GSK Clinical Study Register

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1 In February 2013, GlaxoSmithKline (GSK) announced a commitment to further clinical transparency through the public disclosure of GSK Clinical Study Reports (CSRs) on the GSK Clinical Study Register. The following guiding principles have been applied to the disclosure: Information will be excluded in order to protect the privacy of patients and all named persons associated with the study Patient data listings will be completely removed* to protect patient privacy. Anonymized data from each patient may be made available subject to an approved research proposal. For further information please see the Patient Level Data section of the GSK Clinical Study Register. Aggregate data will be included; with any direct reference to individual patients excluded *Complete removal of patient data listings may mean that page numbers are no longer consecutively numbered

2 HEALTH OUTCOMES STUDY REPORT UNIQUE IDENTIFIER ABBREVIATED TITLE FULL TITLE SPONSORSHIP DIVISION BUSINESS UNIT DEPARTMENT STUDY ACCOUNTABLE PERSON(S) CONTRIBUTING AUTHORS RETENTION CATEGORY INFORMATION TYPE KEY WORDS / MESH HEADINGS / META DATA ASSET ID GSK ASSET FLT Assessment of asthma risk over time Assessment of asthma risk over time in asthma patients in a single health plan Sponsored, Pharma Research & Development US Medical Affairs USHO, LOC (US) Health Outcomes Observational (Non-Interventional) Study Report Asthma risk trends, Inhaled corticosteroids, Asthma medication ratio CCI GR33343 Advair Diskus INDICATION Asthma

3 STUDY SYNOPSIS Unique Identifier Abbreviated Title GSK Product Rationale Objectives (Primary, Secondary & Exploratory) Study Design FLT Assessment of asthma risk in a healthcare system Advair Asthma is a leading cause of preventable hospitalizations, and it accounts for an estimated 14 million days of missed school and 100 million days of restricted activity yearly. It has been estimated that regular use of inhaled corticosteroids (ICSs) could reduce asthma hospitalizations by as much as 80%, and that the risk of death from asthma decreases by 21% for each additional ICS canister used. Previous research have shown that the ratio of the number of controller medications to the total number of asthma medications dispensed is a better predictor of subsequent asthma exacerbations than is the prescription of at least one controller medication. However, asthma exacerbations appear to represent a different dimension than chronic asthma symptoms and control. Primary To examine asthma risk as measured by modified AMR changes over 7 year period adjusting for differences in baseline characteristics Secondary Assess the impact of increasing or decreasing ICS/LABA market share on changes in modified AMR Exploratory To examine asthma risk trends before and after FSC formulary change year (2008) Retrospective cohort design A retrospective cohort design using electronic medical and pharmaceutical claims data from the Sharp Rees-Stealy (SRS) physician group was used to examine asthma risks in patients using asthma medications. Data from January 1, 2003 to December 31, 2010 was available and will constitute the study period (Figure 3-1). Objective 1 For the first objective, asthma patients with at least a diagnosis of asthma were identified as the study population and they should have at least one pharmacy claim for an asthma controller medication: ICS, combination product of inhaled corticosteroid and long-acting beta-agonist (ICS+LABA) or SABA (see Appendix). The index date was defined as the first chronologically occurring pharmacy claim for any of the aforementioned asthma controller medications during the period January 1, 2004 to December 31, 2009 (referred to as the enrollment period) (Figure 3-1). The Asthma Medication Ratio (AMR) which is calculated as total canisters of controller dispensed total canisters of controller dispensed + SABA canisters dispensed, is a validated asthma risk measure used to assess risk of future asthma events on a population level. Modified AMR was used which is calculated as total canisters of ICS/LABA and ICS dispensed total canisters of ICS/LABA abd ICS dispensed + SABA canisters dispensed. The modified AMR was assessed annually and semi-annually in the post period starting from the index date till the end of the follow up period. All 2

4 patients was required to have at least one medical claim (ICD 9 CM 493.xx) with a diagnosis of asthma in any field and in any setting and at least a prescription of asthma controller medication or rescue medication in each year of the follow up period. The 1-year period before this index date, referred to as the pre-index period, was used for baseline assessments and to ensure presence of asthma and no controller use. Annual and Semi-annual estimates of adjusted mean modified AMR estimates, ICS/LABA to ICS market share ratio and number of SABA canisters was plotted for 7 years from 2004 to The impact of changes in ICS/LABA to ICS market share over time on modified AMR will also be assessed. Objective 2 For the second objective, two time periods of three years was used to calculate the overall modified AMR, ICS/LABA to ICS market share ratio and number of SABA canisters for asthma patients. First time frame from Jan 2005 to Dec 2007 (Figure-3.2) was used in which the time period of Jan 2006 to Dec 2006 was used to identify asthma patients who also have at least one prescription of asthma controller medication or rescue medication. The modified AMR was assessed in the post period starting from the index date till the end of the follow up period. All patients was required to have at least one medical claim (ICD 9 CM 493.xx) with a diagnosis of asthma in any field and in any setting and at least a prescription of asthma controller medication or rescue medication in each year of the follow up period. The 1- year period before this index date, referred to as the pre-index period, was used for baseline assessments and to ensure presence of asthma and no controller use. The same analysis was repeated from Jan 2008 to Dec 2010 (Figure-3.2). Estimates of adjusted modified AMR estimates and number of SABA canisters was plotted separately with ICS/LABA to ICS market share ratio for these two time periods to look at the trends over time. Study Population and Sampling Methods Inclusion Criteria 1. 4 years of age during the index year 2. Presence of at least one medical claim in the index year with a diagnosis of asthma in any field (ICD 9 CM: 493.xx) in each year of observation. 3. Presence of at least one asthma controller medication or SABA in each year of follow up period 4. Continuous health plan eligibility in 2 years of the study period, 12 months pre and post index. Exclusion Criteria: 1. Presence of at least one medical claim in the index year with a diagnosis of COPD in any field (ICD 9 CM: 490.xx, 491.0, 491.1, , , , 491.8, 491.9, 492.0, 492.8, 496.xx) in each year of observation. 3

