Adaptive Pathways: Possible Next Steps for Payers in Preparation for Their Potential Implementation
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, onc...
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Format: | Article |
Language: | English |
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Frontiers Media S.A.
2017-08-01
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Series: | Frontiers in Pharmacology |
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Online Access: | http://journal.frontiersin.org/article/10.3389/fphar.2017.00497/full |
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DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Patricia Vella Bonanno Michael Ermisch Brian Godman Brian Godman Brian Godman Antony P. Martin Jesper Van Den Bergh Liudmila Bezmelnitsyna Anna Bucsics Francis Arickx Alexander Bybau Tomasz Bochenek Marc van de Casteele Eduardo Diogene Irene Eriksson Irene Eriksson Jurij Fürst Mohamed Gad Ieva Greičiūtė-Kuprijanov Martin van der Graaff Jolanta Gulbinovic Jolanta Gulbinovic Jan Jones Roberta Joppi Marija Kalaba Ott Laius Irene Langner Ileana Mardare Vanda Markovic-Pekovic Vanda Markovic-Pekovic Einar Magnusson Oyvind Melien Dmitry O. Meshkov Guenka I. Petrova Gisbert Selke Catherine Sermet Steven Simoens Ad Schuurman Ricardo Ramos Jorge Rodrigues Corinne Zara Eva Zebedin-Brandl Alan Haycox |
spellingShingle |
Patricia Vella Bonanno Michael Ermisch Brian Godman Brian Godman Brian Godman Antony P. Martin Jesper Van Den Bergh Liudmila Bezmelnitsyna Anna Bucsics Francis Arickx Alexander Bybau Tomasz Bochenek Marc van de Casteele Eduardo Diogene Irene Eriksson Irene Eriksson Jurij Fürst Mohamed Gad Ieva Greičiūtė-Kuprijanov Martin van der Graaff Jolanta Gulbinovic Jolanta Gulbinovic Jan Jones Roberta Joppi Marija Kalaba Ott Laius Irene Langner Ileana Mardare Vanda Markovic-Pekovic Vanda Markovic-Pekovic Einar Magnusson Oyvind Melien Dmitry O. Meshkov Guenka I. Petrova Gisbert Selke Catherine Sermet Steven Simoens Ad Schuurman Ricardo Ramos Jorge Rodrigues Corinne Zara Eva Zebedin-Brandl Alan Haycox Adaptive Pathways: Possible Next Steps for Payers in Preparation for Their Potential Implementation Frontiers in Pharmacology European Medicines Agency Adaptive Pathways Health Technology Assessment marketing authorization payers |
author_facet |
Patricia Vella Bonanno Michael Ermisch Brian Godman Brian Godman Brian Godman Antony P. Martin Jesper Van Den Bergh Liudmila Bezmelnitsyna Anna Bucsics Francis Arickx Alexander Bybau Tomasz Bochenek Marc van de Casteele Eduardo Diogene Irene Eriksson Irene Eriksson Jurij Fürst Mohamed Gad Ieva Greičiūtė-Kuprijanov Martin van der Graaff Jolanta Gulbinovic Jolanta Gulbinovic Jan Jones Roberta Joppi Marija Kalaba Ott Laius Irene Langner Ileana Mardare Vanda Markovic-Pekovic Vanda Markovic-Pekovic Einar Magnusson Oyvind Melien Dmitry O. Meshkov Guenka I. Petrova Gisbert Selke Catherine Sermet Steven Simoens Ad Schuurman Ricardo Ramos Jorge Rodrigues Corinne Zara Eva Zebedin-Brandl Alan Haycox |
author_sort |
Patricia Vella Bonanno |
title |
Adaptive Pathways: Possible Next Steps for Payers in Preparation for Their Potential Implementation |
title_short |
Adaptive Pathways: Possible Next Steps for Payers in Preparation for Their Potential Implementation |
title_full |
Adaptive Pathways: Possible Next Steps for Payers in Preparation for Their Potential Implementation |
title_fullStr |
Adaptive Pathways: Possible Next Steps for Payers in Preparation for Their Potential Implementation |
title_full_unstemmed |
Adaptive Pathways: Possible Next Steps for Payers in Preparation for Their Potential Implementation |
title_sort |
adaptive pathways: possible next steps for payers in preparation for their potential implementation |
publisher |
Frontiers Media S.A. |
series |
Frontiers in Pharmacology |
issn |
1663-9812 |
publishDate |
2017-08-01 |
description |
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. |
topic |
European Medicines Agency Adaptive Pathways Health Technology Assessment marketing authorization payers |
url |
http://journal.frontiersin.org/article/10.3389/fphar.2017.00497/full |
work_keys_str_mv |
