Adjuvant and neoadjuvant treatment patterns among resectable pancreatic cancer patients in the USA.

Aim: Chemotherapy is standard before and/or after pancreatic cancer resection, yet benefits of pre-resection chemotherapy are unclear. Real-world pre- and post-resection treatment patterns were evaluated retrospectively. Methods: Neoadjuvant (3-months pre-surgery) and adjuvant (6-months post-surgery) treatment claims from 1 January 2016 to 31 December 2019 in US adults with resectable pancreatic cancer were analyzed. Results: Of the 737 patients, 29% received no chemotherapy in either setting; 22% received chemotherapy in both settings. In the neoadjuvant and adjuvant settings, 69 and 33% of patients, respectively, received no treatment at all. FOLFIRINOX and gemcitabine monotherapy were the most common chemotherapies in the neoadjuvant and adjuvant settings, respectively. Adjuvant FOLFIRINOX increased post-2018, whereas gemcitabine-based regimens decreased. Conclusion: Several chemotherapy regimens were used in both settings. Treatment patterns differed between the two settings.

Some patients diagnosed with pancreatic cancer can undergo surgery to remove the tumor. Standard of care is to treat the patient with chemotherapy after the surgery. Chemotherapy is sometimes given before the surgery, yet it is unknown if this pre-treatment is beneficial. This study used insurance claim data from patients with pancreatic cancer in USA to evaluate real-world pre- and post-surgery chemotherapy patterns. Of the 737 analyzed patients, almost a third did not receive chemotherapy at all whereas one-fifth received chemotherapy both pre- and post-surgery. More patients received chemotherapy post-surgery than pre-surgery. Several different chemotherapy regimens were used, but the most common regimens used recently were those that had evidence from clinical trials. Chemotherapy was given more often to patients less than 65 years old than those 65 years or older, indicating more aggressive treatment in younger patients. Overall, the study indicates that a variety of treatments are being used and treatment patterns differ pre- and post-surgery. However, our study also shows that treatment strategies continue to evolve as our understanding of treatment impact and outcomes improves.

Levodopa treatment patterns in Parkinson's disease: A retrospective chart review.

BACKGROUND: Medication regimens for Parkinson's disease (PD) may change as the disease progresses, symptoms fluctuate, or medication-related adverse events occur. This study evaluated treatment trends by observation year for patients initially receiving monotherapy with levodopa and a peripheral dopa decarboxylase inhibitor (PDDI). METHODS: In this retrospective chart review, therapy changes were evaluated for patients across the US diagnosed with PD on or before 6/30/2014 who initially received levodopa-PDDI monotherapy. Index date was the first clinic visit. Post-index was any time between the first 31 days after index and study end (6/30/2019). Index Hoehn-Yahr (H-Y) score and medication changes were also analyzed by index low (<400 mg/day) or high (≥400 mg/day) levodopa doses in the levodopa-PDDI combinations. RESULTS: In the levodopa-PDDI cohort (n = 95), there were 0.39 dose escalations, 0.16 dose reductions, 0.12 discontinuations, 0.19 therapy switches, and 0.24 add-ons per patient per year during the study. Most dose escalations or add-ons occurred within the first 6 months post-index. Of those who ever stopped levodopa-PDDI (n = 34), 31 (91%) restarted within the study period. Most (83%) patients who restarted levodopa-PDDI did so in the same year as stopping treatment. Index low dose users were associated with lower H-Y scores, were more inclined to escalate their dose, and were less inclined to reduce their dose in the first 2 years of treatment than index high dose users. CONCLUSIONS: Prescribers and patients tend to experiment with levodopa-PDDI treatment. Although many patients appeared to stop levodopa-PDDI after an initial course of treatment, most subsequently restarted treatment.

Natural history and patterns of treatment change in Parkinson's disease: A retrospective chart review.

BACKGROUND: Parkinson's disease (PD) management seeks to balance the benefits and harms of current medications and evolves as the disease progresses. The natural history of PD and associated patterns of treatment change were analyzed to identify unmet needs in treatment of PD symptoms. METHODS: Medical charts of patients from clinics across the US diagnosed on or before June 30th, 2014 were retrospectively reviewed. Index date was the first clinic visit, and the post-index period was through study end (June 30th, 2019). Outcomes included the frequency of therapy changes in the post-index period, reasons for therapy change, and adverse events (AE). RESULTS: Patients (n = 203) at index were receiving levodopa-peripheral dopa decarboxylase inhibitor (PDDI) monotherapy (47%), dopaminergic agonist (DA) monotherapy (15%), monoamine oxidase B inhibitor (MAOBI) monotherapy (14%), or combination therapies. The percentage of patients in Hoehn-Yahr disease Stage 1-2 was 52% at index and 20% by the end of the study. Frequencies of motor, non-motor, and neuropsychiatric symptoms increased during the enrollment. Levodopa-PDDI monotherapy and levodopa-PDDI + MAOBI had the lowest rates of therapy changes. Symptom relapse was the most common reason for dose escalation, add-on, and dose reduction, whereas AEs were the most common reason for discontinuation and switching. Dose escalation, add-on, and forward switch were most likely to occur in the first 6 months of treatment. CONCLUSIONS: Therapy changes during the study period reflected the challenging and evolving management of PD as the disease progresses. New or add-on symptomatic treatments are needed that are well-tolerated and able to control PD symptoms.

