payers’ views of the changes arising through the possible adoption of adaptive pathways
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2016
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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.MAPPs will result in new medicines initially 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 considered for approval under MAPPs but subsequently proved ineffective or unsafe in Phase III trials and were never licensed. 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 allocation of resources, 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.
| Reference Key |
ermisch2016frontierspayers
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| Authors | ;Michael Ermisch;Anna Bucsics;Patricia Vella Bonanno;Francis Arickx;Alexander Bybau;Tomasz Bochenek;Marc Van De Casteele;Eduardo Diogene;Jurij Furst;Kristina Garuoliene;Kristina Garuoliene;Martin van der Graaff;Jolanta Gulbinovic;Jolanta Gulbinovic;Alan Haycox;Jan Jones;Roberta Joppi;Ott Laius;Irene Langner;Anthony Martin;Vanda Markovic-Pekovic;Vanda Markovic-Pekovic;Laura McCullagh;Einar Magnusson;Ellen Nilsen;Gisbert Selke;Catherine Sermet;Steven Simoens;Robert Sauermann;Ad Schuurman;Ricardo Ramos;Vera Vlahovic-Palcevski;Corinne Zara;Brian Godman;Brian Godman |
| Journal | chemical research in chinese universities |
| Year | 2016 |
| DOI |
10.3389/fphar.2016.00305
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| URL | |
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