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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.

Published guidelines suggest the management of high-density lipoprotein cholesterol (HDL-C) and triglyceride (TG) values after the low-density lipoprotein cholesterol (LDL-C) goal is achieved.This study evaluated the attainment of optimal combined lipid values (LDL-C, HDL-C, and TGs) and associated therapy over time.This retrospective cohort analysis was conducted among managed-care patients who had a baseline lipid panel taken between October 1, 1999, and September 30, 2000; were naive to lipid therapy; and had plan eligibility for at least 12 months before and 12 to 36 months after the baseline lipid values. Patients were categorized as elevated-risk primary prevention (ERP) or as coronary heart disease (CHD) and CHD risk equivalents (CHD-RE). The attainment of optimal combined lipid values was assessed at baseline and quarterly thereafter. Associations between lipid values and the use of lipid-altering therapy were assessed using multivariate logistic regression.A total of 30,348 patients were monitored for a mean (SD) duration of 27 (8) months. Mean (SD) age was 66 (12) years and 55% (16,549/30,348) were men; 43% (13,059/30,348) were categorized as ERP and 57% (17,289/30,348) as CHD-RE. Combined lipid values were optimal in 14% (4167/30,348),18% (5508/30,348), and 22% (2936/13,100) of patients at baseline, 12 months, and 36 months, respectively. After 36 months, 78% (10,164/13,100) of patients did not attain optimal combined lipid values. Lipid therapy, primarily statin monotherapy (87% [7992/ 92251), was prescribed in 30% (9225/30,348) of patients. After 36 months, 34% (4492/13,100) of patients had isolated elevated LDL-C and 20% (2588/13,100) had non-optimal HDL-C and/or TGs. Lipid therapy was associated with the attainment of optimal combined values for LDL-C and TGs (both, P0.05), but not for HDL-C. Because the study was retrospective, causality cannot be determined.Based on the results of this study, use of combination lipid therapy and targeted therapy aimed at the specific lipid abnormalities may increase the attainment of optimal lipid parameters.

Objective:To evaluate the impact of a student pharmacist-run targeted medication intervention (TMI) program.Methods:Student pharmacists in their third professional year resolved TMIs at 5 independent pharmacies under the supervision of a pharmacist. A claims report of completed TMIs from the medication therapy management (MTM) platform, which captured the category and outcome of the TMIs and the estimated cost avoidance (ECA) level, was analyzed using descriptive statistics. Time spent was calculated using an estimation based on each of the tasks required to complete the TMI.Results:Of the 156 TMIs that were billed, 42 (26.9%) were accepted, 24 (15.4%) were rejected, and 90 (57.7%) were unable to be reached. For TMIs where the prescribers or patients were reached, the acceptance rates were 20% and 71%, respectively. Student pharmacists spent a total of 25.2 hours completing TMIs, and the pharmacist spent 2 hours on administrative tasks. Total revenue generated from all TMIs was US$1058, which led to a revenue generation of US$38.90/h. Successfully completing 42 TMIs resulted in a savings to the health care system of approximately US$121 000.Conclusion:This pilot study demonstrates an innovative model for community pharmacies to complete TMIs by utilizing student pharmacists under the supervision of a pharmacist.

This study evaluated the accuracy of 2 administrative claims-based selection rules to identify patients with hypertension (HTN) using medical records as the gold standard.The claims database consisted of inpatient, outpatient, pharmacy, and eligibility claims for members of a single insurance company from January 2000 through March 2003. Medical records were abstracted for 258 matched patient pairs selected by Rule A (at least 1 HTN-related International Classification of Diseases, 9th Revision [ICD-9] claim) and 138 pairs selected by Rule B (at least 1 HTN-related ICD-9 and at least 1 HTN prescription claim) from 31 provider sites. Sensitivity and specificity of the 2 selection rules were computed using medical chart review as the gold standard for a diagnosis of HTN.Of patients selected by Rule A, chart review identified 281 patients with and 235 patients without HTN. Of patients selected by Rule B, chart review identified 172 patients with and 104 patients without HTN.The sensitivity and specificity was 70.8% and 74.9% for Rule A and 76.2% and 93.3% for Rule B. The kappa score was 0.45 for Rule A and 0.65 for Rule B.To identify patients with HTN, a selection rule using both a diagnosis and prescription claim has greater sensitivity and specificity than a rule using a diagnosis claim only.

Randomized control trials and observational studies show high-quality warfarin therapy leads to safe and effective stroke prophylaxis. In usual community practice, patient, physician and health care system factors are barriers to optimal anticoagulation. We examined the predictive relationship between inpatient and outpatient INR values in chronic non-valvular atrial fibrillation (AF) patients hospitalized for ischemic stroke (S), bleed (B) and control events (C) in usual community practice.This nested case-control analysis identified AF patients hospitalized for S, B and C using medical and pharmacy claims spanning 4.5 years ('98-'03) and validating diagnosis with chart abstraction. AF was defined as 2 medical claims for AFor= 42 days apart with a related prescription claim for warfarin. INRs from both outpatient and inpatient settings were used to yield a continuous history of coagulation status. Time-in-therapeutic-range (TTR) was calculated by Rosendaal's linear interpolation method. Correlation of inpatient and prognostic utility of last outpatient INRs was tested with S or B hospitalizations using univariate and multivariate logistic regression.Overall, 614 hospitalizations (means: age 73.9, CHADS(2) = 3.24; 52% male) included S (n = 98), B (n = 101) and C (n = 415) events. Average TTR was 28.6% (49.4% at INR2.0, 21.9% at INR3.0). First INR on admission (INR2.0 or3.0) was associated with S and B hospitalizations (OR-adjusted [95%CI], 1.68 [1.04-2.73] and 1.72 [1.02-2.90]), respectively. Last outpatient INR2.0 was not associated with S (OR-adjusted [95%CI], 1.12 [0.77-1.81]), and INR3.0 was not associated with B (OR-adjusted [95%CI], 1.25 [0.67-2.32]). Last outpatient INR measurement occurred at 28, 22 and 24 days (median; S, BC, respectively) before hospitalization.Patients were observed within therapeutic range less than 30% of their time on warfarin. While inpatient INRs were clearly associated with both ischemic stroke and bleed events, last outpatient INR before event was not predictive.

