Real-world use of bevacizumab-awwb, a bevacizumab biosimilar, in US patients with metastatic colorectal cancer.

Aim: Evaluated real world use of bevacizumab-awwb (MVASI®), a bevacizumab biosimilar, for treating metastatic colorectal cancer (mCRC). Materials & methods: Adult mCRC patients who received bevacizumab-awwb during the first year after market availability were identified from the ConcertAI oncology dataset. Results: Of 304 patients, 47% initiated bevacizumab-awwb as reference product (RP) naive patients and 53% received bevacizumab-awwb with prior exposure to RP. Overall, 78% received bevacizumab-awwb as first-line therapy; the proportion was higher (91%) in RP-naive patients. Among RP-experienced patients, 83% were transitioned from RP to bevacizumab-awwb in the same line without disease progression; of those, the majority (83%) were transitioned within 28 days. Conclusion: Early evidence from US oncology practices suggests clinical adoption of bevacizumab-awwb in treating mCRC patients.

Real-world Clinical Characteristics, Treatment Patterns, and Exacerbations in US Patients With Asthma Newly Treated With Omalizumab.

PURPOSE: The objective of this study was to examine patient characteristics, treatment patterns, and exacerbations among patients with asthma newly treated with omalizumab. METHODS: Data for this study were obtained from administrative claims and medical records. The index date was the date of the first claim for omalizumab. All patients had ≥12 months of continuous health plan eligibility before and after the index date. Demographic and clinical characteristics were obtained 12 months before the index date. Treatment patterns of asthma medications, including omalizumab, and asthma exacerbations were evaluated in the preindex and postindex periods. FINDINGS: The study included 1564 patients. Asthma-related medication use decreased from the preindex to the postindex periods (oral corticosteroids, 83.3%-66.4%, P < 0.001; inhaled corticosteroids [ICSs], 33.1%-26.8%, P < 0.001; long-acting ß2-adrenergic agonists [LABAs], 6.6%-5.2%, P = 0.009; ICS-LABA combination, 69.3%-64.3%, P < 0.001; leukotriene modifiers, 67.8%-59.7%, P < 0.001). The proportion of patients with any asthma exacerbations decreased by 33.6% (66.6%-44.2%, P < 0.001). Notably, the relative decreases in hospitalization and emergency department exacerbations were 79.3% and 72.2%, respectively. A total of 930 patients (59.5%) discontinued omalizumab treatment during the entire postindex period (maximum, 3400 days [approximately 9 years]), with 353 (38.0%) restarting omalizumab treatment. IMPLICATIONS: In this real-world analysis, patients newly initiating omalizumab therapy for allergic asthma used fewer concomitant asthma medications, while experiencing significant reductions in asthma exacerbations, especially hospitalization- and emergency department-specific exacerbations, from pre- to post-omalizumab treatment initiation periods.

Real-World Characteristics and Treatment Patterns in Patients with Urticaria Initiating Omalizumab in the United States.

BACKGROUND: Omalizumab is indicated for the management of chronic idiopathic urticaria (CIU) in patients aged 12 years or older with persistent hives that are not adequately controlled by H1 antihistamines. While its safety and efficacy in CIU patients have been evaluated in multiple clinical trials, real-world use of omalizaumab in CIU has not been well characterized. OBJECTIVE: To assess demographics, clinical characteristics, and treatment patterns of CIU patients who initiated omalizumab to better understand the usage of this agent in CIU management in the real world. METHODS: This retrospective cohort study used medical and pharmacy claims data in the United States from the HealthCore Integrated Database to identify patients with CIU newly treated with omalizumab (≥ 4 omalizumab claims within 6 months of the initial claim) between March 21, 2014, and October 31, 2015 (study intake period). The index date was defined as the date of the first claim for omalizumab during the study intake period. Demographic and clinical characteristics were described for patients treated with omalizumab, as were treatment patterns associated with omalizumab and concomitant medications associated with CIU treatment. Descriptive and inferential statistics were reported. The Kaplan-Meier method was used to examine omalizumab treatment patterns. RESULTS: This study included 298 omalizumab-treated patients (mean [SD] age of 43.5 [13.64] years; 70.8% female); approximately 84% were seen by an allergist/immunologist. All patients had ≥ 12 months of continuous enrolment and a subset of 138 patients had ≥ 18 months of follow-up. For patients with ≥ 12 months of post-index follow-up, 12.1% (n = 36), 28.5% (n = 85), and 32.9% (n = 98) discontinued omalizumab within the 6-month, 12-month, and the entire post-index periods (mean 530 days), respectively; the mean number of days patients were continuously treated with omalizumab was 443.1 (95% CI = 425.0-461.3); the probabilities of continuous treatment (95% CI) were 0.879 (0.836-0.911), 0.711 (0.656-0.759), and 0.647 (0.585-0.703) for the 6-, 12-, and 18-month post-index periods, respectively. For the 98 patients who discontinued omalizumab during the entire post-index period, 28.6% restarted omalizumab after the first discontinuation within the post-index period (mean time from first discontinuation to first restart=329 days). Use of medications such as oral corticosteroids, montelukast, cyclosporine, and prescription H1 and H2 antihistamines decreased during the 1- to 6-month and 7- to 12-month post-index periods compared with those within the 6-month pre-index period. CONCLUSIONS: In this cohort of CIU patients who were newly prescribed omalizumab, the majority were treated by allergists/immunologists as expected, and approximately 60% of patients continued on therapy beyond 18 months. Concomitant medication use decreased after omalizumab initiation. These data on the real-world use of omalizumab for CIU may help to better inform decision-making processes for health care payers by quantifying omalizumab and concomitant medication treatment patterns over a longer time frame relative to previous studies. DISCLOSURES: This study was sponsored by Novartis Pharmaceuticals, which provided funding support for the conduct of the study. Kavati, Ortiz, and Paknis are employees of Novartis Pharmaceuticals. Ke, Wertz, Huang, Wang, Willey, and Stephenson are employees of HealthCore, an independent research organization that received funding from Novartis Pharmaceuticals for the conduct of this study. Beck is an employee of the University of Rochester Medical Center, who was under contract with Novartis Pharmaceuticals to provide consulting services to this study, and reports grants from Genentech, outside the currently submitted work. Bernstein is affiliated with Bernstein Clinical Research Center, which was under contract with Novartis Pharmaceuticals to provide consulting services to this study, and reports receiving grants and personal fees from Novartis Pharmaceuticals, grants and personal fees from Genentech outside of the submitted work, and is an author on the Joint Task Force for Practice Parameters for Urticaria and the GALEN international guidelines for urticaria under preparation. Selected study data were presented in a poster at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 22nd Annual International Meeting on May 20-24, 2017, in Boston, MA. A poster based on this dataset was presented at the 2017 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting on October 26-30, 2017, in Boston, MA.

