156
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

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

      review-article
      1 , 2 , 1 , 3 , 4 , 3 , 5 , 6 , 7 , 8 , 9 , 10 , 8 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 5 , 30 , 24 , 31 , 32 , 17 , 33 , 33 , 34 , 35 , 3
      Frontiers in Pharmacology
      Frontiers Media S.A.
      European Medicines Agency, Adaptive Pathways, Health Technology Assessment, marketing authorization, payers

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          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.

          Related collections

          Most cited references73

          • Record: found
          • Abstract: found
          • Article: not found

          The concepts and principles of equity and health.

          In 1984, the 32 member states of the World Health Organization European Region took a remarkable step forward in agreeing unanimously on 38 targets for a common health policy for the Region. Not only was equity the subject of the first of these targets, but it was also seen as a fundamental theme running right through the policy as a whole. However, equity can mean different things to different people. This article looks at the concepts and principles of equity as understood in the context of the World Health Organization's Health for All policy. After considering the possible causes of the differences in health observed in populations--some of them inevitable and some unnecessary and unfair--the author discusses equity in relation to health care, concentrating on issues of access to care, utilization, and quality. Lastly, seven principles for action are outlined, stemming from these concepts, to be borne in mind when designing or implementing policies, so that greater equity in health and health care can be promoted.
            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            Equity of access to health care: outlining the foundations for action.

            The Ministers of Health from Chile, Germany, Greece, New Zealand, Slovenia, Sweden, and the United Kingdom recently established The International Forum on Common Access to Health Care Services, based on a common belief that their citizens should enjoy universal and equitable access to good quality health care. The ministers intend to form a network to share thinking and evidence on health care improvements, with the specific aim of sustaining and promoting equitable access to health care. Despite a vast literature on the notion of equity of access, little agreement has been reached in the literature on exactly what this notion ought to mean. This article provides a brief description of the relevance of the access principle of equity, and summarises the research programme that is necessary for turning the principle into a useful, operational policy objective.
              Bookmark
              • Record: found
              • Abstract: found
              • Article: found
              Is Open Access

              Risk sharing arrangements for pharmaceuticals: potential considerations and recommendations for European payers

              Background There has been an increase in 'risk sharing' schemes for pharmaceuticals between healthcare institutions and pharmaceutical companies in Europe in recent years as an additional approach to provide continued comprehensive and equitable healthcare. There is though confusion surrounding the terminology as well as concerns with existing schemes. Methods Aliterature review was undertaken to identify existing schemes supplemented with additional internal documents or web-based references known to the authors. This was combined with the extensive knowledge of health authority personnel from 14 different countries and locations involved with these schemes. Results and discussion A large number of 'risk sharing' schemes with pharmaceuticals are in existence incorporating both financial-based models and performance-based/outcomes-based models. In view of this, a new logical definition is proposed. This is "risk sharing' schemes should be considered as agreements concluded by payers and pharmaceutical companies to diminish the impact on payers' budgets for new and existing schemes brought about by uncertainty and/or the need to work within finite budgets". There are a number of concerns with existing schemes. These include potentially high administration costs, lack of transparency, conflicts of interest, and whether health authorities will end up funding an appreciable proportion of a new drug's development costs. In addition, there is a paucity of published evaluations of existing schemes with pharmaceuticals. Conclusion We believe there are only a limited number of situations where 'risk sharing' schemes should be considered as well as factors that should be considered by payers in advance of implementation. This includes their objective, appropriateness, the availability of competent staff to fully evaluate proposed schemes as well as access to IT support. This also includes whether systematic evaluations have been built into proposed schemes.
                Bookmark

