Complications and Health Care Resource Utilization Associated with Systemic Corticosteroids in Children and Adolescents with Persistent Asthma.

BACKGROUND: Limited comparative data are available on the impact of systemic corticosteroid (SCS) use in children and adolescents. OBJECTIVE: To determine if asthmatic children and adolescents treated with SCS have a higher likelihood of developing complications versus those not receiving SCS and to examine health care resource utilization (HCRU) in this population. METHODS: A retrospective study of data from children and adolescents with persistent asthma retrieved from the MarketScan database, a large US health claims data set, for the period 2000 to 2017 was performed. Propensity score matching was used to pair patients in the SCS and control cohorts. For complications, SCS subgroups (≥4 or 1-3 annual prescriptions) were compared with asthmatic controls without SCS using logistic regression, and for HCRU, cohorts were compared using negative binomial regression. RESULTS: A total of 67,081 patients were included (SCS: 23,898; control: 43,183). The odds of having a complication were 2.9 (95% confidence interval [CI], 2.5-3.2; P < .001) and 1.6 (95% CI, 1.6-1.7; P < .001) times higher in the ≥4 and 1 to 3 SCS groups, respectively, in the first year of follow-up versus controls. For asthma-related hospitalizations, the incidence rate ratio (IRR) was 6.9 (95% CI, 5.6-8.6) and 3.1 (95% CI, 2.8-3.4) times greater in the ≥4 SCS and 1 to 3 SCS groups, respectively, versus controls; for asthma-related emergency department visits, IRR was 5.0 (95% CI, 4.4-5.6) and 2.9 (95% CI, 2.7-3.0) times greater, respectively, versus controls (all P < .01). CONCLUSION: Children and adolescents receiving SCS for persistent asthma have an increased risk of developing complications and have greater HCRU in the first year of follow-up versus those without SCS exposure.

Healthcare resource utilization, expenditures, and productivity in patients with asthma with and without allergies.

Objective: To compare healthcare resource utilization (HCRU), healthcare expenditures, and work productivity and activity impairment within a general asthma population with persistent asthma and evidence of allergy (PA-EA) and persistent asthma with no evidence of allergy (PA-NEA).Methods: We conducted a retrospective analysis of survey responses and claims from the Observational Study of Asthma Control and Outcomes (OSACO) study. Eligible patients with persistent asthma aged ≥12 years were sent four surveys over 15 months. Regression models were used to assess the association between: (1) PA-EA (defined as a positive response to a survey question about hay fever/seasonal allergies AND ≥1 diagnostic code for atopic conditions) and HCRU and expenditures; and (2) PA-EA and Work Productivity and Activity Impairment (WPAI)-Asthma questionnaire scores (vs. PA-NEA).Results: Adjusted data showed that, vs. PA-NEA (n = 312), patients with PA-EA (n = 971) incurred 1.34-times more all-cause prescriptions (95% confidence interval [CI], 1.20-1.48), $132.79 higher prescription costs (95% CI, $22.03-243.56), and $926.11 higher all-cause total healthcare costs (95% CI, $279.67-1572.54), per 4-month period. Patients with PA-EA were 4.1% less productive while working (95% CI, 3.75-4.48%) and experienced a 6.5% reduction in all activities (95% CI, 6.11-6.88%) vs. those with PA-NEA.Conclusions: Patients with PA-EA had greater HCRU, healthcare expenditures, and lower productivity compared with those patients with PA-NEA. These results highlight the burden of atopy in patients with persistent asthma and underscore the importance of allergic endotype identification for more vigilant disease management.

Impact of allergies on health-related quality of life in patients with asthma.

