The Clinical and Economic Benefit of Early Avodart Use vs Early Finasteride Use (Study: 8AVO027HO)

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1 The Clinical and Economic Benefit of Early Avodart Use vs Early Finasteride Use (Study: 8AVO027HO) November 2011 (Revised May 2012) Prepared for: GlaxoSmithKline

2 Please direct comments and questions to: PharmD, PhD Director Xcenda 4114 Woodlands Parkway, Suite 500 Palm Harbor, FL Phone: Fax: GlaxoSmithKline Page 2 of 12

3 TABLE OF CONTENTS 1.0 INTRODUCTION STUDY PURPOSE AND OBJECTIVES METHODS Data Sources Study Design Patient Selection Inclusion Criteria Exclusion Criteria OUTCOMES ASSESSMENT Pre-index (Baseline) Variables ANALYTICAL APPROACH Study Attrition Description of Study Sample Propensity Score Matching Outcome Measures APPENDIX GlaxoSmithKline Page 3 of 12

4 1.0 INTRODUCTION Clinical and Economic Benefit of Early Dutasteride vs Early Finasteride Use Benign prostatic hyperplasia (BPH) affects approximately 50% of American men aged 50 years and 90% of the men aged 80 years, 1 making it the fourth-most-commonly diagnosed condition 2 in older men. The clinical and economic burden of the condition is significant, leading to approximately 4.5 million outpatient visits and $1.1 billion in total medical services annually, according to 2000 estimates. 3 These figures are expected to increase significantly by 2030 with the baby boomer generation approaching old age. 4 Current guidelines recommend alpha blockers (ABs) and/or 5-alpha reductase inhibitors (5ARIs) as first-line pharmacologic treatment for men with bothersome lower urinary tract symptoms (LUTS) due to BPH 5. ABs provide symptomatic relief by decreasing the smooth muscle tone in the prostate, urethra, and bladder. However, they do not affect the prostate size; thus, they do not address the underlying disease process. 6 On the other hand, 5ARIs are considered to be disease-modifying, as they reduce prostate size, thereby reducing the patient s likelihood of developing prostate-related complications, such as acute urinary retention (AUR) and prostate surgery, in addition to providing long-term symptom control. Dutasteride and finasteride are the only 5ARI therapies currently available in the United States (US). Their mechanism of action involves suppression of dihydrotestosterone (DHT), the primary androgen responsible for prostate growth, by blocking the 5-alpha reductase enzyme. 7 The distinction between the two drugs is that finasteride only inhibits the type-2 isozyme, leading to a partial suppression of DHT (70%), whereas dutasteride leads to almost complete suppression of DHT (>90%); blocking both type-1 and type-2 isozymes of the enzyme. 8,9 Previous studies demonstrated that the earlier use of 5ARI therapy resulted in a reduction in AUR, prostate-related surgery and clinical progression, leading to economic benefits. 10,11 Although this work was well received and will be of tremendous value in treating patients with BPH, it presents a 5ARI class-level view. Decision makers may suggest that the effect seen within previous studies is driven by finasteride, or that there are no real-world studies differentiating dutasteride from finasteride. As such, this study will attempt to assess the value of early combination with dutasteride therapy vs finasteride therapy by analyzing a pooled patient sample from previously conducted studies that 10,11 evaluated the value of early 5ARI therapy in combination with AB. 2.0 STUDY PURPOSE AND OBJECTIVES The purpose of this study is to assess whether early combination with dutasteride therapy in patients with BPH results in improved health outcomes and reduced economic burden of illness when 1 National Institute of Diabetes and Digestive and Kidney Disease. Prostate enlargement: benign prostate hyperplasia. National Kidney and Urologic Diseases Information Clearinghouse Accessed July 15, Issa MM, Fenter TC, Black L, Grogg AL, Kruep EJ. An assessment of the diagnosed prevalence of diseases in men 50 years of age or older. Am J Manag Care. 2006;12(4 Suppl):S83-S89. 3 Wei JT, Calhoun E, Jacobsen SJ. Benign Prostatic Hyperplasia. In: National Institute of Diabetes and Digestive and Kidney Diseases. Urologic Diseases in America. Accessed July 15, US Census Bureau. US interim projections by age, sex, race, and Hispanic origin: Accessed February 11, Ponholzer A, Madersbacher S. Lower urinary tract symptoms and erectile dysfunction; links for diagnosis, management and treatment. Int J Impot Res. 2007;19(6): McConnell JD, Roehrborn CG, Bautista OM, et al. The long-term effect of doxazosin, finasteride, and combination therapy on the clinical progression of benign prostatic hyperplasia. N Eng J Med. 2003;349: Lee M. Management of Benign Prostatic Hyperplasia. In: DiPiro J, Talbert R, Yee G, eds. Pharmacotherapy: A Pathophysiologic Approach. 6 th ed. New York: McGraw-Hill; Clark RV, Hermann DJ, Cunningham GR, Wilson TH, Morrill BB, Hobbs S. Marked suppression of dihydrotestosterone in men with benign prostatic hyperplasia, by dutasteride, a dual 5-α reductase inhibitor. J Clin Endocrinol Metab. 2004;89: Roehrborn CG, Boyle P, Nickel JC, et al. Efficacy and safety of a dual inhibitor of 5-alpha reductase types 1 and 2 (dutasteride) in men with benign prostatic hyperplasia. Urology, 2002;60: Naslund M, Eaddy MT, Hogue SL, et al. Impact of delaying 5-α reductase inhibitor therapy in men on alpha blocker therapy to treat BPH: assessment of acute urinary retention and prostate-related surgery. Curr Med Res Opin. 2009;25: Naslund M, Eaddy MT, Hogue SL, et al. The economic impact of delaying 5-alpha reductase therapy in men receiving treatment for symptomatic benign prostatic hyperplasia. Am Health Drug Benefits, 2011:4(3); GlaxoSmithKline Page 4 of 12