Comparative effectiveness of budesonide inhalation suspension and montelukast in children with mild asthma in Korea.

Objective: The comparative effectiveness of low-dose budesonide inhalation suspension (BIS) versus oral montelukast (MON) in managing asthma control among children with mild asthma was assessed in Korea.Methods: Claims from Korea's national health insurance database for children (2-17 years) with mild asthma (GINA 1 or 2) who initiated BIS or MON during 2015 were retrospectively analyzed. Pre- and post-index windows were 1 year each. Adherence, persistency, asthma control, asthma-related health-care resource utilization, and costs were evaluated using unadjusted descriptive statistics and propensity score-matched regression analyses.Results: The number of children identified was 26,052 for unmatched (n = 1,221 BIS; n = 24,831 MON) and 2,290 for matched populations (n = 1,145 per cohort). Medication adherence, measured by proportion of days covered, was low for both cohorts but significantly higher for MON versus BIS (13.8% vs. 4.5%; p < .001). Time to loss of persistency was longer for MON versus BIS (82.3 vs. 78.4 days, respectively; p < .001). Mean number of post-index asthma-related office visits was 6.6 for BIS versus 8.3 for MON (p < .001). However, a greater proportion of patients in the BIS cohort had an asthma exacerbation-related office visit than the MON cohort (78.3% vs. 56.1%; p < .001). Asthma-related total health-care costs were higher with MON versus BIS (₩ 190,185 vs. ₩ 167,432, respectively; p < .001), likely driven by higher pharmaceutical costs associated with MON (₩ 69,113 vs. ₩ 49,225; p < .001).Conclusions: Montelukast patients had better adherence, a longer time to loss of persistency, and were less likely to experience an exacerbation-related office visit in the post-index period than BIS patients.

Risk assessment of post-discharge mortality among recently hospitalized Medicare heart failure patients with reduced or preserved ejection fraction.

Objective: Targeted care management for hospitalized patients with acute decompensated heart failure (ADHF) with reduced or preserved ejection fraction (HFrEF/HFpEF) who are at higher risk for post-discharge mortality may mitigate this outcome. However, identification of the most appropriate population for intervention has been challenging. This study developed predictive models to assess risk of 30 day and 1 year post-discharge all-cause mortality among Medicare patients with HFrEF or HFpEF recently hospitalized with ADHF.Methods: A retrospective study was conducted using the 100% Centers for Medicare Services fee-for-service sample with complementary Part D files. Eligible patients had an ADHF-related hospitalization and ICD-9-CM diagnosis code for systolic or diastolic heart failure between 1 January 2010 and 31 December 2014. Data partitioned into training (60%), validation (20%) and test sets (20%) were used to evaluate the three model approaches: classification and regression tree, full logistic regression, and stepwise logistic regression. Performance across models was assessed by comparing the receiver operating characteristic (ROC), cumulative lift, misclassification rate, the number of input variables and the order of selection/variable importance.Results: In the HFrEF (N = 83,000) and HFpEF (N = 123,644) cohorts, 30 day all-cause mortality rates were 6.6% and 5.5%, respectively, and 1 year all-cause mortality rates were 33.6% and 29.5%. The stepwise logistic regression models performed best across both cohorts, having good discrimination (test set ROC of 0.75 for both 30 day mortality models and 0.74 for both 1 year mortality models) and the lowest number of input variables (18-34 variables).Conclusions: Post-discharge mortality risk models for recently hospitalized Medicare patients with HFrEF or HFpEF were developed and found to have good predictive ability with ROCs of greater than or equal to 0.74 and a reasonable number of input variables. Applying this risk model may help providers and health systems identify hospitalized Medicare patients with HFrEF or HFpEF who may benefit from more targeted care management.

Trends in Asthma Control, Treatment, Health Care Utilization, and Expenditures Among Children in the United States by Place of Residence: 2003-2014.

BACKGROUND: Examining national trends in asthma treatment and control is essential to inform treatment and public health initiatives. OBJECTIVE: Explore national trends in asthma control and treatment over time among children and those residing in poor-urban areas. METHODS: This was an analysis of trends from 2003 to 2014 among children (aged 1-17 years) in the Medical Expenditure Panel Survey. Indicators of poor control included use of more than 3 canisters of short-acting ß-agonists (SABAs) in 3 months, asthma attack, emergency department/inpatient hospitalization, and systemic corticosteroids. Treatment included inhaled corticosteroids, controller medications, SABAs, and greater than or equal to 0.7 ratio of controller-to-total prescriptions. Other measures included the number of asthma medications, outpatient visits, asthma-specific drug, and total expenditures per-patient-per-year. RESULTS: There were 8.4 million children with asthma in the United States in 2014; 11.1% lived in poor-urban areas. There was a statistically significant decrease in the percentage of children using inhaled corticosteroids, controller medications, daily preventive medications, systemic corticosteroids, SABAs, more than 3 canisters of SABAs (in 3 months), overall asthma prescriptions, and outpatient visits. There was a significant increase in the percentage of children reporting having an asthma attack. Trends for children residing in poor-urban areas were compared with all others; however, limited data and variability in annual estimates prevent clear conclusions. CONCLUSIONS: Results suggest lack of improvement in treatment and control since 2003 among children with asthma in the United States. There is significant room for improvement in asthma control and disease management among children.