5 Data Source The study conducted using the data from Sharp HealthCare, the largest health care organization in San Diego County, California, with 6 acute care hospitals, 4 skilled nursing centers, 15 ambulatory clinics, a rehabilitation center, and a large home health agency. Through a network of more than 1000 affiliated physicians, Sharp serves more than a third of San Diego County's population, primarily through managed care risk contracts. Sharp Rees Stealy is a multi-specialty medical group. It has 19 locations and 400 primary care doctors and specialists representing virtually every field of medicine. Sharp Rees-Stealy's mission is to improve the health of its community through a caring partnership of patients, physicians and employees. Its goal is to offer quality services that set community standards and exceed expectations in a caring, convenient, affordable and accessible manner. The source of the data reporting is from its organization data warehouse. Billing In house services provided by Sharp Rees Stealy physicians. These are professional services that take place within the organization. Claims Outside services provided to the Managed Care population. These can include hospitalizations, emergency services, and referred to specialists. Pharmacy Outside pharmacy claim data provided by the Managed Care health plans. These are claims submitted from pharmacy to the health plan. Demographics This file has patient-level demographic information. Data Analysis Methods Sample Size and Power Limitations Asthma risk and ICS/LABA to ICS market share ratio was the main study outcome. Modified AMR was used to assess asthma risk in patients using ICS products. Demographic characteristics and baseline medical conditions were described by cohort using standard summary statistics (means and percentages). Generalized linear mixed models was used to model the AMR, ICS/LABA to ICS market share ratio and number of SABA canisters over time to get estimates of mean modified AMR, mean ICS/LABA to ICS market share ratio and mean numbers of SABA canister controlling for covariates. As this assessment is hypothesis generating in nature, sample size estimates and power calculations are not applicable. There may be factors affecting the observed outcomes that cannot be fully captured, such as lung function information to measure asthma control (e.g., forced expiratory volume in 1 second (FEV1]), physician samples used by patients, socioeconomic factors, education, and employment status. 4

6 ABBREVIATIONS ANOVA CCI CI COBRA COPD Dx ED FP FSC GSK HIPAA HMO ICD-9-CM ICS IPR LABA MPR OCS POS PPO Rx SABA SD TIO AMR SRS ITT Analysis of variance Charlson comorbidity Index Confidence interval Consolidated omnibus budget reconciliation act Chronic obstructive pulmonary disease Diagnosis Emergency Department Fluticasone propionate Fluticasone propionate-salmeterol xinafoate combination GlaxoSmithKline Health Insurance Portability and Accountability Act Health maintenance organization International Classification of Diseases, Ninth Revision, Clinical Modification Inhaled corticosteroid Ipratropium Long-acting beta-agonists Medication possession ratio Oral corticosteroids Point of service organization Preferred provider organization Prescription Short-acting beta-agonists Standard deviation Tiotropium Asthma Medication ratio Sharp Rees-Stealy physician group Intention-to-treat 5

7 1. INTRODUCTION/BACKGROUND Asthma is a chronic inflammatory disorder of the airways characterized by episodic and reversible airflow obstruction, airway hyper-responsiveness, and underlying inflammation. Common asthma symptoms include wheezing, coughing, and shortness of breath. Majority of asthmatic patients can expect optimal symptom control with correct treatment and avoidance of exposure to environmental allergens and irritants that are known to exacerbate asthma. During , an estimated 7.8% of the U.S. population had current asthma. Asthma is a leading cause of preventable hospitalizations, and it accounts for an estimated 14 million days of missed school and 100 million days of restricted activity yearly. It has been estimated that regular use of inhaled corticosteroids (ICSs) could reduce asthma hospitalizations by as much as 80%, and that the risk of death from asthma decreases by 21% for each additional ICS canister used. Previous research have shown that the ratio of the number of controller medications to the total number of asthma medications dispensed is a better predictor of subsequent asthma exacerbations than is the prescription of at least one controller medication. However, asthma exacerbations appear to represent a different dimension than chronic asthma symptoms and control. This study explores the trends of asthma medication ratio over time in a sample of patients defined as having asthma and changes in modified AMR with the change in ICS/LABA market share. 2. OBJECTIVES Primary To examine asthma risk as measured by modified AMR changes over 7 year period adjusting for differences in baseline characteristics Secondary Assess the impact of increasing or decreasing ICS/LABA market share on changes in modified AMR Exploratory To examine asthma risk trends before and after FSC formulary change year (2008) 3. RESEARCH METHODOLOGY 3.1. STUDY DESIGN A retrospective cohort design using electronic medical and pharmaceutical claims data from the Sharp Rees-Stealy (SRS) physician group was used to examine asthma risks in patients using asthma medications. Data from January 1, 2003 to December 31, 2010 was available and will constitute the study period (Figure 3-1). Objective 1 For the first objective, asthma patients with at least a diagnosis of asthma were identified as the study population and they should have at least one pharmacy claim for an asthma controller medication: ICS, combination product of inhaled corticosteroid and long-acting beta-agonist (ICS+LABA) or SABA (see Appendix). The index date and index quarter was defined as the first chronologically occurring pharmacy claim for any of the aforementioned asthma controller medications during the period January 1, 2004 to December 31, 2009 (referred to as the enrollment period) (Figure 3-1). The Asthma Medication Ratio (AMR) which is calculated as total canisters of controller dispensed total canisters of controller dispensed + SABA canisters dispensed, is a validated asthma risk measure used to assess risk of future asthma events on a population level. Modified AMR was used which is calculated as total canisters of ICS/LABA and ICS dispensed total canisters of ICS/LABA abd ICS dispensed + SABA canisters dispensed The modified AMR was assessed annually and semi-annually in the post period starting from the index date till the end of the follow up period. All patients was required to have at least one medical claim (ICD 9 CM 493.xx) with a 6

