Adaptive Pathways : Possible Next Steps for Payers in Preparation for Their Potential Implementation
Vella Bonanno, Patricia (Department of Pharmacoepidemiology, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde)
Ermisch, Michael (Pharmaceutical Department, National Association of Statutory Health Insurance Funds)
Godman, Brian (Karolinska Institutet (Estocolm, Suècia). Division of Clinical Pharmacology)
Martin, Antony P. (Health Economics Centre, University of Liverpool Management School)
Van Den Bergh, Jesper (Department of Health)
Bezmelnitsyna, Liudmila (National Research Institution for Public Health)
Bucsics, Anna (Mechanism of Coordinated Access to Orphan Medicinal Products (MoCA))
Arickx, Francis (Department of Pharmaceutical Policy, National Institute for Health and Disability Insurance)
Bybau, Alexander (Zilveren Kruis Achmea)
Bochenek, Tomasz (Department of Drug Management, Faculty of Health Sciences, Jagiellonian University Medical College)
van de Casteele, Marc (Department of Pharmaceutical Policy, National Institute for Health and Disability Insurance)
Diogène Fadini, Eduard (Hospital Universitari Vall d'Hebron)
Eriksson, Irene (Karolinska Institutet (Estocolm, Suècia). Department of Medicine Solna)
Fürst, Jurij (Medicinal Products Department, Health Insurance Institute of Slovenia)
Gad, Mohamed (Global Health and Development Group, Imperial College)
Greičiūtė-Kuprijanov, Ieva (Department of Pharmacy, Ministry of Health of the Republic of Lithuania)
van der Graaff, Martin (National Health Care Institute (ZIN))
Gulbinovič, Jolanta (State Medicines Control Agency)
Jones, Jan (Scottish Medicines Consortium)
Joppi, Roberta (Clinical Research and Drug Assessment Unit)
Kalaba, Marija (Pediatric Cardiology, Primary Healthcare Centre "Zemun")
Laius, Ott (Department of Post-authorisation Safety, State Agency of Medicines)
Langner, Irene (Wissenschaftliches Institut der AOK)
Mardare, Ileana (Faculty of Medicine, Public Health and Management Department, "Carol Davila" University of Medicine and Pharmacy Bucharest)
Markovic-Pekovic, Vanda (Department of Social Pharmacy, Medical Faculty, University of Banja Luka)
Magnusson, Einar (Department of Health Services, Ministry of Health)
Melien, Oyvind (Norwegian Directorate for Health)
Meshkov, Dmitry O. (Department of Health)
Petrova, Guenka I. (Department of Social Pharmacy and Pharmacoeconomics, Faculty of Pharmacy, Medical University of Sofia)
Selke, Gisbert (Wissenschaftliches Institut der AOK)
Sermet, Catherine (Institut de Recherche et Documentation en Economie de la Santé (IRDES))
Simoens, Steven (KU Leuven Department of Pharmaceutical and Pharmacological Sciences)
Schuurman, Ad (National Health Care Institute (ZIN))
Ramos, Ricardo (Health Technology Assessment, Pricing and Reimbursement Department, Central Administration of the Health System, National Authority of Medicines and Health Products (I.P., INFARMED))
Rodrigues, Jorge (Health Technology Assessment, Pricing and Reimbursement Department, Central Administration of the Health System, National Authority of Medicines and Health Products (I.P., INFARMED))
Zara, Corinne (Servei Català de la Salut)
Zebedin-Brandl, Eva (Main Association of Austrian Social Insurance Institutions. Department of Pharmaceutical Affairs)
Haycox, Alan (Health Economics Centre, University of Liverpool Management School)
Universitat Autònoma de Barcelona

Data:	2017
Resum:	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 post-authorization 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.
Nota:	Altres ajuts: There was no funding body. However, the writeup work was in part supported by grants from the Karolinska Institutet, Sweden.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	European Medicines Agency ; Adaptive Pathways ; Health Technology Assessment ; Marketing authorization ; Payers
Publicat a:	Frontiers in Pharmacology, Vol. 8 (august 2017) , ISSN 1663-9812

DOI: 10.3389/fphar.2017.00497
PMID: 28878667

13 p, 1.0 MB

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