Health Disparities Among Children with Asthma in the United States by Place of Residence.

BACKGROUND: Children residing in poor-urban areas may have greater asthma morbidity. It is unclear whether this is due to individual characteristics such as race and ethnicity or place of residence. OBJECTIVE: Assess indicators of control and treatment by residence. METHODS: This was a cross-sectional analysis of children (aged 1-17 years) in the 2000-2014 Medical Expenditure Panel Survey (MEPS). Indicators of poor control included use of more than 3 canisters of short-acting beta agonist (SABA) in 3 months, asthma attack, and emergency department (ED) or inpatient (IP) visit during the year. Treatment measures included use of controller medications and a ratio of controller-to-total prescriptions of 0.7 or more. RESULTS: There were 15,052 children with asthma in the MEPS 2000-2014 data, reflecting 8.4 million children in 2014. After controlling for covariates, children with asthma residing in poor-urban areas had lower odds of using controller medications (odds ratio [OR] = 0.77), having a controller-to-total ratio of 0.7 or more (OR = 0.75), and reporting an asthma attack (OR = 0.75) and higher odds of having an ED/IP visit (OR = 1.3) compared with those living elsewhere. Black race and Hispanic ethnicity were associated with greater odds of excessive SABA use (OR = 2.11) and ED/IP visits (OR = 2.03) and lower odds of controller-to-total ratio of 0.07 or more (OR = 0.50). CONCLUSIONS: Poor-urban residence may be independently associated with asthma control and treatment even after controlling for individual characteristics such as race and ethnicity. Future research is needed to understand the sources of these geographic health disparities to more successfully target public health interventions.

School absence and productivity outcomes associated with childhood asthma in the USA.

BACKGROUND: Previous studies have examined the association between childhood asthma and lost productivity; however, more data are needed to understand its impact. METHODS: This was a retrospective analysis of cross-sectional data in the nationally representative 2007-2013 Medical Expenditure Panel Survey (MEPS). School-aged children (SAC), children (age 6-11), and adolescents (age 12-17) with asthma were compared to those without asthma to examine annual missed school days. Adult parents/caregivers of SAC with asthma were compared to those of SAC without asthma to examine missed work days. The cost of premature asthma mortality for SAC was also estimated. Negative binomial regression was used for missed school days, and a two-part model structure was used for missed work days. All analyses controlled for sociodemographics and other covariates. RESULTS: There were 44,320 SAC of whom 5,890 had asthma. There were 43,496 employed adults with at least one child. SAC (6-17) with asthma missed 1.54 times the number of school days compared to SAC without asthma. Caregivers of SAC (6-17) with asthma missed 1.16 times the number of work days to care for others compared to caregivers of SAC without asthma. SAC in the USA missed an additional 7 million school days associated with asthma (3.7 million children and 3.3 million adolescent). There were 130 asthma deaths resulting in an annual cost of $211 million ($US 2015). CONCLUSIONS: Childhood asthma is associated with a significant school absence and productivity loss in the USA. Better treatment and asthma management programs are needed to alleviate this burden.

National Prevalence of Poor Asthma Control and Associated Outcomes Among School-Aged Children in the United States.

BACKGROUND: The degree of asthma control among school-aged children (SAC) nationally is not well understood. OBJECTIVE: The objective of this study was to characterize poor control among SAC (aged 6-17 years) in the United States. METHODS: This was a retrospective analysis of the 2007-2013 Medical Expenditure Panel Survey. Indicators of poor control included exacerbation in previous year; use of >3 canisters of short-acting ß-agonist (SABA) in 3 months; and asthma-specific (AS) emergency department (ED) or inpatient (IP) visits. Treatment indicators included daily controller medication and peak flow meter use. Negative binomial regression was used for health resource utilization (HRU); generalized linear models with log-link were used for health care expenditures. RESULTS: There were 44,320 SAC, of whom 5,890 had asthma. The prevalence of poor control and treatment among SAC with asthma were as follows: exacerbation (59%), >3 canisters of SABA (4%), ED/IP visit (3%), daily controller (19%), peak flow (12%). In 2013, 3.4 million SAC had an asthma exacerbation and 200,000 had an AS ED/IP visit. SAC with asthma and an exacerbation had 18.9 times more annual AS ED visits (and 43.3 times more AS hospitalizations) than SAC with asthma but no exacerbation. SAC with asthma and an indicator of poor control incurred greater annual all-cause expenditures than SAC without asthma ($US 2015): $1,144 (exacerbation), $1,859 (≥3 canisters of SABA), and $3,063 (ED/IP visit). Use of daily controller medication was low even among SAC with poor control (27% to 61%). CONCLUSION: Renewed and vigilant asthma management and treatment is necessary to mitigate the current and long-term public health effects and expenditures associated with poor asthma control.

