Satisfactory Adherence to Intranasal Corticosteroids is Associated - PowerPoint PPT Presentation

Satisfactory Adherence to Intranasal Corticosteroids is Associated With Significantly Reduced Number and Costs of Outpatient Visits Among Patients Newly Diagnosed With Allergic Rhinitis Philip O. Buck 1 ; Cheryl S. Hankin 2 ; Linda Cox 3 ; Amy Bronstone 2 ; Zhaohui Wang 2 ; Mark S. Lepore 1 1 Teva Pharmaceuticals, Inc., Frazer, PA; 2 BioMedEcon, Moss Beach, CA; 3 Nova Southeastern University School of Osteopathic Medicine, Ft Lauderdale, FL Funding for this research was provided by Teva Pharmaceuticals 1

Background  Estimated global prevalence of allergic rhinitis (AR): 400 million 1 • 10-30% of adults • 40% of children  Global prevalence is on the rise • Climate change and increased air pollution • Greatest risk within urban and polluted regions  AR is a well-documented risk factor for 2,3 • Asthma • Obstructive sleep apnea • Eustachian tube dysfunction • Conjunctivitis • Sinusitis • Otitis media with effusion Eczema • Pharyngitis • • Other respiratory infections  Patient-related burden of AR 4-6 • Poor quality of life • Learning difficulties • Decreased appetite • Impaired school and work • Excessive daytime fatigue and • Reduced participation in sports performance somnolence and outdoor activities • Sleep disturbance • Depressed mood and irritability • Compromised social interactions  Economic burden of AR 7  In the U.S. alone, AR affects 30 to 60 million people and accounts for an estimated $14 billion (2012 USD) in annual direct costs.  This is roughly equivalent to the annual direct costs of adult vision problems in the U.S. 8 1. World Health Organization. White Book on Allergy 2011-2012 Executive Summary. By Prof. Ruby Pawankar, MD, PhD, Prof. Giorgio Walkter Canonica, MD, Prof. Stephen T. Holgate, BSc, MD, DSc, FMed Sci and Prof. Richard F. Lockey, MD.Wallace DV, Dykewicz MS, Bernstein DI, et al. J Allergy Clin Immunol. 2008;122(2 Suppl):S1-84. 2. Settipane RA. Complications of allergic rhinitis. Allergy Asthma Proc 1999;20:209-13. 3. Lack G. Pediatric allergic rhinitis and comorbid disorders. J Allergy Clin Immunol. 2001;108(suppl):S9 –S15. 4. Sundberg R, Toren K, Hoglund D, Aberg N, Brisman J. Nasal symptoms are associated with school performance in adolescents. J Adolesc Health. 2007;40:581–583. 5. Walker S, Khan-Wasti S, Fletcher M, Cullinan P, Harris J, Sheikh A. Seasonal allergic rhinitis is associated with a detrimental effect on examination performance in United Kingdom teenagers: case-control study. J Allergy Clin Immunol. 2007;120:381–387. 6. Leger D, Annesi-Maesano I, Carat F, et al. Allergic rhinitis and its consequences on quality of sleep: an unexplored area. Arch Intern Med. 2006;166:1744 –1748. 7. Soni A. Allergic rhinitis: Trends in use and expenditures, 2000 to 2005. Statistical Brief #204. Bethesda, MD: Agency for Healthcare Research and Quality; 2008. 8. Prevent Blindness America. The economic impact of vision problems: The toll of major adult eye disorders, visual impairment, and bliindness on the U.S. Economy. 2007. Accessed October 1, 2 2012. http://www.preventblindness.net/site/DocServer/Impact_of_Vision_Problems.pdf.

Study Objective  Intranasal corticosteroids (INS), first-line pharmacological treatment for moderate to severe persistent AR, 1 must be used continuously for maximum effectiveness. 2  Because of the chronic, long-term nature of persistent AR, adherence to therapy is difficult 3,4 and may result in unsatisfactory disease control, thereby increasing health care costs.  The objective of this study was to examine the relationship between adherence to INS and health care costs among patients with newly- diagnosed AR who initiate INS. 1. Soni A. Allergic rhinitis: Trends in use and expenditures, 2000 to 2005. Statistical Brief #204. Bethesda, MD: Agency for Healthcare Research and Quality; 2008. 2. Laekeman G, Simoens S, Buffels J et al. Respir Med . 2010;104:615-25 . 3. Wagner S, Luskin A, Bukstein D, et al. J Allergy Clin Immunol. 2009;123:S46. 4. Bukstein D, Luskin AT, Farrar JR. Allergy Asthma Proc. 2011;32:265-71 . 3

