Adaptive pathways: Possible next steps for payers in preparation for their potential implementation

Patricia Vella Bonanno, Michael Ermisch, Brian Godman, Antony P. Martin, Jesper Van Den Bergh, Liudmila Bezmelnitsyna, Anna Bucsics, Francis Arickx, Alexander Bybau, Tomasz Bochenek, Marc van de Casteele, Eduardo Diogene, Irene Eriksson, Jurij Fürst, Mohamed Gad, Ieva Greičiute-Kuprijanov, Martin van der Graaff, Jolanta Gulbinovic, Jan Jones, Roberta JoppiMarija Kalaba, Ott Laius, Irene Langner, Ileana Mardare, Vanda Markovic-Pekovic, Einar Magnusson, Oyvind Melien, Dmitry O. Meshkov, Guenka I. Petrova, Gisbert Selke, Catherine Sermet, Steven Simoens, Ad Schuurman, Ricardo Ramos, Jorge Rodrigues, Corinne Zara, Eva Zebedin-Brandl, Alan Haycox

Research output: Contribution to journalReview articleResearchpeer-review

27 Citations (Scopus)

Abstract

© 2017 Vella Bonanno, Ermisch, Godman, Martin, Van Den Bergh, Bezmelnitsyna, Bucsics, Arickx, Bybau, Bochenek, van de Casteele, Diogene, Eriksson, Fürst, Gad, Greičiūte-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. 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 postauthorization 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.
Original languageEnglish
Article number497
JournalFrontiers in Pharmacology
Volume8
Issue numberAUG
DOIs
Publication statusPublished - 23 Aug 2017

Keywords

  • Adaptive Pathways
  • European Medicines Agency
  • Health Technology Assessment
  • Marketing authorization
  • Payers

Fingerprint

Dive into the research topics of 'Adaptive pathways: Possible next steps for payers in preparation for their potential implementation'. Together they form a unique fingerprint.

Cite this