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      Policies for biosimilar uptake in Europe: An overview

      research-article
      1 , * , 2 , 1 , 1 , 3 , 4 , 5 , 6 , 7 , 8 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 18 , 19 , 20 , 21 , 22 , 23 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 , 1
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          Abstract

          Background

          Across European countries, differences exist in biosimilar policies, leading to variations in uptake of biosimilars and divergences in savings all over Europe.

          Objectives

          The aim of this article is to provide an overview of different initiatives and policies that may influence the uptake of biosimilars in different European countries. Recommendations will be formulated on how to create sustainable uptake.

          Methods

          An overview of policies on biosimilars was obtained via a questionnaire, supplemented with relevant articles. Topics were organized in five themes: availability, pricing, reimbursement, demand-side policies, and recommendations to enhance uptake.

          Results

          In all countries studied, biological medicines are available. Restrictions are mainly dependent on local organization of the healthcare system. Countries are willing to include biosimilars for reimbursement, but for commercial reasons they are not always marketed. In two thirds of countries, originator and biosimilar products may be subjected to internal reference pricing systems. Few countries have implemented specific incentives targeting physicians. Several countries are implementing pharmacist substitution; however, the scope and rules governing such substitution tend to vary between these countries. Reported educational policies tend to target primarily physicians, whereas fewer initiatives were reported for patients. Recommendations as proposed by the different country experts ranged from the need for information and communication on biosimilars to competitive pricing, more support for switching and guidance on substitution.

          Conclusions

          Most countries have put in place specific supply-side policies for promoting access to biosimilars. To supplement these measures, we propose that investments should be made to clearly communicate on biosimilars and educate stakeholders. Especially physicians need to be informed on the entry and use of biosimilars in order to create trust. When physicians are well-informed on the treatment options, further incentives should be offered to prescribe biosimilars. Gainsharing can be used as an incentive to prescribe, dispense or use biosimilars. This approach, in combination with binding quota, may support a sustainable biosimilar market.

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          Most cited references22

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          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.
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            Patient attitudes and understanding about biosimilars: an international cross-sectional survey

            Objective To understand the levels of awareness, usage, and knowledge of biosimilars among patients, caregivers, and the general population in the US and the European Union; perceptions of biosimilars compared to originator biologics; perceived benefits and drawbacks of clinical trials; and whether advocacy groups impact patients’ willingness to try a biosimilar. Methods An international survey was conducted which contained up to 56 closed-ended (requiring yes/no or ranking answers) and open-ended questions, depending on the population assigned. The survey was divided into distinct sections, including medication-class awareness, usage, and knowledge about biologic and biosimilar therapies; perceptions of clinical trials; and involvement in advocacy groups. Interviews were conducted in adults categorized as: 1) diagnosed: patients with inflammatory bowel disease including Crohn’s disease and ulcerative colitis, rheumatoid arthritis, psoriasis, breast cancer, lung cancer, colorectal cancer, or non-Hodgkin’s lymphoma; 2) diagnosed advocacy: individuals with these diseases who participated in patient support groups; 3) caregiver: has a loved one with these conditions and is involved in medical decisions; 4) general population: aged 18–64 years, without these conditions. Statistical analyses among groups within a region (US or EU) used column proportions test with a 95% confidence interval. Results In all, 3,198 individuals responded. Awareness about biologic therapies was significantly higher in diagnosed, diagnosed advocacy, and caregiver groups (45%–78%) versus general population (27%; P<0.05). Across all groups, awareness of biosimilars was low; only 6% of the general population reported at least a general impression of biosimilars. Awareness was significantly higher in the diagnosed advocacy group (20%–30%; P<0.05). Gaps in knowledge about biosimilars included safety, efficacy, and access to these agents. Respondents had generally positive perceptions of clinical trials, although barriers to participation were identified. Conclusion An immediate need exists for patient education about biosimilars and clinical trials to ensure educated and informed decisions are made about biosimilar use.
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              Personalizing health care: feasibility and future implications

              Considerable variety in how patients respond to treatments, driven by differences in their geno- and/ or phenotypes, calls for a more tailored approach. This is already happening, and will accelerate with developments in personalized medicine. However, its promise has not always translated into improvements in patient care due to the complexities involved. There are also concerns that advice for tests has been reversed, current tests can be costly, there is fragmentation of funding of care, and companies may seek high prices for new targeted drugs. There is a need to integrate current knowledge from a payer’s perspective to provide future guidance. Multiple findings including general considerations; influence of pharmacogenomics on response and toxicity of drug therapies; value of biomarker tests; limitations and costs of tests; and potentially high acquisition costs of new targeted therapies help to give guidance on potential ways forward for all stakeholder groups. Overall, personalized medicine has the potential to revolutionize care. However, current challenges and concerns need to be addressed to enhance its uptake and funding to benefit patients.
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                Author and article information