Real-world treatment patterns and outcomes of omalizumab use in patients with chronic idiopathic urticaria.

OBJECTIVE: To examine treatment patterns, treatment response, and demographic and clinical characteristics of patients with chronic idiopathic urticaria (CIU) newly initiated on omalizumab therapy in real-world practice in the US. METHODS: This retrospective observational cohort study used US claims data from the HealthCore Integrated Research Database (HIRD®) augmented with medical record data to identify CIU patients newly-treated with omalizumab (≥4 omalizumab claims within 6 months of initial claim; index date = first omalizumab claim date) between March 21, 2014 and October 31, 2015 and with ≥6 months pre- and ≥12 months post-index health plan eligibility. Study outcomes were captured from medical records for up to 12 months pre-index and up to 24 months post-index. Descriptive statistics were reported. RESULTS: This study consisted of 88 patients with a mean (SD) age of 43.4 (± 13.46) years, 68.2% were female, and 36 patients had ≥18 months post-index eligibility. Among 69 patients with documented index dose, 75.4% received omalizumab 300 mg and 69.6% remained on index dose throughout follow-up. For 52 patients with documented index dosing frequency, 96.2% had every 4-week dosing frequency. Among 86 patients with omalizumab documentation, 83.7% reported CIU improvement after omalizumab initiation and 24.4% discontinued omalizumab. For all patients, the proportion using oral corticosteroids (OCS) decreased pre- to post-index (52.3% vs 39.8%). Similar results were observed for patients with ≥18 months post-index eligibility. CONCLUSIONS: In this real-world analysis, the majority of patients remained on omalizumab for ≥12 months, and had a positive response. OCS use decreased following omalizumab initiation.

Clinical and economic burden of dyspnea and other COPD symptoms in a managed care setting.

PURPOSE: The degree to which symptoms such as dyspnea affect patients with COPD is individualized. To address the gap between clinical symptom measures and self-perceived disease burden, we investigated the symptom status of adult patients with COPD and followed with an administrative claims analysis of health care resource utilization and costs. METHODS: This was a hybrid US observational study consisting of a cross-sectional patient survey followed by a retrospective analysis of administrative claims data. The primary COPD symptom measures were the modified Medical Research Council (mMRC) Dyspnea scale and the COPD Assessment Test (CAT). RESULTS: A total of 673 patients completed the survey. Of these, 65% reported mMRC grades 0-1 (low symptomatology) and 35% reported mMRC grades 2-4 (high symptomatology); 25% reported CAT score <10 (low symptomatology) and 75% reported CAT score ≥10 (high symptomatology). More patients with high symptomatology (by either measure) had at least one COPD-related inpatient hospitalization, emergency room visit, physician office visit, or other outpatient services, and filled at least one COPD-related prescription medication vs patients with low symptomatology. COPD-related costs were higher for patients with high symptomatology than patients with low symptomatology. In a multivariate analysis, COPD-related costs were also higher in patients reporting severe symptoms. CONCLUSION: Patients with high COPD symptomatology utilized more health care resources and had higher COPD-related health care costs during the 6-month post-survey period than patients with low symptomatology.

Real-World Characteristics and Treatment Patterns in Patients with Urticaria Initiating Omalizumab in the United States.

