References 1 Dennison C, Prasad M, Lloyd A, Bhattacharyya SK, Dhawan R, Coyne K. The health- related quality-of-life and economic burden of constipation. Pharmacoeconomics. 2005;23:461-76. 2 Kleinman NL, Brook RA, Melkonian AK, Baran RW. Healthcare Cost Comparisons by Point of Service for Persons With or Without Constipation. Am J Gastroenterol. Sep 2006; 101(suppl2):S408. 3 Brook RA, Kleinman NL, Melkonian AK, Baran RW. Cost of Illness for Constipation: Medical, Pharmacy, and Work Absence Costs in Employees With or Without Constipation. Am J Gastroenterol. Sep 2006; 101(suppl2):S408. 4 Martin BC, Barghout V, Cerulli A. Direct medical costs of constipation in the United States. Manag Care Interface. 2006 Dec;19(12):43-9. 5 Nyrop KA, Palsson OS, Levy RL, Korff MV, Feld AD, Turner MJ, Whitehead WE. Costs of health care for irritable bowel syndrome, chronic constipation, functional diarrhea and functional abdominal pain. Aliment Pharmacol Ther. 2007 Jul;26(2):237-248 6 Cash B, Sullivan S, Barghout V. Total costs of IBS: employer and managed care perspective. Am J Manag Care. 2005;11:S7-16. 7 Longstreth GF, Wilson A, Knight K, Wong J, Chiou CF, Barghout V, Frech F, Ofman JJ. Irritable bowel syndrome, healthcare use, and costs: a U.S. managed care perspective. Am J Gastroenterol. 2003;98:600-7. 8 Leong SA, Barghout V, Birnbaum HG, Thibeault CE, Ben-Hamadi R, Frech F, Ofman JJ. The economic consequences of irritable bowel syndrome: a US employer perspective. Arch Intern Med. 2003;163:929-35. 9 Charlson ME, Pompei P, Ales KL, MacKenzie CR.. A new method of classifying prognostic comorbidity in longitudinal studies: development and validation. J Chronic Dis. 1987;40:373-83. 10 Mitra D, Davis KL, Baran RW. Health care utilization and costs associated with constipation (C-only) and co-occurring irritable bowel syndrome and constipation (IBS+C) compared to migrane in a large managed care population. Value Health. 2007; 10(3):A148- A149. Presented at the 13th Annual International Meeting of the International Society for Pharmacoeconomics and Outcomes Research May 3-7, 2008, Sheraton Centre Toronto, Toronto, Ontario, Canada Citation: Kleinman NL, Brook RA, Melkonian AK, Evans S, Talley NJ, Baran RW. Direct Cost Similarities by Point of Service for Persons with Constipation or Irritable Bowel Syndrome Plus Constipation in the 6 Months Before and After Diagnosis: An Employer Perspective. Value Health. 2008; 11(3) Introduction: •฀ Constipation฀and฀Irritable฀Bowel฀Syndrome฀with฀Constipation฀(IBS+C)฀impose฀ substantial direct and indirect costs on the healthcare system and impair health-related quality-of-life. 1-5 •฀ Recent฀research฀demonstrates: – The projected total incremental direct costs for constipation in all US employees is $3.12 billion per year. 3 – The total direct costs in the US for healthcare encounters where constipation is the primary diagnosis exceeds $235 million annually. 4 – Patients presenting for GI complaints within the Group Health Cooperative health system incur annual mean direct costs of $5,049 for IBS and $7,522 for constipation. 