CHARACTERISTICS & OUTCOMES OF INSURED PATIENTS TREATED WITH EXTENDEDRELEASE NALTREXONE (XR-NTX) OR ORAL ALCOHOL DEPENDENCE MEDICATIONS TAMI L. MARK, PHD, MBA ACADEMY HEALTH ANNUAL MEETING JUNE 29, 2010 AUTHORS Tami L L. Mark PhD PhD, MBA1 Leslie Montejano1 Henry R R. Kranzler Kranzler, MD2 David R. Gastfriend, MD3 Mady Chalk, PhD4 1 Thomson 2 Reuters, Reuters Inc Inc. University of Connecticut School of Medicine 3 Alkermes, Inc. 4 Treatment Research Institute, Inc. 2 FINANCIAL DISCLOSURE This study was funded through a contract from Alkermes to Thomson Reuters. 3 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 ALCOHOLISM MEDICATIONS Product Introduced in US. Market Disulfiram (Antabuse®) 1940s Naltrexone (ReVia®) 1995 Acamprosate (Campral®) 2004 Extended-Release E t d dR l N lt Naltrexone (Vivitrol®) 2006 5 PRESCRIPTIONS, 2007 XR-Naltrexone, XR Naltrexone, 15,000 Disulfiram, 179,000 Acamprosate, 306 000 306,000 Oral Naltrexone, 221,000 Total Alcoholism Rx Prescriptions: 720,000 Total Antidepressant prescriptions: 226 million T t l persons with Total ith alcohol l h l dependence: d d 7.9 7 9 million illi 6 METHODS 7 DATA SOURCE • Thomson Reuters’ Reuters MarketScan® commercial claims • E Enrollment ll t iinformation f ti and d medical di l and d prescription drug claims from large self-insured employers and regional health plans plans. • A parallel analyses with MarketScan Multi-State Medicaid Database Database, however however, the sample size of XR-NTX was small in this database 8 SAMPLE SELECTION MarketScan Jan 2006 – Dec 2008 XR – NTX NTX Acamprosate Disulfiram (295) (2,064) (5,068) (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 INCLUSION CRITERIA • 6 months of continuous enrollment pre pre-index 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. vs no Rx comparison) 10 OUTCOME MEASURES: PERSISTENCE • XR-NTX: XR NTX: Unique dates of service x 30 30.5 5 days • Oral Agents: days supplied summed • Expressed as a percent of 182.5 days 11 OUTCOME MEASURES: INPATIENT UTILIZATION • Measured 6 months post index: • Percent with inpatient admission: – detoxification admission (ICD (ICD-9-CM 9 CM Proc for Detoxification) – alcohol-related admission (ICD-9-CM Alcohol Principal Dx) – admission d i i ffor other th reasons • Total inpatient days: – iinpatient ti t d detoxification t ifi ti d days – alcohol-related inpatient days – all other inpatient p days y 12 OUTCOME MEASURES: VISITS • Alcohol-related Alcohol related ED visit • Visit with primary MHSA Dx • Visit with primary SA Dx 13 OUTCOME MEASURES: CHARGES • Charge per day • For detoxification hospitalization • For alcohol hospitalization • Based on HCUP HCUP-NIS NIS data for 2007 14 PROPENSITY SCORE MATCHING OR WEIGHTING • Demographics: age, age gender gender, region region, employee type • Neighborhood characteristics: household income, poverty, p y African American, College g 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 Pre-Period Period Copayments 15 RESULTS NO O RX VS. S ANY RX 16 UNADJUSTED SAMPLE DESCRIPTION Category Male Age Group 18-34 35-44 45-54 55 64 55-64 Median household income Below poverty level African American College graduate Any Alcohol Medication 59 8% 59.8% 15.0% 27.3% 37.7% 20 0% 20.0% $51,314 8.9% 9.3% 27.5% No Alcohol Medication 66 8% 66.8% 21.0% 22.4% 32.9% 23 7% 23.7% $49,976 6.9% 16.4% 14.7% 17 UNADJUSTED SAMPLE DESCRIPTION Pre-Period Utilization 50.0% 45.0% 40 0% 40.0% 35.0% 30.0% 25 0% 25.0% 20.0% 15.0% 10 0% 10.0% 5.0% 0.0% Detoxification Admission Alcohol-Related Alcohol Related Non Alcohol Non-Alcohol Alcohol Related Alcohol-Related Admission related Admission ED Visit Any Alcohol Medication Psychiatrist Visit No Alcohol Medication 18 PERCENT WITH HOSPITAL EVENTS (DURING 6 MONTHS POST INDEX) 16.0% % 14.0% *** 13.4% *** 11 2% 11.2% 12 0% 12.0% 11.4%11.6% ** 10.3% 10.0% 8.7% 8 0% 8.0% 8.3% 6.8% 6.0% 4 0% 4.0% 2.0% 0.0% Detoxification Admission Alcohol-Related Admission Alcohol Rx Non-Alcohol Admission No Alcohol Rx