BACKGROUND: Omalizumab is indicated for the management of chronic idiopathic urticaria (CIU) in patients aged 12 years or older with persistent hives that are not adequately controlled by H1 antihistamines. While its safety and efficacy in CIU patients have been evaluated in multiple clinical trials, real-world use of omalizaumab in CIU has not been well characterized. OBJECTIVE: To assess demographics, clinical characteristics, and treatment patterns of CIU patients who initiated omalizumab to better understand the usage of this agent in CIU management in the real world. METHODS: This retrospective cohort study used medical and pharmacy claims data in the United States from the HealthCore Integrated Database to identify patients with CIU newly treated with omalizumab (≥ 4 omalizumab claims within 6 months of the initial claim) between March 21, 2014, and October 31, 2015 (study intake period). The index date was defined as the date of the first claim for omalizumab during the study intake period. Demographic and clinical characteristics were described for patients treated with omalizumab, as were treatment patterns associated with omalizumab and concomitant medications associated with CIU treatment. Descriptive and inferential statistics were reported. The Kaplan-Meier method was used to examine omalizumab treatment patterns. RESULTS: This study included 298 omalizumab-treated patients (mean [SD] age of 43.5 [13.64] years; 70.8% female); approximately 84% were seen by an allergist/immunologist. All patients had ≥ 12 months of continuous enrolment and a subset of 138 patients had ≥ 18 months of follow-up. For patients with ≥ 12 months of post-index follow-up, 12.1% (n = 36), 28.5% (n = 85), and 32.9% (n = 98) discontinued omalizumab within the 6-month, 12-month, and the entire post-index periods (mean 530 days), respectively; the mean number of days patients were continuously treated with omalizumab was 443.1 (95% CI = 425.0-461.3); the probabilities of continuous treatment (95% CI) were 0.879 (0.836-0.911), 0.711 (0.656-0.759), and 0.647 (0.585-0.703) for the 6-, 12-, and 18-month post-index periods, respectively. For the 98 patients who discontinued omalizumab during the entire post-index period, 28.6% restarted omalizumab after the first discontinuation within the post-index period (mean time from first discontinuation to first restart=329 days). Use of medications such as oral corticosteroids, montelukast, cyclosporine, and prescription H1 and H2 antihistamines decreased during the 1- to 6-month and 7- to 12-month post-index periods compared with those within the 6-month pre-index period. CONCLUSIONS: In this cohort of CIU patients who were newly prescribed omalizumab, the majority were treated by allergists/immunologists as expected, and approximately 60% of patients continued on therapy beyond 18 months. Concomitant medication use decreased after omalizumab initiation. These data on the real-world use of omalizumab for CIU may help to better inform decision-making processes for health care payers by quantifying omalizumab and concomitant medication treatment patterns over a longer time frame relative to previous studies. DISCLOSURES This study was sponsored by Novartis Pharmaceuticals, which provided funding support for the conduct of the study. Kavati, Ortiz, and Paknis are employees of Novartis Pharmaceuticals. Ke, Wertz, Huang, Wang, Willey, and Stephenson are employees of HealthCore, an independent research organization that received funding from Novartis Pharmaceuticals for the conduct of this study. Beck is an employee of the University of Rochester Medical Center, who was under contract with Novartis Pharmaceuticals to provide consulting services to this study, and reports grants from Genentech, outside the currently submitted work. Bernstein is affiliated with Bernstein Clinical Research Center, which was under contract with Novartis Pharmaceuticals to provide consulting services to this study, and reports receiving grants and personal fees from Novartis Pharmaceuticals, grants and personal fees from Genentech outside of the submitted work, and is an author on the Joint Task Force for Practice Parameters for Urticaria and the GALEN international guidelines for urticaria under preparation. Study concept and design were primarily contributed by Kavati, Ortiz, and Paknis, with assistance from the other authors. Huang, Wang, and Ke took the lead in data collection, with assistance from Wertz, Willey, and Stephenson. Data interpretation was performed by Ke, Wertz, and Willey, assisted by the other authors. The manuscript was written by Stephenson, Ke, and Wang, along with Willey, Wertz, and Huang, and revised by Bernstein and Beck, with assistance from the other authors. Selected study data were presented in a poster at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 22nd Annual International Meeting on May 20-24, 2017, in Boston, Massachusetts. A poster based on this dataset was presented at the 2017 American College of Allergy, Asthma & Immunology (ACAAI) Annual Scientific Meeting on October 26-30, 2017, in Boston, Massachusetts.

Impact of lung function on exacerbations, health care utilization, and costs among patients with COPD.