5 •฀ Understanding฀how฀direct฀costs฀of฀constipation฀and฀IBS+C฀are฀segmented฀ throughout the healthcare system is important to managed care payers for effective cost containment. •฀ While฀some฀point-of-service฀(POS)฀direct฀cost฀analyses฀have฀been฀conducted฀ on IBS, 6-8 none have compared IBS+C with Constipation. •฀ Constipation฀and฀IBS+C฀may฀have฀a฀similar฀cost฀impact฀on฀the฀healthcare฀ system. •฀ This฀cost฀impact฀is฀also฀relevant฀to฀employers฀who฀fund฀healthcare. Aim: •฀ To฀examine฀the฀comparative฀direct฀cost฀burden฀of฀constipation฀and฀IBS+C฀for฀ insured employees by quantifying direct costs of illness by point-of-service throughout the healthcare continuum. Methods: •฀ A฀retrospective฀analysis฀was฀performed฀on฀data฀extracted฀from฀the฀Human฀ Capital Management Services (HCMS) Research consisting of approximately 510,000 employees representative of the US Employed Civilian Labor Force (2004). •฀ Patient฀healthcare฀claims฀from฀1/1/2001฀to฀6/30/2006฀were฀included฀in฀the฀ analysis. •฀ All฀research฀adhered฀to฀HIPAA฀Guidelines.฀ •฀ Healthcare฀for฀the฀entire฀employee฀cohort฀was฀provided฀through฀managed฀ care plans contracted by respective employers. •฀ International฀Classiication฀of฀Diseases฀v.9฀(ICD-9)฀codes฀in฀claims฀records฀ were used to identify employees with primary, secondary, or tertiary diagnoses: – 564.0 (Constipation) ฀ –฀564.00฀(Constipation,฀Unspeciied)฀฀ – 564.01 564.01 (Constipation, Slow Transit) – 564.09 (Constipation, Other) – 564.1 (IBS) •฀ IBS+C฀was฀represented฀by฀the฀condition฀where฀an฀ICD-9฀for฀Constipation฀ plus an ICD-9 for IBS were co-occurring in the employee’s claims records. •฀ Two฀cohorts฀were฀created฀for฀comparison฀purposes:฀ – Constipation (C) cohort: Employees with at least one record of constipation diagnosis (constipation ICD-9 codes listed above) and no ICD-9 for IBS. – Irritable Bowel Syndrome plus constipation (IBS+C) cohort: Employees with at least one record of constipation diagnosis (constipation ICD-9 codes listed above) and at least one record of IBS diagnosis (ICD-9 for IBS). •฀ The฀index฀date฀in฀the฀C฀cohort฀was฀deined฀as฀the฀date฀of฀irst฀diagnosis฀of฀ constipation during 2001 or later as noted by ICD-9 code in the claims record. •฀ The฀index฀date฀in฀the฀IBS+C฀cohort฀was฀deined฀as฀the฀date฀of฀irst฀diagnosis฀ of IBS during 2001 or later as noted by ICD-9 code in the claims record. •฀ Employees฀were฀required฀to฀be฀continuously฀employed฀and฀eligible฀for฀health฀ beneits฀for฀at฀least฀six฀months฀before฀and฀six฀months฀after฀their฀index฀date.฀฀ •฀ C฀and฀IBS+C฀cohorts฀were฀compared฀over฀the฀six฀months฀preceding฀and฀ following the employee’s “index date.” •฀ The฀following฀outcomes฀measures฀were฀compared฀between฀C฀and฀IBS+C฀ cohorts: – POS direct costs: ฀ ฀฀฀•฀฀ Direct฀medical฀costs:฀Doctor’s฀Ofice;฀Inpatient฀Hospital;฀Outpatient฀ Hospital or Clinic; Emergency Department (ED); Laboratory; and “Other.” ฀ ฀฀฀•฀Prescription฀Drug฀(Rx)฀costs.฀ – Per member per month (PMPM) costs for each POS category. – Total direct costs: direct medical costs + Rx costs. Statistical Analysis: •฀ For฀each฀employee฀in฀the฀IBS+C฀cohort,฀5฀C฀employees฀were฀matched฀using฀ logistic regression and propensity scores for age, tenure (years with current employer),฀sex,฀marital฀status,฀race,฀exempt/nonexempt฀status฀(exempt฀ employees are not paid on an hourly basis and are not paid for overtime work),฀full-time/part-time฀status,฀salary,฀Charlson฀Comorbidity฀Index฀score, 9 region฀(deined฀by฀irst฀digit฀of฀employee’s฀postal฀zip฀code),฀and฀existence฀of฀ a direct medical claim. •฀ All฀costs฀were฀adjusted฀to฀2006฀dollars.