5 compared to early combination with finasteride therapy. Specifically, this study will accomplish the following objectives: Assess the impact of early combination dutasteride vs finasteride therapy in patients receiving AB on 2 adverse outcomes: rates of AUR and prostate-related surgery Compare and contrast the BPH-related costs across treatment cohorts (early combination dutasteride vs finasteride starters) 3.0 METHODS The current study will combine patient samples from previously conducted studies 10,11 in which the benefits of early 5ARI in combination with AB therapy have been investigated. These studies have a similar study design, patient selection criteria and other methodological considerations. The following sub-sections (data sources, study design and patient selection) state these methodological considerations initially and further explain the additional criteria for the current study. 3.1 Data Sources Data sources employed for previously conducted studies 10,11 include i3 Impact, IMS LifeLink, and MarketScan databases. Descriptions for these follow. Ingenix Impact National Managed Care Database (i3 Impact, formerly IHCIS) The Ingenix Impact National Benchmark database (formerly IHCIS) is a comprehensive, de-identified US medical claims database that is generally representative of the insured US population <65 years old. It does not include Medicaid or Medicare information. The database contains inpatient/outpatient and pharmacy claims, lab results, and enrollment information on over 98 million lives from 1997 to Roughly 30.8 million patients in the IHCIS database have at least 2 years of both medical and pharmacy benefits; roughly 18.3 million patients have at least 3 years of both medical and pharmacy benefits. Additionally, laboratory test/result information can be found on roughly 16% of the patients in IHCIS. The data are collected from over 46 different healthcare plans serving members across 9 census regions. The database is a fully de-identified, Health Insurance Portability and Accountability Act (HIPAA)-compliant dataset that includes the complete patient complete patient managed care organization-reimbursable medical history, and features encrypted member and provider IDs. IMS LifeLink TM Health Plan Claims Database The IMS LifeLink Health Plan Claims Database will be used for this analysis. This claims database contains data from over 90 different managed healthcare plans, encompassing over 60 million lives. The database includes inpatient and outpatient diagnoses (in International Classification of Diseases, Ninth Revision, Clinical Modification [ICD-9-CM] format) and procedures (in Current Procedural Terminology [CPT-4] and Healthcare Common Procedure Coding System [HCPCS] formats), as well as standard and mail-order prescription records. Both paid and charged amounts are available for all services rendered, as well as dates of service for all claims. The payer type distribution for this data source is 80% commercial, 3% Medicaid, and 1.7% Medicare Risk, with the rest categorized as other. GSK will provide the data cut for this study. MarketScan Commercial Database The MarketScan databases capture person-specific clinical utilization, expenditures, and enrollment data across inpatient, outpatient, prescription drug, and carve-out services from a selection of large employers, health plans, and government and public organizations. The MarketScan databases link paid claims and encounter data to detailed patient information across sites and types of providers, as well as over time. The annual medical databases include private sector health data from approximately 100 payers. Historically, more than 500 million claim records are available in the MarketScan databases. The MarketScan Commercial Database represents the medical experience of GlaxoSmithKline Page 5 of 12