OBJECTIVE: To evaluate the impact of lung function, measured as forced expiratory volume in 1 second (FEV1) % predicted, on health care resource utilization and costs among patients with COPD in a real-world US managed-care population. METHODS: This observational retrospective cohort study utilized administrative claim data augmented with medical record data. The study population consisted of patients with one or more medical claims for pre- and postbronchodilator spirometry during the intake period (July 1, 2012 to June 30, 2013). The index date was the date of the earliest medical claim for pre- and postbronchodilator spirometry. Spirometry results were abstracted from patients' medical records. Patients were divided into two groups (low FEV1% predicted [,50%] and high FEV1% predicted [≥50%]) based on the 2014 Global Initiative for Chronic Obstructive Lung Disease report. Health care resource utilization and costs were based on the prevalence and number of discrete encounters during the 12-month postindex follow-up period. Costs were adjusted to 2014 US dollars. RESULTS: A total of 754 patients were included (n=297 low FEV1% predicted group, n=457 high FEV1% predicted group). COPD exacerbations were more prevalent in the low FEV1% predicted group compared with the high group during the 12-month pre- (52.5% vs 39.6%) and postindex periods (49.8% vs 36.8%). Mean (standard deviation) follow-up all-cause and COPD-related costs were $27,380 ($38,199) and $15,873 ($29,609) for patients in the low FEV1% predicted group, and $22,075 ($28,108) and $10,174 ($18,521) for patients in the high group. In the multivariable analyses, patients in the low FEV1% predicted group were more likely to have COPD exacerbations and tended to have higher COPD-related costs when compared with patients in the high group. CONCLUSION: Real-world data demonstrate that patients with COPD who have low FEV1% predicted levels use more COPD medications, have more COPD exacerbations, and incur higher COPD-related health care costs than those with high FEV1% predicted levels.

Treatment pattern changes in high-risk patients newly initiated on statin monotherapy in a managed care setting.

BACKGROUND: For high-risk patients who do not achieve guideline-recommended LDL-C levels, more intensive treatment including statin-uptitration to higher doses or potency, as well as combination therapy may be considered. A better understanding of statin treatment patterns in real-world clinical practice may contribute to improved lipid-lowering management in these patients. OBJECTIVE: We determined treatment pattern changes among patients with high risk of cardiovascular disease who were not at low-density lipoprotein cholesterol (LDL-C) goal on statin monotherapy. METHODS: Treatment pattern changes were evaluated among patients newly initiated on statins between January 1, 2006, and August 31, 2009, in the HealthCore Integrated Research Database. Rates and mean time to first and second treatment changes were examined in patients with claims for coronary heart disease (CHD), atherosclerotic vascular disease (AVD), and diabetes mellitus during 12 months before index, who were not at LDL-C <70 mg/dL at their first-eligible LDL-C test (≥ 4 weeks after index). Therapy change was assessed for 12 months after the LDL-C result. RESULTS: Of 11,473 eligible subjects, 61.3% had diabetes, 26.6% had CHD and AVD, and 12.1% had CHD and AVD and diabetes. At index, patients were prescribed medium-potency levels of statins, including simvastatin (44.7%), atorvastatin (31.5%), and other statins (23.8%). Mean ± SD LDL-C before statin initiation was 138 ± 34 mg/dL, and at the first-eligible LDL-C result after index, it was 101 ± 25 mg/dL. During follow-up, 7444 subjects (64.9%) experienced a first treatment change, with mean time to change of 93.8 ± 92 days, whereas 4029 (36.1%) had no treatment change. Discontinuation of index therapy occurred in 46.9% of subjects and medication switches or titration in 18.0% (index statin titration, switch to other statins, other lipid-lowering therapies [LLT], including ezetimibe). Of the discontinuers, 27.4% restarted LLT. Of subjects with a first treatment change who did not discontinue, 48.9% experienced a second therapy change. Results were similar between the 3 high-risk groups. CONCLUSIONS: In this managed-care setting, among patients with high risk of cardiovascular disease who were not at LDL-C goal, statins were usually started at medium-potency doses without being titrated up, whereas nearly one-half had a discontinuation of LLT within 12 months. These treatment patterns indicate the need for better patient and provider education as well as other system-wide modifications to improve medication adherence.

Cardiovascular event rates in atorvastatin patients versus patients switching from atorvastatin to simvastatin.

OBJECTIVE: Statin dose, adherence, and cardiovascular (CV) outcomes are important factors when considering switching statin therapies. The objective of the study was to compare CV event rates and risk in managed care patients receiving atorvastatin versus those switched to simvastatin from atorvastatin. METHODS: Patients 18-64 years, with ≥3 continuous pharmacy claims for atorvastatin between 1/1/05-11/30/07 and ≥12 months pre- and ≥3 months post-index continuous eligibility were identified using HealthCore Integrated Research Database (HIRD). Patients were stratified into two cohorts: one continued atorvastatin without interruption and the other switched to simvastatin. Patients were matched 1:10 (continue atorvastatin/switch simvastatin) on five variables, excluding lipid parameters due to limited data availability. Descriptive statistics were reported for sample characteristics. A multivariate Cox proportional hazards model was developed to evaluate adjusted CV risk. RESULTS: In total 73,960 atorvastatin patients and 7396 simvastatin-switch patients were analyzed. The mean age was 54 ± 7 years (both cohorts). Mean follow-up was 440 days for atorvastatin patients and 237 days for simvastatin-switch patients. Mean dose and therapy duration for atorvastatin was 20 mg and 321 days compared with 33 mg and 195 days for simvastatin-switch, respectively. Of the simvastatin-switch patients, 32% were switched to a less potent simvastatin dose (<2× prior atorvastatin dose). After adjusting for demographic/clinical characteristics, no significant differences were found in CV risk between cohorts. LIMITATIONS: Limitations include use of administrative claims data without lipid level laboratory results data and the length of follow-up which may not have been sufficient to demonstrate significant differences in event rates between groups. CONCLUSION: In this managed care population, no significant differences were found in risk of CV events among patients switching to simvastatin compared to patients continuing atorvastatin. Switched patients may differ from controls for reasons not captured in the database.

