PMID- 31562607 OWN - NLM STAT- MEDLINE DCOM- 20200617 LR - 20231014 IS - 1865-8652 (Electronic) IS - 0741-238X (Print) IS - 0741-238X (Linking) VI - 36 IP - 11 DP - 2019 Nov TI - 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. PG - 3079-3095 LID - 10.1007/s12325-019-01095-1 [doi] AB - 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. FAU - Long, Grainne H AU - Long GH AD - Roche Pharmaceuticals Ltd., Real World Data Science, Hertfordshire, UK. FAU - Tatro, Amanda R AU - Tatro AR AD - Genentech, Inc., South San Francisco, CA, USA. FAU - Oh, Young S AU - Oh YS AD - Genentech, Inc., South San Francisco, CA, USA. FAU - Reddy, Sheila R AU - Reddy SR AD - Partnership for Health Analytic Research, Beverly Hills, CA, USA. FAU - Ananthakrishnan, Ashwin N AU - Ananthakrishnan AN AD - Massachusetts General Hospital, Boston, MA, USA. aananthakrishnan@mgh.harvard.edu. AD - Harvard Medical School, Boston, MA, USA. aananthakrishnan@mgh.harvard.edu. LA - eng PT - Journal Article PT - Research Support, Non-U.S. Gov't DEP - 20190927 PL - United States TA - Adv Ther JT - Advances in therapy JID - 8611864 RN - 0 (Adrenal Cortex Hormones) RN - 0 (Immunosuppressive Agents) MH - Adrenal Cortex Hormones/therapeutic use MH - Adult MH - Colitis, Ulcerative/drug therapy/economics MH - Crohn Disease/drug therapy/economics MH - Female MH - Health Care Costs MH - Health Resources MH - Hospitalization/*economics MH - Humans MH - Immunosuppressive Agents/therapeutic use MH - Inflammatory Bowel Diseases/*drug therapy/*economics MH - Male MH - Middle Aged MH - Treatment Outcome MH - United States PMC - PMC6822802 OTO - NOTNLM OT - Aminosalicylates OT - Annualized medical cost OT - Anti-tumor necrosis factor alpha OT - Claims database OT - Corticosteroids OT - Crohn's disease OT - Gastroenterology OT - Healthcare resource utilization OT - Ulcerative colitis EDAT- 2019/09/29 06:00 MHDA- 2020/06/18 06:00 PMCR- 2019/09/27 CRDT- 2019/09/29 06:00 PHST- 2019/04/12 00:00 [received] PHST- 2019/09/29 06:00 [pubmed] PHST- 2020/06/18 06:00 [medline] PHST- 2019/09/29 06:00 [entrez] PHST- 2019/09/27 00:00 [pmc-release] AID - 10.1007/s12325-019-01095-1 [pii] AID - 1095 [pii] AID - 10.1007/s12325-019-01095-1 [doi] PST - ppublish SO - Adv Ther. 2019 Nov;36(11):3079-3095. doi: 10.1007/s12325-019-01095-1. Epub 2019 Sep 27.