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doaj-f04463fb5300454ea10bcc289ffc51ff2020-11-24T22:57:05ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122017-08-01810.3389/fphar.2017.00497279908Adaptive Pathways: Possible Next Steps for Payers in Preparation for Their Potential ImplementationPatricia Vella Bonanno0Michael Ermisch1Brian Godman2Brian Godman3Brian Godman4Antony P. Martin5Jesper Van Den Bergh6Liudmila Bezmelnitsyna7Anna Bucsics8Francis Arickx9Alexander Bybau10Tomasz Bochenek11Marc van de Casteele12Eduardo Diogene13Irene Eriksson14Irene Eriksson15Jurij Fürst16Mohamed Gad17Ieva Greičiūtė-Kuprijanov18Martin van der Graaff19Jolanta Gulbinovic20Jolanta Gulbinovic21Jan Jones22Roberta Joppi23Marija Kalaba24Ott Laius25Irene Langner26Ileana Mardare27Vanda Markovic-Pekovic28Vanda Markovic-Pekovic29Einar Magnusson30Oyvind Melien31Dmitry O. Meshkov32Guenka I. Petrova33Gisbert Selke34Catherine Sermet35Steven Simoens36Ad Schuurman37Ricardo Ramos38Jorge Rodrigues39Corinne Zara40Eva Zebedin-Brandl41Alan Haycox42Department of Pharmacoepidemiology, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of StrathclydeGlasgow, United KingdomPharmaceutical Department, National Association of Statutory Health Insurance FundsBerlin, GermanyDepartment of Pharmacoepidemiology, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of StrathclydeGlasgow, United KingdomHealth Economics Centre, University of Liverpool Management SchoolLiverpool, United KingdomDivision of Clinical Pharmacology, Karolinska InstitutetStockholm, SwedenHealth Economics Centre, University of Liverpool Management SchoolLiverpool, United KingdomDepartment of HealthEcorys, Rotterdam, NetherlandsNational Research Institution for Public HealthMoscow, RussiaMechanism of Coordinated Access to Orphan Medicinal Products (MoCA)Brussels, BelgiumDepartment of Pharmaceutical Policy, National Institute for Health and Disability InsuranceBruxelles, BelgiumZilveren Kruis AchmeaLeiden, Netherlands0Department of Drug Management, Faculty of Health Sciences, Jagiellonian University Medical CollegeKraków, PolandDepartment of Pharmaceutical Policy, National Institute for Health and Disability InsuranceBruxelles, Belgium1Clinical Pharmacology Service, University Hospital Vall d'Hebron, Universitat Autonoma de BarcelonaBarcelona, Spain2Department of Healthcare Development, Stockholm County CouncilStockholm, Sweden3Department of Medicine Solna, Karolinska InstitutetStockholm, Sweden4Medicinal Products Department, Health Insurance Institute of SloveniaLjubljana, Slovenia5Global Health and Development Group, Imperial CollegeLondon, United Kingdom6Department of Pharmacy, Ministry of Health of the Republic of LithuaniaVilnius, Lithuania7National Health Care Institute (ZIN)Diemen, Netherlands8Department of Pathology, Forensic Medicine and Pharmacology, Faculty of Medicine, Vilnius UniversityVilnius, Lithuania9State Medicines Control AgencyVilnius, Lithuania0Scottish Medicines ConsortiumGlasgow, United Kingdom1Clinical Research and Drug Assessment UnitVerona, Italy2Pediatric Cardiology, Primary Healthcare Centre “Zemun”Belgrade, Serbia3Department of Post-authorisation Safety, State Agency of MedicinesTartu, Estonia4Wissenschaftliches Institut der AOKBerlin, Germany5Faculty of Medicine, Public Health and Management Department, “Carol Davila” University of Medicine and Pharmacy BucharestBucharest, Romania6Ministry of Health and Social WelfareBanja Luka, Bosnia and Herzegovina7Department of Social Pharmacy, Medical Faculty, University of Banja LukaBanja Luka, Bosnia and Herzegovina8Department of Health Services, Ministry of HealthReykjavík, Iceland9Norwegian Directorate for HealthOslo, NorwayDepartment of HealthEcorys, Rotterdam, Netherlands0Department of Social Pharmacy and Pharmacoeconomics, Faculty of Pharmacy, Medical University of SofiaSofia, Bulgaria4Wissenschaftliches Institut der AOKBerlin, Germany1Institut de Recherche et Documentation en Economie de la Santé (IRDES)Paris, France2KU Leuven Department of Pharmaceutical and Pharmacological SciencesLeuven, Belgium7National Health Care Institute (ZIN)Diemen, Netherlands3Health Technology Assessment, Pricing and Reimbursement Department, Central Administration of the Health System, National Authority of Medicines and Health Products (I.P., INFARMED)Lisboa, Portugal3Health Technology Assessment, Pricing and Reimbursement Department, Central Administration of the Health System, National Authority of Medicines and Health Products (I.P., INFARMED)Lisboa, Portugal4Barcelona Health Region, Catalan Health ServiceBarcelona, Spain5Department of Pharmaceutical Affairs, Main Association of Austrian Social Insurance InstitutionsVienna, AustriaHealth Economics Centre, University of Liverpool Management SchoolLiverpool, United KingdomMedicines 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.http://journal.frontiersin.org/article/10.3389/fphar.2017.00497/fullEuropean Medicines AgencyAdaptive PathwaysHealth Technology Assessmentmarketing authorizationpayers |