Idioma:

Payers' Views of the Changes Arising through the Possible Adoption of Adaptive Pathways

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

Frontiers in pharmacology, 2016-09, Vol.7, p.305-305 [Periódico revisado por pares]

Switzerland: Frontiers Research Foundation

Texto completo disponível

Citações Citado por

Enviar para

Título:
Payers' Views of the Changes Arising through the Possible Adoption of Adaptive Pathways
Autor: Ermisch, Michael ; Bucsics, Anna ; Vella Bonanno, Patricia ; Arickx, Francis ; Bybau, Alexander ; Bochenek, Tomasz ; van de Casteele, Marc ; Diogene, Eduardo ; Fürst, Jurij ; Garuolienė, Kristina ; van der Graaff, Martin ; Gulbinovič, Jolanta ; Haycox, Alan ; Jones, Jan ; Joppi, Roberta ; Laius, Ott ; Langner, Irene ; Martin, Antony P ; Markovic-Pekovic, Vanda ; McCullagh, Laura ; Magnusson, Einar ; Nilsen, Ellen ; Selke, Gisbert ; Sermet, Catherine ; Simoens, Steven ; Sauermann, Robert ; Schuurman, Ad ; Ramos, Ricardo ; Vlahovic-Palcevski, Vera ; Zara, Corinne ; Godman, Brian
Assuntos: Adaptive pathways ; Consumers ; Drug approval ; EMA ; Europe ; Influence ; Management ; Marketing authorisation ; Payers ; Pharmacology ; Social aspects
É parte de: Frontiers in pharmacology, 2016-09, Vol.7, p.305-305
Notas: ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
Edited by: Dominique J. Dubois, Université libre de Bruxelles, Belgium
Reviewed by: Wil Toenders, ToendersdeGroot BV, Netherlands; David Pruce, ICON, UK
This article was submitted to Pharmaceutical Medicine and Outcomes Research, a section of the journal Frontiers in Pharmacology
Descrição: 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.
Editor: Switzerland: Frontiers Research Foundation
Idioma: Inglês

Links

View this record in MEDLINE/PubMed

Voltar para lista de resultados

Realização: Logos de Redes Sociais:

Payers' Views of the Changes Arising through the Possible Adoption of Adaptive Pathways

Switzerland: Frontiers Research Foundation

Buscando em bases de dados remotas. Favor aguardar.