8 diagnosis of asthma in any field and in any setting and at least a prescription of asthma controller medication or rescue medication in each year of the follow up period. The 1-year period before this index date, referred to as the pre-index period, was used for baseline assessments and to ensure presence of asthma and no controller use. Estimates of adjusted mean modified AMR estimates, ICS/LABA to ICS market share ratio and number of SABA canisters was plotted for 7 years from 2004 to The impact of changes in ICS/LABA to ICS market share over time on modified AMR will also be assessed. Objective 2 For the second objective, two time periods of three years was used to calculate the overall AMR, ICS/LABA to ICS market share ratio and number of SABA canisters for asthma patients. First time frame from Jan 2005 to Dec 2007 (Figure-3.2) was used in which the time period of Jan 2006 to Dec 2006 was used to identify asthma patients who also have at least one prescription of asthma controller medication or rescue medication. The AMR was assessed annually and semi-annually in the post period starting from the index date till the end of the follow up period. All patients was required to have at least one medical claim (ICD 9 CM 493.xx) with a diagnosis of asthma in any field and in any setting and at least a prescription of asthma controller medication or rescue medication in each year of the follow up period. The 1-year period before this index date, referred to as the pre-index period, was used for baseline assessments and to ensure presence of asthma and no controller use. The same analysis was repeated from Jan 2008 to Dec 2010 (Figure-3.2). Estimates of adjusted modified AMR estimates and number of SABA canisters was plotted separately with ICS/LABA to ICS market share ratio for these two time periods to look at the trends over time. Figure 3-1: Study Design Study period use Enrollment as index date period Jan 1, 2003 Jan 1, 2004 Dec 31, 2009 Dec 31, year pre-index Index: Incident SABA or controller Rx Variable length follow-up period - Pre-index utilization - Asthma diagnosis - No controller meds - Overall modified AMR - ICS/LABA to ICS market share ratio - No. of SABA canisters 7

9 Figure 3-2: Study Design Period - 1 Period - 2 Study period Study period use Enrollment as index date period use Enrollment as index date period Jan 1, 2005 Jan 1, 2006 Dec 31, 2006 Dec 31, 2007 Jan 1, 2008 Jan 1, 2009 Dec 31, 2009 Dec 31, year pre-index Variable length follow-up period 1 year pre-index Variable length follow-up period Index: Incident SABA Index: Incident SABA or controller Rx or controller Rx Pre-index utilization Asthma diagnosis No controller meds Overall modified AMR ICS/LABA to ICS market share ratio No. of SABA canisters Pre-index utilization Asthma diagnosis No controller meds Overall modified AMR ICS/LABA to ICS market share ratio No. of SABA canisters 8

10 3.2. STUDY POPULATION ELIGIBILITY CRITERIA Inclusion Criteria 1. 4 years of age during the index year 2. Presence of at least one medical claim in the index year with a diagnosis of Asthma in any field in each year of observation 3. Presence of at least one asthma controller medication or SABA in each year of follow up 4. Continuous health plan eligibility in 2 years of the study period, 12 months pre and post index Exclusion Criteria: 1. Presence of at least one medical claim in the index year with a diagnosis of COPD in any field in each year of observation SAMPLING The sample for this study is based on a large convenience sample. All patients from the Sharp HealthCare, the largest health care organization in San Diego County, California, with 6 acute care hospitals, 4 skilled nursing centers, 15 ambulatory clinics, a rehabilitation center, and a large home health agency, was included in the study DATA SOURCE The study was conducted at Sharp HealthCare, the largest health care organization in San Diego County, California, with 6 acute care hospitals, 4 skilled nursing centers, 15 ambulatory clinics, a rehabilitation center, and a large home health agency. Through a network of more than 1000 affiliated physicians, Sharp serves more than a third of San Diego County's population, primarily through managed care risk contracts. Sharp Rees Stealy is a multi-specialty medical group. It has 19 locations and 400 primary care doctors and specialists representing virtually every field of medicine. Sharp Rees-Stealy's mission is to improve the health of its community through a caring partnership of patients, physicians and employees. Its goal is to offer quality services that set community standards and exceed expectations in a caring, convenient, affordable and accessible manner. The source of the data reporting is from its organization data warehouse DATA COLLECTION Billing In house services provided by Sharp Rees Stealy physicians. These are professional services that take place within the organization. Claims Outside services provided to the Managed Care population. These can include hospitalizations, emergency services, and referred to specialists. Pharmacy Outside pharmacy claim data provided by the Managed Care health plans. These are claims submitted from pharmacy to the health plan. Demographics This file has patient-level demographic information. 9

