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      Analysis of Safety, Medical Resource Utilization, and Treatment Costs by Drug Class for Management of Inflammatory Bowel Disease in the United States Based on Insurance Claims Data

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          Abstract

          Introduction

          Conventional pharmaceutical interventions for inflammatory bowel disease (IBD) provide limited disease/symptom control and are associated with an increased risk of adverse events (AEs). These limitations increase patient morbidity, medical resource utilization (MRU), and costs.

          Methods

          The IQVIA™ Real-World Data Adjudicated Claims–US database was leveraged to identify adult patients (> 18 years) with Crohn’s disease (Crohn’s) or ulcerative colitis (UC), who were new and chronic users (≥ 60 days) of oral corticosteroids (OCS), immunosuppressants (IS), anti-tumor necrosis factor agents (anti-TNF) or combinations thereof. Using aminosalicylate-treated patients as a reference, we compared AE incidence, MRU, and medical costs across drug classes.

          Results

          The analysis included 30,676 patients (Crohn’s: n = 14,528; UC: n  = 16,148). OCS monotherapy was the strongest predictor of any AE occurring [Crohn’s: hazard ratio 1.62 (1.51–1.73); UC: hazard ratio 1.57 (1.49–1.66)]. A similar pattern was observed for severe infection and bone-related conditions. Patients with UC or Crohn’s receiving OCS or IS plus OCS were more likely to have emergency department visits, IBD-related hospitalizations/visits/procedures, and gastrointestinal surgery than were patients receiving other therapies. Annualized total medical costs (pharmacy plus hospital service costs) were greatest for anti-TNF plus IS or anti-TNF therapy in both Crohn’s and UC. Annualized medical service costs (excluding IBD drug costs) were highest for patients initiating OCS-containing therapies [Crohn’s: OCS, $27,041 (24,882–29,200) and OCS plus IS, $23,332 (19,889–26,775); UC: OCS, $19,659 (17,977–21,340)].

          Conclusion

          Although biologic therapies have higher pharmacy costs, treatment decisions should consider the increased AE risks and long-term MRU costs associated with chronic use of OCS-containing therapies.

          Funding

          This study was funded by F. Hoffmann-La Roche Ltd. The journal’s Rapid Service Fee and Open Access publication were paid for by ApotheCom on behalf of Genentech, a member of the Roche group who funded the study.

          Electronic Supplementary Material

          The online version of this article (10.1007/s12325-019-01095-1) contains supplementary material, which is available to authorized users.

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          Most cited references23

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          Burden of Gastrointestinal, Liver, and Pancreatic Diseases in the United States.

          Gastrointestinal (GI), liver, and pancreatic diseases are a source of substantial morbidity, mortality, and cost in the United States. Quantification and statistical analyses of the burden of these diseases are important for researchers, clinicians, policy makers, and public health professionals. We gathered data from national databases to estimate the burden and cost of GI and liver disease in the United States.
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            Prevalence of Inflammatory Bowel Disease Among Adults Aged ≥18 Years - United States, 2015.

            Crohn's disease and ulcerative colitis, collectively known as inflammatory bowel disease (IBD), are characterized by chronic inflammation of the gastrointestinal tract (1). IBD has been associated with poor quality of life and extensive morbidity and often results in complications requiring hospitalizations and surgical procedures (2-4). Most previous studies of IBD have used administrative claims data or data collected from limited geographic areas to demonstrate increases in estimated prevalence of IBD within the United States (5,6). Few national prevalence estimates of IBD among adults based on large, nationally representative data sources exist, and those that do tend to be based on older data. For example, the most recent national study used 1999 National Health Interview Survey (NHIS) data and estimated that 1.8 million (0.9%) U.S. adults had IBD (7). To examine the prevalence of IBD among the civilian, noninstitutionalized U.S. adult population, data from the 2015 NHIS were analyzed. Overall, an estimated 3.1 million, or 1.3%, of U.S. adults have received a diagnosis of IBD. Within population subgroups, a higher prevalence of IBD was identified among adults aged ≥45 years, Hispanics, non-Hispanic whites, and adults with less than a high school level of education, not currently employed, born in the United States, living in poverty, or living in suburban areas. The use of a nationally representative data source such as the NHIS to estimate the prevalence of IBD overall and by population subgroups is important to understand the burden of IBD on the U.S. health care system.
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              Side effects of corticosteroid therapy.

              Corticosteroids have been used for the treatment of inflammatory bowel disease since the late 1940s. Upwards of 80% of patients may respond acutely to treatment with these medications, although 20% or more may be refractory and others become dependent on corticosteroid use to suppress disease activity. Side effects in the acute situation are relatively minor, although significant side effects (e.g., psychosis) have been encountered; the long-term use of corticosteroids is more problematic. This creates a milieu for the potential for serious and irreversible problems. These side effects are discussed in detail. The side effects from corticosteroids emulate from exogenous hypercortisolism, which is similar to the clinical syndrome of Cushing's disease. PubMed search for years 1966-2000, author's personal manuscript/abstract files, and citations of known references. Short-term corticosteroid use is associated with generally mild side effects, including cutaneous effects, electrolyte abnormalities, hypertension, hyperglycemia, pancreatitis, hematologic, immunologic, and neuropsychologic effects, although occasionally, clinically significant side effects may occur. Long-term corticosteroid use may be associated with more serious sequel, including osteoporosis, aseptic joint necrosis, adrenal insufficiency, gastrointestinal, hepatic, and ophthalmologic effects, hyperlipidemia, growth suppression, and possible congenital malformations.
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                Author and article information

                Contributors
                aananthakrishnan@mgh.harvard.edu
                Journal
                Adv Ther
                Adv Ther
                Advances in Therapy
                Springer Healthcare (Cheshire )
                0741-238X
                1865-8652
                27 September 2019
                27 September 2019
                2019
                : 36
                : 11
                : 3079-3095
                Affiliations
                [1 ]Roche Pharmaceuticals Ltd., Real World Data Science, Hertfordshire, UK
                [2 ]GRID grid.418158.1, ISNI 0000 0004 0534 4718, Genentech, Inc., ; South San Francisco, CA USA
                [3 ]GRID grid.430055.7, Partnership for Health Analytic Research, ; Beverly Hills, CA USA
                [4 ]GRID grid.32224.35, ISNI 0000 0004 0386 9924, Massachusetts General Hospital, ; Boston, MA USA
                [5 ]GRID grid.38142.3c, ISNI 000000041936754X, Harvard Medical School, ; Boston, MA USA
                Article
                1095
                10.1007/s12325-019-01095-1
                6822802
                31562607
                64dbc913-9628-48ba-bc05-0c78277df4de
                © The Author(s) 2019

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 International License ( http://creativecommons.org/licenses/by-nc/4.0/), which permits any noncommercial use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

                History
                : 12 April 2019
                Funding
                Funded by: This study was supported by Genentech, Inc., a Member of the Roche Group
                Categories
                Original Research
                Custom metadata
                © Springer Healthcare Ltd., part of Springer Nature 2019

                aminosalicylates,annualized medical cost,anti-tumor necrosis factor alpha,claims database,corticosteroids,crohn’s disease,gastroenterology,healthcare resource utilization,ulcerative colitis

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