6 insured employees and their dependents for active employees, early retirees, COBRA continues, and their dependents insured by employer-sponsored plans (ie, non-medicare-eligibles). The data are HIPAA-compliant; thus, all patients have been anonymized. MarketScan Commercial Database roughly represents 86 million lives. 3.2 Study Design Key study variables are operationally defined below. Study Period: The time period from July 1, 2002 through June 30, This period allows for a sufficient number of patients to be enrolled in the study based on the selection criteria described below, and for patient-specific outcomes to be assessed 6 months prior to and 12 months after the index date. The study period includes the enrollment period, pre-index period, and the post-index period. Index Date: The date of each patient s first fill for an AB prescription. Enrollment Period: The period of time during which patients will be enrolled into the study. It spans January 1, 2003 through June 30, Pre-index Period: A 6-month period prior to the index date will be used to evaluate baseline characteristics of the patients. Peri-period: A 5-month period after the index date will be analyzed to ensure no surgeries have occurred. Also, AURs that occur in this period will not be included in the outcomes assessment. Outcomes Assessment Period: A 7-month period after the peri-period analyzed to assess patient outcomes. Post-index Period: A 12-month period after the index date, including the peri-period and the outcomes assessment period. The study will be a retrospective comparative analysis of the rates of AUR and prostate surgery in patients with BPH treated with ABs and concomitant dutasteride vs finasteride therapy. Patients identified for study inclusion will be placed into cohorts based on their 5ARI therapy (ie, early dutasteride or early finasteride). Patients who start dutasteride therapy within 30 days of initiating AB treatment will be classified into the early dutasteride cohort. Similarly, those that start finasteride therapy within 30 days of initiating AB treatment will be classified into the early finasteride cohort. Since 5ARIs take 4 to 5 months to affect the prostate, it will be assumed that AURs and surgeries prior to this time period would not be avoided by 5ARI therapy. As such, only AURs and surgeries occurring after 150 days of therapy will be evaluated (a 150-day clean period). The study design is graphically depicted in Figure 1. GlaxoSmithKline Page 6 of 12

7 Figure 1. Study Design Study Period Enrollment Period 07/01/ /01/ /30/ month pre-index period Index Date 12-month post-index period 06/30/2008 Sensitivity analysis 5-month peri-period Surgery-free and no assessment of AUR 7-month outcomes assessment period AUR, surgery, and costs 3.3 Patient Selection In previously conducted studies 10,11, patients were selected based on the following criteria: Inclusion Criteria Patients were included if they: 1) Had a claim with a diagnosis for BPH (see Appendix, Table 5-1) in the enrollment period or pre-index period 2) Had a prescription for an AB (alfuzosin, doxazosin, tamsulosin, or terazosin) and a 5ARI (finasteride or dutasteride) in the enrollment period; the 5ARI must have occurred within 30 days (early) of the AB 3) Were continuously eligible to receive medical and pharmacy services from 6 months prior to through 12 months following the index treatment date 4) Were males aged 50 years at the time of index treatment date Exclusion Criteria Patients were excluded if they: 1) Were diagnosed with prostate or bladder cancer (Table 5-1) during the study period 2) Used finasteride 1 mg tablets for the treatment of male-pattern baldness in the study period 3) Had a history of prostate surgery within 5 months of index date; this criterion will be modified for sensitivity analyses 4) Received 5ARI therapy prior to initiating AB therapy GlaxoSmithKline Page 7 of 12

8 For the current study, once patient samples have been obtained and combined from previous studies based on above criteria, patients will also be excluded if they: 1) Have an index year prior to ) Have the same index date, age, and enrollment date as individual patients across the datasets (i3 Impact, IMS LifeLink, and MarketScan) 3) Have received index 5ARIs more than 30 days post-index date 4) Have evidence of switching 5ARIs 3.4 Outcomes Assessment This section lists the outcomes for which statistical comparisons between the early dutasteride and early finasteride cohorts will be performed. 1. Primary outcomes (Clinical): Proportion of patients experiencing the following clinical outcomes will be computed in the 7- month outcomes assessment period. a. AUR only: AUR will be defined as presence of at least 1 claim with a primary diagnosis of AUR (see Appendix, table 5-2, for ICD-9-CM codes) b. Prostate-related surgery only: Prostate-related surgery will be defined as the presence of at least 1 claim with a procedure code for prostate-related surgery (see Appendix, table 5-2, for CPT codes) c. Clinical progression: Clinical progression will be defined as presence of AUR and/or prostate-related surgery. 2. Secondary outcomes (Economic): a. BPH-related Medical Costs: Similar to the primary outcomes, medical costs will be assessed over the 7-month outcomes assessment period following the outcomes exclusionary peri-period. BPH-related medical costs will be defined as medical claims with a primary diagnosis of BPH (see Appendix, table 5-1). b. BPH-related Pharmacy costs: BPH-related pharmacy costs will be assessed over the entire 12-month post-index period so that the economic analysis will help us evaluate the incremental change in pharmacy costs that could be affected by dutasteride, as well as the total costs of utilizing dutasteride. Pharmacy costs will be computed for the following drug classes: 1) ABs (alfuzosin, doxazosin, tamsulosin, or terazosin) and 2) 5ARIs (finasteride and dutasteride). c. Total BPH-related Costs: Total BPH-related costs will be defined as the sum of BPHrelated medical and pharmacy costs. BPH-related costs will be standardized to 2009 US dollars (USD) using the consumer price index for US medical care Pre-index (Baseline) Variables This section lists the variables that will be used to illustrate demographic/clinical characteristics and comorbidity profile of the study sample at baseline. All pre-index (baseline) variables will be measured during the 6-month pre-index period, except if stated otherwise. 1. Demographic characteristics Age: The patient s age as of the index date will be obtained using year-of-birth information from the eligibility file. 12 United States Department of Labor. Bureau of Labor Statistics. Last accessed on July 22, GlaxoSmithKline Page 8 of 12