                Contributors
                Role: InvestigationRole: MethodologyRole: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: SupervisionRole: Writing – review & editing
                Role: ConceptualizationRole: SupervisionRole: Writing – review & editing
                Role: ConceptualizationRole: Writing – review & editing
                Role: ConceptualizationRole: MethodologyRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
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                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: InvestigationRole: Writing – review & editing
                Role: ConceptualizationRole: MethodologyRole: SupervisionRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                28 December 2017
                2017
                : 12
                : 12
                : e0190147
                Affiliations
                [1 ] KU Leuven Department of Pharmaceutical and Pharmacological Sciences, Leuven, Belgium
                [2 ] Hospital Pharmacy, Erasmus University Medical Center, Rotterdam, The Netherlands
                [3 ] Medicines for Europe, Brussels, Belgium
                [4 ] Department of Laboratory Medicine, Karolinska Institutet, Stockholm, Sweden
                [5 ] Strathclyde Institute for Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, United Kingdom
                [6 ] Main Association of Austrian Social Security Institutions, Vienna, Austria
                [7 ] Faculty of pharmaceutical sciences, Ghent University, Ghent, Belgium
                [8 ] Faculty of Pharmacy, Medical University of Sofia, Sofia, Bulgaria
                [9 ] Croatian Health Insurance Fund, Zagreb, Croatia
                [10 ] State Institute for Drug Control, Prague, Czech Republic
                [11 ] State Institute for Drug Control, Brno, Czech Republic
                [12 ] State Agency of Medicines, Tartu, Estonia
                [13 ] Department of Traumatology and Orthopedics, University of Tartu, Tartu, Estonia
                [14 ] Karr Consultancy Ltd, Hertfordshire, United Kingdom
                [15 ] OMEDIT Alsace, Agence Régionale de Santé du Grand Est, Strasbourg, France
                [16 ] Research Unit, Social Insurance Institution, Helsinki, Finland
                [17 ] Wissenschaftliches Institut der AOK (WIdO), Berlin, Germany
                [18 ] Department of Pharmacology and Therapeutics, Trinity College Dublin, Dublin, Ireland
                [19 ] National Centre for Pharmacoeconomics, St James's Hospital, Dublin, Ireland
                [20 ] Department of Biomedical and Dental Sciences and Morphofunctional Imaging, University of Messina, Messina, Italy
                [21 ] Strathclyde Institute for Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, United Kingdom
                [22 ] Division Pharmaceuticals, Norwegian Hospital Procurement Trust, Oslo, Norway
                [23 ] Department of Medicines and Medical Devices, The National Health Service, Riga, Latvia
                [24 ] HTA Consulting, Cracow, Poland
                [25 ] Faculty of Pharmacy, University of Lisbon, Lisbon, Portugal
                [26 ] Semashko National Research Institute for Public Health, Moscow, Russia
                [27 ] Primary healthcare center Zemun, Belgrade, Serbia
                [28 ] Agency for Medicinal Products and Medical Devices of the Republic of Slovenia, Ljubljana, Slovenia
                [29 ] Health Insurance Institute, Ljubljana, Slovenia
                [30 ] Barcelona Health Region, Catalan Health Service, Barcelona, Spain
                [31 ] TLV, Stockholm, Sweden
                [32 ] Ministry of Welfare, Reykjavik, Iceland
                Jagiellonian University, POLAND
                Author notes

                Competing Interests: Steven Simoens, Isabelle Huys, and Arnold G. Vulto are the founders of the KU Leuven Fund on Market Analysis of Biologics and Biosimilars following Loss of Exclusivity. Steven Simoens, Isabelle Huys, and Arnold G. Vulto are conducting biosimilar research sponsored by Hospira (now Pfizer). Steven Simoens is involved in a stakeholder roundtable on biosimilars sponsored by Amgen, Pfizer and MSD, and has participated in an advisory board meeting on biosimilars for Pfizer. Arnold G. Vulto is involved in consulting, advisory work and speaking engagements for a number of companies, a.o. AbbVie, Amgen, Biogen, EGA, Pfizer/Hospira, Mundipharma, Roche, Sandoz. Pieter Dylst was employed full-time by Medicines for Europe at the time of the study and did not receive any honoraria from pharmaceutical companies. Gianluca Trifirò participated in the last five years in expert meeting boards organized by Sandoz and Hospira. Simona Mencej Bedrač declares that she was an employee of Lek Pharmaceuticals d. d. (Sandoz group). All remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. These interests do not alter our adherence to PLOS ONE policies on sharing data and materials.

                Author information
                http://orcid.org/0000-0002-9570-470X
                Article
                PONE-D-17-26394
                10.1371/journal.pone.0190147
                5746224
                29284064
                bbd5f6e7-8d64-4b78-9b55-5eb1925eda35
                © 2017 Moorkens et al

                This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

                History
                : 13 July 2017
                : 9 December 2017
                Page count
                Figures: 0, Tables: 1, Pages: 17
                Funding
                The authors received no specific funding for this work.
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