member states. Moreover, if the financial and side-effect burden from the period of conditional approval until granting full marketing authorization is shifted to the post-authorization phase, payers may have to bear such burdens. Collection of robust data during routine clinical use is challenging along with high prices for new medicines during data collection. This paper presents the concept of MAPPs and possible challenges. Concerns and potential ways forward are discussed and a number of recommendations are presented from the perspective of payers.
Date Issued
2017-08-23
Date Acceptance
2017-07-12
Citation
Frontiers in Pharmacology, 2017, 8, pp.1-13
ISSN
1663-9812
Publisher
Frontiers Media
Start Page
1
End Page
13
Journal / Book Title
Frontiers in Pharmacology
Volume
8
Copyright Statement
© 2017 Vella Bonanno, Ermisch, Godman, Martin, Van Den Bergh, Bezmelnitsyna, Bucsics, Arickx, Bybau, Bochenek, van de Casteele, Diogene, Eriksson, Fürst, Gad, Greičiūtė-Kuprijanov, van der Graaff, Gulbinovic, Jones, Joppi, Kalaba, Laius, Langner, Mardare, Markovic-Pekovic, Magnusson, Melien, Meshkov, Petrova, Selke, Sermet, Simoens, Schuurman, Ramos, Rodrigues, Zara, Zebedin-Brandl and Haycox. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
License URL
Identifier
http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000408517100001&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=1ba7043ffcc86c417c072aa74d649202
Subjects
Science & Technology
Life Sciences & Biomedicine
Pharmacology & Pharmacy
European Medicines Agency
Adaptive Pathways
Health Technology Assessment
marketing authorization
payers
HEALTH-CARE
CANCER DRUGS
MEDICINES
PRICE
COST
DABIGATRAN
AGREEMENTS
INNOVATION
FRAMEWORKS
APPROVALS
Publication Status
Published
Article Number
ARTN 497
Date Publish Online
2017-08-23