The national cost of asthma among school-aged children in the United States.

BACKGROUND: Recent research has quantified the national health care resource use (HCRU) and health care expenditure (HCE) burden associated with adult asthma; however, estimates specific to school-aged children are more than 2 decades old. OBJECTIVE: To estimate the national HCRU and HCEs attributable to asthma among school-aged children in the United States. METHODS: This was a cross-sectional retrospective analysis of school-aged children (aged 6-17 years) in the nationally representative 2007-2013 Medical Expenditure Panel Survey. All-cause HCRU and HCEs of school-aged children with asthma were compared with school-aged children without asthma, controlling for sociodemographics and comorbidities. HCRU encounters included emergency department (ED) and outpatient visits, hospitalizations, and prescriptions. Expenditures included total, medical, ED, inpatient, outpatient, and pharmacy. Negative binomial regression analyses were used for HCRU and Heckman selection with logarithmic transformation, and smearing retransformation was used for HCEs. RESULTS: There were 44,320 school-aged children of whom 5,890 had asthma. Children with asthma incurred a higher rate of all-cause annual ED visits (incidence rate ratio [IRR], 1.5; P < .001), hospitalizations (IRR, 1.4; P < .05), outpatient visits (IRR, 1.4; P < .001), and prescription drugs (IRR, 3.3; P < .001) compared with school-aged children without asthma. They incurred US$847 (2015 dollars) more annually in all-cause expenditures (P < .001). Private insurance and Medicaid paid the largest share of expenditures. Pharmacy and outpatient costs represented the largest proportion of total expenditures. On the basis of the nationally representative Medical Expenditure Panel Survey sample weights from 2013, the total annual HCEs attributable to asthma for school-aged children in the United States was US$5.92 billion (2015 dollars). CONCLUSION: Childhood asthma continues to represent a prevalent and significant clinical and economic burden in the United States. More aggressive treatment and asthma management programs are needed to address this national financial and resource burden.

Indicators of poorly controlled asthma and health-related quality of life among school-age children in the United States.

BACKGROUND: Poorly controlled asthma has far-reaching effects on school-age children and their parents, but little is known about the national impact on health-related quality of life (HRQoL). OBJECTIVE: To examine HRQoL associated with asthma and indicators of poorly controlled asthma in the United States. METHODS: This was a cross-sectional analysis of HRQoL among school-age children (age range, 6-17 years) with asthma in the nationally representative 2007-2013 Medical Expenditure Panel Survey (MEPS). Indicators of poor asthma control included the following: exacerbation in the previous 12 months, use of more than three canisters of short-acting beta agonist in 3 months, and annual asthma-specific emergency department or inpatient visits. Health status and HRQoL instruments included the following: the Columbia Impairment Scale (CIS), Child Health Questionnaire (CHQ), Children with Special Health Care Needs Screener (CSHCN), and self-perceived physical and mental health. Ordered logistic regression was used for ordered categorical variables, and logistic regression was used for binary variables. All regressions controlled for sociodemographics and other covariates. RESULTS: There were 44,320 school-age children in the MEPS, of whom 5890 had asthma. School-age children with indicators of poorly controlled asthma had higher odds of feeling unhappy and/or sad or nervous and/or afraid, and of having problems with sports and/or hobbies and schoolwork on the CIS. Results from the CHQ showed that parents of school-age children with asthma and indicators of poorly controlled asthma had higher odds of worrying about their child's health and future. Results from the CSHCN showed that school-age children with asthma and indicators of poorly controlled asthma were more likely to have special health care needs. School-age children with asthma and indicators of poorly controlled asthma had higher odds of having poor perceived physical health. CONCLUSION: This nationally representative study provided novel information on the burden of poorly controlled asthma on emotional problems, school-related and activity limitations, general health status, and worry among school-age children and their families as measured by validated instruments.

Persistency, medication prescribing patterns, and medical resource use associated with multiple sclerosis patients receiving oral disease-modifying therapies: a retrospective medical record review.

