CHARACTERISTICS & OUTCOMES OF INSURED PATIENTS TREATED WITH EXTENDED- RELEASE NALTREXONE (XR-NTX) OR ORAL ALCOHOL DEPENDENCE MEDICATIONS

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1 CHARACTERISTICS & OUTCOMES OF INSURED PATIENTS TREATED WITH EXTENDED- RELEASE NALTREXONE (XR-NTX) OR ORAL ALCOHOL DEPENDENCE MEDICATIONS TAMI L. MARK, PHD, MBA ACADEMY HEALTH ANNUAL MEETING JUNE 29, 2010

2 AUTHORS Tami L. Mark PhD, MBA 1 Leslie Montejano 1 Henry R. Kranzler, MD 2 David R. Gastfriend, MD 3 Mady Chalk, PhD 4 1 Thomson Reuters, Inc. 2 University of Connecticut School of Medicine 3 Alkermes, Inc. 4 Treatment Research Institute, Inc. 2

3 FINANCIAL DISCLOSURE This study was funded through a contract from Alkermes to Thomson Reuters. 3

4 OBJECTIVES Compare the association between use of any alcoholism medication and no medication on utilization outcomes Compare the differences among the four alcoholism medications in terms of adherence and utilization outcomes 4

5 ALCOHOLISM MEDICATIONS Product Disulfiram (Antabuse ) Introduced in US. Market 1940s Naltrexone (ReVia ) 1995 Acamprosate (Campral ) 2004 Et Extended-Release ddr Naltrexone 2006 (Vivitrol ) 5

6 PRESCRIPTIONS, 2007 XR-Naltrexone, 15,000 Acamprosate, 306, Disulfiram, 179,000 Oral Naltrexone, 221,000 Total Alcoholism Rx Prescriptions: 720,000 Total Antidepressant prescriptions: 226 million Total persons with alcohol l dependence: d 7.9 million 6

7 METHODS 7

8 DATA SOURCE Thomson Reuters MarketScan commercial claims Enrollment information and medical and prescription drug claims from large self-insured employers and regional health plans. A parallel analyses with MarketScan Multi-State Medicaid Database, however, the sample size of XR-NTX was small in this database 8

9 SAMPLE SELECTION MarketScan Jan 2006 Dec 2008 XR NTX (295) NTX (2,064) Acamprosate (5,068) Disulfiram (2,076) Alcohol Dependence Dx No Rx (17,632) Alcohol Use Disorder In the Pre-period Any Rx (4,047) Alcohol Use Disorder In Pre-period No Rx (4,730) 9

10 INCLUSION CRITERIA 6 months of continuous enrollment pre-index 6 months of continuous enrollment post-index 18 years or older Alcoholism medication claim for medication group Alcohol use disorder diagnosis in pre-period (only for Any Rx vs. no Rx comparison) 10

11 OUTCOME MEASURES: PERSISTENCE XR-NTX: Unique dates of service x 30.5 days Oral Agents: days supplied summed Expressed as a percent of days 11

12 OUTCOME MEASURES: INPATIENT UTILIZATION Measured 6 months post index: Percent with inpatient admission: detoxification admission (ICD-9-CM CM Proc for Detoxification) alcohol-related admission (ICD-9-CM Alcohol Principal Dx) admission i for other reasons Total inpatient days: inpatient t detoxification ti days alcohol-related inpatient days all other inpatient days 12

13 OUTCOME MEASURES: VISITS Alcohol-related ED visit Visit with primary MHSA Dx Visit with primary SA Dx 13

14 OUTCOME MEASURES: CHARGES Charge per day For detoxification hospitalization For alcohol hospitalization Based on HCUP-NIS data for

15 PROPENSITY SCORE MATCHING OR WEIGHTING Demographics: age, gender, region, employee type Neighborhood characteristics: household income, poverty, African American, College Graduate Clinical Drug abuse Dx % with psychiatric Dxs Charlson-Deyo Comorbidity index Chronic Disease Score Pre-Period Utilization % with detoxification admission % with alcohol-related admission % with alcohol-related ED visit Pre-Period Period Copayments 15

16 RESULTS NO RX VS. ANY RX 16

17 UNADJUSTED SAMPLE DESCRIPTION Category Any Alcohol Medication No Alcohol Medication Male 59.8% 66.8% Age Group % 21.0% % 22.4% % 32.9% % 0% 23.7% Median household income $51,314 $49,976 Below poverty level 8.9% 6.9% African American 9.3% 16.4% College graduate 27.5% 14.7% 17

18 UNADJUSTED SAMPLE DESCRIPTION 50.0% 45.0% 40.0% 0% 35.0% 30.0% 25.0% 20.0% 15.0% 10.0% 0% 5.0% Pre-Period Utilization 0.0% Detoxification Alcohol-Related Non-Alcohol Alcohol-Related Psychiatrist Visit Admission Admission related Admission ED Visit Any Alcohol Medication No Alcohol Medication 18

19 PERCENT WITH HOSPITAL EVENTS (DURING 6 MONTHS POST INDEX) 16.0% 14.0% 12.0% 10.0% 80% 8.0% 8.7% 13.4% 6.8% 11.2% 11.4% 11.6% 8.3% ** 10.3% 6.0% 40% 4.0% 2.0% 0.0% Detoxification Admission Alcohol-Related Admission Non-Alcohol Admission Alcohol Rx No Alcohol Rx Emergency Room Visit P < 0.01 ** P <

