edt Evidence Discovery Tool Overview Frequency of Diagnosis of Respiratory Disease Resource Utilization Review Medication Adherence

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1 Uncover Evidence. Discover Solutions edt Evidence Discovery Tool Uncover Evidence. Discover Solutions edt Evidence Discovery Tool Evidence Discovery Tool Overview Frequency of Diagnosis of Respiratory Disease Resource Utilization Review Medication Adherence Pharma-lab Analyzer

2 EDT Overview edt Evidence Discovery Tool Uncover Evidence. Discover Solutions EDT is an easy-to-use software program designed to help managed care organizations efficiently facilitate decision making related to medication therapy and population health management. Getting started with EDT EDT is available within 2 different software environments, MS Access and SQL. EDT features Analyzes multiple organization-specific data sources, including member demographics, pharmacy and medical claims Evaluates impact of disease management programs in multiple disease states Maps data fields for customized analysis Generates a variety of data reports 1 2 Choose your operating platform based on which system requirements your computer meets. Please refer to the associated help file for complete instructions. MS Access Modules require running Microsoft Access version 2002 SP3 or higher Choose Operating Platform Download and install EDT SQL EDT SQL System requirements: 1. Windows XP Service Pack 2 or later or Windows Vista Service Pack 1 2. NET Framework Windows PowerShell 4. SQL Server Express Microsoft Report Viewer Select and download module of interest 4 Obtain Medical Claims, Pharmacy Claims, and Demographics data from IT 5 Import Medical Claims, Pharmacy Claims, and Demographics data into EDT 6 EDT processes and maps data fields 7 Generate multiple data reports Use of the EDT is for informational purposes only. Results obtained from reports generated from user-provided data should not supersede standard clinical practice or replace the clinical judgment of the healthcare provider. Boehringer Ingelheim does not guarantee this software and is not responsible for the inadvertent download of computer viruses. Boehringer Ingelheim recommends that all computers used with the modules be equipped with the necessary antiviral software. 2 3

3 Frequency of Diagnosis of Respiratory Disease Module Background Features of this module An estimated 24 million Americans have evidence of impaired lung function, which may be chronic obstructive pulmonary disease (COPD)1 Assesses the incidence and frequency of diagnoses for asthma and COPD Nearly 50% of patients with COPD are undiagnosed2 Generates reports for analysis of existing gaps in the percentage of patients appropriately diagnosed with COPD vs asthma pre- and postintervention Profiles the change in incidence, frequency, and mix of diagnosed respiratory disease COPD is often misdiagnosed as asthma 3 Undiagnosed COPD is associated with higher direct medical costs4 Sample report Direct medical costs of undiagnosed COPD4 Direct medical costs ($) $14,000 Percentage of patients with appropriate diagnosis pre- and postintervention 4921 $12,000 Cases Control 2489 $10,000 Difference in Cost $8000 $6000 $4000 $2000 $ months before 12 1 months before 1 12 months after months after Time before and after COPD diagnosis 17.8% of patients did not have a diagnosis of COPD until they underwent hospitalization for the disease4 4 5