BACKGROUND: In the US, the approved multiple sclerosis (MS) oral disease-modifying therapies (ODMTs) are fingolimod (FTY), teriflunomide (TFN), and dimethyl fumarate (DMF). FTY and TFN are recommended with once-daily doses with no up-titration, whereas DMF treatment is recommended twice-daily (BID) and is initiated with a 7-day starter dose of 120 mg BID before up-titration to the maintenance dose of 240 mg BID. Limited information exists regarding real-world ODMT prescribing patterns to aid physician/patient decision-making. METHODS: Eligible patients for this retrospective medical record review were ≥18 years, had one visit related to ODMT initiation (index visit), and ≥1 visit within 12 months before and after the index visit. Primary objectives were to assess post-index ODMT persistency (i.e., discontinuation), prescribing patterns (medication switching, dose up-titrations, dose reduction, re-starts, and add-ons) and medical resource utilization (office-visits, MRI procedures, and mobility indicators) at distinct time windows of 3, 6, 9, and 12 months. Chi-square or Wilcoxon Rank Sum tests were used for 3-way ODMT group comparisons. RESULTS: Medical records of 293 MS-diagnosed patients using ODMTs were abstracted from 19 US-based neurology clinics between December 31, 2010 and June 30, 2014 (FTY: 101; DMF: 133; TFN: 59). Persistency rates among ODMT groups were similar. MS-related medication switching, dose reduction, re-starts, and add-ons were infrequently observed and were similar across ODMT groups. Of DMF patients with a confirmed starting dose of 120 mg BID with ≥12 months follow-up (n = 26), the percentage who were prescribed dose up-titrations to the recommended maintenance DMF dose was 23.1 % at 1-3 months, 26.9 % at 4-6 months, 42.3 % at 7-9 months, and 0 % at 10-12 months. There were no significant differences at any time window among the ODMT groups in the number of office visits or percent of patients receiving MRIs. Mobility indicator patterns (proportion of patients with abnormal gait, wheelchair use, etc.) were consistent over time. CONCLUSIONS: There was no difference in persistency, prescribing patterns (medication switching, dose reduction, re-starts, and add-ons) or medical resource utilization (office-visits, MRI procedures, and mobility indicators) among the ODMTs. However, in a small sub-group of patients, delays of up to 9 months in DMF dose-up titration to the recommended maintenance dose were observed.

Association between cardiac, renal, and hepatic biomarkers and outcomes in patients with acute heart failure.

OBJECTIVES: Myocardial injury, worsening renal function, and hepatic impairment are independent risk factors for poor patient acute heart failure (AHF) outcomes. Biomarkers of organ damage may be useful in identifying patients at risk for poor outcomes. The objective of this analysis was to assess the relationship between abnormal AHF biomarkers and outcomes in AHF patients. METHODS: AHF admissions (N = 104,794) data from the Cerner Health Facts® inpatient database were analyzed retrospectively. Multivariate predictive models determined the impact of biomarkers on mortality, readmission, length of stay (LOS), and cost from index admission through 180 days post discharge. Thirty and 60 day time windows are reported but 180 day results were consistent with 60 day outcomes. Biomarkers evaluated were aspartate transaminase (AST), estimated glomerular filtration rate (eGFR), high sensitivity cardiac troponin, bilirubin, alanine transaminase (ALT), sodium, high sensitivity C-reactive protein (hs-CRP), uric acid, B-type natriuretic peptide (BNP), NT-ProBNP, blood urea nitrogen (BUN), serum creatinine (SCr), and hemoglobin. RESULTS: All biomarkers evaluated except hs-CRP, uric acid, and NT-ProBNP were significant (p < 0.0001) predictors of mortality at all timepoints; non-significance for these 3 biomarkers is likely due to low patient counts (1%-2%). Odds ratios for significant biomarkers of mortality ranged from 1.168-2.076 at index admission, 1.205-1.946 at 30 days post-discharge, and 1.233-1.991 at 60 days post-discharge. AST, eGFR, troponin, ALT, BNP, BUN, SCr, and hemoglobin were significant (p < 0.0001) predictors of readmission risk at all timepoints. AST, eGFR, troponin, bilirubin, BUN, SCr, and hemoglobin were significant (p < 0.0001) predictors of cumulative LOS at all timepoints. AST, eGFR, troponin, ALT, sodium, BUN, and hemoglogin were significant (p < 0.0001) cost predictors at 30 and 60 days post-discharge. CONCLUSIONS: Renal function measures were associated with outcomes in patients hospitalized for AHF. Increased vigilance of renal biomarkers may be warranted to assess risk and promote proactive clinical management to improve outcomes.

Comparative Assessment of Medical Resource Use and Costs Associated with Patients with Symptomatic Peripheral Artery Disease in the United States.

