Adaptive Pathways: Possible Next Steps for Payers in Preparation for Their Potential Implementation.

Autor:	Vella Bonanno P; Department of Pharmacoepidemiology, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of StrathclydeGlasgow, United Kingdom., Ermisch M; Pharmaceutical Department, National Association of Statutory Health Insurance FundsBerlin, Germany., Godman B; Department of Pharmacoepidemiology, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of StrathclydeGlasgow, United Kingdom.; Health Economics Centre, University of Liverpool Management SchoolLiverpool, United Kingdom.; Division of Clinical Pharmacology, Karolinska InstitutetStockholm, Sweden., Martin AP; Health Economics Centre, University of Liverpool Management SchoolLiverpool, United Kingdom., Van Den Bergh J; Department of HealthEcorys, Rotterdam, Netherlands., Bezmelnitsyna L; National Research Institution for Public HealthMoscow, Russia., Bucsics A; Mechanism of Coordinated Access to Orphan Medicinal Products (MoCA)Brussels, Belgium., Arickx F; Department of Pharmaceutical Policy, National Institute for Health and Disability InsuranceBruxelles, Belgium., Bybau A; Zilveren Kruis AchmeaLeiden, Netherlands., Bochenek T; Department of Drug Management, Faculty of Health Sciences, Jagiellonian University Medical CollegeKraków, Poland., van de Casteele M; Department of Pharmaceutical Policy, National Institute for Health and Disability InsuranceBruxelles, Belgium., Diogene E; Clinical Pharmacology Service, University Hospital Vall d'Hebron, Universitat Autonoma de BarcelonaBarcelona, Spain., Eriksson I; Department of Healthcare Development, Stockholm County CouncilStockholm, Sweden.; Department of Medicine Solna, Karolinska InstitutetStockholm, Sweden., Fürst J; Medicinal Products Department, Health Insurance Institute of SloveniaLjubljana, Slovenia., Gad M; Global Health and Development Group, Imperial CollegeLondon, United Kingdom., Greičiūtė-Kuprijanov I; Department of Pharmacy, Ministry of Health of the Republic of LithuaniaVilnius, Lithuania., van der Graaff M; National Health Care Institute (ZIN)Diemen, Netherlands., Gulbinovic J; Department of Pathology, Forensic Medicine and Pharmacology, Faculty of Medicine, Vilnius UniversityVilnius, Lithuania.; State Medicines Control AgencyVilnius, Lithuania., Jones J; Scottish Medicines ConsortiumGlasgow, United Kingdom., Joppi R; Clinical Research and Drug Assessment UnitVerona, Italy., Kalaba M; Pediatric Cardiology, Primary Healthcare Centre 'Zemun'Belgrade, Serbia., Laius O; Department of Post-authorisation Safety, State Agency of MedicinesTartu, Estonia., Langner I; Wissenschaftliches Institut der AOKBerlin, Germany., Mardare I; Faculty of Medicine, Public Health and Management Department, 'Carol Davila' University of Medicine and Pharmacy BucharestBucharest, Romania., Markovic-Pekovic V; Ministry of Health and Social WelfareBanja Luka, Bosnia and Herzegovina.; Department of Social Pharmacy, Medical Faculty, University of Banja LukaBanja Luka, Bosnia and Herzegovina., Magnusson E; Department of Health Services, Ministry of HealthReykjavík, Iceland., Melien O; Norwegian Directorate for HealthOslo, Norway., Meshkov DO; Department of HealthEcorys, Rotterdam, Netherlands., Petrova GI; Department of Social Pharmacy and Pharmacoeconomics, Faculty of Pharmacy, Medical University of SofiaSofia, Bulgaria., Selke G; Wissenschaftliches Institut der AOKBerlin, Germany., Sermet C; Institut de Recherche et Documentation en Economie de la Santé (IRDES)Paris, France., Simoens S; KU Leuven Department of Pharmaceutical and Pharmacological SciencesLeuven, Belgium., Schuurman A; National Health Care Institute (ZIN)Diemen, Netherlands., Ramos R; Health Technology Assessment, Pricing and Reimbursement Department, Central Administration of the Health System, National Authority of Medicines and Health Products (I.P., INFARMED)Lisboa, Portugal., Rodrigues J; Health Technology Assessment, Pricing and Reimbursement Department, Central Administration of the Health System, National Authority of Medicines and Health Products (I.P., INFARMED)Lisboa, Portugal., Zara C; Barcelona Health Region, Catalan Health ServiceBarcelona, Spain., Zebedin-Brandl E; Department of Pharmaceutical Affairs, Main Association of Austrian Social Insurance InstitutionsVienna, Austria., Haycox A; Health Economics Centre, University of Liverpool Management SchoolLiverpool, United Kingdom.
Jazyk:	angličtina
Zdroj:	Frontiers in pharmacology [Front Pharmacol] 2017 Aug 23; Vol. 8, pp. 497. Date of Electronic Publication: 2017 Aug 23 (Print Publication: 2017).
DOI:	10.3389/fphar.2017.00497
Abstrakt:	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.
Databáze:	MEDLINE
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