Clinical and economic outcomes of the Cincinnati Pharmacy Coaching Program for diabetes and hypertension.

PURPOSE: Value-based insurance designs (VBID) have been developed by health insurance companies and used by employers to allocate health care resources appropriately and to lower patients' out-of-pocket costs for services related to chronic conditions. The purpose of this study was to evaluate the effect of the Cincinnati Pharmacy Coaching Program (CPCP) on clinical and economic outcomes. The CPCP is a VBID implemented by Anthem Blue Cross & Blue Shield in Ohio. It provided tailored pharmacist-based educational services and financial incentives to participants. METHODS: This was a quasi-experimental pre/post longitudinal study in which patients were identified as they enrolled in the CPCP between Jan. 1, 2008, and Dec. 31, 2009. Patients could participate in a Diabetes Coaching Program (DCP) or a Heart Healthy Coaching Program (HHCP). Control subjects were selected from patients who were invited but did not choose to participate. Control subjects were matched to intervention cohorts using propensity score matching. Clinical (blood pressure, lipid levels, and hemoglobin A1c) and economic (all-cause and disease-attributable) outcomes were evaluated using within-subject (pre-post) and between-subject comparison (intervention-control) design. RESULTS: A total of 607 patients were enrolled in intervention groups, and 557 control subjects were selected after matching. Significant reductions were found in blood pressure, lipid levels, and hemoglobin A1c after enrollment, and a significantly greater proportion of patients, compared with controls, achieved their clinical goals according to national guidelines in both programs. Hypertension-related cost trends were favorable for HHCP relative to the control cohort. Diabetes-related costs increased for all groups from pre- to post-index, largely driven by office visits and medication costs in the DCP and inpatient/ER visits in the control cohort. CONCLUSION: Results showed significant improvements in all diabetes- and hypertension-related clinical measures. This study shows the effect of a comprehensive VBID on the health of patients with chronic disease.

Concomitant asthma medication use in patients receiving omalizumab: results from three large insurance claims databases.

BACKGROUND: Omalizumab (Xolair®) is a monoclonal antibody indicated for moderate to severe persistent allergic asthma patients with symptoms that are inadequately controlled with inhaled corticosteroids (ICS). OBJECTIVE: This study describes concomitant asthma medication use in patients treated with omalizumab. METHODS: An analysis of health insurance claims from MarketScan (2002-2009), Medicaid (2002-2009), and the HealthCore Integrated Research Database (HIRD™) (2002-2010) was conducted. Medical charts were also extracted for a subset of HIRD patients. Patients aged ≥12 years and newly initiated on omalizumab with 12 months of continuous insurance coverage prior to the first omalizumab dispensing (baseline period) and ≥2 asthma claims were included. Concomitant asthma medication use was summarized in eight medication classes. RESULTS: A total of 6038 patients were identified (Medicaid: 731; MarketScan: 3521; HIRD: 1786). A high proportion of new omalizumab users had an asthma-related emergency room visit (Medicaid: 34%; MarketScan: 17%; HIRD: 16%) or hospitalization (Medicaid: 36%; MarketScan: 14%; HIRD: 21%) within 12 months prior to initiating omalizumab. Most patients (Medicaid: 96%; MarketScan: 89%; HIRD: 86%) received three concomitant asthma medication classes or more during the baseline period. Concomitant ICS use was observed in 95%, 89%, and 86% of Medicaid, MarketScan, and HIRD patients, respectively. In HIRD patients without evidence of receiving other asthma medication prior to omalizumab, 17 out of 20 patients had a documented baseline history of asthma-related medication use in their medical charts. CONCLUSIONS: This large observational study using health insurance claims from three databases and confirming results from medical charts provides evidence that nearly all omalizumab users had received other asthma medications prior to initiating omalizumab.

Economic impact of tobramycin in patients with cystic fibrosis in a managed care population.