Objective: To estimate the health-related quality of life (HRQoL) and health utilities among asthma patients with and without comorbid allergies in a managed care population.Methods: This was a retrospective analysis of patient survey responses and pharmacy claims from the Observational Study of Asthma Control and Outcomes (OSACO). Patients ≥12 years-old with persistent asthma received four identical surveys between April-2011 and December-2012. The presence of allergy was identified by a positive response to a survey question about hay fever/seasonal allergies and ≥1 diagnosis-related ICD-9-CM code(s) for allergic conditions. HRQoL instruments included generic utility (EQ-5D-3L [including VAS]), asthma-specific utility (AQL-5D) and asthma-specific health status (Mini Asthma Quality of Life Questionnaire [MiniAQLQ]). Median regression was used for utility scores and Least Squares regression for MiniAQLQ, adjusting for sociodemographic characteristics and smoking.Results: Of the 2681 asthmatics who completed the first survey in the OSACO study, 971 had comorbid allergies. After adjusting for covariates, asthma patients with comorbid allergies had significantly lower MiniAQLQ scores than patients without allergies (-0.489 [95% CI -0.570, -0.409]; p < 0.01), with the greatest decrement/impairment observed for the environmental stimuli domain (-0.729 [95% CI -0.844, -0.613]; p < 0.01). Utility scores were also statistically significantly lower for asthma patients with comorbid allergies compared to those without allergies (EQ-5D, -0.031 [95% CI -0.047, -0.015]; AQL-5D, -0.036 [95% CI -0.042, -0.029]; p < 0.01 each).Conclusions: The presence of allergies with persistent asthma is associated with a significant deleterious impact on several different measures of HRQoL.

Cost-effectiveness of omalizumab for the treatment of moderate-to-severe uncontrolled allergic asthma in the United States.

Objective: Uncontrolled asthma is associated with considerable clinical burden and costs to payers and patients. US economic models evaluating biologics using data from clinical trials demonstrate high incremental cost-effectiveness ratios (ICERs), but the cost-effectiveness based on real-world treatment patterns is unknown. This analysis used real-world evidence to assess the cost-effectiveness of adding omalizumab to standard of care (SOC).Methods: A Markov model was applied to track patients' health states in 2-week cycles, comparing costs and treatment effects of SOC alone versus SOC + omalizumab over a lifetime (US payer perspective). Outcomes included exacerbation events, life years, quality-adjusted life years (QALYs), total costs, and an ICER. Patient characteristics, exacerbations, patient-reported outcomes, and work productivity were derived from the real-world PROSPERO (Prospective Study to Evaluate Predictors of Clinical Effectiveness in Response to Omalizumab) study. Published literature informed mortality, exacerbation-related disutility, and unit costs. Sensitivity analyses assessed model robustness.Results: Over a lifetime horizon, omalizumab was associated with an increase of 2.0 QALYs at a cost of $US 148,319 in patients with uncontrolled asthma (ICER of $75,319/QALY gained) and a reduction in exacerbations of 6.0 events/patient. Accounting for responder status improved the ICER ($70,505/QALY); incorporating indirect costs further reduced the ICER. One-way and multivariate sensitivity analyses confirmed that the base case outcome was robust to variation in inputs.Conclusions: Based on real-world outcomes, omalizumab may be cost-effective for uncontrolled asthma from the US payer perspective. Including broader evidence on treatment discontinuation, caregiver burden, and oral corticosteroid reduction from real-world studies may better reflect the effects and value of omalizumab for all healthcare stakeholders.

Medication use and indicators of poor asthma control in patients with and without allergies.

Background: Approximately two-thirds of people with asthma have some evidence of allergy; their condition differs from nonallergic asthma in terms of predominant symptoms and clinical outcomes. Objective: To compare asthma control and medication use among patients with persistent asthma with evidence of allergy (PA-EA) and patients with persistent asthma with no evidence of allergy (PA-NEA). Methods: A retrospective analysis of survey responses and medication claims data from the Observational Study of Asthma Control and Outcomes study, a prospective survey linked to retrospective claims-based analysis of patients ages ≥ 12 years with persistent asthma in a U.S. health maintenance organization. Evidence of allergy was defined as both a positive response to a survey question about hay fever and/or seasonal allergies and one or more medical diagnostic codes for atopic conditions. Regression models were used to compare asthma control (Asthma Control Questionnaire [ACQ] scores) and asthma medication use between PA-EA and PA-NEA. Results: Adjusted data showed that, versus the patients with PA-NEA (n = 312), patients with PA-EA (n = 971) had higher (worse) 5-item and 6-item ACQ (ACQ-5 and ACQ-6) scores (by 0.34 [95% confidence interval {CI}, 0.24-0.44]; and 0.31 [95% CI, 0.21-0.40], respectively), were more likely to have poorly controlled asthma (ACQ-5 score ≥ 1.5: odds ratio 3.37 [95% CI, 2.07-5.50]; ACQ-6 score ≥ 1.5: odds ratio 3.46 [95% CI, 2.13-5.62]) and less likely to have well-controlled asthma (ACQ-5 score ≤ 0.75: odds ratio 0.21 [95% CI, 0.13-0.34]; ACQ-6 score ≤ 0.75: odds ratio 0.21 [95% CI, 0.13-0.35]). Patients with PA-EA also had greater asthma medication use, most notably 2.5 times more prescriptions of high-dose inhaled corticosteroid in a 4-month period (95% CI, 1.21-5.16) and 16.15 times higher odds of chronic oral corticosteroid use (95% CI, 1.50-174.09) versus PA-NEA. Conclusion: The patients with PA-EA versus PA-NEA had worse asthma control and greater medication use. These patients may need more vigilant clinical oversight and treatment management to ensure adequate asthma control.