11 Term Description Visits Prescription fills Asthma-related visit A visit was defined as a unique date of service for all visits except hospitalization, and as a unique admission and discharge date for a hospitalization Number of claims for a drug regardless of days of supply Was defined as a visit having at least 1 claim with a primary diagnosis of Asthma (see Appendix, Table 5-1 for diagnosis codes) for all types of visits except hospitalization where only a primary discharge diagnosis of ASTHMA was used to designate the hospitalization as ASTHMA-related. KEY: CPT Current Procedural Terminology; E&M evaluation and management; ED emergency department This section lists the variables that were used to compute adjusted asthma risk controlling for these factors. 1. Demographic Characteristics Age: The patient s age as of the index year was computed using year of birth information from the eligibility file. Gender: The patient s gender was obtained from the eligibility file. 2. Overall Disease Burden The following variables was computed for each patient during the pre-index year: Number of unique Rx classes: a unique count of prescription drug categories received Total number of prescriptions filled Number of unique 3-digit diagnosis codes: a unique count of disease states beyond those used to calculate the Charlson Index Number of OCS prescriptions filled Number of SABA canisters filled Charlson comorbidity: The Charlson comorbidity index (CCI) score was calculated based on the presence of ICD-9-CM codes that comprise the index. The Charlson comorbidity index was developed by Charlson and colleagues using diagnoses and procedure codes from medical record review 1. This original index was not created using ICD-9-CM codes. Hence, researchers have adapted this index by matching most of the diagnoses and procedures included in the Charlson index with similar ICD-9-CM codes 2,3,4. For this study, the Dartmouth-Manitoba adaptation that uses ICD-9-CM codes to represent both etiologies and manifestations or sequel of the 19 categories of comorbidities specified in the original Charlson index was included. However, codes for COPD, specifically 491.xx, 492.xx, and 496.xx was excluded. Higher CCI scores represent a higher burden of comorbidity. 1 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 Jun;45(6) Romano PS, Roos LL, Jollis JG. Adapting a clinical comorbidity index for use with ICD-9-CM administrative data: differing perspectives. J Clin Epidemiol Oct;46(10): D Hoore W, Bouckaert A, Tilquin C. Practical considerations on the use of the Charlson comorbidity index with administrative databases. J Clin Epidemiol Dec;49(12):

12 3. Proxies for Asthma Severity The following variables were computed during the pre-index year. Variables defined as having a diagnosis of Asthma on a medical claim was computed for Asthma patients. Presence of asthma related hospitalizations Presence of asthma related ED visits Presence of asthma related office visits 11

13 3.5. ENDPOINTS Asthma Medication Use The HEDIS definition was used to count asthma medication use 5. For oral medications, a dispensing event is 1 prescription of an amount lasting 30 days. For prescriptions with days supply >30 days, the days supply was divided by 30 and rounded down to convert. Thus, a 100 day prescription for example is equal to 3 dispensing events (100/30=3.33 rounded down to 3). Two different prescriptions dispensed on the same day were counted as 2 different dispensing events. For inhaled medications, fills of inhalers was counted as 1 dispensing event (e.g. an inhaler with a 90-day supply is considered 1 dispensing event). Multiple inhalers of the same medication filled on the same date were counted as 1 dispensing event. For injected medications, 1 unit was 1 claim. The number of inhaler canisters dispensed in each claim was determined by a ratio of quantity to package size. For example, a claim for Azmacort Inhalation Aerosol Solution, 75 mcg per actuation (20g package size) with a quantity of 20 was interpreted as 1 canister. Any claim with a ratio of quantity to package size less than 1 was counted as 1 canister. Claims with quantity to package size ratios >1, was rounded to a whole number of canisters. If a claim is for more than 12 canisters, it was truncated to 12 canisters. Canister equivalents (CE) were computed as a proxy for number of canisters for nebulized dose forms. This was done by equating the number of doses in a standard package of a nebulizer dose form to the number of doses available in an inhaler canister for a particular generic drug. For example, if 60 doses are available in an inhaler canister for budesonide, then the number of doses in a standard package of the nebulizer dose form was converted to a CE by dividing by 60. The number of doses in a standard package of a nebulizer dose form was assessed by the ratio of total package size in ml to the ml per unit dose. Controller-to-Total Asthma Medication Ratio Controller-to-Total asthma medication ratio was calculated as the ratio of the units of controller medications used during the post-index period divided by the sum of the units of controller medications plus the units of inhaled shortacting beta-agonist (SABAs) used during the post-index period. Controller medications for the ratio measure included ICS and ICS+LABA combination product. The ratio ranged from 0 (no controller + SABA) to 1 (controller + no SABA). Patients using no medications would have missing ratio values and were excluded. Units of controller medications and SABAs was defined as follows (see section for computation of canisters and dispensing events): A unit of inhaled SABA = 1 canister A unit of an inhaled controller medication = 1 canister A unit of an oral controller medication = 1 dispensing event A unit of an injectable controller medication = 1 canister Following types of measures were computed : 1. Ratio-orig - included aforementioned controllers as shown in the formula below: 5 Schatz M, Broder M, Chang E, O Connor R, Luskin A, Solari PG. Asthma quality-of-care measures using administrative data: identifying the optimal denominator. Annals of Allergy, Asthma, and Immunology. 2009; 102:

14 Ratio-orig = (ICS canisters or (ICS/LABA) canisters) (SABA canisters + ICS canisters or (ICS+LABA) canisters) 2. ICS/LABA to ICS market share ratio - included ratio of ICS/LABA to total controller Rx. ICS/LABA to ICS market share ratio = (ICS/LABA canisters) (ICS canisters + ICS/LABA canisters) 3. Number of SABA canisters included the number of SABA canisters Adjusted estimates of mean modified AMR and mean ICS/LABA to ICS market share ratio was examined and plotted to look at the trends across 7 years. Similar plot of mean number of SABA canisters and mean ICS/LABA to ICS market share ratio was created to look at the trends Data Analysis Demographic characteristics and baseline medical conditions were described by cohort using standard summary statistics (means and percentages). To ensure accuracy, the data was reviewed for internal consistency and checked for influential outliers. Generalized linear mixed models was used to model the modified AMR, ICS/LABA to ICS market share ratio and number of SABA canisters over time to get estimates of mean modified AMR, mean ICS/LABA to ICS market share ratio and mean numbers of SABA canister controlling for covariates. The covariates used for the analyses was demographic characteristics, overall asthma burden and asthma severity in the pre-index period. Random effect by patient and the correlations among different quarters was handled by specifying appropriate random effects in the generalized linear mixed models. Appropriate distribution and link function was specified for each endpoint considered. Generalized linear mixed models was also used to model the relationship between ICS/LABA to ICS market share ratio and modified AMR where AMR was considered as dependent variables and ICS/LABA to ICS was considered as independent variables with adjustment of other covariates and time. For the second objective, there was a separate analysis for each period. Generalized linear mixed models was used to model the modified AMR, ICS/LABA to ICS market share ratio and number of SABA canisters over time to get estimates of mean modified AMR, mean ICS/LABA to ICS market share ratio and mean numbers of SABA canister controlling for covariates. 13

15 4. RESULTS 4.1. Study Attrition This section will summarize the number (%) of recipients excluded due to each criterion presented in Table 4-1. The number (%) will not be mutually exclusive to permit assessment of the most important criteria affecting sample size. Table 4-1. Study Attrition There were 11,970 patients with asthma and no COPD using at least one controller or SABA during the period. Exclusion criteria applied to this population is shown in below figure % N=23,230 Reason For Exclusion n a % Asthma pts with no COPD using controller/saba 11, % Asthma in pre-index and no controller in pre-index 5, % Asthma dx and controller/saba in all f-up years 1, % Age 4 years % FINAL SAMPLE SIZE 990 a Not mutually exclusive 4.2. Description of Study Sample A final population of 990 patients met all the inclusion criteria. Mean age of the population was about 35 years with mostly males (62%). About 15% of these patients had SABA and OCS prescription in their pre-index period. Other baseline characteristics of these patients are presented in the table below. N= 990 patients Mean (std) or N (%) Mean age 34.7 (18.2) Gender Female 611 (61.7%) Male 379 (38.3%) Number of SABA users 147 (14.9%) Mean number of SABA Rx 0.53 (1.85) Number of OCS users 150 (15.2%) Mean number of OCS Rx 0.25 (0.83) Mean number of Rx 7.9 (13.5) 14

16 Mean number of unique RX class 3.1 (3.6) Charlson comorbidity index 0.22 (0.92) Mean number of unique dx codes 9.9 (12.8) Asthma severity Number of asthma related IP visits 21 (2.1%) Mean number of asthma related IP visits 0.05 (0.54) Number of asthma related ER visits 55 (5.6%) Mean number of asthma related ER visits 0.08 (0.42) Number of asthma related office visits 577 (58.3%) Mean number of asthma related office visits 1.25 (1.83) 4.3 Annual AMR, SABA use and Market share estimates Charts of annual and semi-annual adjusted AMR, SABA and market share ratio over a 7 year period is plotted below. Overall trend depicts that mean AMR increases over time and mean SABA use decreases over time. 0.6 Mean AMR Mean AMR Years 15

17 Mean SABA Mean SABA Years Mean Mkt share Years Mean Mkt share 16

18 4.4 Semi-Annual AMR, SABA use and Market share estimates Mean AMR 0.2 Mean AMR Semi-annual Mean SABA Semi-annual Mean SABA 17

19 Mean Mkt share Semi-annual Mean Mkt share 4.5 Relationship between Modified AMR and Market share ratio Annual estimates Regression results report that with 10% increase in market share of ICS/LABA, there is a 9% increased likelihood of AMR of 0.5 which suggests that increase in market share of ICS/LABA is associated with lower asthma risk in asthma patients Increase in market share Odds Ratio 95% CI 10% 1.09 (1.06, 1.12) 20% 1.19 (1.12, 1.26) 30% 1.3 (1.17, 1.41) 40% 1.4 (1.24, 1.6) 50% 1.53 (1.31, 1.8) 18

20 4.6 Relationship between Modified AMR and Market share ratio Semi-Annual estimates Regression results report that with 10% increase in market share of ICS/LABA, there is a 8% increased likelihood of AMR of 0.5 which suggests that increase in market share of ICS/LABA is associated with lower asthma risk in asthma patients Increase in market share Odds Ratio 95% CI 10% 1.08 (1.05, 1.11) 20% 1.17 (1.1, 1.24) 30% 1.26 (1.15, 1.38) 40% 1.37 (1.21, 1.54) 50% 1.48 (1.27, 1.72) 4.7 Mean AMR, SABA use and market share ratio before and after formulary change Annual estimates 19

21 20

22 4.8 Mean AMR, SABA use and market share ratio before and after formulary change Semi-annual estimates 21