BACKGROUND: There is growing concern about appropriate disease management for peripheral artery disease (PAD) because of the rapidly expanding population at risk for PAD and the high burden of illness associated with symptomatic PAD. A better understanding of the potential economic impact of symptomatic PAD relative to a matched control population may help improve care management for these patients. OBJECTIVE: To compare the medical resource utilization, costs, and medication use for patients with symptomatic PAD relative to a matched control population. METHODS: In this retrospective longitudinal analysis, the index date was the earliest date of a symptomatic PAD record (symptomatic PAD cohort) or any medical record (control cohort), and a period of 1 year pre-index and 3 years post-index was the study time frame. Symptomatic PAD patients and control patients (aged ≥ 18 years) enrolled in the MarketScan Commercial and Encounters database from January 1, 2006, to June 30, 2010, were identified. Symptomatic PAD was defined as having evidence of intermittent claudication (IC) and/or acute critical limb ischemia requiring medical intervention. Symptomatic PAD patients were selected using an algorithm comprising a combination of PAD-related ICD-9-CM diagnostic and diagnosis-related group codes, peripheral revascularization CPT-4 procedure codes, and IC medication National Drug Code numbers. Patients with stroke/transient ischemic attack, bleeding complications, or contraindications to antiplatelet therapy were excluded from the symptomatic PAD group but not the control group. A final 1:1 symptomatic PAD to control population with an exact match based on age, sex, index year, and Charlson Comorbidity Index (CCI) was identified. Descriptive statistics comparing patient demographics, comorbidities, medical resource utilization, cost, and medication use outcomes were generated. Generalized linear models were developed to compare the outcomes while controlling for residual difference in demographics, comorbidities, pre-index resource use, and pre-index costs. RESULTS: 3,965 symptomatic PAD and 3,965 control patients were matched. In both cohorts, 54.7% were male, with a mean age (SD) of 69.0 (12.9) years and a CCI score of 1.3 (0.9). Symptomatic PAD patients had more cardiovascular comorbidities than control patients (27.7% vs. 12.6% coronary artery disease, 27.1% vs. 15.9% hyperlipidemia, and 49.8% vs. 28.2% hypertension) in the pre-index period. Post-index rates of ischemic stroke, non-ST segment elevation myocardial infarction, unstable angina, and cardiovascular- or PAD-related procedures (limb amputations, endovascular procedures, open surgical procedures, percutaneous coronary intervention, and coronary artery bypass graft) were higher among symptomatic PAD patients versus control patients. All-cause annualized inpatient admissions (0.46 vs. 0.22 admissions), emergency department/urgent care days (0.27 vs. 0.22 days), and office visit days (12.5 vs. 10.2 days) were higher among symptomatic PAD versus control patients post-index. Annualized all-cause inpatient costs ($8,494 vs. $3,778); outpatient costs ($8,459 vs. $5,692); and total costs ($20,880 vs. $12,501) were higher among symptomatic PAD versus control patients post-index. Only 17.8% of symptomatic PAD patients versus 6.6% of control patients were on clopidogrel pre-index. In the post-index period, clopidogrel prescriptions in the symptomatic PAD population increased to 38.0%. Results were consistent in the regression models with the symptomatic PAD population having a higher number of all-cause post-index inpatient admissions, emergency department/urgent care days, office visit days, inpatient costs, outpatient costs, and total costs versus control patients (P ≤ 0.026). CONCLUSIONS: Symptomatic PAD patients have significantly higher medical resource use and costs when compared with a matched control population. As the prevalence of symptomatic PAD increases, there will be a significant impact on the population and health care system. The rates of use of evidence-based secondary prevention therapies, such as antiplatelet medication, were low. Therefore, greater effort must be made to increase utilization rates of appropriate treatments to determine if the negative economic and clinical impacts of symptomatic PAD can be minimized. DISCLOSURES: This study was funded by Merck & Co., Kenilworth, New Jersey. Chase and Heithoff are employees of Merck & Co., Kenilworth, New Jersey, and Upper Gwynedd, Pennsylvania. Friedman and Navaratnam are paid consultants for Merck & Co. Simpson is a paid consultant for Merck, Pfizer, and Amgen and has received speaker's fees from Merck and Pfizer. Study concept and design were contributed by Chase, Navaratnam, and Heilhoff, along with Simpson and Friedman. Friedman collected the data, which was interpreted by Simpson and Navaratnam, along with Friedman. The manuscript was written by Navaratnam and Friedman, along with Chase, Heilhoff and Simpson, and revised by all of the authors.

Determinants of high cost in multiple sclerosis patients: a claims and chart review study.

OBJECTIVE: To identify factors associated with high cost multiple sclerosis (MS) patients using integrated administrative claims and medical charts data. METHODS: This study identified newly diagnosed MS patients (≥18 years) in a large United States managed care claims database between 1 January 2007 and 30 April 2011 using the ICD-9-CM code (340.xx). Mean annualized MS-related costs higher than the third quartile were categorized as high cost, lower than the first quartile as low, and the rest as medium. Patients were compared across cohorts with descriptive and inferential statistics. Baseline high cost factors were identified with multivariable logistic regression models. RESULTS: Administrative claims (n = 4342) and medical chart records (n = 400) data was evaluated. Mean (SD) annualized MS-related costs were $6313 ($14,177) for patients overall and $18,398 ($24,483) for high cost patients. Inpatient costs accounted for the largest proportion (49.69%) of MS-related costs among high cost patients. MS relapses and MS-related comorbidities were more prevalent in the high cost patients. In the multivariable analyses, patients with baseline use of antidepressants or corticosteroids, baseline muscle weakness, and initial treatment from a non-neurologist were likelier to be high cost MS patients. LIMITATIONS: MS-related clinical information was not completely available from medical chart data. The specificity of true MS-related costs may have been limited and the definition of the cost-based cohort segmentations was arbitrary. CONCLUSIONS: Overall, baseline use of MS-related medications, the presence of baseline MS-related comorbidities, MS relapses, and MS-related hospitalizations were significantly associated with high cost patients. Future comparative effectiveness studies of currently approved disease modifying therapies for MS may help to identify best strategies for individual patients to minimize clinical events that are associated with high disease related costs.