Spirometry is a pulmonary function test that is routinely performed in hospitals and physicians’ offices to assist in the diagnosis of asthma and chronic obstructive pulmonary disease.[1][1] Spirometry can also be used to monitor patients who have already been diagnosed with a respiratory disease

To measure the per-event health plan costs for acute and follow-up treatment not directed by a clinical study protocol in a group of commercially insured patients in 2 managed care organizations following an incident hospitalization that included a diagnosis for a venous thromboembolism (VTE) event.A cohort of patients with an incident in-hospital VTE event, consisting of deep vein thrombosis (DVT), or pulmonary embolism (PE), or both DVT + PE, was retrospectively identified from the administrative claims databases of 2 large U.S. health care plans. Inclusion criteria were (a) an inpatient VTE event between January 1, 1998, and December 31, 2000, (b) no VTE diagnosis or anticoagulation therapy 3 months prior to the incident VTE in-hospital event, (c) at least 1 anticoagulation pharmacy fill following the incident hospital VTE, and (d) continuous health plan enrollment 3 months prior to and 6 months following the incident hospital VTE event. Total costs were reported on a per-event basis and consisted of the aggregated amount paid by the health plan to the provider after subtraction of member cost-share. Costs were collected separately, first for the incident VTE event for all patients identified and second for patients who had at least 1 of the following events in the follow-up period: bleed requiring or not requiring hospitalization, a recurrent VTE event requiring hospitalization, or a recurrent VTE and bleed (VTE + bleed) event requiring hospitalization. Costs were compared between incident diagnosis groups using multivariate generalized linear model techniques.A total of 2,147 patients (DVT=1,499 [69.8%], PE=373 [17.4%], DVT+PE= 275 [12.8%]) were identified (mean age=61.6standard deviation [SD] 16 years; 46.3% male) and were followed for an average of 21.3 (median, 19.2) months. Disease severity was high in these patients, including 59.2% with a history of or active malignancy. The prevalence of VTE was 2.04 per 100,000 study-eligible health plan members. For the incident VTE events, average costs were 7,712+/-18,339 US dollars (median, 3,131 US dollars) per incident DVT event; 9,566+/-13,512 US dollars (median, 6,424 US dollars) per PE incident event; and 12,200+/-24,038 US dollars (median, 6,678 US dollars) per incident DVT+PE event. Warfarin treatment following the incident VTE event was administered to 97.3% of patients for an average of 6.7 (median, 5.0) months at an average cost of 19.40 US dollars per patient per month. During the average period of 21.3 months, 534 patients (24.9%) experienced an average of 1.24 bleed or recurrent VTE events per patient that required hospitalization at a mean cost of 14,975 US dollars per event or 2,101 US dollars per patient per year. For patients with a bleed in the follow-up period that required hospitalization, average costs were 12,326+/-24,448 US dollars (median, 5,736 US dollars) per recurrent VTE; 15,339+/-52,029 US dollars (median, 4,999 US dollars) per bleed; or 24,085+/-65,411 US dollars (median, 10,185 US dollars) per recurrent VTE + bleed event. During the follow-up period, a total of 612 patients (28.5%) experienced 1,489 recurrent bleed events that did not require hospitalization, at an average cost of 239+/-386 US dollars (median, 95 US dollars) per event. There were no significant differences in mean total costs for all pair-wise comparisons between the 3 incident diagnosis groups.Of patients who experienced a VTE event during the incident hospital stay for any diagnosis, 1 in 4 experienced an average of 1.24 bleed or recurrent VTE events that required hospitalization in the 21 months of follow-up and incurred an average health plan cost of 14,957 US dollars per event. These data may be of interest to managed care decision makers when evaluating the cost impact of new therapies or providing more comprehensive anticoagulation management services for existing therapies.

Purpose. The relationship between low-density lipoprotein (LDL) cholesterol reduction in the first 3 months of statin therapy and medication adherence during a 33-month follow-up period was studied. Methods. A retrospective cohort study was conducted among enrollees in a Southeastern managed care plan who started therapy with atorvastatin, fluvastatin, lovastatin, pravastatin, or simvastatin between October 1999 and August 2001, were enrolled for ≥12 months before and ≥6 months after treatment initiation, and had at least one LDL cholesterol measurement in the year before and 4–12 weeks after the start of therapy. Patients were followed up via electronic pharmacy and medical records for up to 33 more months. The follow-up period was divided into 3-month intervals; patients were considered adherent if statin therapy was available ≥80% of the time. A generalized linear model for repeated measures quantified the association between change in LDL cholesterol at 4–12 weeks and medication adherence in subsequent intervals, adjusting for demographic, clinical, and health-service-use variables. Results. The final sample consisted of 9510 patients. Medication adherence decreased significantly over time: 59%, 40%, 34%, and 21% of patients were adherent at 3, 6, 12, and 36 months, respectively. Mean ± S.D. LDL cholesterol reduction at 12 weeks was 28.9% ± 19.9%. The relative LDL cholesterol reduction at 12 weeks was significantly and independently associated with subsequent medication adherence: Compared with subjects in the first quartile of LDL cholesterol reduction, those in quartiles 2, 3, and 4 were more likely to be adherent in any subsequent interval (adjusted odds ratio [95% confidence interval], 1.26 [1.12–1.42], 1.25 [1.11–1.40], and 1.15 [1.02–1.29], respectively). Other independent predictors of adherence in months 4–36 included adherence during the initial three months of therapy, age, and recent history of coronary revascularization. Conclusion. Greater reduction in LDL cholesterol levels during the first three months of statin therapy was associated with greater adherence to lipid-lowering drug therapy.