23 22

24 5. LIMITATIONS There may be factors affecting the observed outcomes that cannot be fully captured, such as lung function information to measure asthma control (eg, forced expiratory volume in 1 second (FEV1]), physician samples used by patients, socioeconomic factors, education, and employment status. Severity of disease is not known in this dataset. The methodology and statistical plan for this study was used to mitigate the effect of prescribing bias and severity can influence outcomes of interest. However residual confounding may still exist due to the observational nature of this study. 6. CONCLUSION The results of this study suggest that the mean modified AMR increased over a 7-year time period and that the mean SABA use decreased over that time. The regression analysis adjusting for differences in groups showed that a 10% increase in percent of ICS/LABA used in the first year of the evaluation was associated with a 9% increased likelihood of modified AMR being >= 0.5, which suggests that an increase in percent of ICS/LABA used may be associated with lower asthma risk in asthma patients. 23

25 7. APPENDIX Controller Medications Inhaled Corticosteroids (ICS) 1) Beclomethasone 2) Budesonide 3) Flunisolide 4) Fluticasone 5) Triamcinolone 6) Mometasone Fixed dose Combination Therapy (FDCT) 1) Fluticasone + Salmeterol (Advair) 2) Budesonide + Formoterol (Symbicort) Reliever Medications Short-Acting, Inhaled Beta-2 Agonist (SABA) 1) Albuterol 2) Bitolterol 3) Isoetharine 4) Isoproterenol 5) Levalbuterol 6) Metaproterenol 7) Pirbuterol 8) Terbutaline 24

26 HEALTH OUTCOMES PROTOCOL UNIQUE IDENTIFIER ABBREVIATED TITLE FINAL PROTOCOL APPROVED FULL TITLE SPONSORSHIP DIVISION BUSINESS UNIT DEPARTMENT STUDY ACCOUNTABLE PERSON(S) CONTRIBUTING AUTHORS RETENTION CATEGORY INFORMATION TYPE KEY WORDS / MESH HEADINGS / META DATA ASSET ID GSK ASSET FLT Assessment of asthma risk over time 04 June 2012 Assessment of asthma risk over time in asthmaa patients in a single health plan Sponsored, Pharma Research & Development US Medical Affairs USHO, LOC (US) Health Outcomes Observational (Non-Interventional) Protocol Asthma risk trends, Inhaled corticosteroids, Asthma medication ratio CCI18781 FLOVENT INDICATION Asthma

27 2 SPONSOR SIGNATORY ProtocolID:FLT Title:GHO113282/FLT114941Assessmentofasthmariskovertimeinasthmapatientsinasingle healthplan Version:1.0 Date:04June2012 NAME TITLE/ROLE SIGNATURE DATE Theauthorconfirmsthatthisdocumenthasbeenpreparedinaccordancewithpolicies&proceduresand thatrelevantinputhasbeenobtainedandincorporatedfromcontributoryauthors&reviewers. StudyAccountablePerson/Author isignsignatureblock isignsignatureblock TheBusinessUnitVPsignstoconfirmthatthedocumentmeetsUSHOstandards,policiesand procedures. HealthOutcomesVP isignsignatureblock isignsignatureblock ArepresentativeofHOPRCsignstoconfirmthattheprotocolwasreviewed&approvedbythepeer committeeofhealthoutcomes,statistics&epidemiologyexperts. HOProtocolReviewCommittee isignsignatureblock isignsignatureblock

28 PROTOCOL SYNOPSIS Unique Identifier Abbreviated Title GSK Product Rationale Objectives (Primary, Secondary & Exploratory) Study Design FLT Assessment of asthma risk in a healthcare system NA Asthma is a leading cause of preventable hospitalizations, and it accounts for an estimated 14 million days of missed school and 100 million days of restricted activity yearly. It has been estimated that regular use of inhaled corticosteroids (ICSs) could reduce asthma hospitalizations by as much as 80%, and that the risk of death from asthma decreases by 21% for each additional ICS canister used. Previous research have shown that the ratio of the number of controller medications to the total number of asthma medications dispensed is a better predictor of subsequent asthma exacerbations than is the prescription of at least one controller medication. However, asthma exacerbations appear to represent a different dimension than chronic asthma symptoms and control. Primary To examine asthma risk as measured by modified AMR changes over 7 year period adjusting for differences in baseline characteristics Secondary Assess the impact of increasing or decreasing ICS/LABA market share on changes in modified AMR Exploratory To examine asthma risk trends before and after FSC formulary change year (2008) Retrospective cohort design A retrospective cohort design using electronic medical and pharmaceutical claims data from the Sharp Rees-Stealy (SRS) physician group will be used to examine asthma risks in patients using asthma medications. Data from January 1, 2003 to December 31, 2010 will be available and will constitute the study period (Figure 3-1). Objective 1 For the first objective, asthma patients with at least a diagnosis of asthma were identified as the study population and they should have at least one pharmacy claim for an asthma controller medication: ICS, combination product of inhaled corticosteroid and long-acting beta-agonist (ICS+LABA) or SABA (see Appendix). The index date and index quarter will be defined as the first chronologically occurring pharmacy claim for any of the aforementioned asthma controller medications during the period January 1, 2004 to December 31, 2009 (referred to as the enrollment period) (Figure 3-1). The Asthma Medication Ratio (AMR) which is calculated as total canisters of controller dispensed total canisters of controller dispensed + SABA canisters dispensed, is a validated asthma risk measure used to assess risk of future asthma events on a population level. Modified AMR will be used which is calculated as total canisters of ICS/LABA and ICS dispensed total canisters of ICS/LABA abd ICS dispensed + SABA canisters dispensed. The modified AMR will be assessed quarterly in the post period starting from the index date till the end of the follow up period. All patients 3