Methods: Study Design and Sample Selection DESIGN: All Florida Medicaid enrollees (1997-2009) Retrospective matched cohort study of Florida N=7,524,231 Medicaid claims data (July 1, 1997 to June 30, 2009) AR and age ≥12 years No AR or age <12 years SELECTION CRITERIA: N=7,416,181 N=108,050 • Age ≥12 years at 1 st identified AR claim • “Newly diagnosed” with AR Newly diagnosed AR Not newly diagnosed AR • No AR diagnosis ≥1 year preceding 1 st N=75,337 N=32,713 identified AR claim (ICD-9 477.0, 477.8, 477.9) Ever received ≥1 INS Rx Never received INS Rx • Ever received ≥1 INS Rx (per National Drug N=60,346 N=14,991 Codes; NDC) ≥1 year claims data preceding • Previously naïve to INS <1 year claims data ≥1 year preceding index INS fill without • index INS fill without any INS claim preceding index INS fill any claim filed for INS N=4,197 N=10,794 Index INS fill followed initial AR Index INS fill preceded initial AR • Index INS fill followed (rather than diagnosis diagnosis preceded) newly diagnosed AR N=5,405 N=5,389 • Sufficient data (≥3 years following ≥3 years claims data following <3 years claims data following index INS fill) for analysis index INS fill index INS fill N=3,665 N=1,740 Unsatisfactory INS adherence in Year 1 following index Satisfactory INS adherence in Year 1 following INS fill index INS fill N=3,179 N=486 Satisfactory adherence = Unsatisfactory adherence = Medication Possession Ratio ≥70% Medication Possession Ratio <70% 4

Methods: Analytic Approach  Definition of adherence  Medication possession ratio (MPR) = Total days supplied X 100 365 days following 1 st INS fill  “Satisfactory” INS adherence (Satisfactory- INS): MPR ≥70%  “Unsatisfactory” INS adherence (Unsatisfactory-INS): MPR <70%  Satisfactory-INS patients were matched 1:3 to Unsatisfactory-INS patients on  Age at first AR diagnosis ( ± 6 months)  Sex  Race/ethnicity  Charlson Comorbidity Index 1 year prior to initial AR diagnosis  Comorbid atopy (asthma, atopic dermatitis, conjunctivitis) 1 year prior to index INS fill  If an Satisfactory-INS patient had more than 3 Unsatisfactory-INS matches, we randomly selected 3 Unsatisfactory-INS patients from eligible matches  Because cost data are typically highly skewed, we conducted paired t-tests on log-transformed geometric mean costs. 5

Demographics After Matching Matched Control SATISFACTORY-INS UNSATISFACTORY-INS P Characteristic (N=343) (N=698) Value 12-17 years 29 (8.5) 65 (9.3) 18-29 years 52 (15.2) 122 (17.5) 30-39 years 68 (19.8) 154 (22.1) Age at initial AR 0.530 diagnosis, N (%) 40-49 years 69 (20.1) 154 (22.1) 50-59 years 53 (15.4) 97 (13.9) ≥60 years 72 (21.0) 117 (16.8) Sex, N (%) Female 279 (81.3) 596 (85.4) 0.094 White, non-Hispanic 162 (47.2) 361 (51.7) Black 56 (16.3) 113 (16.2) Race/ethnicity, N (%) 0.491 Hispanic 44 (12.8) 84 (12.0) Other 81 (23.6) 140 (20.1) 0 (minimal) 228 (66.5) 497 (71.2) Charlson Index, N (%) 0.118 ≥1 (mod/severe) 115 (33.5) 201 (28.8) Asthma 38 (11.1) 53 (7.6) 0.079 Comorbidity, N (%) Atopic dermatitis 0 (0) 0 (0) NA Conjunctivitis 5 (1.5) 7 (1.0) 0.544 6

Health care utilization in the 6, 12, and 18 months after 1 st INS fill by satisfactory versus unsatisfactory adherence Matched Control SATISFACTORY-INS (N=343) UNSATISFACTORY-INS (N=698) Health Services Use # N Mean ± SD N Mean ± SD P Value* NUMBER OF INPATIENT STAYS 6 months 5 4.4 ± 3.2 5 1.2 ± 0.4 0.151 12 months 14 3.7 ± 4.4 14 1.7 ± 1.1 0.177 18 months 23 3.7 ± 5.1 25 2.9 ± 3.6 0.606 NUMBER OF OUTPATIENT VISITS 6 months 302 10.5 ± 10.8 598 10.9 ± 10.6 0.027 12 months 325 18.8 ± 21.4 651 20.1 ± 22.8 0.005 18 months 333 27.3 ± 31.9 670 29.6 ± 37.2 0.0007 NUMBER OF PHARMACY FILLS 6 months 343 38.0 ± 25.6 698 28.8 ± 17.3 <0.0001 12 months 343 69.7 ± 49.9 698 54.8 ± 34.9 0.0007 18 months 343 101.0 ± 75.3 698 80.2 ± 52.6 <0.0001 * p-value comparisons of log-transformed geometric means. # Based on a 2-part conditional model for each type of Health Services Use: 1) identification of each patient with any use in the Satisfactory-INS group and matched up to 3 with patients in the Unsatisfactory-INS group with any such use, followed by 2) paired t-tests of log-transformed geometric means. If no match was available in the Unsatisfactory-INS group, the patient in the Satisfactory-INS group was excluded from further analysis. − Duan, N., W.G. Manning, C.N. Morris, et al., "A Comparison of Alternative Models for the Demand for Medical Care," J Bus Econ Stat 1983;1(2): 115 ‐ 126. − Duan, N., W.G. Manning, C.N. Morris, et al., "Choosing Between the Sample Selection Model and the Multi ‐ Part Model," J Bus Econ Stat . 1984; 2(3):283 ‐ 289.. North Holland:Elsevier;2000. p.265-344. − Manning W.G. . Dealing with Skewed Data on Costs and Expenditures. In Jones A, editor. The Elgar Companion to Health Economics, 2 nd Edition. Northhampton:Edward Elgar Publishing Inc;2012.p 439-446. 7