9 2. Comorbidity burden Clinical and Economic Benefit of Early Dutasteride vs Early Finasteride Use Charlson comorbidity: A Charlson comorbidity index (CCI) score will be calculated for each patient based on the presence of ICD-9-CM codes during the 6-month pre-index period. The CCI was developed by Charlson and colleagues using diagnoses and procedure codes from medical record review. 13 This original index was not created using ICD-9-CM codes. Thus, researchers have adapted this index by matching most of the diagnoses and procedures included in the CCI with similar ICD-9-CM codes. 14,15,16 For this study, the Dartmouth-Manitoba adaptation will be employed, which uses ICD-9-CM codes to represent both etiologies and manifestations or sequelae of the 19 categories of comorbidities specified in the original CCI. Higher scores represent a higher burden of comorbidity. Number of unique diagnoses: a unique count of disease states beyond those used to calculate the Charlson index. Number of unique Rx classes: a unique count of prescription drug categories received. 3. BPH specific Pre-Index (Baseline) variables Presence of AUR: AUR will be defined as presence of at least 1 claim with a diagnosis of acute urinary retention (see Appendix, table 5-2 for ICD-9-CM codes). BPH stage: Patients will be categorized into 1 of the 7 disease-severity stages based on the presence of ICD-9-CM codes in the 6-month period before the index date (see Appendix, table 5-3). Presence of urologist visit (specialty care). 4. Database Type: Type of database that each patient belongs to will also be documented and included as a pre-index variable. As mentioned earlier, 3 databases will be i3 Impact, IMS LifeLink and MarketScan. 4.0 ANALYTICAL APPROACH The following section describes the proposed plan for analyzing the data and provides sample templates. All results will be displayed in tables or in charts/figures as considered appropriate in the final study report. Table shells are provided in this section for example only. The final charts/figures may vary in accordance with the interpretation of the results Study Attrition The final study sample will be obtained based on the study design in Section 3.4 and after applying all the study criteria specified in Section 3.3. This section will summarize the number and percentage of patients excluded due to each criterion. The number and percentage of patients will not be mutually exclusive, in order to permit assessment of the most important criteria affecting sample size. 13 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(5): Deyo RA, Cherkin DC, Ciol MA. Adapting a clinical comorbidity index for use with ICD-9-CM administrative databases. J Clin Epidemiol. 1992;45; Romano PS, Roos LL, Jollis JG. Adapting a clinical comorbidity index for use with ICD-9-CM administrative data: differing perspectives. J Clin Epidemiol. 1993;46(10): D Hoore W, Bouckaert A, Tilquin C. Practical considerations on the use of the Charlson comorbidity index with administrative database. J Clin Epidemiol (12); GlaxoSmithKline Page 9 of 12