Background—The American Heart Association (AHA) recently established evidence-based recommendations for cardiovascular disease (CVD) prevention in women, including lipid management. This study evaluated optimal lipid-level attainment and treatment patterns on the basis of these guidelines in high-risk women in a managed care setting.Methods and Results—We conducted a historical prospective cohort analysis of a 1.1-million-member, integrated, managed-care database. Eligible high-risk women were those with evidence of previous CVD or risk equivalent who had a full lipid panel available between October 1, 1999, and September 30, 2000; were naive to lipid therapy; and had a minimum of 12 months health plan eligibility preindex and postindex lipid panel. Optimal lipid levels were defined as LDL cholesterol (LDL-C) 50 mg/dL, non–HDL-C Conclusions—Among high-risk women, few attained the AHA’s standards for all lipid fractions, and only one third received recommended drug therapy, highlighting significant opportunities to apply evidence-based recommendations to manage lipid abnormalities in high-risk women.

To compare hypoglycemia event rates in patients initiated on long-acting insulin analog (glargine) or intermediate-acting insulin (NPH) and to analyze the associated cost-consequence from a managed care perspective.A retrospective analysis of pharmacy and medical claims and electronic laboratory result data using a southeastern United States managed care health plan.Patients newly initiated on glargine or NPH between July 1, 2000 and August 31, 2002 were included. Hypoglycemia events were identified from medical claims by their ICD-9CM codes. Multivariable techniques were used to compare hypoglycemia event rates between cohorts.A total of 1434 patients were eligible (glargine = 310, NPH = 1124). The mean age was 53 years +/- 17 years and 51% of patients were male. The mean treatment duration was 8.6 months +/- 4.5 months. Multivariate analyses showed that patients in the NPH group had a higher hypoglycemia event rate than the glargine group (18.3 versus 7.3 per 100 patients per year; p = 0.009). The number needed to treat (glargine versus NPH) to avoid one hypoglycemia event per patient per year was nine patients at an A1C of 7%. The mean annual index medication cost was $47 more for glargine ($390) than for NPH ($343) per patient per year (p = 0.042). The mean cost per hypoglycemia event was $1087 (95% CI: $764-$1409).Patients treated with glargine had significantly lower hypoglycemia event rates compared to the NPH group. The risk difference indicated that one hypoglycemia event would be avoided for every nine patients treated with glargine instead of NPH. The cost increase associated with treating nine patients with glargine rather than NPH is less than the cost of treating one hypoglycemia event. In this population, the savings associated with reduced hypoglycemic events more than offset the increased acquisition cost associated with glargine.

Introduction and Objective: The National Cholesterol Education Program recommends regular physician follow-up and lipid testing to promote adherence with lipidlowering medications. The objective of this study was to determine whether lipid tests and physician visits after treatment initiation are indeed associated with adherence to statin therapy. Subjects and Methods: A retrospective cohort study was conducted among 19 422 enrolees in a US managed care plan who initiated treatment with a statin between October 1999 and August 2001. Computerised pharmacy, medical and laboratory records were used to study the patterns and predictors of adherence with lipid-lowering therapy for up to 3 years. Adherence was assessed in 3-month intervals with patients considered ‘adherent’ if ≥80% of days were covered by lipid-lowering therapy. Results: In the first 3 months, 40% of patients had follow-up lipid tests and only 21% had dyslipidaemia visits (14% had both). Those receiving such care were substantially more likely to be adherent in subsequent intervals. Compared with those without follow-up, the relative odds of adherence were 1.42 and 1.27 for patients with one or more lipid test and one or more dyslipidaemia visit, respectively (95% confidence intervals [CI] 1.33, 1.50 and 1.16, 1.39). Patients who received a followup visit and lipid test were 45% more likely to be adherent (95% CI 1.34, 1.55). Similar associations were observed when lipid tests and dyslipidaemia visits occurred later in therapy. Conclusion: Early and frequent follow-up by physicians — especially lipid testing — was associated with improved adherence to lipid-lowering therapy. A randomised prospective study is needed to determine whether this relationship is causal.