Gender Disparities in Lipid-Lowering Therapy in Cardiovascular Disease: Insights from a Managed Care Population.

BACKGROUND: Numerous studies have documented the strong inverse relationship between low-density lipoprotein cholesterol (LDL-C) levels and atherosclerotic cardiovascular disease (ASCVD). However, women are less likely to be screened for hypercholesterolemia, receive lipid-lowering therapy (LLT), and achieve optimal LDL-C levels. MATERIALS AND METHODS: Data were extracted from a U.S. administrative claims database between January 2008 and December 2012 for patients with established ASCVD. The earliest date of valid LDL-C value was defined as the index date. Patients were followed for ±12 months from the index date and were stratified by gender, by baseline LDL-C level, and whether they were initially treated with a LLT then propensity score matched by gender using demographic and clinical characteristics. Both descriptive statistics and logistic regression models were used to explore the association of gender with the frequency of LDL-C monitoring, LLT treatment initiation in initially untreated patients, and prescribing patterns in initially treated patients. RESULTS: A total of 76,414 subjects with established ASCVD were identified; 42% of the sample was women. In the unmatched cohort, 50.3% of men and 32.0% of women were prescribed a preindex statin (p < 0.0001). Among matched patients (n = 51,764), women initially treated with LLT were significantly less likely to receive a prescription for a higher potency LLT. Even among those with LDL-C levels above 160 mg/dL, women were more likely to discontinue LLT, odds ratio (95% confidence interval) 1.8 (1.2-2.3). Female gender and older age were significant predictors of discontinuation, and the potency of the index medication was the strongest predictor of dose titration. Initially untreated women were less likely to initiate LLT treatment than men, irrespective of index LDL-C levels (p < 0.0001). CONCLUSIONS: The observed disparities further reinforce the need for targeted efforts to reduce the gender gap for secondary prevention in women at high risk of cardiovascular disease.

Resource use and costs in high-risk symptomatic peripheral artery disease patients with diabetes and prior acute coronary syndrome: a retrospective analysis.

OBJECTIVES: As the prevalence of peripheral artery disease (PAD) increases there is growing concern about the associated healthcare burden. This burden has not been well-characterized in high-risk patients with concurrent diabetes and/or acute coronary syndrome (ACS). The objective of this analysis was to assess comorbidities, medication use, outcomes, services and costs for 3 high-risk symptomatic PAD groups. METHODS: This retrospective longitudinal analysis used the MarketScan Commercial Claims and Encounters Database (2005-2013). The 3 high-risk symptomatic PAD groups were (1) symptomatic PAD with/without diabetes, (2) symptomatic PAD with/without prior ACS, and (3) symptomatic PAD with/without diabetes and prior ACS. The study time frame was a period of 1-year before the earliest date of a symptomatic PAD record and 3 years post. RESULTS: In all, 16,663 symptomatic PAD patients were identified across the three risk groups. Mean age ranged from 66.4-67.4 years; the majority (55.0%-63.3%) were men. At 3 years post index, patients with symptomatic PAD and a risk factor had significantly higher use of beta-blockers, ACE inhibitors and statins (P<0.0007), and higher rates of all-cause and symptomatic PAD-related medical services, diagnoses and procedures (P<0.05). Clopidogrel and statins were used by ≤ 41.2% and ≤ 66.7% of symptomatic PAD patients without risk, respectively, and ≤ 68.9% and ≤ 80.2% of patients with risks. All cause and symptomatic PAD-related treatment costs (P<0.0001) were higher for symptomatic PAD patients with risks versus patients without risks where annualized all-cause cost differences ranged from $7,482 to $13,504 and annualized PAD-related cost differences ranged from $605 to $1,997. CONCLUSIONS: Symptomatic PAD patients with diabetes and/or prior ACS have significantly higher medical resource use and costs compared to symptomatic PAD patients without these risk factors. The utilization rate of secondary prevention therapies is suboptimal; therefore, greater effort must be made to increase utilization and optimize treatment to minimize the impact of symptomatic PAD.

Advancing Best Practices for Prescription Drug Labeling.

OBJECTIVE: Problematic prescription drug labeling has been cited as a root cause of patient misunderstanding, medication errors, and nonadherence. Although numerous studies have recently been conducted to identify and test labeling best practices, the last systematic review on this topic was conducted a decade ago. The objective of this review was, therefore, to examine, summarize, and update best practices for conveying written prescription medication information and instructions to patients. DATA SOURCES: English-language articles published from June 2005 to June 2015 were identified in MEDLINE and CINAHL by searching the following text words: 'medication OR prescription OR drug' AND 'label OR leaflet OR brochure OR pamphlet OR medication guide OR medication insert OR drug insert OR medication information OR drug information OR instructions' AND 'patient OR consumer.' Reference mining and secondary searches were also performed. STUDY SELECTION AND DATA EXTRACTION: A total of 31 articles providing evidence on how to improve written, prescription drug labeling for patient use were selected. Two reviewers independently screened articles, rated their quality, and abstracted data. DATA SYNTHESIS: Identified best practices included the use of plain language, improved formatting and organization, and more explicit instructions to improve patient comprehension. The use of icons had conflicting findings, and few studies tested whether practices improved knowledge or behaviors with patients' actual prescribed regimens. CONCLUSIONS: Future studies are needed to determine how specific modifications and improvements in drug labeling can enhance patient knowledge and behavior in actual use. Synthesizing best practices across all patient materials will create a more useful, coordinated system of prescription information.