4 Resource Utilization Review Module COPD background The Resource Utilization Review Module provides medication use information for 3 therapeutic areas: atrial fibrillation (AF), COPD, and cardiovascular risk reduction (CVRR) An estimated 24 million Americans have evidence of impaired lung function, which may be chronic obstructive pulmonary disease (COPD)1 AF background $3000 $2500 Nearly 50% of patients with COPD are undiagnosed2 Non-valvular AF is associated with nearly a 5-fold increase in the risk of stroke6 AF imposes a substantial economic burden to the healthcare system7 Avoiding ischemic stroke in the setting of AF could save an average of $36,000 for the first hospitalization alone8 The majority of patients with COPD are among the working age population Nearly 70% of patients with COPD are less than 65 years of age2 $1500 $1000 Patients with COPD incur disproportionately high healthcare costs9 7 $0 COPD 23% Outpatient 29% Inpatient incremental costs *Data source: Healthcare Cost and Utilization Project (HCUP); National Ambulatory Medical Care Survey (NAMCS); National Hospital Ambulatory Medical Care Survey (NHAMCS). Cost estimates based on 2001 data updated to 2005 US dollars. Direct inpatient costs refer to costs associated with hospitalization with AF as a principal discharge diagnosis. Inpatient incremental costs estimated based on a case-control comparison with patients hospitalized for the same primary diagnosis without the secondary diagnosis of AF. 6 CVRR background An estimated 80 million Americans have cardiovascular disease (CVD)10 Men or women with hypertension have a 2 to 3 times greater risk of developing coronary heart disease, stroke, peripheral artery disease, or congestive heart failure than normotensive men or women11 History of CVD in ischemic stroke patients leaves members vulnerable to higher rates for future CVD events and cost12 Age-matched controls Direct medical costs for stroke-related and nonstroke-related CV events at 12 months12 $ $2000 Cost ($) 44% Age Age % $6.65 billion = total estimated annual medical costs for the treatment of non-valvular AF in the United States* $500 Drugs Direct inpatient $2000 Cost ($) Prevalence of AF increases with age5 Economic burden of AF Total per-patient monthly healthcare charges vs matched controls9 $ $1000 $500 $0 68 Stroke Stroke Control Nonstroke CV Nonstroke CV Control 7

5 Resource Utilization Review Module Features of this module Examines changes in the distribution of diagnoses over the preintervention and postintervention periods Sample reports Percentage of patients treated pre- and postintervention Pre-intervention patients with no evidence of treatment Determines the percentage of patients treated with selected therapies and those without evidence of therapy initiation or continuation (diagnosed patient who remains untreated) Detects shifts in diagnosis patterns and changes in utilization of therapies for certain disease states Determines the percentage of diagnosed patients who remain untreated after disease management initiatives are implemented Generates reports allowing the user to identify members who are not receiving therapy in either the pre- or postintervention periods, allowing for refined targeting of disease management efforts Examines specific drugs employed in the preintervention and postintervention periods if the intervention calls for a modification in drug therapy Resource utilization reports 8 Report Type Report Content Percentage of patients treated % of patients with diagnosis receiving drug therapy before and after disease management initiatives are implemented Prelist/no therapy List of patients in preintervention period who have no evidence of receiving therapy Postlist/no therapy List of patients in postintervention period who have no evidence of receiving therapy Pre/posteligible treatment List of patients identified in preintervention period who are eligible for treatment and without pharmacy claims in either pre- or postintervention period Pre/postcontinuation List of patients continuously eligible for treatment and with evidence of treatment initiation during postintervention period Discontinued therapy List of patients who initiated treatment during the preintervention period and who discontinued therapy during postintervention period First drug % of patients receiving treatment according to first medication prescribed during pre- and postintervention periods First and last drug % of patients according to first and last medication used by patients in pre- and postintervention periods Initial diagnosis % of patients receiving treatment by ICD-9 code after diagnosis in either the pre- or postintervention periods Diagnosis counts % of patients receiving treatment according to unique diagnosis codes determined in either pre- or postintervention periods Pre-intervention treated patients continuing therapy on the post intervention period 9

