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      Addressing the challenge of high-priced prescription drugs in the era of precision medicine: A systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks

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          Abstract

          Context

          Recent public outcry has highlighted the rising cost of prescription drugs worldwide, which in several disease areas outpaces other health care expenditures and results in a suboptimal global availability of essential medicines.

          Method

          A systematic review of Pubmed, the Financial Times, the New York Times, the Wall Street Journal and the Guardian was performed to identify articles related to the pricing of medicines.

          Findings

          Changes in drug life cycles have dramatically affected patent medicine markets, which have long been considered a self-evident and self-sustainable source of income for highly profitable drug companies. Market failure in combination with high merger and acquisition activity in the sector have allowed price increases for even off-patent drugs. With market interventions and the introduction of QALY measures in health care, governments have tried to influence drug prices, but often encounter unintended consequences. Patent reform legislation, reference pricing, outcome-based pricing and incentivizing physicians and pharmacists to prescribe low-cost drugs are among the most promising short-term policy options. Due to the lack of systematic research on the effectiveness of policy measures, an increasing number of ad hoc decisions have been made with counterproductive effects on the availability of essential drugs. Future challenges demand new policies, for which recommendations are offered.

          Conclusion

          A fertile ground for high-priced drugs has been created by changes in drug life-cycle dynamics, the unintended effects of patent legislation, government policy measures and orphan drug programs. There is an urgent need for regulatory reform to curtail prices and safeguard equitable access to innovative medicines.

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          Most cited references188

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          Commercial features of placebo and therapeutic efficacy.

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            Is pharma running out of brainy ideas?

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              Cancer drugs in 16 European countries, Australia, and New Zealand: a cross-country price comparison study.

              Cancer drugs challenge health-care systems because of their high prices. No cross-country price comparison of cancer drugs for a large number of countries has been published. We aimed to survey the prices of cancer drugs in high-income countries (Europe, Australia, and New Zealand).
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                Author and article information

                Contributors
                Role: ConceptualizationRole: Data curationRole: Formal analysisRole: InvestigationRole: MethodologyRole: Writing – original draftRole: Writing – review & editing
                Role: Writing – original draftRole: Writing – review & editing
                Role: ConceptualizationRole: Formal analysisRole: InvestigationRole: MethodologyRole: Project administrationRole: ResourcesRole: SupervisionRole: ValidationRole: VisualizationRole: Writing – original draftRole: Writing – review & editing
                Role: Editor
                Journal
                PLoS One
                PLoS ONE
                plos
                plosone
                PLoS ONE
                Public Library of Science (San Francisco, CA USA )
                1932-6203
                16 August 2017
                2017
                : 12
                : 8
                : e0182613
                Affiliations
                [1 ] Department of Pharmaceutical Sciences, Utrecht Institute for Pharmaceutical Sciences (UIPS), Utrecht University, Utrecht, the Netherlands
                [2 ] Institute for Medical Technology Assessment, Department of Health Policy & Management, Erasmus University, Rotterdam, the Netherlands
                Deakin University, AUSTRALIA
                Author notes

                Competing Interests: The authors have declared that no competing interests exist.

                Author information
                http://orcid.org/0000-0002-8156-8436
                Article
                PONE-D-16-25070
                10.1371/journal.pone.0182613
                5559086
                28813502
                6b3fa70c-b6d3-4a5d-81fe-837ab7b2f46a
                © 2017 Gronde 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
                Page count
                Figures: 3, Tables: 1, Pages: 34
                Funding
                This study was performed in the context of regular research of the Division of Pharmacoepidemiology and Clinical Pharmacology (Utrecht University), employing authors TvdG and TP, and of the Institute for Medical Technology Assessment, Department of Health Policy & Management, Erasmus University, Rotterdam, employing CU. The university had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
                Categories
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                Medicine and Health Sciences
                Pharmacology
                Drug Research and Development
                Medicine and Health Sciences
                Health Care
                Health Care Policy
                Drug Policy
                Medicine and Health Sciences
                Public and Occupational Health
                Drug Policy
                Medicine and Health Sciences
                Pharmacology
                Drug Research and Development
                Drug Marketing
                Medicine and Health Sciences
                Pharmacology
                Drug Research and Development
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                Medicine and Health Sciences
                Pharmacology
                Drug Research and Development
                Drug Licensing
                Biology and Life Sciences
                Developmental Biology
                Life Cycles
                Medicine and Health Sciences
                Pharmacology
                Drugs
                Medicine and Health Sciences
                Health Care
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                Medical Doctors
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