Adaptive pathways

possible next steps for payers in preparation for their potential implementation

Patricia Vella Bonanno, M. Ermisch, B. Godman, A.P. Martin, J. Van Den Bergh, L.Y. Bezmelnitsyna, A. Bucsics, F. Arickx, A. Bybau, T. Bochenek, M. van de Casteele, E. Diogene, I. Erickson, J. Fürst, M. Gad, L. Greičiūtė-Kuprijanov, M. van der Graaff, J. Gulbinovič, J. Jones, R. Joppi & 18 others M. Kalaba, O. Laius, I. Langner, I. Mardare, V. Markovic-Pekovic, E. Magnusson, O. Melien, D.O. Meshkov, G. Petrova, G. Selke, C. Sermet, S. Simoens, A. Schuurman, R. Ramos, J. Rodrigues, C. Zara, E.M. Zebedin-Brandl, A. Haycox

Research output: Contribution to journalArticle

14 Citations (Scopus)
41 Downloads (Pure)

Abstract

Medicines receiving a conditional marketing authorisation 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 authorised 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 authorisation is shifted to the post-authorisation 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
Early online date23 Aug 2017
DOIs
Publication statusE-pub ahead of print - 23 Aug 2017

Fingerprint

Marketing
Uncertainty
Biomedical Technology Assessment
Negotiating
Medicine

Keywords

  • European medicines agency
  • adaptive pathways
  • health technology assessment
  • marketing authorisation
  • payers

Cite this

Vella Bonanno, Patricia ; Ermisch, M. ; Godman, B. ; Martin, A.P. ; Van Den Bergh, J. ; Bezmelnitsyna, L.Y. ; Bucsics, A. ; Arickx, F. ; Bybau, A. ; Bochenek, T. ; van de Casteele, M. ; Diogene, E. ; Erickson, I. ; Fürst, J. ; Gad, M. ; Greičiūtė-Kuprijanov, L. ; van der Graaff, M. ; Gulbinovič, J. ; Jones, J. ; Joppi, R. ; Kalaba, M. ; Laius, O. ; Langner, I. ; Mardare, I. ; Markovic-Pekovic, V. ; Magnusson, E. ; Melien, O. ; Meshkov, D.O. ; Petrova, G. ; Selke, G. ; Sermet, C. ; Simoens, S. ; Schuurman, A. ; Ramos, R. ; Rodrigues, J. ; Zara, C. ; Zebedin-Brandl, E.M. ; Haycox, A. / Adaptive pathways : possible next steps for payers in preparation for their potential implementation. In: Frontiers in Pharmacology . 2017 ; Vol. 8.
@article{f34cf545d16949e794e36b6666272917,
title = "Adaptive pathways: possible next steps for payers in preparation for their potential implementation",
abstract = "Medicines receiving a conditional marketing authorisation 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 authorised 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 authorisation is shifted to the post-authorisation 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.",
keywords = "European medicines agency, adaptive pathways, health technology assessment, marketing authorisation, payers",
author = "{Vella Bonanno}, Patricia and M. Ermisch and B. Godman and A.P. Martin and {Van Den Bergh}, J. and L.Y. Bezmelnitsyna and A. Bucsics and F. Arickx and A. Bybau and T. Bochenek and {van de Casteele}, M. and E. Diogene and I. Erickson and J. F{\"u}rst and M. Gad and L. Greičiūtė-Kuprijanov and {van der Graaff}, M. and J. Gulbinovič and J. Jones and R. Joppi and M. Kalaba and O. Laius and I. Langner and I. Mardare and V. Markovic-Pekovic and E. Magnusson and O. Melien and D.O. Meshkov and G. Petrova and G. Selke and C. Sermet and S. Simoens and A. Schuurman and R. Ramos and J. Rodrigues and C. Zara and E.M. Zebedin-Brandl and A. Haycox",
note = "This Document is Protected by copyright and was first published by Frontiers. All rights reserved. it is reproduced with permission.",
year = "2017",
month = "8",
day = "23",
doi = "10.3389/fphar.2017.00497",
language = "English",
volume = "8",
journal = "Frontiers in Pharmacology",
issn = "1663-9812",