OBJECTIVE: Guidelines recommend chronic use of tobramycin solution for inhalation (TSI) for cystic fibrosis (CF) patients with moderate-to-severe lung disease and persistent airway Pseudomonas aeruginosa. This study evaluated the economic impact of TSI in managed care CF patients. METHODS: Patients (0-64 years) with ≥2 CF medical claims between 01/01/04-03/31/09 were identified. For TSI users, the index date was the first TSI claim in the period; for non-users, a pseudo-index date was determined and randomly assigned by simulating the distribution of index dates of TSI users. Maximum sample size was obtained for patients with ≥3 months pre- and ≥12 months post-index eligibility. Users were categorized by number of TSI prescriptions filled during 12-month post-index period as low (1 fill), medium (2-3 fills) and high adherence (≥4 fills). Differences in per member per month (PMPM) costs pre-index to post-index were analyzed using paired t-tests. RESULTS: A total of 388 TSI users (mean age 19 years, 48% female) and 444 non-users (mean age 30 years, 54% female) met study criteria. In users, total and CF-related PMPM costs decreased $959 (17%) and $113 (3%), respectively, after starting TSI. Among TSI users, CF-related inpatient PMPM costs decreased by $1171 (49%; p=0.01), while CF-related prescription PMPM costs increased by $992 (p<0.01). CF-related inpatient PMPM costs decreased by $381 (38%; p=0.16) for low and $1425 (50%; p=0.21) for medium users and decreased by $1829 (51%; p=0.02) for high users. LIMITATIONS: Limitations include use of administrative claims data, small sample size due to disease rarity, random assignment of pseudo-index date to non-users and differences in baseline characteristics between TSI users and non-users. CONCLUSION: All-cause and CF-related PMPM medical costs significantly decreased after TSI initiation. Among TSI users, total healthcare costs decreased, although not significantly, due to PMPM increases in prescription costs. A trend towards greater decrease in inpatient PMPM costs was observed with increasing TSI adherence.

Impact of asthma control on sleep, attendance at work, normal activities, and disease burden.

BACKGROUND: The 2007 Expert Panel Report 3 asthma treatment guidelines place substantial emphasis on understanding the effectiveness of treatment strategies on outcomes such as disease control. OBJECTIVE: To assess the impact of asthma control on patient-reported outcomes and disease burden in a real-world setting. METHODS: Patients aged 18 to 64 years with moderate to severe asthma defined by medical and pharmaceutical use were asked to participate in a cross-sectional survey of asthma care, control, and burden. Patients were included if they had an International Classification of Diseases, Ninth Revision, Clinical Modification code for asthma, a prescription for an Expert Panel Report 3-defined controller medication (or combinations), and 24-month pre-index continuous eligibility. Patients with chronic obstructive pulmonary disease were excluded. Survey respondent data were linked to commercial health claims information to create the research database. The Asthma Therapy Assessment Questionnaire (ATAQ) was used as the measure of control. The ATAQ scores range from 0 to 4, with 0 indicating no asthma control problems. RESULTS: A total of 1,199 patients (73% women) completed the survey and had their claims data linked for analysis. Age, sex, and comorbidity index measures did not differ between respondents and nonrespondents. Only 12.2% of respondents scored 0 on the ATAQ, 77.0% scored 1 or 2, and 10.8% scored 3 or 4. The ATAQ scores were moderately correlated with patient-rated severity. Decreasing levels of asthma control were associated with greater prevalences of sleep problems, depression, functional impairment, and effect on work and regular activities. CONCLUSIONS: Approximately 88% of patients with moderate to severe asthma were not fully controlled despite anti-inflammatory drug treatment. Lack of asthma control is associated with substantial patient burden.

Risk of cardiovascular events and all-cause mortality in patients treated with thiazolidinediones in a managed-care population.

BACKGROUND: This study directly compares risk of acute myocardial infarction (AMI), acute heart failure (AHF), or all-cause death among pioglitazone- and rosiglitazone-treated patients in a managed-care population. METHODS AND RESULTS: Patients ≥18 years of age, newly initiated on rosiglitazone or pioglitazone between January 1, 2001, and December 12, 2005, were included. The date of the first pharmacy claim for rosiglitazone or pioglitazone was defined as index date. Patients were excluded if they had <1 year continuous eligibility preindex or a preindex insulin claim. Primary outcome measure was time to composite event of AMI, AHF or death among pioglitazone- and rosiglitazone-treated patients. The National Death Index database was accessed to obtain date of death for patients who died during the study period. Propensity score matching was used to control for potential confounders. The Cox proportional hazards model was used to evaluate effects of exposure to rosiglitazone and pioglitazone on time to event. A total of 36 628 patients (58% male; mean age, 54 years) were identified. Of the rosiglitazone-treated patients, 602 (4.16%) had an AMI, AHF, or death compared with 599 (4.14%) propensity score-matched pioglitazone-treated patients. No significant difference was observed between matched groups for risk of composite event (hazard ratio, 1.03; 95% confidence interval, 0.91 to 1.15; P=0.666) when patients were followed from index date until end of study period, termination of enrollment status, or diagnosis of AMI/AHF/death. CONCLUSIONS: In this retrospective cohort study directly comparing rosiglitazone and pioglitazone with a propensity score-matched population that includes mortality data, no significant differences were found in the risk of AMI, AHF or death.

Resource utilization impact of topiramate for migraine prevention in the managed-care setting.

