Payers' views of the changes arising through the possible adoption of adaptive pathways

Michael Ermisch, Anna Bucsics, Patricia Vella Bonanno, Francis Arickx, Alexander Bybau, Tomasz Bochenek, Marc van de Casteele, Eduardo Diogene, Jurij Fürst, Kristina Garuoliene, Martin van der Graaff, Jolanta Gulbinovic, Alan Haycox, Jan Jones, Roberta Joppi, Ott Laius, Irene Langner, Antony P. Martin, Vanda Markovic-Pekovic, Laura McCullaghEinar Magnusson, Ellen Nilsen, Gisbert Selke, Catherine Sermet, Steven Simoens, Robert Sauermann, Ad Schuurman, Ricardo Ramos, Vera Vlahovic-Palcevski, Corinne Zara, Brian Godman*

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

34 Citations (Scopus)

Abstract

Payers are a major stakeholder in any considerations and initiatives concerning adaptive licensing of new medicinal products, also referred to as Medicines Adaptive Pathways to patients (MAPPs). Firstly, the scope and necessity of MAPPs need further scrutiny, especially with regard to the definition of unmet need. Conditional approval pathways already exist for new medicines for seriously debilitating or life-threatening diseases and only a limited number of new medicines are innovative. Secondly, MAPPs will result in new medicines on the market with limited evidence about their effectiveness and safety. Additional data are to be collected after approval. Consequently, adaptive pathways may increase the risk of exposing patients to ineffective or unsafe medicines. We have already seen medicines approved conventionally that subsequently proved ineffective or unsafe amongst a wider, more co-morbid population as well as medicines that could have been considered for approval under MAPPs but subsequently proved ineffective or unsafe in Phase III trials and were never licensed. Thirdly, MAPPs also put high demands on payers. Routine collection of patient level data is difficult with high transaction costs. It is not clear who will fund these. Other challenges for payers include shifts in the risk governance framework, implications for evaluation and HTA, increased complexity of setting prices, difficulty with ensuring equity in the allocation of resources, definition of responsibility and liability and implementation of stratified use. Exit strategies also need to be agreed in advance, including price reductions, rebates, or reimbursement withdrawals when price premiums are not justified. These issues and concerns will be discussed in detail including potential ways forward.

Original languageEnglish
Article number305
JournalFrontiers in Pharmacology
Volume7
Issue numberSEP
DOIs
Publication statusPublished - 28 Sep 2016
Externally publishedYes

Keywords

  • Adaptive pathways
  • EMA
  • Europe
  • Marketing authorization
  • Payers

Fingerprint

Dive into the research topics of 'Payers' views of the changes arising through the possible adoption of adaptive pathways'. Together they form a unique fingerprint.

Cite this