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      Can biosimilars help achieve the goals of US health care reform?

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          Abstract

          The US Patient Protection and Affordable Care Act (ACA) aims to expand health care coverage, contain costs, and improve health care quality. Accessibility and affordability of innovative biopharmaceuticals are important to the success of the ACA. As it is substantially more difficult to manufacture them compared with small-molecule drugs, many of which have generic alternatives, biologics may increase drug costs. However, biologics offer demonstrated improvements in patient care that can reduce expensive interventions, thus lowering net health care costs. Biosimilars, which are highly similar to their reference biologics, cost less than the originators, potentially increasing access through reduced prescription drug costs while providing equivalent therapeutic results. This review evaluates 1) the progress made toward enacting health care reform since the passage of the ACA and 2) the role of biosimilars, including the potential impact of expanded biosimilar use on access, health care costs, patient management, and outcomes. Barriers to biosimilar adoption in the USA are noted, including low awareness and financial disincentives relating to reimbursement. The evaluated evidence suggests that the ACA has partly achieved some of its aims; however, the opportunity remains to transform health care to fully achieve reform. Although the future is uncertain, increased use of biosimilars in the US health care system could help achieve expanded access, control costs, and improve the quality of care.

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          Most cited references 56

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          What do people really think of generic medicines? A systematic review and critical appraisal of literature on stakeholder perceptions of generic drugs

          Background Considerable emphasis is presently being placed on usage of generic medicines by governments focussed on the potential economic benefits associated with their use. Concurrently, there is increasing discussion in the lay media of perceived doubts regarding the quality and equivalence of generic medicines. The objective of this paper is to report the outcomes of a systematic search for peer-reviewed, published studies that focus on physician, pharmacist and patient/consumer perspectives of generic medicines. Methods Literature published between January 2003 and November 2014, which is indexed in PubMed and Scopus, on the topic of opinions of physicians, pharmacists and patients with respect to generic medicines was searched, and articles within the scope of this review were appraised. Search keywords used included perception, opinion, attitude and view, along with keywords specific to each cohort. Results Following review of titles and abstracts to identify publications relevant to the scope, 16 papers on physician opinions, 11 papers on pharmacist opinions and 31 papers on patient/consumer opinions were included in this review. Quantitative studies (n = 37) were the most common approach adopted by researchers, generally in the form of self-administered questionnaires/surveys. Qualitative methodologies (n = 15) were also reported, albeit in fewer cases. In all three cohorts, opinions of generic medicines have improved but some mistrust remains, most particularly in the patient group where there appears to be a strongly held belief that less expensive equals lower quality. Acceptance of generics appears to be higher in consumers with higher levels of education while patients from lower socioeconomic demographic groups, hence generally having lower levels of education, tend to have greater mistrust of generics. Conclusions A key factor in improving confidence in generic products is the provision of information and education, particularly in the areas of equivalency, regulation and dispelling myths about generic medicines (such as the belief that they are counterfeits). Further, as patient trust in their physician often overrules their personal mistrust of generic medicines, enhancing the opinions of physicians regarding generics may have particular importance in strategies to promote usage and acceptance of generic medicines in the future.
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            The economics of biosimilars.

            The high cost of pharmaceuticals, especially biologics, has become an important issue in the battle to control healthcare costs. The Hatch-Waxman Act encourages generic competition but still provides incentives for pioneers to develop new drugs. The Biologics Price Competition and Innovation Act is intended to do the same for biologics and biosimilars.
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              Potential cost savings from chemotherapy-induced febrile neutropenia with biosimilar filgrastim and expanded access to targeted antineoplastic treatment across the European Union G5 countries: a simulation study.

              The objectives of this study were to simulate for the European Union G5 countries the potential cost savings of converting patients from originator granulocyte colony-stimulating factor (G-CSF) filgrastim and pegfilgrastim to a biosimilar filgrastim, to evaluate how reallocating these savings could increase patient access to antineoplastic therapy, and to estimate the number of patients needed to convert to provide antineoplastic treatment to one patient.
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                Author and article information

                Journal
                Cancer Manag Res
                Cancer Manag Res
                Cancer Management and Research
                Cancer Management and Research
                Dove Medical Press
                1179-1322
                2017
                01 June 2017
                : 9
                : 197-205
                Affiliations
                [1 ]Center for Cancers and Blood Disorders, Bethesda, MD
                [2 ]Global Medical Affairs, Pfizer Inc., New York, NY
                [3 ]US Government Relations, Pfizer Inc., Washington, DC
                [4 ]Sylvester Comprehensive Cancer Center, University of Miami, Miami, FL, USA
                Author notes
                Correspondence: Ira Jacobs, Global Medical Affairs, Pfizer Inc., 235 East 42nd Street, New York, NY 10017-5755, USA, Tel +1 212 733 0876, Fax +1 845 474 5301, Email ira.jacobs@ 123456pfizer.com
                Article
                cmar-9-197
                10.2147/CMAR.S133442
                5459961
                © 2017 Boccia et al. This work is published and licensed by Dove Medical Press Limited

                The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License ( http://creativecommons.org/licenses/by-nc/3.0/). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed.

                Categories
                Review

                Oncology & Radiotherapy

                affordable care act, biologics, health policy, patient care, access

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