29 will be required to have at least one medical claim (ICD 9 CM 493.xx) with a diagnosis of asthma in any field and in any setting and at least a prescription of asthma controller medication or rescue medication in each year of the follow up period. The 1-year period before this index date, referred to as the pre-index period, will be used for baseline assessments and to ensure presence of asthma and no controller use. Quarterly estimates of adjusted mean modified AMR estimates, ICS/LABA to ICS market share ratio and number of SABA canisters will be plotted for 7 years from 2004 to The impact of changes in ICS/LABA to ICS market share over time on modified AMR will also be assessed. Objective 2 For the second objective, two time periods of three years will be used to calculate the overall modified AMR, ICS/LABA to ICS market share ratio and number of SABA canisters for asthma patients. First time frame from Jan 2005 to Dec 2007 (Figure-3.2) will be used in which the time period of Jan 2006 to Dec 2006 will be used to identify asthma patients who also have at least one prescription of asthma controller medication or rescue medication. The modified AMR will be assessed quarterly in the post period starting from the index date till the end of the follow up period. All patients will be required to have at least one medical claim (ICD 9 CM 493.xx) with a diagnosis of asthma in any field and in any setting and at least a prescription of asthma controller medication or rescue medication in each year of the follow up period. The 1-year period before this index date, referred to as the pre-index period, will be used for baseline assessments and to ensure presence of asthma and no controller use. The same analysis will be repeated from Jan 2008 to Dec 2010 (Figure-3.2). Quarterly estimates of adjusted modified AMR estimates and number of SABA canisters will be plotted separately with ICS/LABA to ICS market share ratio for these two time periods to look at the trends over time. Study Population and Sampling Methods Inclusion Criteria 1. 4 years of age during the index year 2. Presence of at least one medical claim in the index year with a diagnosis of asthma in any field (ICD 9 CM: 493.xx) in each year of observation. 3. Presence of at least one asthma controller medication or SABA in each year of follow up period 4. Continuous health plan eligibility in 2 years of the study period, 12 months pre and post index. Exclusion Criteria: 1. Presence of at least one medical claim in the index year with a diagnosis of COPD in any field (ICD 9 CM: 490.xx, 491.0, 491.1, , , , 491.8, 491.9, 492.0, 492.8, 496.xx) in each year of observation. 4

30 Data Source The study will be conducted using the data from Sharp HealthCare, the largest health care organization in San Diego County, California, with 6 acute care hospitals, 4 skilled nursing centers, 15 ambulatory clinics, a rehabilitation center, and a large home health agency. Through a network of more than 1000 affiliated physicians, Sharp serves more than a third of San Diego County's population, primarily through managed care risk contracts. Sharp Rees Stealy is a multi-specialty medical group. It has 19 locations and 400 primary care doctors and specialists representing virtually every field of medicine. Sharp Rees-Stealy's mission is to improve the health of its community through a caring partnership of patients, physicians and employees. Its goal is to offer quality services that set community standards and exceed expectations in a caring, convenient, affordable and accessible manner. The source of the data reporting is from its organization data warehouse. Billing In house services provided by Sharp Rees Stealy physicians. These are professional services that take place within the organization. Claims Outside services provided to the Managed Care population. These can include hospitalizations, emergency services, and referred to specialists. Pharmacy Outside pharmacy claim data provided by the Managed Care health plans. These are claims submitted from pharmacy to the health plan. Demographics This file has patient-level demographic information. Data Analysis Methods Sample Size and Power Limitations Asthma risk and ICS/LABA to ICS market share ratio will be the main study outcome. Modified AMR will be used to assess asthma risk in patients using ICS products. Demographic characteristics and baseline medical conditions will be described by cohort using standard summary statistics (means and percentages). Generalized linear mixed models will be used to model the AMR, ICS/LABA to ICS market share ratio and number of SABA canisters) over time (by quarter) to get estimates of quarterly mean modified AMR, mean ICS/LABA to ICS market share ratio and mean numbers of SABA canister controlling for covariates. As this assessment is hypothesis generating in nature, sample size estimates and power calculations are not applicable. There may be factors affecting the observed outcomes that cannot be fully captured, such as lung function information to measure asthma control (e.g., forced expiratory volume in 1 second (FEV1]), physician 5

31 samples used by patients, socioeconomic factors, education, and employment status. 6

32 TABLE OF CONTENTS HEALTH OUTCOMES PROTOCOL... 1 PROTOCOL SYNOPSIS... 3 TABLE OF CONTENTS... 7 ABBREVIATIONS INTRODUCTION/BACKGROUND OBJECTIVES RESEARCH METHODOLOGY STUDY DESIGN STUDY POPULATION ELIGIBILITY CRITERIA SAMPLING DATA SOURCE DATA COLLECTION ENDPOINTS SAMPLE SIZE / POWER CALCULATIONS HYPOTHESES DATA ANALYSIS CONSIDERATIONS Study Attrition Analysis LIMITATIONS STUDY CONDUCT, MANAGEMENT & ETHICS ETHICS/IRB APPROVAL INFORMED CONSENT DATA PRIVACY PERSONALLY IDENTIFIABLE INFORMATION (PII) AE REPORTING DATA STORAGE/ARCHIVAL EXTERNAL INVOLVEMENT Third Party Supplier (Company Name, Address & Staff Names/ /Phone) External Expert/Health Care Professionals (Consultants & Research PIs) APPENDIX..19 MILESTONES DATA DISSEMINATION PLAN