Association Between Pulmonary Function and Asthma Symptoms.

BACKGROUND: FEV1 as a percentage of predicted (FEV1%pred) is commonly measured in asthma clinical studies; however, reports vary on its association with asthma control instruments evaluating symptoms. OBJECTIVE: Assess the association between FEV1%pred and Asthma Control Questionnaire (ACQ) scores in a managed-care population with persistent asthma. METHODS: Retrospective analysis of survey responses and spirometry results of patients (aged ≥12 years) with persistent asthma from the Observational Study of Asthma Control and Outcomes was done. Eligible patients received 4 identical surveys including the 5-item ACQ (ACQ-5)/6-item ACQ (ACQ-6) and completed spirometry in parallel. Longitudinal analyses, comparisons of change over time, and fixed- and random-effects regression analyses were conducted, with/without adjustment for covariates. RESULTS: There were 1748 survey responses with valid spirometry results. In unadjusted models, coefficients for ACQ-5/ACQ-6 scores were not statistically significant and coefficient of determination (R2) was low (0.03). When adjusted for covariates, ACQ-5 and ACQ-6 scores were significantly associated with FEV1%pred (P < .001) and R2 increased to 0.11 and 0.12, respectively. In adjusted models, every 1-point increase in ACQ-5 and ACQ-6 scores was associated with a 1.7% and 1.9% decrease, respectively, in FEV1%pred. Change in FEV1%pred and change in ACQ-5/ACQ-6 scores were not significantly associated in regressions with/without covariates. CONCLUSIONS: The weak and statistically insignificant association between FEV1%pred and ACQ-5/ACQ-6 scores in unadjusted models suggests a high degree of unexplained variation between these measures. Results support the use of both symptoms and pulmonary function, rather than relying on one measure alone, to assess asthma control in clinical care and outcomes studies.

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.

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.

Estimating asthma control questionnaire (ACQ) scores from claims data.

BACKGROUND: Asthma control is the main focus of treatment guidelines. Valid instruments such as the Asthma Control Questionnaire (ACQ) require prospective survey. These surveys may be challenging for large population health applications. OBJECTIVE: To develop an algorithm for estimating ACQ-5 scores from commonly available claims data. METHODS: Data was derived from four prospective surveys including the ACQ-5 combined with retrospective claims of Kaiser Permanente of Colorado (KPCO) patients. The statistical approach consisted of derivation and validation of a prediction algorithm including medical and pharmacy claims data using stepwise regression elimination. Validation was conducted by estimating mean squared error (MSE) and mean absolute error (MAE) in one hundred split-sample iterations. Ordinary least squares (OLS), Tobit and Median regression were used. RESULTS: There were 2,657 individuals with valid ACQ-5 scores, claims and eligibility at baseline. The following had statistically significant associations with ACQ-5 scores: gender, use of oral corticosteroids and short-acting beta agonists, the number of asthma drug classes, and emergency and outpatient visits. Average MSE and MAE were similar for the estimation and validation samples. CONCLUSION: This research provides preliminary results of the feasibility of predicting ACQ-5 scores using commonly available medical and pharmacy claims data. The resulting algorithm may facilitate public health and population level analyses of asthma control. Future studies in different populations will be important to validate the algorithm.

Oral corticosteroid exposure and adverse effects in asthmatic patients.