OBJECTIVE: To determine the pattern of headache-related resource utilization and costs before and after initiation of preventive migraine treatment with topiramate in a sample of a large managed-care population. METHODS: This study was a retrospective, longitudinal, cohort study analysis of medical and pharmacy claims using The HealthCore Integrated Research Network Database. Patients were required to have had at least one pharmacy claim for topiramate between 7/1/00 and 11/30/04, and at least 12 dosage units dispensed of any combination of acute migraine treatments (triptan, ergotamine, or ergotamine combination) during the 6-month period preceding the first pharmacy claim for topiramate (the index date). Headache-related inpatient and outpatient resource utilizations were compared pre-index vs. post-index period 1 (months 1-6) and pre-index vs. post-index period 2 (months 7-12). Statistical analyses included McNemar tests for categorical variables and paired t-tests for continuous variables. RESULTS: A total of 3246 patients met the inclusion criteria. The mean (+/- SD) age was 44 +/- 10 years and 88% were female. From pre- to post-index period 2, outpatient visits significantly decreased by 30% (p < 0.0001), diagnostic procedures decreased by 74% (p = 0.0013), emergency room (ER) visits decreased by 27% (p < 0.0001), and abortive prescriptions decreased by 25% (p < 0.0001). No significant differences were found in mean number of hospitalization days. Total headache-related inpatient costs and outpatient costs decreased (p < 0.01) during post-index period 2 (43 and 46%, respectively). Headache-related pharmacy costs increased from pre- to post-index period 2. CONCLUSION: Topiramate treatment for migraine prevention was associated with significantly lower healthcare resource use (ER visits, diagnostics, acute treatment) in the first 6 months of treatment, with continuing decreases, including physician office visits, during the second 6 months of treatment. LIMITATIONS: Since this study is a claims-based analysis there is the potential introduction of non-claims identifiable factors that might influence resource use such as lifestyle modifications and over-the-counter medications. In addition, adherence to topiramate treatment was not accounted for in this study. Nonetheless, this study provides important insights into the benefit of preventive migraine treatment in actual clinical practice.

Comparison of cardiovascular event rates in patients without cardiovascular disease in whom atorvastatin or simvastatin was newly initiated.

OBJECTIVE: To compare cardiovascular (CV) event rates and risk in patients without previous CV disease in whom atorvastatin or simvastatin was newly initiated in a managed care setting. PATIENTS AND METHODS: Patients aged 18 to 64 years in whom atorvastatin or simvastatin was newly initiated between January 1, 2003, and December 31, 2006, and who had no history of CV disease and at least 12 months of preindex and 3 months of postindex continuous eligibility in a managed care health plan, were identified using administrative claims from the HealthCore Integrated Research Database. Descriptive statistics were reported for sample characteristics. Unadjusted CV event rates were compared between treatment groups. A multivariate Cox proportional hazards model was developed to evaluate adjusted CV risk in all patients, as well as in a subset of patients with diabetes mellitus. RESULTS: A total of 168,096 patients in the atorvastatin group and 51,333 patients in the simvastatin group were analyzed. Mean+/-SD age was 50.2+/-9.0 years for patients using atorvastatin and 50.6+/-9.0 years for patients using simvastatin. Mean+/-SD follow-up time was 664.2+/-386.2 days for the atorvastatin group and 511.4+/-359.8 days for the simvastatin group. Mean+/-SD dose and mean+/-SD therapy duration for patients taking simvastatin were 29.1+/-15.1 mg and 188.6+/-236.3 days, respectively, compared with 16.8+/-11.1 mg and 241.8+/-292.0 days, respectively, for patients taking atorvastatin. Unadjusted CV event rates were lower with use of atorvastatin than with simvastatin (hazard ratio, 0.80; 95% confidence interval, 0.75-0.84; P<.001). Adjusting for demographic/clinical characteristics, patients taking atorvastatin experienced a 13% risk reduction in total CV events during the entire follow-up period compared with those who were taking simvastatin (hazard ratio, 0.87; 95% confidence interval, 0.82-0.92; P<.001). No significant differences in CV events were found between patients taking atorvastatin or simvastatin in the diabetes mellitus subset (n=36,969). CONCLUSION: In a managed care population with no history of CV disease, risk of CV events was lower among patients taking atorvastatin compared with patients taking simvastatin, after adjusting for known baseline differences.

Persistence with migraine prophylactic treatment and acute migraine medication utilization in the managed care setting.

OBJECTIVE: The aim of this study was to describe persistence with migraine prophylactic treatment and acute migraine medication utilization in patients prescribed migraine prophylaxis. METHODS: For this retrospective cohort study, the Health Core Integrated Research Database provided pharmacy/medical claims data from 5 commercial health insurance plans (ie, excluding Medicare and Medicaid) on adult patients with migraine. Eligible patients had >or=1 pharmacy claim for a migraine prophylactic medication between July 1, 2000, and May 31, 2005, and >or=12 U of any combination of acute treatment (serotonin receptor agonist [triptan], ergotamine, or ergotamine combination) dispensed during the 180-day period preceding a first pharmacy claim for a prophylactic medication (index date). The prophylactic medication identified at index date was used for categorizing patients into 1 of 4 cohorts: amitriptyline, propranolol/timolol, divalproex sodium, or topiramate (reference). Kaplan-Meier curves were used for evaluating unadjusted risk for discontinuation over time, and a multivariate Cox proportional hazards model was developed to analyze factors associated with discontinuation of prophylactic medication. RESULTS: A total of 12,783 patients met the inclusion criteria and were included in the analysis (amitriptyline, 3749; propranolol/timolol, 2718; divalproex sodium, 1644; and topiramate, 4672). The mean (SD) ages were not significantly different across cohorts (43.9 [11.3], 42.0 [11.1], 43.1 [11.3], and 43.9 [10.6] years, respectively). The mean duration of treatment was significantly longer (131 [184] days) with topiramate compared with amitriptyline (94 [152] days), propranolol/ timolol (119 [180] days), and divalproex sodium (109 [158] days) (P < 0.001, P = 0.005, and P<0.001,respectively). The risks for discontinuing prophylactic treatment were 23%, 6%, and 11% higher with amitriptyline, propranolol/timolol, and divalproex sodium, respectively, compared with topiramate (P<0.001, P = 0.024, and P <0.001). Patients prescribed topiramate had a higher mean consumption rate of triptans preindex; postindex, decreases in triptan use were observed in all cohorts, although the magnitude of the decrease was greatest in patients prescribed topiramate compared with the other cohorts. CONCLUSIONS: In this study, prescription of topiramate was associated with greater persistence with prophylactic treatment than the other prophylactic drugs. Furthermore, greater reductions in acute treatment utilization, particularly triptans, were observed among patients prescribed topiramate compared with the other prophylactic cohorts.