20 INPATIENT DAYS PER 1,000 PATIENTS 1,400 1,200 1,163 1,086 Days per 1,0 000 Patients 1, Detoxification Alcohol-Related Inpatient Other Inpatient Alcohol Rx No Alcohol Rx P <

21 PERCENT WITH SUBSTANCE ABUSE OR MENTAL HEALTH VISIT 120.0% 100.0% 94.9% 97.3% 80.0% 60.0% 62.8% 80.8% 40.0% 20.0% 0.0% SA Visit MHSA Visit Alcohol Rx No Alcohol Rx P <

22 AVERAGE NUMBER OF VISITS SA Visit MHSA Visit P < 0.01 Alcohol Rx No Alcohol Rx 22

23 RESULTS: COMPARISON OF ALCOHOL MEDICATIONS TO XR-NALTREXONE (VIVITROL) 23

24 UNADJUSTED SAMPLE COMPARISON 50% 45% 40% 35% 30% 25% 20% 15% 10% 5% 0% Detoxification Alcohol-Related Non-Alcohol Alcohol-Related Psychiatrist Admission Admission related ED Visit Visit Admission XR-naltrexone Oral naltrexone Disulfram Acamprosate 24

25 PERSISTENCE: PERCENT OF TIME OVER 6 MONTHS WITH MEDICATION Per cent of Day ys Covered 45% 40% 35% 30% 25% 20% 15% 10% 5% 0% 41% XR-naltrexone (n=295) 37% 37% Oral naltrexone (n=2,064) Disulfiram (n = 2,076) 34% Acamprosate (n = 5,068) P <

26 PERCENT WITH DETOXIFICATION ADMISSION (COMPARED TO XR-NTX) 10.0% 9.0% 8.0% 7.0% 6.0% 5.7% 5.8% * 6.5% 5.0% 4.0% 4.1% 3.0% 2.0% 1.0% 0.0% XR-naltrexone (n=295) Oral naltrexone (n=2,064) Disulfiram (n=2,076) Acamprosate (n=5,068) * P< 0.1 ** P< 0.05 P <

27 PERCENT WITH PRINCIPAL ALCOHOL ADMISSION (COMPARED TO XR-NTX) 5.0% 50% 4.5% 4.0% * 4.4% ** 4.5% 3.5% 3.0% 3.1% 25% 2.5% 23% 2.3% 2.0% 1.5% 1.0% 0.5% 0.0% XR-naltrexone (n=295) Oral naltrexone (n=2,064) Disulfiram (n=2,076) Acamprosate (n=5,068) * P< 0.1 ** P< 0.05 P <

28 DETOXIFICATION DAYS PER 1,000 PATIENTS (COMPARED TO XR-NTX) s per 1,000 0 patients Day * 0 XR-naltrexone oral naltrexone disulfiram (n = acamprosate (n = (n=295) (n=2,064) 2,076) 5,068) * P< 0.1 ** P< 0.05 P <

29 PRINCIPAL ALCOHOL DX INPATIENT DAYS PER 1,000 PATIENTS (COMPARED TO XR-NTX) 600 Days per 1,0 000 patients 500 s XR-naltrexone (n=295) oral naltrexone (n=2,064) disulfiram (n = 2,076) acamprosate (n = 5,068) * P< 0.1 ** P< 0.05 P <

30 EMERGENCY DEPARTMENT, SUD AND MENTAL HEALTH & SUD VISITS 90.0% 0% 80.0% 70.0% 60.0% 50.0% 40.0% 30.0% 20.0% 0% 10.0% 0.0% XR-naltrexone (n=295) Oral naltrexone (n=2,064) Disulfiram (n = 2,076) Acamprosate (n = 5,068) Emergency Department Visits SA Visit MHSA Visit P <

31 CHARGES FOR DETOXIFICATION DAYS PER 1,000 PATIENTS (COMPARED TO XR- NTX) $1,600, $1,400,000 $1,200, $1,000,000 * $800,000 $600,000 $400,000 $200,000 $0 XR-NALTREXONE ORAL NALTREXONE DISULFIRAM ACAMPROSATE * P< 0.1 ** P< 0.05 P <

32 CHARGES FOR PRINCIPAL ALCOHOL DX INPATIENT DAYS PER 1,000 PATIENTS (COMPARED TO XR-NTX) $1,400, $1,200,000 $1,000,000 $800,000 $600,000 $400,000 $200,000 $0 XR-NALTREXONE ORAL NALTREXONE DISULFIRAM ACAMPROSATE * P< 0.1 ** P< 0.05 P <

33 LIMITATIONS & STRENGTHS May be unmeasured differences between populations (e.g., motivation to quit) Only focus is on utilization outcomes, not other domains Real-world effectiveness analysis across insurers Largest health econ analysis of XR-NTX to date First study to analyze all Alc Dep Rxs and No Rx Severity of illness bias likely l to work against XR-NT 33

34 CONCLUSIONS Alcoholism medications are associated with significantly and substantially lower detoxification and hospitalization utilization rates relative to similar patients who received no medication 34

35 CONCLUSIONS CONTINUED XR-NTX shows significant & substantial advantages in reduced detoxification and hospitalization days over oral alcoholism medications XR-NTX shows a pattern of fewer days of intensive i (i.e., inpatient) services with increased outpatient service utilization 35

36 FUTURE WORK Findings need to be replicated with larger samples, in populations with different types of insurance (e.g. Medicaid) and in pragmatic clinical trials 36

37 THANK YOU!! (301)