6 Medication Adherence Module Background Medication adherence reports Nonadherence is common for newly prescribed medications treating chronic conditions13 Many of the problems with persistence measurements derive from the same methodologies employed to execute medication possession ratio (MPR) Inconsistent exposure times to therapy Continuous eligibility Percentage Persistence to medication declines over time across therapeutic areas14 Report Type Report Content 1.00 Days of therapy intent-to-treat Average number of days patients are adherent to initial prescribed medication 0.75 Days of therapy patient type Average number of days patients are adherent to the medication drug class and segmented into new or continuer patient groups 0.50 MPR 180, 270, 365 days MPR or patients in new or continuer treatment groups for 6, 9, and 12 months 0.25 MPR intent-to-treat MPR for 6, 9, and 12 months for patients according to initial therapy prescribed Persistence intent-to-treat Overall persistency rates for the membership population segmented according to initial therapy prescribed Persistence patient type Overall persistency rates for the membership population according to new and continuer treatment groups Persistence of selected chronic medications Days amlodipine bes(qd) (n=2046) vs. carvedilol phos(qd) (n=326) vs. captopril(tid) (n=94) carvedilol(bid) (n=1786) metformin(bid) (n=917) vs. metformin ER (QD) (n=305) warfarin new users (n/a) Therapy switching Members nonpersistent Identifies and lists members who have been found to be nonpersistent with at X months therapy for specific period of time MPR deficient at 180, 270, and 365 days Identifies and lists members who do not meet a user-defined minimum threshold for MPR at 6, 9, and 12 months Broad therapy class definition Grouping of patients new to treatment and continuing therapy Exclusion of trial patients Sample reports Patients with MPR 180, 270, or 365 days Member list of patients nonpersistent at X months Features of this module Provides an understanding of population-specific medication adherence for selected medications Assesses adherence as measured by treatment persistence, length of therapy, and MPR at 6, 9, and 12 months Generates an intent-to-treat analysis for specific medications and segments patients into groups of new to therapy or continuer of therapy based on their history of medication use Segments patients into smaller groups based on the first agent prescribed for the period of analysis Identifies the first fill date and uses this fill date as the initial therapy marker to generate 12-month persistence analyses 10 11

7 Pharma-lab Analyzer Module Background Pharma-lab analyzer reports An estimated 16.2 million Americans Nearly 40% of patients with have diabetes and by the year 2050 type 2 diabetes have CKD16 the number may reach 48.3 million15 Nearly 40% of patients with type 2 diabetes may have some degree of 8.6% Stage 1: chronic kidney disease (CKD)16 GFR 90* 20% of patients with type 2 diabetes 11.1% Stage 2: GFR 60-89* and CKD have moderate-to-severe renal insufficiency (RI) or end-stage renal disease (ESRD) % Stage 3: GFR 30-59* Earlier diagnosis of RI and more aggressive treatment of those patients 2.3% Stage4/5: GFR<30 with type 2 diabetes and RI may lead to improved outcomes and may delay Glomerular filtration rate (GFR)=mL/min/1.73 m. *With kidney damage. 17 the onset of ESRD RI in patients with type 2 diabetes is often undiagnosed18; however, it should be considered when medications are prescribed, especially in patients with diabetes, because many agents are contraindicated or require dosage adjustments19 Report Type Report Content Patient/member distribution by observed laboratory values This report breaks down the percentage of members with lab values that are above normal, below normal, or within normal limits Observed laboratory values This report summarizes the percentage of members with lab values that are by medication type above normal, below normal, or within normal limits by type of medication Observed laboratory values This report identifies the percentage of members with normal or abnormal by type of test (eg, SCr, values according to the specific test CCR, egfr) Observed laboratory values This report identifies the percentage of members with normal or abnormal by prescriber ID laboratory value results according to the prescriber/physician ID ZIP code This report identifies members in specific ZIP codes with laboratory values that are within or outside the normal range. Prescriber ID can also be identified for this report Pre- and postintervention laboratory results This report identifies the changes in laboratory values across member populations during a designated pre- and postintervention period Member lists This report generates member lists that identify important trends over time in laboratory values 2 Features of this module Review laboratory values for serum creatinine, creatinine clearance, and estimated GFR for members with type 2 diabetes and identify either specific members or percentage of members who have above normal levels, below normal levels, or levels within normal limits Link observed laboratory values to the use of specific medications included in the analysis Customize reports by medication, prescriber ID, network ID, ZIP code, gender, or state to target either specific patients for intervention or use prescriber ID information to assess gaps in care management Generate a customized analysis regarding percentage of members whose laboratory values fall above and below clinical guidelines Identify changes in laboratory values in the pre- and postintervention periods for up to 24 months of eligibility for member populations Uncover gaps in care and identify appropriate patients for intervention or medication management 12 Sample reports Distribution of patients by observed laboratory report Member list of patients above normal limits 13