฀ •฀ Differences฀were฀explored฀for฀signiicance: – Between cohorts (C vs. IBS+C), for the: ฀ ฀฀฀•฀฀ 6฀months฀prior฀to฀the฀index฀date,฀ ฀ ฀฀฀•฀฀ 6฀months฀after฀the฀index฀date,฀and฀ •฀฀ Change฀(after฀minus฀prior)฀ – Within cohorts (6 months prior to index date vs. 6 months after index date) •฀ Signiicant฀differences฀in฀costs฀between฀and฀within฀cohorts฀C฀and฀IBS+C฀ cohorts฀were฀deined฀via฀t tests at P < 0.05. Results: •฀ Data฀were฀available฀for฀203฀IBS+C฀employees฀and฀1015฀propensity-score฀ matched C employees (Table 1). ฀ –฀฀Following฀propensity฀score฀matching,฀no฀signiicant฀differences฀in฀the฀ demographic and other matching variables were observed between cohorts. •฀ Comparison฀of฀direct฀PMPM฀POS฀costs฀showed฀few฀signiicant฀differences฀ between the C and IBS+C cohorts (Table 2) ฀ –฀฀ Non-signiicant฀cost฀differences฀(all฀P > 0.05): ฀ ฀฀฀•฀฀ For฀all฀variables฀in฀the฀“before”฀period. ฀ ฀฀฀•฀฀ After฀period฀costs฀in฀the฀Outpatient฀Hospital/Clinic,฀Doctor’s฀Ofice,฀ED฀ and Laboratory were almost identical between the cohorts. ฀ ฀฀฀•฀฀ After฀period฀costs฀in฀the฀Inpatient฀Hospital฀were฀$228.1฀for฀C฀and฀$137.4฀ for฀IBS+C,฀however฀the฀$90.8฀difference฀was฀not฀signiicant ฀ –฀฀ Signiicant฀differences฀(all฀P < 0.05) between C and IBS+C cohorts were observed for after period: ฀฀ ฀฀฀•฀฀ “Other” costs were $18.3 for C vs. $2.6 for IBS+C (difference between cohorts $15.6, P=0.0426) ฀ ฀฀฀•฀Prescription drug costs were $977 for C and $136.7 for IBS+C (difference between cohorts -$39.0, P=0.0062) •฀ Comparison฀of฀direct฀PMPM฀POS฀costs฀showed฀few฀signiicant฀differences฀ within (prior - after) the C and IBS+C cohorts (Figure 1) although nearly all POS cost categories were higher after diagnosis ฀ –฀฀ Both฀cohorts฀signiicantly฀increased฀their฀expenditures฀for฀Prescription฀ Drugs (C by $13.4 and IBS+C by $45.4, both P<0.001). ฀ ฀฀฀•฀Prescription฀drug฀changes฀also฀signiicant฀between฀cohorts ฀ –฀฀ The฀C฀cohort฀also฀signiicantly฀increased฀for:฀ ฀฀฀฀•฀฀Outpatient฀Hospital฀or฀Clinic฀($75.8,฀P=0.0018) and ฀ ฀฀฀•฀฀ Emergency฀Department฀($6.6,฀P=0.0448) Limitations: •฀ Both฀constipation฀and฀IBS+C฀may฀be฀underreported฀in฀healthcare฀databases฀ due to ICD-9 coding anomalies. •฀ Cohorts฀were฀composed฀of฀continuously฀employed฀subjects,฀suggesting฀a฀ relatively healthy population for analysis and the potential for underestimation of disease burden. •฀ The฀clinical฀diagnosis฀of฀IBS-C฀must฀be฀inferred฀from฀the฀operational฀ deinition฀of฀the฀IBS+C฀cohort Summary and Conclusions: •฀ Both฀constipation฀and฀IBS+C฀are฀associated฀with฀substantial฀direct฀cost฀of฀ illness similar in magnitude to other chronic diseases, 10 which can be a large inancial฀liability฀to฀payers฀and฀employers. •฀ The฀only฀cost฀differences฀between฀groups฀in฀the฀after฀period฀were฀for: – Prescription drugs, which may be due to medications that are uniquely indicated for IBS+C. – “Other” services, which were higher for the constipation cohort. •฀ Prescription฀drug฀costs฀for฀both฀cohorts฀increased฀signiicantly฀within฀groups฀ (after-prior) •฀ Outpatient฀hospital฀or฀Clinic฀costs฀and฀ED฀costs฀also฀signiicantly฀increased฀ in the constipation cohort after diagnosis. •฀ Within฀(after-prior)฀cohort฀costs฀were฀increased฀for฀most฀categories฀in฀both฀ cohorts,฀but฀did฀not฀consistently฀reach฀signiicance. •฀ These฀results฀indicate฀an฀opportunity฀for฀improved฀management฀of฀patients฀ with both constipation and IBS-C, which may result in reduced costs from a payer and an employer perspective. DIRECT COST SIMILARITIES BY POINT OF SERVICE FOR PERSONS WITH CONSTIPATION OR IRRITABLE BOWEL SYNDROME PLUS CONSTIPATION IN THE 6 MONTHS BEFORE AND AFTER DIAGNOSIS: AN EMPLOYER PERSPECTIVE Kleinman NL 1 , Brook RA 2 , Melkonian AK 3 , Evans S 4 , Talley NJ 5 , Baran RW 6 1 HCMS Group, Paso Robles, CA; 2 The JeSTARx Group, Newfoundland, NJ, 3 HCMS Group, Yerevan, Armenia; 4 Sierra Health Services, Las Vegas, NV; 5 Mayo Clinic, Jacksonville, FL; 6 Takeda฀Global฀Research฀and฀Development,฀Deerield,฀IL฀ Table 1: Descriptive Statistics for Matched Cohorts of Employees with Constipation vs. Employees with IBS+C Employees with Constipation Employees with IBS+C Characteristic N Mean (S.E.) or n (% ) N Mean (S.E.) or n (%) Difference Age (at index date), years 1,015 40.83 (0.34) 203 39.55 (0.73) -1.28 Tenure, years 1,015 7.47 (0.23) 203 6.92 (0.48) -0.55 Female, % 1,015 742 (73.1) 203 160 (78.8) 5.7% Married, % 995 488 (49.0) 199 89 (44.7) -4.3% White, % 1,015 576 (56.7) 203 121 (59.6) 2.9% Black, % 1,015 124 (12.2) 203 24 (11.8) -0.4% Hispanic, % 1,015 160 (15.8) 203 30 (14.8) -1.0% Exempt, % 1,015 373 (36.7) 203 79 (38.9) 2.2% Full Time, % 1,015 986 (97.1) 203 195 (96.1) -1.1% Annual Salary, US $ 1,015 $51,913 ($1,070) 203 $51,702 ($2,069) -$211 All variables similar (P>0.05). S.E. = Standard Error Table 2: Between Cohort Per Member Per Month Point-of-Service Costs Employees with Constipation Employees with IBS+C Constipation vs. IBS+C (N=1015) (N=203) Between Cohort Difference in means, $ US Per Member Per Month Cost Adjusted Mean Cost, $ US Adjusted Mean Cost, $ US Prior to Diagnosis ฀ ฀ Doctor’s฀Ofice฀ $110.2฀ $118.0฀ -$7.8 Inpatient Hospital $240.8 $113.5 $127.3 Outpatient Hospital or Clinic $187.8 $187.5 $0.3 Emergency Department $10.4 $8.9 $1.6 Laboratory $3.3 $5.6 -$2.4 Other $5.7 $4.1 $1.7 Prescription Drug $84.4 $91.3 -$7.0 Total $642.5 $528.8 $113.8 After Diagnosis ฀ ฀ Doctor’s฀Ofice฀ $127.7฀ $127.7฀ -$0.1 Inpatient Hospital $228.1 $137.4 $90.8 Outpatient Hospital or Clinic $263.6 $263.5 $0.1 Emergency Department $17.1 $15.6 $1.4 Laboratory $4.2 $5.7 -$1.5 Other $18.3 $2.6 $15.6* Prescription Drug $97.7 $136.7 -$39.0* Total $756.7 $689.4 $67.4 * Signiicant฀Difference฀Between฀cohorts฀(P≤0.05). $1.0 $9.8 $23.9 $6.8 $0.1 -$1.4 $160.6 $75.8 † $6.6 † -$12.6 $17.5 $13.4* † $12.6 $114.2 $76.1 $45.4* ‡ -$25 $25 $75 $125 $175 Doctor's Office Inpatient Hospital Outpatient Hospital or Clinic Emergency Department Laboratory Total Point-of-Service PMPM Cost Change (after-prior) Employees with Constipation Employees with IBS+C Other Drug Prescription Figure 1: Change in Per Member Per Month Point-of-Service Costs Signiicantly฀(P<0.05) different: *Between Cohorts (C vs. IBS+C); Within (After-Before) Cohort: † C Cohort; ‡ IBS+C Cohort This study funded by Takeda Global Research and Development, Deerfield, IL