Objective: The objectives of this study were to observe a commercially insured sample diagnosed with a venous thromboembolism (VTE) event and treated postevent with warfarin and to detail the thromboembolic and bleeding outcomes in the time periods during warfarin therapy and after discontinuation of such therapy. Methods: This retrospective, observational cohort study used medical, pharmacy, and eligibility data from 2 US health plans. Study inclusion required an inpatient diagnosis of deep venous thrombosis (DVT) or pulmonary embolism (PE) between January 1, 1998, and December 31, 2000; warfarin, heparin, or low-molecular-weight heparin within 30 days after diagnosis; no VTE diagnosis; and no anticoagulant use for 3 months preceding diagnosis. A random sample of medical charts was abstracted to validate VTE events and collect prothrombin time/international normalized ratio (INR) result data. Recurrent VTE events, bleeding events, and proportion of time within INR range were captured in the postindex VTE event time period. Univariate and multivariate statistical techniques were used to assess outcomes. Results: A total of 2090 patients were identified with a newly diagnosed VTE event (DVT only, 1450; PE with or without DVT, 640). Mean (SD) age was 61.7 (16) years; mean (SD) follow-up time after the index diagnosis was 21.3 (10) months. Overall mean (SD) length of warfarin therapy was 6.6 (6) months. During the follow-up period, 224 patients (10.7%) experienced a recurrent VTE event and 122 patients (5.8%) experienced a bleeding event requiring hospitalization. The cumulative incidence of recurrent VTE events over 3 and 6 months was 9.0% and 10.9%, respectively. Using the chart abstraction subset, patients were within the appropriate INR range 37.7% of the time while receiving warfarin. Conclusions: Negative outcomes associated with warfarin therapy—recurrent VTE events and bleeding requiring hospitalization—were experienced by 10.7% and 5.8% of patients, respectively. These data suggest that negative outcomes may be more prevalent in usual community medical practice compared with rates observed in the controlled environment of the clinical trial or specialized anticoagulation clinic.

Studies have found that non-high-density lipoprotein cholesterol (non-HDL-C) is a superior marker for coronary heart disease compared to low-density lipoprotein cholesterol (LDL-C). Little is known about achievement of non-HDL-C goals outside clinical trials. Within a population of 146,064 patients with dyslipidemia in the PINNACLE Registry and a subgroup of 36,188 patients with diabetes mellitus (DM), we examined the proportion of patients and patient characteristics associated with having LDL-C, non-HDL-C, and both LDL-C and non-HDL-C levels at National Cholesterol Education Program goals. LDL-C, non-HDL-C, and both LDL-C and non-HDL-C goals in the overall cohort were achieved by 73%, 73.4%, and 68.9% patients, respectively. Significant predictors of meeting all 3 goals were age, male gender, statin, nonstatin, and combined statin plus nonstatin use. Patients with co-morbidities of hypertension, previous stroke or transient ischemic attack, peripheral arterial disease, myocardial infarction, and smoking were less likely to have LDL-C, non-HDL-C, and both LDL-C and non-HDL-C levels at National Cholesterol Education Program goal. In the overall cohort, patients with DM were less likely to meet non-HDL-C and both LDL-C and non-HDL-C goals. In the subgroup of patients with DM, predictors of meeting lipid goals were similar to the overall cohort. In conclusion, these data suggest contemporary treatment patterns by cardiologists successfully achieve lipid goals in most patients. Younger, female patients and those with atherosclerotic cardiovascular disease and risk factors, such as hypertension and DM, are less likely to achieve goals and may require more careful follow-up after statin initiation. Both LDL-C and non-HDL-C goals are achieved in70% of patients, suggesting room for improvement if a goal-targeted individualized strategy is adopted.

• The prevalence of chronic kidney disease (CKD) among individuals with type 2 diabetes mellitus (T2DM) is common. • Literature reports that 34.5% to 42.3% of individuals with T2DM in the United States have CKD (due primarily to early stage CKD).1-5 • Information is lacking on the recent temporal trends and prevalence within key demographic subgroups. Temporal Trend and Prevalence of CKD Stages (KDIGO 2012) in US Adults with Type 2 Diabetes Mellitus and Demographic Subgroups: NHANES 2007-2012 Bingcao Wu, MS,1 Kelly Bell, PharmD,2 David M Kern, MS,1 Ozgur Tunceli, PhD,1 Vincent Willey, PharmD,1 Suma Vupputuri, PhD,1 Amy Stanford, PharmD,3 Iftekhar Kalsekar, PhD2 1HealthCore Inc., Wilmington, Delaware, USA; 2AstraZeneca LP, Fort Washington, Pennsylvania, USA; 3 Bristol-Myers Squibb Company, Plainsboro, New Jersey, USA 1085-P

Objectives To introduce pharmacy practitioners to spirometry testing and provide strategies for integrating this "value-added" tool with other direct patient care pharmacy services. Data sources Spirometry literature and resources obtained through search strategies including Ovid, PubMed, and Google Scholar. Summary Pharmacists are distinctive members of the multidisciplinary patient care team and can contribute by performing spirometry services for pulmonary patients. Pharmacists have been largely absent from performing this much needed service, perhaps as a result of lack of training or because this testing may be perceived as irrelevant to the pharmacist scope of practice. However, pharmacists are actively integrated with many aspects of pulmonary patient care, including recommending and adjusting inhaled pharmacological agents, monitoring for potential drug–drug and drug–disease interactions, recommending smoking cessation, assessing patient prescription insurance coverage, and educating patients, caregivers, and health care providers on use of prescribed respiratory delivery devices. Adding quality spirometry services, based on American Thoracic Society guidelines for accuracy, would increase the breadth and depth of services for pharmacy practitioners. Conclusion Spirometry testing is an added tool for expanding direct patient care pharmacy services. Physician support, appropriate pharmacist training, and understanding of reimbursement of spirometry services are essential in providing quality spirometry testing. Future studies are needed to assess the role of pharmacists in performing spirometry and measuring the performance outcomes of pulmonary patients.

e18003Background: Through Anthem’s Cancer Care Quality Program (CCQP), oncologists can submit requests and accompanying clinical rationale for cancer treatments. Qualifying treatments within eviden...

6539Background: The proliferation of novel treatment options has placed an increased emphasis on our need to better understand the variability in treatment choice and treatment patterns in oncology...