                Author and article information

                Contributors
                URI : http://loop.frontiersin.org/people/366009/overview
                URI : http://loop.frontiersin.org/people/362653/overview
                URI : http://loop.frontiersin.org/people/14310/overview
                URI : http://loop.frontiersin.org/people/359048/overview
                URI : http://loop.frontiersin.org/people/66208/overview
                URI : http://loop.frontiersin.org/people/393745/overview
                URI : http://loop.frontiersin.org/people/278995/overview
                URI : http://loop.frontiersin.org/people/459243/overview
                URI : http://loop.frontiersin.org/people/385411/overview
                URI : http://loop.frontiersin.org/people/375405/overview
                URI : http://loop.frontiersin.org/people/459239/overview
                URI : http://loop.frontiersin.org/people/461722/overview
                URI : http://loop.frontiersin.org/people/278586/overview
                URI : http://loop.frontiersin.org/people/158660/overview
                URI : http://loop.frontiersin.org/people/452815/overview
                URI : http://loop.frontiersin.org/people/359044/overview
                URI : http://loop.frontiersin.org/people/343221/overview
                URI : http://loop.frontiersin.org/people/452932/overview
                URI : http://loop.frontiersin.org/people/91670/overview
                URI : http://loop.frontiersin.org/people/14301/overview
                URI : http://loop.frontiersin.org/people/359209/overview
                URI : http://loop.frontiersin.org/people/459426/overview
                URI : http://loop.frontiersin.org/people/90535/overview
                URI : http://loop.frontiersin.org/people/17497/overview
                Journal
                Front Pharmacol
                Front Pharmacol
                Front. Pharmacol.
                Frontiers in Pharmacology
                Frontiers Media S.A.
                1663-9812
                23 August 2017
                2017
                : 8
                : 497
                Affiliations
                [1] 1Department of Pharmacoepidemiology, Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde Glasgow, United Kingdom
                [2] 2Pharmaceutical Department, National Association of Statutory Health Insurance Funds Berlin, Germany
                [3] 3Health Economics Centre, University of Liverpool Management School Liverpool, United Kingdom
                [4] 4Division of Clinical Pharmacology, Karolinska Institutet Stockholm, Sweden
                [5] 5Department of Health Ecorys, Rotterdam, Netherlands
                [6] 6National Research Institution for Public Health Moscow, Russia
                [7] 7Mechanism of Coordinated Access to Orphan Medicinal Products (MoCA) Brussels, Belgium
                [8] 8Department of Pharmaceutical Policy, National Institute for Health and Disability Insurance Bruxelles, Belgium
                [9] 9Zilveren Kruis Achmea Leiden, Netherlands
                [10] 10Department of Drug Management, Faculty of Health Sciences, Jagiellonian University Medical College Kraków, Poland
                [11] 11Clinical Pharmacology Service, University Hospital Vall d'Hebron, Universitat Autonoma de Barcelona Barcelona, Spain
                [12] 12Department of Healthcare Development, Stockholm County Council Stockholm, Sweden
                [13] 13Department of Medicine Solna, Karolinska Institutet Stockholm, Sweden
                [14] 14Medicinal Products Department, Health Insurance Institute of Slovenia Ljubljana, Slovenia
                [15] 15Global Health and Development Group, Imperial College London, United Kingdom
                [16] 16Department of Pharmacy, Ministry of Health of the Republic of Lithuania Vilnius, Lithuania
                [17] 17National Health Care Institute (ZIN) Diemen, Netherlands
                [18] 18Department of Pathology, Forensic Medicine and Pharmacology, Faculty of Medicine, Vilnius University Vilnius, Lithuania
                [19] 19State Medicines Control Agency Vilnius, Lithuania
                [20] 20Scottish Medicines Consortium Glasgow, United Kingdom
                [21] 21Clinical Research and Drug Assessment Unit Verona, Italy
                [22] 22Pediatric Cardiology, Primary Healthcare Centre “Zemun” Belgrade, Serbia
                [23] 23Department of Post-authorisation Safety, State Agency of Medicines Tartu, Estonia
                [24] 24Wissenschaftliches Institut der AOK Berlin, Germany
                [25] 25Faculty of Medicine, Public Health and Management Department, “Carol Davila” University of Medicine and Pharmacy Bucharest Bucharest, Romania
                [26] 26Ministry of Health and Social Welfare Banja Luka, Bosnia and Herzegovina
                [27] 27Department of Social Pharmacy, Medical Faculty, University of Banja Luka Banja Luka, Bosnia and Herzegovina
                [28] 28Department of Health Services, Ministry of Health Reykjavík, Iceland
                [29] 29Norwegian Directorate for Health Oslo, Norway
                [30] 30Department of Social Pharmacy and Pharmacoeconomics, Faculty of Pharmacy, Medical University of Sofia Sofia, Bulgaria
                [31] 31Institut de Recherche et Documentation en Economie de la Santé (IRDES) Paris, France
                [32] 32KU Leuven Department of Pharmaceutical and Pharmacological Sciences Leuven, Belgium
                [33] 33Health Technology Assessment, Pricing and Reimbursement Department, Central Administration of the Health System, National Authority of Medicines and Health Products (I.P., INFARMED) Lisboa, Portugal
                [34] 34Barcelona Health Region, Catalan Health Service Barcelona, Spain
                [35] 35Department of Pharmaceutical Affairs, Main Association of Austrian Social Insurance Institutions Vienna, Austria
                Author notes

                Edited by: Dominique J. Dubois, Free University of Brussels, Belgium

                Reviewed by: Wil Toenders, ToendersdeGroot BV, Netherlands; David Pruce, Icon, United Kingdom

                *Correspondence: Brian Godman brian.godman@ 123456ki.se

                This article was submitted to Pharmaceutical Medicine and Outcomes Research, a section of the journal Frontiers in Pharmacology

                Article
                10.3389/fphar.2017.00497
                5572364
                28878667
                8c9f7fb2-eca7-4974-b8f4-097aa3f767d8
                Copyright © 2017 Vella Bonanno, Ermisch, Godman, Martin, Van Den Bergh, Bezmelnitsyna, Bucsics, Arickx, Bybau, Bochenek, van de Casteele, Diogene, Eriksson, Fürst, Gad, Greičiūtė-Kuprijanov, van der Graaff, Gulbinovic, Jones, Joppi, Kalaba, Laius, Langner, Mardare, Markovic-Pekovic, Magnusson, Melien, Meshkov, Petrova, Selke, Sermet, Simoens, Schuurman, Ramos, Rodrigues, Zara, Zebedin-Brandl and Haycox.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

                History
                : 10 May 2017
                : 12 July 2017
                Page count
                Figures: 1, Tables: 0, Equations: 0, References: 116, Pages: 13, Words: 12601
                Categories
                Pharmacology
                Review

                Pharmacology & Pharmaceutical medicine
                european medicines agency,adaptive pathways,health technology assessment,marketing authorization,payers

                Comments

                Comment on this article