Emergency Room Visit *** P < 0.01 ** P < 0.05 19 INPATIENT DAYS PER 1,000 PATIENTS 1,400 *** 1,163 Days per 1,0 000 Patients s 1,200 *** 1,086 967 1,000 862 800 706 650 600 400 200 0 Detoxification Alcohol-Related Inpatient Other Inpatient *** P < 0.01 Alcohol Rx No Alcohol Rx 20 PERCENT WITH SUBSTANCE ABUSE OR MENTAL HEALTH VISIT 120.0% *** *** 100.0% 97.3% 94.9% 80.8% 80.0% 62.8% 60.0% 40.0% 20.0% 0.0% SA Visit MHSA Visit Alcohol Rx *** P < 0.01 No Alcohol Rx 21 AVERAGE NUMBER OF VISITS 12 *** *** 10 9.0 7.7 8 6 10.5 5.4 4 2 0 SA Visit MHSA Visit *** P < 0.01 Alcohol Rx No Alcohol Rx 22 RESULTS: COMPARISON RESULTS OF ALCOHOL MEDICATIONS TO XR NALTREXONE XR-NALTREXONE (VIVITROL) 23 UNADJUSTED SAMPLE COMPARISON 50% 45% 40% 35% 30% 25% 20% 15% 10% 5% 0% Detoxification Admission Alcohol-Related Admission XR-naltrexone Non-Alcohol related Admission Oral naltrexone Alcohol-Related ED Visit Disulfram Psychiatrist y Visit Acamprosate 24 Percent of Day ys Covered d PERSISTENCE: PERCENT OF TIME OVER 6 MONTHS WITH MEDICATION 45% 40% 35% 30% 25% 20% 15% 10% 5% 0% 41% 37% 37% *** 34% XR-naltrexone (n=295) Oral naltrexone (n=2,064) Disulfiram (n = 2,076) Acamprosate (n = 5,068) ***P < 0.001 25 PERCENT WITH DETOXIFICATION ADMISSION (COMPARED TO XR-NTX) 10.0% 9.0% 8.0% * 7.0% 6.5% 6.0% 5.0% 5.7% 5.8% Oral naltrexone (n=2,064) Disulf iram (n=2,076) 4.1% 4.0% 3.0% 2.0% 1.0% 0.0% XR-naltrexone (n=295) Acamprosate (n=5,068) * P< 0.1 ** P< 0.05 ***P < 0.01 26 PERCENT WITH PRINCIPAL ALCOHOL ADMISSION (COMPARED TO XR-NTX) 5.0% 5 0% * 4.4% 4.5% ** 4.5% 4.0% 3.5% 3.1% 3.0% 2 5% 2.5% 2 3% 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 < 0.01 27 DETOXIFICATION DAYS PER 1,000 , PATIENTS (COMPARED TO XR-NTX) 600 *** *** Days per 1,000 0 patients 500 * 400 300 200 100 0 XR-naltrexone (n=295) oral naltrexone (n=2,064) disulfiram ((n = 2,076) acamprosate p ((n = 5,068) * P< 0.1 ** P< 0.05 ***P < 0.01 28 PRINCIPAL ALCOHOL DX INPATIENT DAYS PER 1,000 PATIENTS (COMPARED TO XR-NTX) 600 Days per 1,0 D 000 patients s 500 *** *** 400 300 200 100 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 < 0.01 29 EMERGENCY DEPARTMENT,, SUD AND MENTAL HEALTH & SUD VISITS 90 0% 90.0% 80.0% *** 70.0% *** *** 60.0% 50.0% *** 40.0% *** *** 30.0% *** 20 0% 20.0% 10.0% 0.0% XR-naltrexone (n=295) Oral naltrexone (n=2,064) Emergency Department Visits Disulfiram (n = 2,076) SA Visit Acamprosate (n = 5,068) MHSA Visit ***P < 0.01 30 CHARGES FOR DETOXIFICATION DAYS PER 1,000 , PATIENTS (COMPARED ( TO XRNTX) *** $1 600 000 $1,600,000 *** $1,400,000 $1 200 000 $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 < 0.01 31 CHARGES FOR PRINCIPAL ALCOHOL DX INPATIENT DAYS PER 1,000 , PATIENTS (COMPARED TO XR-NTX) $1 400 000 $1,400,000 *** $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 < 0.01 32 LIMITATIONS & STRENGTHS • May be unmeasured differences between populations (e.g., motivation to quit) • Only focus is on utilization outcomes, outcomes not other domains • Real-world effectiveness analysis across insurers • Largest health econ analysis of XR-NTX XR NTX to date • First study to analyze all Alc Dep Rxs and No Rx • Severity S it off illness ill bi bias lik likely l tto work k against i t XR XR-NT NT 33 CONCLUSIONS • Alcoholism medications are associated with significantly and substantially lower detoxification and hospitalization p utilization rates relative to similar patients who received no medication 34 CONCLUSIONS CONTINUED • XR XR-NTX NTX shows significant & substantial advantages in reduced detoxification and hospitalization p days y over oral alcoholism medications • XR XR-NTX NTX shows h a pattern tt off ffewer d days off iintensive t i (i.e., inpatient) services with increased outpatient service utilization 35 FUTURE WORK • Findings need to be replicated with larger samples samples, in populations with different types of insurance (e.g. Medicaid)) and in p pragmatic g clinical trials 36 THANK YOU!! • Tami.Mark@Thomsonreuters.com • (301) 214 - 2211 37