8 References: 1. Mannino DM, Homa DM, Akinbami LJ, Ford ES, Redd SC. Chronic obstructive pulmonary disease surveillance United States, MMWR Surveill Summ. 2002;51(SS-6): Pleis JR, Lethbridge-Çejku M. Summary health statistics for U.S. adults: national health interview survey, Vital Health Stat. 2006;10(232): Tinkelman DG, Price DB, Nordyke RJ, Halbert RJ. Misdiagnosis of COPD and asthma in primary care patients 40 years of age and over. J Asthma. 2006;43: Mapel DW, Robinson SB, Dastani HB, Shah H, Phillips AL, Lydick E. The direct medical costs of undiagnosed chronic obstructive pulmonary disease. Value Health. 2008;11: Go AS, Hylek EM, Phillips KA, et al. Prevalence of diagnosed atrial fibrillation in adults: national implications for rhythm management and stroke prevention: the AnTicoagulation and Risk Factors In Atrial Fibrillation (ATRIA) Study. JAMA. 2001;285: Wolf PA, Abbott RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke. 1991;22: Coyne KS, Paramore C, Grandy S, Mercader M, Reynolds M, Zimetbaum P. Assessing the direct costs of treating nonvalvular atrial fibrillation in the United States. Value Health. 2006;9: Harley C, Sander SD, Shah H, Horstman T, Rey GG. Direct costs and health care utilization associated with stroke in the presence of atrial fibrillation in the United States. Poster presented at: American Stroke Association International Stroke Conference; February 17-20, 2009; San Diego, CA. 9. Tinkelman DG, George D, Halbert RJ. Chronic obstructive pulmonary disease in patients under age 65: utilization and costs from a managed care sample. J Occup Environ Med. 2005;47: Lloyd-Jones D, Adams RJ, Brown TM, et al; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart disease and stroke statistics 2010 update: a report from the American Heart Association. Circulation. 2010;121:e46-e Kannel WB. Blood pressure as a cardiovascular risk factor: prevention and treatment. JAMA. 1996;275: Roberts CS, Gorelick PB, Ye X, Harley C, Goldberg GA. Additional stroke-related and non stroke-related cardiovascular costs and hospitalizations in managed-care patients after ischemic stroke. Stroke. 2009;40: Fischer MA, Stedman MR, Lii J, et al. Primary medical non-adherence: analysis of 195,930 electronic prescriptions. J Gen Intern Med. 2010;25: Song X, Sander SD, Varker H, Amin A. Patterns and predictors of persistence of warfarin and other commonly-utilized chronic medications among patients with atrial fibrillation. Poster presented at: International Society of Pharmacoeconomics and Outcomes Research 15th Annual Meeting; May 15-19, 2010; Atlanta, GA. 15. Narayan KMV, Boyle JP, Geiss LS, Saaddine JB, Thompson TJ. Impact of recent increase in incidence on future diabetes burden: U.S., Diabetes Care. 2006;29: Koro CE, Lee BH, Bowlin SJ. Antidiabetic medication use and prevalence of chronic kidney disease among patients with type 2 diabetes mellitus in the United States. Clin Ther. 2009;31: Zoungas S, de Galan BE, Ninomiya T; ADVANCE Collaborative Group. Combined effects of routine blood pressure lowering and intensive glucose control on macrovascular and microvasular outcomes in patients with type 2 diabetes: new results from the ADVANCE trial. Diabetes Care. 2009;32: Burke JP, Sander SD, Parker M, Moran HJ, Thayer S. Prevalence of renal insufficiency in a commercially-insured population with type 2 diabetes mellitus enrolled in a large, US national health plan. Poster presented at: International Society of Pharmacoeconomics and Outcomes Research 15th Annual Meeting; May 15-19, 2010; Atlanta, GA. 19. National Kidney Foundation. KDOQI clinical practice guidelines and clinical practice recommendations for diabetes and chronic kidney disease. Am J Kidney Dis. 2007;49(suppl 2):S1-S179. HEOR Driving Value. Delivering Solutions. Health Economics & Outcomes Research Enhancing Qua lity of Care & Outcomes. Copyright 2010 Boehringer Ingelheim Pharmaceuticals, Inc. All rights reserved. Printed in the U.S.A. (12/10) MI85917HQO