10 Table 4-1. Attrition Table Total Number of Patients (Combined Patient Sample From Previously Conducted Studies in i3 Impact, IMS LifeLink and MarketScan Databases); Criteria a n % Patients whose index year is prior to 2003 Patients who have the same index date, age, and enrollment date Patients who had evidence of switching 5ARIs Patients who didn t receive a 5ARI prescription within 30 days of the index AB prescription a Criteria not mutually exclusive; 5ARI 5-alpha reductase inhibitor; AB alpha blocker N= Description of Study Sample Baseline demographic and patient characteristics will be summarized by cohort (early dutasteride vs early finasteride) using standard summary statistics (means and/or proportions), presented in Table 4-2a. Inferential statistics will be used to describe and quantify inter-cohort differences in these parameters. For categorical variables, chi-square tests will be used. For interval variables, Student s t- tests and/or analysis of variance (ANOVA) tests of inter-cohort differences will be conducted. All statistical tests performed will test a 2-sided hypothesis of no difference between treatment groups at a significance level of Propensity Score Matching Differences in baseline demographic and patient characteristics between cohorts could possibly lead to biased results when analyzing outcomes by cohort. So a matched cohort analytical approach will be adopted, where the early dutasteride cohort will be matched to the early finasteride cohort on a 1:1 basis using propensity score matching. The propensity score for each patient will be defined as the probability of receiving dutasteride therapy contingent on (or based only on) baseline variables including demographics (age), comorbidity measures (charlson comorbidity index, number of unique Rx classes, number of unique diagnoses), BPH severity measures (BPH stage, pre-index BPHrelated costs, proportion of patients with AUR, proportion of patients with a urologist visit) and database type. Matching will then be done using the technique of nearest available matching on the estimated propensity score. The matching will be performed up to 3 decimal places (0.001). The success of the resulting propensity score to reduce selection bias will be assessed by evaluating the balance in the covariates between the cohorts after matching. After matching, baseline covariates (presented as means and/or proportions) will be compared between cohorts using paired t tests or Wilcoxon signed rank tests for continuous variables and McNemar s test for categorical variables (table 4-2b). Table 4-2a. Description of Study Sample before match Characteristics Total Early Dutasteride Early Finasteride P-value Mean age (mean, SD) CCI (mean, SD) Mean count of unique diagnosis codes (mean, SD) Mean count of unique medication classes (mean, SD) AUR (n, %) GlaxoSmithKline Page 10 of 12

11 BPH stage (mean, SD) Pre-index BPH-related costs (mean, SD) Urologist visit (specialty care) (n, %) Database Type (n, %) AUR acute urinary retention; BPH benign prostatic hyperplasia; CCI Charlson comorbidity index; SD standard deviation Table 4-2b. Description of Study Sample after match Characteristics Total Early Dutasteride Early Finasteride P-value Mean age (mean, SD) CCI (mean, SD) Mean count of unique diagnosis codes (mean, SD) Mean count of unique medication classes (mean, SD) AUR (n, %) BPH stage (mean, SD) Pre-index BPH-related costs (mean, SD) Urologist visit (specialty care) (n, %) Database Type (n, %) AUR acute urinary retention; BPH benign prostatic hyperplasia; CCI Charlson comorbidity index; SD standard deviation Outcome Measures Outcomes will be summarized using standard summary statistics (means and/or proportions) and differences between cohorts will be assessed using paired t tests or Wilcoxon signed rank tests for continuous variables and McNemar s test for categorical variables. Table 4-3. Outcomes: Early Dutasteride vs Early Finasteride Outcome Early Dutasteride Early Finasteride P-value Primary Outcomes (n, %) AUR Prostate surgery Clinical progression Secondary Outcomes (mean, SD) BPH-related total costs BPH-related pharmacy costs BPH-related medical costs AUR acute urinary retention; BPH benign prostatic hyperplasia; ED emergency department; SD standard deviation GlaxoSmithKline Page 11 of 12

12 5.0 APPENDIX Table 5-1. Inclusion and Exclusion ICD-9 Codes Inclusion ICD-9-CM Codes Benign prostatic hyperplasia 222.2, 600.xx Exclusion ICD-9-CM Codes Prostate cancer 185, , 233.4, 236.5, 239.5, V10.46 Bladder cancer 188, 198.1, 223.3, 233.7, 239.4, V10.51 Table 5-2. ICD-9-CM and CPT-4 Codes for Acute Urinary Retention and Prostate-related Surgeries Outcomes of Interest CPT or ICD-9-CM Codes Transurethral electrosurgical resection of the prostate Transurethral resection of the prostate 52612, 52614, 52620, Laser coagulation Laser vaporization Prostatectomy 55801, 55821, Transurethral microwave thermotherapy Transurethral needle ablation Transurethral water-induced thermotherapy Acute urinary retention* (excluding ), *ICD-9-CM codes will be used to identify this outcome Table 5-3. BPH Disease Stage Stage Description ICD-9-CM Codes 0 Benign prostatic hypertrophy 222.2, 600.xx 1 With urinary tract infection Stage With bladder outlet obstruction Stage , 596.0, With hydronephrosis Stage xx 4 With renal failure Stage xx, 586.xx 5 With sepsis Stage xx 6 With shock Stage , GlaxoSmithKline Page 12 of 12

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