Objective To describe the estimated prevalence and temporal trends of chronic kidney disease (CKD) treatment patterns, and the association between CKD and potential factors for type 2 diabetes mellitus (T2DM) in different demographic subgroups. Research design and methods This was a cross-sectional analysis of adults with T2DM based on multiple US National Health and Nutrition Examination Survey (NHANES) datasets developed during 2007–2012. CKD severity was defined according to the Kidney Disease: Improving Global Outcomes (KDIGO) 2012 guidelines using the CKD Epidemiology Collaboration (CKD-EPI) equation: mild to moderate=stages 1–3a; moderate to kidney failure=stages 3b–5. Multivariable logistic regression analyses were performed to assess the associations between CKD and potential factors. Results Of the adult individuals with T2DM (n=2006), age-adjusted CKD prevalence was 38.3% during 2007–2012; 77.5% were mild-to-moderate CKD. The overall age-adjusted prevalence of CKD was 40.2% in 2007–2008, 36.9% in 2009–2010, and 37.6% in 2011–2012. The prevalence of CKD in T2DM was 58.7% in patients aged ≥65 years, 25.7% in patients aged

OBJECTIVE To compare the cardiac effects of levalbuterol with those of racemic albuterol based on changes in heart rate (HR) in pediatric patients. METHODS The medical records of hospitalized children ages 1 month to 12 years, who received either levalbuterol or racemic albuterol via nebulizer for 3 consecutive doses between January 2006 and December 2008 were reviewed. The documented HR was collected prior to and after each administered dose of bronchodilator. The primary outcome was the largest percentage of change in HR between groups. Secondary outcomes of comparisons of the number of patients who had more than a 10% change in HR and incidence of tachycardia were included. RESULTS A total of 50 patients, 25 in each group, was included in the study. All patients in the racemic albuterol group received 2.5 mg per dose, while most of the patients in the levalbuterol group received 0.63 mg per dose (19 patients, 76%). Only 6 levalbuterol patients received a dose of 1.25 mg. Nineteen of 25 patients (76%) in the levalbuterol group were tachycardic prior to the first recorded dose compared to 15 patients (60%) in the racemic albuterol group (p = 0.36). The median of the largest percentage of change in HR was 4.1% (interquartile range [IQR], 1.8–8.7) in the levalbuterol group compared to 5% (IQR, 1.9–7.8) in the racemic albuterol group (p = 0.763). Four patients in the levalbuterol group experienced an HR increase of more than 10% compared to 5 patients in the racemic albuterol group (p = 1.0). CONCLUSION Levalbuterol and racemic albuterol bronchodilator therapies produced similar effects on HR. No clinically significant differences were detected in HR changes between the two treatment groups, despite administration of a larger equipotent albuterol dose in the racemic albuterol group than in the levalbuterol group.

Background: Medication Therapy Management (MTM) is a mandated component of Medicare Part D whereby a pharmacist-patient encounter identifies, resolves and prevents medication-related problems. MTM programs have been shown to improve drug therapy goal attainment while reducing overall costs in cardiac patients; however, MTM has been greatly underutilized. The purpose of this study is to identify the proportion of patients eligible for MTM from those enrolled in the NCDR's outpatient PINNACLE Registry. Methods: MTM eligibility is based on the presence of multiple chronic diseases and medications plus the likelihood of exceeding an annual drug cost threshold ($4000 in 2009 and $3000 in 2010). Patients from PINNACLE (5/1/08 to 9/30/10) with 3 or more of the following diseases were identified: HTN, HF, dyslipidemia, DM, CAD. Patient demographics, cardiac diseases, and cardiac drug classes prescribed (individual drugs not available) were captured. To estimate individual patient drug costs to determine MTM eligibility, a weighted average cost was calculated using nationally representative drug utilization data and average wholesale prices (AWP). Sensitivity analyses for determining MTM eligibility were performed by varying drug costs using AWP for the highest cost and clinician-defined most frequently prescribed drugs in each class. Results: Of the 160,593 Medicare patients enrolled in PINNACLE, 93,089 (58%) were identified with ≥ 3 cardiac diseases. The cohort’s mean age was 74.4 ± 9.2 yrs, 54.4% were male and 86.5% were white. Patients were prescribed a mean of 3.5 cardiac drugs. The table displays drug costs and MTM eligibility results. Conclusions: A substantial number of patients met MTM eligibility requirements with this conservative approach using only cardiac drug costs, although variability existed based on cost method. These data serve to raise cardiologists' awareness of their patients' potential eligibility to receive the benefits of MTM services. Cost Methodology Median Annual Cost (IQR) 2009 MTM Eligibility [N (%)] 2010 MTM Eligibility [N (%)] Weighed average cost $1329 (915,2609) 6,202 (6.7% ) 19,903 (21.4%) Frequently prescribed cost $366 (193,1361) 1084 (1.2% ) 7326 (7.9%) High cost $3,958 (2406,5358) 46,477 (49.9% ) 59,619 (64%) 2009 and 2010 MTM eligibility based on likelihood of exceeding drug cost threshold of $4000 and $3000, respectively. IQR - interquartile range; MTM - medication therapy management.