}

Vella Bonanno, P, Ermisch, M, Godman, B, Martin, AP, Van Den Bergh, J, Bezmelnitsyna, LY, Bucsics, A, Arickx, F, Bybau, A, Bochenek, T, van de Casteele, M, Diogene, E, Erickson, I, Fürst, J, Gad, M, Greičiūtė-Kuprijanov, L, van der Graaff, M, Gulbinovič, J, Jones, J, Joppi, R, Kalaba, M, Laius, O, Langner, I, Mardare, I, Markovic-Pekovic, V, Magnusson, E, Melien, O, Meshkov, DO, Petrova, G, Selke, G, Sermet, C, Simoens, S, Schuurman, A, Ramos, R, Rodrigues, J, Zara, C, Zebedin-Brandl, EM & Haycox, A 2017, 'Adaptive pathways: possible next steps for payers in preparation for their potential implementation', Frontiers in Pharmacology , vol. 8, 497. https://doi.org/10.3389/fphar.2017.00497

Adaptive pathways : possible next steps for payers in preparation for their potential implementation. / Vella Bonanno, Patricia; Ermisch, M.; Godman, B.; Martin, A.P.; Van Den Bergh, J.; Bezmelnitsyna, L.Y.; Bucsics, A.; Arickx, F.; Bybau, A.; Bochenek, T.; van de Casteele, M.; Diogene, E.; Erickson, I.; Fürst, J.; Gad, M.; Greičiūtė-Kuprijanov, L.; van der Graaff, M.; Gulbinovič, J.; Jones, J.; Joppi, R.; Kalaba, M.; Laius, O.; Langner, I.; Mardare, I.; Markovic-Pekovic, V.; Magnusson, E.; Melien, O.; Meshkov, D.O.; Petrova, G.; Selke, G.; Sermet, C.; Simoens, S.; Schuurman, A.; Ramos, R.; Rodrigues, J.; Zara, C.; Zebedin-Brandl, E.M.; Haycox, A.

In: Frontiers in Pharmacology , Vol. 8, 497, 23.08.2017.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Adaptive pathways

T2 - possible next steps for payers in preparation for their potential implementation

AU - Vella Bonanno, Patricia

AU - Ermisch, M.

AU - Godman, B.

AU - Martin, A.P.

AU - Van Den Bergh, J.

AU - Bezmelnitsyna, L.Y.

AU - Bucsics, A.

AU - Arickx, F.

AU - Bybau, A.

AU - Bochenek, T.

AU - van de Casteele, M.

AU - Diogene, E.

AU - Erickson, I.

AU - Fürst, J.

AU - Gad, M.

AU - Greičiūtė-Kuprijanov, L.

AU - van der Graaff, M.

AU - Gulbinovič, J.

AU - Jones, J.

AU - Joppi, R.

AU - Kalaba, M.

AU - Laius, O.

AU - Langner, I.

AU - Mardare, I.

AU - Markovic-Pekovic, V.

AU - Magnusson, E.

AU - Melien, O.

AU - Meshkov, D.O.

AU - Petrova, G.

AU - Selke, G.

AU - Sermet, C.

AU - Simoens, S.

AU - Schuurman, A.

AU - Ramos, R.

AU - Rodrigues, J.

AU - Zara, C.

AU - Zebedin-Brandl, E.M.

AU - Haycox, A.

N1 - This Document is Protected by copyright and was first published by Frontiers. All rights reserved. it is reproduced with permission.

PY - 2017/8/23

Y1 - 2017/8/23

N2 - Medicines receiving a conditional marketing authorisation 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 authorised 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 authorisation is shifted to the post-authorisation 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.

AB - Medicines receiving a conditional marketing authorisation 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 authorised 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 authorisation is shifted to the post-authorisation 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.

KW - European medicines agency

KW - adaptive pathways

KW - health technology assessment

KW - marketing authorisation

KW - payers

UR - http://journal.frontiersin.org/article/10.3389/fphar.2017.00497/full

U2 - 10.3389/fphar.2017.00497

DO - 10.3389/fphar.2017.00497

M3 - Article

VL - 8

JO - Frontiers in Pharmacology

JF - Frontiers in Pharmacology

SN - 1663-9812

M1 - 497

ER -