BACKGROUND: Significant adverse effects (AEs) have been associated with continuous exposure to oral corticosteroids (OCSs). The potential association with intermittent exposure is unknown. OBJECTIVE: We sought to assess the association between OCSs and AEs based on the number of OCS prescriptions. METHODS: This was a retrospective cohort study of asthmatic patients 18 years and older in the 2000-2014 MarketScan data set. Propensity score matching was used at baseline (12 months before the index date: first OCS use). Logistic regression was used to examine the association between OCSs and new incident AEs (either combined or individual) controlling for covariates. Follow-up continued for 24 months minimum and 10 years maximum after the index date. RESULTS: There were 72,063 and 156,373 subjects in the OCS and no OCS cohorts, respectively. Subjects taking 4 or more OCS (1-3) prescriptions within the year had 1.29 (1.04) times the odds of experiencing a new AE within the year. Each year of exposure to 4 or more OCS prescriptions (current and past) resulted in 1.20 times the odds of having an AE in the current year. Exposure to 4 or more prescriptions was associated with significantly greater odds of AEs for osteoporosis, hypertension, obesity, type 2 diabetes, gastrointestinal ulcers/bleeds, fractures, and cataracts (odds, 1.21-1.44 depending on the AE). CONCLUSION: Although previous research has documented the deleterious effect of continuous OCS exposure in patients with severe asthma, our results suggest that each OCS prescription might result in a cumulative burden on current and future health regardless of dose and duration. OCS-sparing strategies are extremely important to improve patient outcomes.

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.

Measuring the cost of poor asthma control and exacerbations.

BACKGROUND: Previous studies have shown an association between cost and poor asthma control. However, longitudinal studies of general populations are lacking. OBJECTIVE: To examine the cost of poor asthma control and exacerbations across a broad spectrum of asthma patients. METHODS: The Observational Study of Asthma Control and Outcomes (OSACO) was a prospective survey of persistent asthma patients in Kaiser Colorado in 2011-2012. Patients received a survey 3 times in one year, which included the Asthma Control Questionnaire (ACQ) and questions on exacerbations. Self-reported exacerbations were compared to actual oral corticosteroid (OCS) use. Regression analyses examined the association of control (ACQ-5 scores) and exacerbations with healthcare expenditures, controlling for sociodemographics and smoking. Analyses of expenditures used Generalized Linear Models (GLM) with log-link. RESULTS: 2681 individuals completed at least one survey; 1799 completed all three. ACQ-5 scores were associated with higher all-cause and asthma-specific expenditures across all categories of costs (medical, outpatient, ER, pharmacy) except for inpatient expenditures. Each 1-point increase in the ACQ-5 score (i.e., worse control) was associated with a corresponding increase in all-cause annual healthcare and asthma-specific expenditures of $1443 and $927 ($US 2013). Asthma exacerbations with documented OCS use were associated with an increase of $3014 and $1626 over 4 months, while self-reported exacerbations were $713 and $506. CONCLUSION: Results demonstrate that poor asthma control and exacerbations are strongly associated with higher healthcare expenditures. Results also confirm that collection of validated measures of control such as the ACQ-5 may provide valuable information toward improving clinical and economic outcomes.

Health-related quality of life associated with systemic corticosteroids.

BACKGROUND: Systemic corticosteroids (SCS) are commonly used but are associated with adverse effects. Given their prevalent use, the potential impact of SCS use on health-related quality of life (HRQoL) is important to characterize. OBJECTIVE: To assess the HRQoL of patients taking SCS. METHODS: The 2000-2003 Medical Expenditure Panel Survey was used to examine EQ-5D and SF-6D scores associated with SCS use in adults. The study sample was restricted to those with a condition for which SCS are prescribed. SCS use was categorized into three levels: none; 1-3; and ≥4 prescriptions per year. HRQoL scores were regressed on SCS use (1-3 or ≥4 annual prescriptions) controlling for age, gender, race, ethnicity, education, income category, geographic region, number of ER visits, number of outpatient visits, total number of chronic conditions (for which SCS are not used) and conditions for which SCS are clinically indicated. RESULTS: There were 54,856 individuals with no SCS exposure, 2245 with 1-3 and 624 with ≥4 annual SCS prescriptions. In adjusted analyses, use of ≥4 annual SCS prescriptions appeared to be associated with significantly lower EQ-5D (US), EQ-5D (UK), SF-6D and EQ-5D VAS scores compared to no exposure: -0.032, -0.047, -0.036, and -7.58. CONCLUSION: While SCS are efficacious and widely used for numerous conditions, results suggest that their use may be associated with a substantial deleterious impact on HRQoL. This potential negative effect should be considered in balance with the cost and efficacy of comparable treatments.

EQ-5D Scores for Diabetes-Related Comorbidities.