Dabigatran etexilate is a prescription medication used to slow and inhibit the formation of blood clots. Dabigatran is known by the trade name Pradaxa in the United States and all other countries in which it is marketed except Japan (Prazaxa) and Canada (Pradax). Although forming blood clots is a normal and important body function needed to stop bleeding, for some people the blood clot formation process can become harmful. For example, people with an irregular heart rhythm known as atrial fibrillation are at an increased risk of stroke because of the formation of harmful blood clots. Dabigatran is an anticoagulant type of medication. Anticoagulants prevent blood clots from forming. The medication warfarin (Coumadin) is another example of an anticoagulant. Anticoagulants are also commonly called blood thinners, although they work by preventing blood clot formation and not by making the blood thinner. The formation of blood clots in the body is a very complex process that requires multiple steps occurring in a particular order. Substances known as clotting factors are used and produced in each step in the process. One of the final steps of clot formation involves a clotting factor known as thrombin. Dabigatran works in the blood by blocking the action of thrombin, which inhibits the clot-making process. Dabigatran has been approved in the United States to reduce the risk of stroke and other harmful blood clots in people with nonvalvular atrial fibrillation. Dabigatran is available as a capsule in doses of 75 and 150 mg (Figure, A and B). The usual dose of dabigatran is a 150-mg capsule twice a day by mouth. For people with certain types of kidney problems, the dose may be decreased to 75 mg twice a day. The dabigatran capsule may …

Because second generation antipsychotics (SGA) might affect the risk of suicide, systematic assessment of suicide risk associated with SGA in the postmarketing setting is important and of interest to regulatory authorities. To fulfill a postmarketing request, our objective was to determine suicide event (attempted or completed) incidence in patients with schizophrenia or bipolar disorder, prescribed aripiprazole.Using administrative data from three US sources, we assessed study endpoints of suicide attempts and death by suicide in patients aged ≥18 enrolled continuously for ≥3 months in their health plans before receiving their first ever antipsychotic (November 2002-December 2005).Among 20 489 antipsychotic users (8985 patient-years), unadjusted suicide event rates (per 1000 patient-years) were: 20.69 (aripiprazole); 23.99 (olanzapine); 32.33 (quetiapine); 19.69 (risperidone); 48.52 (ziprasidone). Compared with current users of other SGA combined, aripiprazole users did not have an increased risk of suicide events (crude hazard ratio (HR) = 0.79, 95%CI: 0.48-1.30; adjusted HR = 0.69, 95%CI: 0.42-1.14-(controlling for study site, age, sex, index prescription year, antipsychotic use history, other pharmacotherapy exposure, comorbidity presence, schizophrenia/bipolar disorder, suicide attempts, number inpatient/outpatient encounters).In this large, multi-site study, compared with other SGA combined, aripiprazole is not associated with an increased risk of suicide events in an inception cohort of patients with ICD-9/ICD-10 codes indicative of schizophrenia or bipolar disorder.

The objective was to evaluate the use of a payer-based electronic health record (P-EHR), which is a clinical summary of a patient's medical and pharmacy claims history, in an emergency department (ED) on length of stay (LOS) and plan payments.A large urban ED partnered with the dominant health plan in the region and implemented P-EHR technology in September 2005 for widespread use for health plan members presenting to the ED. A retrospective observational study design was used to evaluate this previously implemented P-EHR. Health plan and electronic hospital data were used to identify 2,288 ED encounters. Encounters with P-EHR use (n = 779) were identified between September 1, 2005, and February 17, 2006; encounters from the same health plan (n = 1,509) between November 1, 2004, and March 31, 2005, were compared. Outcomes were ED LOS and plan payment for the ED encounter. Analyses evaluated the effect of using the P-EHR in the ED setting on study outcomes using multivariate regressions and the nonparametric bootstrap.After covariate adjustment, among visits resulting in discharge (ED-only), P-EHR visits were 19 minutes shorter (95% confidence interval [CI] = 5 to 33 minutes) than non-P-EHR visits. Among visits resulting in hospitalization, the P-EHR was associated with an average 77-minute shorter ED LOS (95% CI = 28 to 126 minutes), compared to non-P-EHR visits. The P-EHR was associated with an average of $1,560 (95% CI = $43 to $2,910) lower total plan expenditures for hospitalized visits. No significant difference in total payments was observed among discharged visits.In the study ED, the P-EHR was associated with a significant reduction in ED LOS overall and was associated with lower plan payments for visits that resulted in hospitalization.

Objective: The aim of this work was to analyze chemotherapy treatment patterns in patients with advanced breast cancer who had been previously exposed to an anthracycline, a taxane, and capecitabine. Methods: This retrospective cohort study used medical and pharmacy administrative claims with health-plan enrollment data and medical-record review from a large, US-based health insurer database, the HealthCore Integrated Research Database. Women were included if they were aged ≥18 years at the initial breast cancer diagnosis between January 1999 and July 2005 and had received all 3 drug classes of interest, as well as an initial diagnosis of American Joint Committee on Cancer stage I to III breast cancer with metastatic recurrence or an initial diagnosis of stage IV disease. Information about demographics, clinical and pathologic characteristics, survival, and treatments were obtained from computerized data and medical record review. Descriptive analyses were conducted to characterize the treatment patterns. Results: One hundred forty-four women with advanced breast cancer were identified. Patients ranged in age from 28 to 76 years, with a mean (SD) age of 48.2 (9.1) years, and with 54 patients (37.5%) aged 40 to 49 years and 48 patients (33.3%) aged 50 to 59 years at the time of initial diagnosis. Ninety-three patients (64.6%) were white, 15 (10.4%) were black, 7 (4.9%) were Hispanic, and 4 (2.8%) were Asian. Overall, 89 patients (61.8%) received ≥1 additional chemotherapy regimen after exposure to all 3 chemotherapy agents of interest; 55 (38.2%) received ≥2 additional regimens. A variety of chemotherapeutic regimens were prescribed; 14 monotherapy regimens and 37 combination therapy regimens were used. The most common regimens (both as single agents and combination therapy) included gemcitabine, vinorelbine, or retreatment with a taxane. Of the 89 patients who received ≥1 retreatment, 7 (7.9%) were retreated with anthracycline, 12 (13.5%) with a taxane, and 9 (10.1%) with capecitabine. For first and second treatment after exposure to all 3 agents of interest, the most common single-agent regimens were gemcitabine (first: 17 patients [19.1%]; second: 9 patients [16.4%]) and vinorelbine (first: 14 patients [15.7%]; second: 9 patients [16.4%]). The most common combination therapies for first retreatment were carboplatin based (6 patients [6.7%]). Conclusions: Of these patients with advanced breast cancer, 61.8% received ≥1 additional chemotherapy regimen after previous treatment with an anthracycline, a taxane, and capecitabine. The variety of agents prescribed suggests a lack of standard of care. Rigorous clinical effectiveness studies of common regimens in heavily pretreated and chemotherapy-resistant populations with breast cancer are warranted.