33 ABBREVIATIONS ANOVA CCI CI COBRA COPD Dx ED FP FSC GSK HIPAA HMO ICD-9-CM ICS IPR LABA MPR OCS POS PPO Rx SABA SD TIO AMR SRS ITT Analysis of variance Charlson comorbidity Index Confidence interval Consolidated omnibus budget reconciliation act Chronic obstructive pulmonary disease Diagnosis Emergency Department Fluticasone propionate Fluticasone propionate-salmeterol xinafoate combination GlaxoSmithKline Health Insurance Portability and Accountability Act Health maintenance organization International Classification of Diseases, Ninth Revision, Clinical Modification Inhaled corticosteroid Ipratropium Long-acting beta-agonists Medication possession ratio Oral corticosteroids Point of service organization Preferred provider organization Prescription Short-acting beta-agonists Standard deviation Tiotropium Asthma Medication ratio Sharp Rees-Stealy physician group Intention-to-treat 8

34 1. INTRODUCTION/BACKGROUND Asthma is a chronic inflammatory disorder of the airways characterized by episodic and reversible airflow obstruction, airway hyper-responsiveness, and underlying inflammation. Common asthma symptoms include wheezing, coughing, and shortness of breath. Majority of asthmatic patients can expect optimal symptom control with correct treatment and avoidance of exposure to environmental allergens and irritants that are known to exacerbate asthma. During , an estimated 7.8% of the U.S. population had current asthma. Asthma is a leading cause of preventable hospitalizations, and it accounts for an estimated 14 million days of missed school and 100 million days of restricted activity yearly. It has been estimated that regular use of inhaled corticosteroids (ICSs) could reduce asthma hospitalizations by as much as 80%, and that the risk of death from asthma decreases by 21% for each additional ICS canister used. Previous research have shown that the ratio of the number of controller medications to the total number of asthma medications dispensed is a better predictor of subsequent asthma exacerbations than is the prescription of at least one controller medication. However, asthma exacerbations appear to represent a different dimension than chronic asthma symptoms and control. This study explores the trends of asthma medication ratio over time in a sample of patients defined as having asthma and changes in modified AMR with the change in ICS/LABA market share. 2. OBJECTIVES Primary To examine asthma risk as measured by modified AMR changes over 7 year period adjusting for differences in baseline characteristics Secondary Assess the impact of increasing or decreasing ICS/LABA market share on changes in modified AMR Exploratory To examine asthma risk trends before and after FSC formulary change year (2008) 3. RESEARCH METHODOLOGY 3.1. STUDY DESIGN A retrospective cohort design using electronic medical and pharmaceutical claims data from the Sharp Rees-Stealy (SRS) physician group will be used to examine asthma risks in patients using asthma medications. Data from January 1, 2003 to December 31, 2010 will be available and will constitute the study period (Figure 3-1). Objective 1 For the first objective, asthma patients with at least a diagnosis of asthma were identified as the study population and they should have at least one pharmacy claim for an asthma controller medication: ICS, combination product of inhaled corticosteroid and long-acting beta-agonist (ICS+LABA) or SABA (see Appendix). The index date and index quarter will be defined as the first chronologically occurring pharmacy claim for any of the aforementioned asthma controller medications during the period January 1, 2004 to December 31, 2009 (referred to as the enrollment period) (Figure 3-1). The Asthma Medication Ratio (AMR) which is calculated as total canisters of controller dispensed total canisters of controller dispensed + SABA canisters dispensed, is a validated asthma risk measure used to assess risk of future asthma events on a population level. Modified AMR will be used which is calculated as total canisters of ICS/LABA and ICS dispensed total canisters of ICS/LABA abd ICS dispensed + SABA canisters dispensed The modified AMR will be assessed quarterly in the post period starting from the index date till the end of the follow up period. All patients will be required to have at least one medical claim (ICD 9 CM 493.xx) with a diagnosis of 9

35 asthma in any field and in any setting and at least a prescription of asthma controller medication or rescue medication in each year of the follow up period. The 1-year period before this index date, referred to as the pre-index period, will be used for baseline assessments and to ensure presence of asthma and no controller use. Quarterly estimates of adjusted mean modified AMR estimates, ICS/LABA to ICS market share ratio and number of SABA canisters will be plotted for 7 years from 2004 to The impact of changes in ICS/LABA to ICS market share over time on modified AMR will also be assessed. Objective 2 For the second objective, two time periods of three years will be used to calculate the overall AMR, ICS/LABA to ICS market share ratio and number of SABA canisters for asthma patients. First time frame from Jan 2005 to Dec 2007 (Figure-3.2) will be used in which the time period of Jan 2006 to Dec 2006 will be used to identify asthma patients who also have at least one prescription of asthma controller medication or rescue medication. The AMR will be assessed quarterly in the post period starting from the index date till the end of the follow up period. All patients will be required to have at least one medical claim (ICD 9 CM 493.xx) with a diagnosis of asthma in any field and in any setting and at least a prescription of asthma controller medication or rescue medication in each year of the follow up period. The 1-year period before this index date, referred to as the pre-index period, will be used for baseline assessments and to ensure presence of asthma and no controller use. The same analysis will be repeated from Jan 2008 to Dec 2010 (Figure-3.2). Quarterly estimates of adjusted modified AMR estimates and number of SABA canisters will be plotted separately with ICS/LABA to ICS market share ratio for these two time periods to look at the trends over time. Figure 3-1: Study Design Studyperiod useasindexdate Enrollmentperiod Jan1,2003 Jan1,2004 Dec31,2009 Dec31,2010 1yearpreindex Index:IncidentSABA orcontrollerrx Variablelengthfollowupperiod Preindexutilization Asthmadiagnosis Nocontrollermeds OverallmodifiedAMR ICS/LABAtoICSmarket shareratio No.ofSABAcanisters 10

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