ORIGINAL ARTICLE Resources Utilization and Costs the Year Before and After Starting Treatment with Adalimumab in Crohn’s Disease Patients Cristina Saro, MD,* Daniel Ceballos, MD, † Fernando Muñoz, MD, ‡ Cristóbal De la Coba, MD,* María Dolores Aguilar, MD, MPH, PhD, § Pablo Lázaro, MD, MBA, PhD, § Eva Iglesias-Flores, MD, jj ,¶ Manuel Barreiro-de Acosta, MD, PhD,** María-Dolores Hernández-Durán, MD, †† Jesús Barrio, MD, ‡‡ Sabino Riestra, MD, PhD, §§ and Luis Fernández Salazar, MD, PhD jjjj on behalf of the EFICADEC Researchers Group Background: This study examines the resources utilization in patients with Crohn’s disease (CD) during the year before (Y 2 1) and after (Y + 1) starting treatment with adalimumab and the drug’s efficiency. Methods: Observational, multicenter, prospective cohort study of patients with CD naive to biological drugs. The proportion of patients with CD Activity Index (CDAI) ,150 was considered as the effectiveness variable. Costs considered were direct costs (DC) related to the use of health care resources, and indirect costs (IC) related to sick leave in Y 2 1 and Y + 1. Adalimumab efficiency was estimated as the incremental cost/effectiveness ratio. A deterministic sensitivity analysis was performed building 3 scenarios: base case, the least favorable, and the most favorable case for adalimumab. Results: In the cohort of 126 patients (50.8% men; age 39.1 6 13.8 yr), the proportion of patients in remission increased from 34.1% by the end of Y 2 1 to 83.3% by the end of Y + 1. Although the DC increase by the use of adalimumab, the use of doctor visits, emergency room visits, laboratory tests, diagnostic examinations, and nonbiological drug treatment were lower (P , 0.05) in Y + 1 than Y 2 1. In the base case scenario, considering only DC, the incremental cost/effectiveness ratio was €31,308 and including IC, it was €28,936. In patients with CDAI . 150 at the onset, incremental cost/ effectiveness ratio was €20,119 and €18,223, considering DC alone or included IC, respectively. Conclusions: In patients with CD, adalimumab increases pharmacological costs at the expense of biological therapy but reduces the cost of other drugs, the use of health care resources, and IC. Adalimumab efficiency is 30% greater in patients with CDAI . 150. (Inflamm Bowel Dis 2015;21:1631–1640) Key Words: adalimumab, Crohn’s disease, IBD, resources utilization C rohn’s disease (CD) is a chronic inflammatory disease, which may involve any area of the gastrointestinal tract and with a clinical course characterized by periods of relapse and remission. Clinical manifestations are varied, and the trans- mural involvement that typifies the disease leads to different clin- ical patterns, such as nonstenotic and nonpenetrating pattern or inflammatory pattern (penetrating or stenotic), and different com- plications, such as stenosis, fistulae, or abscesses. 1,2 CD’s incidence rate has been increasing in recent years with latest estimates at about 9 cases per 100,000 inhabitants/ year. 3–6 CD tends to be diagnosed during young adulthood, and despite having a mortality rate similar to that of the general pop- ulation, the morbidity related to the disease and treatments is high and affects patients for most of their lives with the corresponding impact on their quality of life, work productivity, personal life, and use of health care resources. 7–9 Concerns over CD’s financial impact have generated research on CD-related health care and social costs. Hay et al, in a 1992 study in the United States, estimated an annual average direct cost per patient of $6561 of whom 56% went to hospitalization, followed by surgery costs. Over one-third of the cost (34.3%) was attributed to 2% of the patients, and 80% of the cost generated by 20% of patients. 10 A 2000 Canadian study, by Feagan et al, 8 estimated $12,417 as the average annual direct cost per patient (57% hospi- talization costs) with 25% of patients originating 80% of the cost. Received for publication February 22, 2015; Accepted February 27, 2015. From the *Gastroenterology Service, Hospital de Cabueñes, Gijón, Spain; † Gas- troenterology Service, Hospital Dr. Negrín, Las Palmas, Spain; ‡ Gastroenterology Ser- vice, Complejo Asistencial Universitario de León, León, Spain; § Research Department, Advanced Techniques for Health Services Research, Madrid, Spain; jj Digestive System Service, Hospital Universitario Reina Sofía, Córdoba, Spain; ¶ Instituto Maimónides de Investigación Biomédica de Córdoba (IMIBIC), Universidad de Córdoba, Córdoba, Spain; **Gastroenterology Service, Hospital Clínico Universitario de Santiago, Santiago de Compostela, Spain; †† Gastroenterology Service, Hospital Virgen del Puerto, Plasencia, Cáceres, Spain; ‡‡ Gastroenterology Service, Hospital Universitario Río Hortega, Valladolid, Spain; §§ Gastroenterology Department, University Central Hospital of Asturias, Oviedo, Spain; and jjjj Gastroenterology Unit, Hospital Clínico Universitario de Valladolid, Valladolid, Spain. Supported by a grant from the Spanish Working Group on Crohn’s Disease and Ulcerative Colitis (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa [GETECCU]). The authors have no relevant conflicts of interest to disclose. Members of the EFICADEC Researchers Group are listed in the Acknowledgments. Reprints: Pablo Lázaro, MD, MBA, PhD, Costa Brava 47, Esc. 1, 38C, 28034 Madrid, Spain (e-mail: plazaro@gmx.es). Copyright © 2015 Crohn’s & Colitis Foundation of America, Inc. DOI 10.1097/MIB.0000000000000413 Published online 8 May 2015. Inflamm Bowel Dis  Volume 21, Number 7, July 2015 www.ibdjournal.org | 1631 Copyright © 2015 Crohn’s & Colitis Foundation of America, Inc. Unauthorized reproduction of this article is prohibited. Downloaded from https://academic.oup.com/ibdjournal/article-abstract/21/7/1631/4604266 by guest on 01 June 2020