Purpose The purpose of this study was to examine the association between atypical antipsychotics, including the newer agents, aripiprazole and ziprasidone, and newly treated diabetes, using the largest post-marketing cohort of patients exposed to these newer treatments that has been studied to date. Methods Identified two overlapping cohorts—a simple cohort (all antipsychotic users) and an inception cohort (new users of antipsychotics)—using automated data from three United States sites (60.4 million covered lives). Patients exposed to antipsychotics ≥ 45 days were identified and followed for incident diagnoses of treated diabetes. Data analysis accounted for drug switching and non-consistent drug use. Results In the 55 287-member inception cohort, 357 cases of newly treated diabetes were identified. Compared with current use of typical antipsychotics, current users of aripiprazole (adjusted hazard ratio (aHR) 0.93, 95% confidence interval (CI) 0.50–1.76), quetiapine (aHR 1.04, 95%CI, 0.67–1.62), risperidone (aHR 0.85, 95%CI, 0.54–1.36) and ziprasidone (aHR 1.05, 95%CI, 0.54–2.08) had similar low risk of diabetes. Patients exposed to olanzapine had an increased risk of diabetes (aHR 1.71, 95%CI, 1.12–2.61), and although the effect estimate is imprecise, clozapine-exposed patients had a trend towards an elevated hazard ratio (aHR 2.58, 95%CI, 0.76–8.80). Results for the simple cohort were similar. Conclusions Relative to typical antipsychotics, aripiprazole, ziprasidone, risperidone and quetiapine were not associated with an increased risk of diabetes; olanzapine and clozapine were associated with an increased risk. This analysis constitutes the largest post-marketing pharmacoepidemiologic study to date that includes the newer agents. Copyright © 2009 John Wiley & Sons, Ltd.

BACKGROUND: African-American women have increased breast cancer mortality compared with white women. Diagnostic and treatment gaps may contribute to this disparity. METHODS: In this retrospective, longitudinal cohort study, Southern US health plan claims data and linked medical charts were used to identify racial disparities in the diagnoses, treatment, and mortality of commercially insured women with newly diagnosed breast cancer. White women (n ¼ 476) and African-American women (n ¼ 99) with newly diagnosed breast cancer were identified by breast cancer claims codes (International Classification of Diseases, Ninth Revision, Clinical Modification codes 174, 233.0, 238.3, and 239.3) between January 2000 and December 2004. Race, diagnoses (breast cancer stage, estrogen/progesterone receptor [ER/PR]-positive status), treatment (breast-conserving surgery, antiestrogen therapy, and chemotherapy interruption or reduction), and all-cause mortality were assessed from medical charts. Multivariate regression analyses were adjusted for age, geography, and socioeconomic status to test the association of race with diagnoses/ treatment. RESULTS: White women were older (P < .001) and had higher rates of diagnosis at stage 0/I (55.2% vs 38.4%; P < .05) than African-American women. More white women had positive ER/PR status (75% vs 56% AfricanAmerican; P ¼ .001) and received antiestrogen therapy if they were positive (37.2% vs 27.3% African-American; P < .001). White women received slightly more breast-conserving surgery and chemotherapy dose modification than African-American women (P value nonsignificant). African-American women had a higher mortality rate (8.1%) than white women (3.6%; P ¼ .06). In adjusted analyses, African-American women were diagnosed at later stages (odds ratio, 1.71; P ¼ .02), and white women received more antiestrogen therapy (odds ratio, 2.1; P ¼ .03). CONCLUSIONS: Disparities in medical care among patients with newly diagnosed breast cancer were evident between African-American women and white women despite health plan insurance coverage. Interventions that address the gaps identified are needed. Cancer 2010;116:193–202. V C 2010 American Cancer Society.

Chronic and severe health problems place an enormous financial burden on individuals, employers, and health plan providers, requiring all to make tough decisions about healthcare. Specialty pharmaceuticals are increasingly attractive treatment options, but employers need tangible ways to incorporate these medications into benefit plans. Benefit managers can take a proactive role in addressing cost and compliance issues, using evidence-based data about true patient costs to develop policies that encourage employees to seek appropriate care. Achieving savings in direct and indirect costs will require more than shifting coverage, which can lead to nonadherence and increase costs elsewhere.

This study examines the overall profile and costs associated with severely ill commercially insured people. We found severely ill members to have the highest costs, from both the insurer and member perspective. Even for the most costly members where specialty medication use was highest, biologics represented less than one-third of the pharmacy spending and 6.6 percent of overall spending. Out-of-pocket spending rose dramatically when medications were paid for under the pharmacy benefit rather than the medical benefit. The advantages of paying for specialty medications under the pharmacy benefit should be evaluated in conjunction with the potential consequences of increased out-of-pocket burden.