Association of persistent and transient worsening renal function with mortality risk, readmissions risk, length of stay, and costs in patients hospitalized with acute heart failure.

BACKGROUND: Data comparing effects of transient worsening renal function (WRFt) and persistent WRF (WRFp) on outcomes in patients hospitalized with acute heart failure (AHF) are lacking. We determined the characteristics of hospitalized AHF patients who experienced no worsening renal function (non-WRF), WRFt, or WRFp, and the relationship between cohorts and AHF-related outcomes. METHODS AND RESULTS: A patient's first AHF hospitalization (index) was identified in the Cerner Health Facts(®) database (January 2008-March 2011). Patients had WRF if serum creatinine (SCr) was ≥0.3 mg/dL and increased ≥25% from baseline, and they were designated as WRFp if present at discharge or WRFt if not present at discharge. A total of 55,436 patients were selected (non-WRF =77%, WRFp =10%, WRFt =13%). WRFp had greater comorbidity burden than WRFt. At index hospitalization, WRFp patients had the highest mortality, whereas WRFt patients had the longest length of stay (LOS) and highest costs. These trends were observed at 30, 180, and 365 days postdischarge and confirmed by multivariable analyses. WRF patients had more AHF-related readmissions than non-WRF patients. In sensitivity analyses of the patient subset with live index hospitalization discharges, postdischarge LOS and costs were highest in WRFt patients, whereas mortality associated with a HF hospitalization was significantly higher for WRF patients vs non-WRF patients, with no difference between WRFp and WRFt. CONCLUSION: In patients hospitalized for AHF, WRFp was associated with the highest mortality, whereas WRFt was associated with the highest LOS and costs. WRF patients had higher readmissions than non-WRF patients. Transient increases in SCr appear to be associated with detrimental outcomes, especially longer LOS and higher costs.

Patterns of medication utilization and costs associated with the use of etanercept, adalimumab, and ustekinumab in the management of moderate-to-severe psoriasis.

BACKGROUND: Dose escalations of biologic agents may be attempted in the management of moderate-to-severe psoriasis. This has implications for the real-world cost of treatment. OBJECTIVE: To examine the utilization patterns and costs associated with the use of etanercept, adalimumab, and ustekinumab among patients with moderate-to-severe psoriasis. METHODS: This was a retrospective cross-sectional study. Patients with 2 or more medical claims with a diagnosis of psoriasis (excluding psoriatic arthritis) who were enrolled in large employer-sponsored health plans (including a pharmacy benefit) in the United States from January 2007 to March 2012 were identified and extracted from the MarketScan Commercial Encounters Database. Patients aged at least 18 years were required to have 2 or more pharmacy claims for etanercept, adalimumab, or ustekinumab; the index date was the first biologic fill date. Demographics and comorbidities were identified during the 1-year pre-index period, and medication utilization and costs were evaluated in the 1-year post-index period after a titration period according to the product prescribing information (2 weeks to 12 weeks). Medication utilization parameters such as dose escalation, dose reduction, persistence, switching, discontinuation, and restarts were assessed at 6, 9, and 12 months from the end of the dose titration window. RESULTS: A total of 4,309 patients were included with a mean average age of 46 years, and 55% were male. Fifty-seven percent of the patients were started on etanercept, 39% on adalimumab, and 5% on ustekinumab. Patients had substantial dose escalation rates (etanercept: 41%; adalim-umab: 37%; ustekinumab: 36%, P less than 0.05) and discontinuation rates (etanercept: 35%; adalimumab: 27%; ustekinumab: 16%, P less than 0.05) over the 12-month post-titration period. Many patients also restarted the same biologic (etanercept: 37%; adalimumab: 10%; ustekinumab: 6%, P less than 0.05) or switched to another biologic (etanercept: 15%; adalimumab: 10%; ustekinumab: 5%, P less than 0.05) over the 12-month post-titration period. The persistence rates over 12 months were 19%, 53%, and 71% for etanercept, adalimumab, and ustekinumab, respectively (P less than 0.05). Close to one-third of the patients at 6 months and 39% at 12 months postdose titration experienced a dose escalation. Approximately half of the patients who experienced a dose escalation also had a discontinuation or a dose reduction over the 12-month post-titration period. CONCLUSIONS: Over one-third of psoriasis patients experienced a dose escalation of their biologic agents, and most of the dose escalation occurred during the first 6 months. Restarting, switching, and discontinuing index biologics were also common.