Effectiveness of rosuvastatin versus atorvastatin in reducing lipid levels and achieving low-density-lipoprotein cholesterol goals in a usual care setting.

PURPOSE: The effectiveness of rosuvastatin versus atorvastatin in reducing lipid levels and achieving low-density-lipoprotein (LDL) cholesterol goals in patients treated in a usual care setting was studied. METHODS: Electronic medical and pharmacy administrative claims from a western U.S. health plan with approximately 8 million covered members were extracted and used in this retrospective, longitudinal cohort study. Patients age 18 years or older who were newly initiated on rosuvastatin or atorvastatin between August 1, 2003, and June 30, 2004, were included. Propensity-score matching on baseline characteristics was used to minimize selection bias between groups. Administrative claims and medical records were used to assign patients a cardiovascular risk status and corresponding LDL cholesterol goal using guidelines from the National Cholesterol Education Program (NCEP). Changes in lipid levels and attainment rates of goal LDL cholesterol levels were estimated after accounting for baseline covariates using regression techniques. RESULTS: A total of 453 patients met the study criteria. The mean dose of rosuvastatin was 11 mg compared with 15 mg for atorvastatin. After adjusting for baseline differences between groups, patients receiving rosuvastatin had significantly greater mean percent reductions in LDL cholesterol, total cholesterol, and non-high-density-lipoprotein (non-HDL) cholesterol than did patients receiving atorvastatin (p < 0.001 for all comparisons). No significant differences were found in HDL cholesterol and triglyceride levels between groups. Attainment rates for NCEP LDL cholesterol goals were significantly higher in patients receiving rosuvastatin. CONCLUSION: Patients treated in a usual care setting with rosuvastatin had significantly greater reductions in LDL cholesterol, non-HDL cholesterol, and total cholesterol levels compared with those receiving atorvastatin. Patients receiving rosuvastatin were more likely to attain NCEP LDL cholesterol goals compared with patients treated with atorvastatin.

Effect of rosuvastatin compared with other statins on lipid levels and National Cholesterol Education Program goal attainment for low-density lipoprotein cholesterol in a usual care setting.

STUDY OBJECTIVE: To compare, in a usual care setting, the effects of rosuvastatin and other 3-hydroxy-3-methylglutaryl coenzyme A inhibitors (statins) on lipid levels and on goal attainment of low-density lipoprotein cholesterol (LDL) levels from the National Cholesterol Education Program (NCEP) third report of the Adult Treatment Panel (ATP III). DESIGN: Retrospective, longitudinal, cohort study. DATA SOURCE: Managed care medical and pharmacy claims and laboratory database. PATIENTS: A total of 8251 patients starting treatment with rosuvastatin, atorvastatin, simvastatin, pravastatin, lovastatin, or fluvastatin from August 1, 2003-September 30, 2004, excluding those who received dyslipidemic therapy in the previous 12 months. MEASUREMENTS AND MAIN RESULTS: Patients with at least one pretreatment and posttreatment lipid level were followed until their initial statin was changed or they reached the end of benefit eligibility or the study period. Percent changes in lipid levels were calculated, and adjusted changes in LDL and goal attainment were evaluated by regression techniques. Absolute and percent reductions in LDL, triglyceride, and total cholesterol levels were significantly greater with rosuvastatin than with other statins (all p<0.05 except for triglyceride reduction vs atorvastatin). After adjustment for age, sex, and baseline LDL, percent LDL reductions still were significantly greater with rosuvastatin than with other statins (p<0.05). Changes in high-density lipoprotein cholesterol were not significant. Goal attainment was higher with rosuvastatin than with other statins after adjustment for age, sex, baseline LDL, risk status, dose, and duration of therapy (p<0.05). Dose-stratified analysis showed that LDL goal attainment was significantly higher with rosuvastatin 10 mg than with atorvastatin 10 or 20 mg. CONCLUSION: Rosuvastatin was more effective than other statins in reducing LDL, triglyceride (except vs atorvastatin), and total cholesterol levels. Significantly more patients taking rosuvastatin than patients taking other statins attained their LDL goals.