6571 Background: Payment for treatment planning and care coordination for cancer care in the U.S. has been largely funded through the margin between the acquisition cost and reimbursement of cancer drugs. The Institute of Medicine has called for new payment models to align reimbursement to support patient-centered, high-quality affordable cancer care. Methods: In July 2014, 6 commercial HPs in the Midwest and Georgia implemented a cancer care quality program that included additional reimbursement for treatment planning and care coordination when oncologists selected regimens that were on a pathway. Cancer treatment pathways were developed using an evidence-based process with expert advisors from academic centers and community practices for breast, lung and colorectal cancer (available at www.cancercarequalityprogram.com). Practices provided clinical data on HP members starting systemic therapy through a web portal, including tumor type, stage, line of therapy, biomarkers, performance status, and planned t...

Purpose. Rates of hypoglycemic events and their associated costs were compared among patients with type 2 diabetes mellitus newly initiated on insulin glargine or a premixed insulin fixed-combination product. Methods. Patients newly initiated on insulin glargine or premixed insulin fixed-combination products (including pen delivery systems) between June 1, 2001, and February 29, 2004, were identified using an administrative claims database. Hypoglycemic events were identified from International Classification of Diseases, 9th Revision, Clinical Modification codes. Multivariate analyses were performed. Results. A total of 2315 patients met the inclusion criteria. Of those, 1212 received insulin glargine and 1103 received a premixed fixed-combination insulin product. The mean ± S.D. treatment duration was 13.7 ± 8.1 months. Patients treated with premixed insulin had a higher hypoglycemic event rate than glargine patients (13.8 versus 7.0/100 patients/year; p = 0.027), which yielded a number needed to treat of 15 patients. The mean cost per hypoglycemic event was $1049 (95% confidence interval, $426–1672). The mean annual cost of all insulin use was $46 more for the insulin glargine cohort than for those who received premixed insulin ($534 versus $488, respectively) ( p < 0.05). Mean postindex insulin use was higher in patients receiving premixed insulin than in those treated with insulin glargine (48.1 versus 43.8 units per day) ( p < 0.05). Conclusion. Patients with type 2 diabetes mellitus who were newly initiated on insulin glargine had a lower rate of hypoglycemic events compared with patients newly initiated on a premixed fixed-combination insulin product. Treatment of 15 patients with insulin glargine instead of premixed insulin for one year would avoid one hypoglycemic event per year.

In this paper we examine spending by privately insured patients with four conditions often treated with specialty drugs: cancer, kidney disease, rheumatoid arthritis, and multiple sclerosis. Despite having employer-sponsored health insurance, these patients face substantial risk for high out-of-pocket spending. In contrast to traditional pharmaceuticals, we find that specialty drug use is largely insensitive to cost sharing, with price elasticities ranging from 0.01 to 0.21. Given the expense of many specialty drugs, care management should focus on making sure that patients who will most benefit receive them. Once such patients are identified, it makes little economic sense to limit coverage.

The large administrative databases of health plans contain information on drug-related medical adverse events (AE) and constitute an increasingly powerful tool for the assessment of drug safety. We conducted a retrospective observational study using an administrative managed care claims database covering 9 million members from diverse regions of the United States. Patients aged ≥18 years who received ≥2 prescriptions for lipid-lowering drugs between July 1, 2000 and December 1, 2004 were included in the study. Hospitalizations with diagnosis codes ( International Classification of Diseases, 9th Revision, Clinical Modification [ICD-9]) related to muscle, kidney, and liver were determined for patients exposed to 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins), fibrates, extended-release niacin, cholesterol absorption inhibitors, or statin combination therapy. A total of 473,343 patients contributed 490,988 person-years of monotherapy and 11,624 person-years of combination dyslipidemia therapy. Rates of hospitalization due to AEs in patients on monotherapy with currently available statins were similar, whereas the incidence of hospitalization for muscle disorders increased 6.7-fold with cerivastatin therapy. Patients who received a lipid-lowering medication with a concomitant cytochrome P450 3A4 (CYP3A4) inhibitor had a 6-fold increased rate of muscle disorders, including rhabdomyolysis. Hypertension was associated with a 5-fold increase in both muscle and renal events, whereas patients with diabetes mellitus had a 2.5-fold increased risk of renal events. No hospitalized cases of the index AEs were observed in study subjects during the 6-month period before initiation of the lipid-lowering drug. Statin monotherapy as currently prescribed is generally well tolerated and safe.

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

To identify a possible gender bias in lipid assessment and treatment of patients following percutaneous coronary intervention (PCI).Following PCI, patients were identified from a cardiology practice database, with retrospective follow-up achieved through medical record review in a private cardiology practice and in primary care physician practices. Patients were assessed for lipid measurement of total cholesterol, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides, and for changes in these measures.A total of 356 patients were identified for analysis: 221 men (62%) and 135 women (38%). Mean post-PCI follow-up was 2.2 +/- 1.6 years. Among females, 80% had lipids measured, as compared with 87% of males (P = 0.07). At pre- and post-PCI, all fractions were significantly higher (P0.05) in women, except pre-PCI triglycerides, which were significantly lower in women. From pre- to post-PCI, HDL-C and triglycerides improved significantly more in males, while LDL-C improved significantly more in females. Target LDL-C levels (100 mg/dL) were achieved in 46.4% of the overall group. There were no significant gender-related differences in the number of patients treated with dyslipidemic medications or in patients achieving an LDL-C of100 mg/dL (P = 0.081).Following PCI, a gender bias did not exist for lipid assessment, number of patients treated with pharmacotherapy, or achievement of target LDL-C (100 mg/dL). However, in terms of absolute levels achieved, women were treated less aggressively than men for all lipid fractions.