BACKGROUND: A single-source catalogue of nationally representative EuroQol five-dimensional questionnaire (EQ-5D) scores for chronic conditions in the United States and the United Kingdom from the Medical Expenditure Panel Survey (MEPS) has been published and has been used extensively for public health and cost-effectiveness modeling. OBJECTIVES: To estimate EQ-5D scores for diabetes-related chronic conditions that are consistent with the previous catalogue. METHODS: The MEPS is a nationally representative survey of the US civilian population. EQ-5D-3L questionnaire responses were mapped from short-form 12 health survey responses in 2000 to 2011 MEPS data using multinomial logistic regression. Country-specific tariffs were applied to the mapped EQ-5D responses for the United Kingdom, the United States, France, and Spain. EQ-5D scores were regressed on diabetes-related comorbidities controlling for sociodemographic characteristics, body mass index, and comorbidity using robust (median) regression. Methods were consistent with the previously published catalogue of EQ-5D scores for the United States. RESULTS: There were 20,705 individuals with diabetes and a valid mapped EQ-5D score in the 2000 to 2011 MEPS data. Unadjusted mapped EQ-5D scores for individuals with diabetes varied by country-specific tariff from 0.70 (France) to 0.79 (United States). Regression results reflecting marginal disutility estimates for EQ-5D scores are provided for 17 diabetes-related comorbidities and body mass index categories for US, UK, French, and Spanish tariffs. CONCLUSIONS: The estimates provided in this research may be useful for analysts attempting to model the impact of diabetes and diabetes-related comorbid conditions on utility. They are derived from a single-source, nationally representative population and augment the existing "off-the-shelf" catalogue of EQ-5D scores for chronic conditions.

Exploring asthma control cutoffs and economic outcomes using the Asthma Control Questionnaire.

BACKGROUND: Understanding the effect of worsening asthma control on expenditures and health resource utilization (HRU) is important. OBJECTIVE: To explore the association of economic outcomes with asthma control cutoffs and longitudinal changes on the Asthma Control Questionnaire 5 (ACQ-5). METHODS: The Observational Study of Asthma Control and Outcomes was a survey of patients with persistent asthma who were patients of Kaiser Colorado, including claims-based HRU. Patients completed the ACQ-5 three times during 1 year between April 2011 and June 2012. The ACQ-5 cutoffs that indicated control were assessed in cross-sectional analyses. Longitudinal changes in control were explored: controlled (ACQ-5 score <0.75), indeterminate (ACQ-5 score 0.75 to <1.5), not well controlled (ACQ-5 score 1.5 to <3.0), and very poorly controlled (ACQ-5 score ≥3.0). Analyses used generalized linear models with log link (expenditures) and negative binomial regression (HRU). RESULTS: There were 6,666 completed surveys (1,799 individuals completed all 3 survey waves). In the cross-sectional analyses, compared with an ACQ-5 score less than 0.5, individuals with ACQ-5 scores of 4 to 4.5 incurred 7.2 times the number of oral corticosteroid prescriptions, 4.3 times the number of emergency department visits, 6 times the number of inpatient visits, 10.4 times the number of asthma-specific emergency department visits, 4.58 times the number of asthma-specific inpatient visits, and $2,892 more in all-cause and $1,877 in asthma-specific expenditures during 4 months. In the longitudinal change analyses, individuals who improved from an ACQ-5 of 3.0 or greater to less than 0.75 incurred $6,023 less in asthma-specific expenditures during 4 months than those remaining at an ACQ-5 score of 3.0 or higher. CONCLUSION: Results provide preliminary economic data on possible control cutoffs for the ACQ-5. Improving asthma control over time may result in significant savings that may justify financial investments designed to improve control.

Measurement of utility in asthma: evidence indicating that generic instruments may miss clinically important changes.

BACKGROUND: Accurate assessment of preference-based health-related quality of life is important in determining the value of asthma interventions. OBJECTIVE: To examine the sensitivity and responsiveness of the EQ-5D and the AQL-5D to differences in asthma control measured by the Asthma Control Questionnaire (ACQ-5). METHODS: The Observational Study of Asthma Control and Outcomes was a prospective survey of persistent asthma patients ≥12 years old in Kaiser Colorado. Patients received a survey three times in 1 year, including the ACQ-5, AQL-5D and EQ-5D-3L (including VAS). Censored Least Absolute Deviations (CLAD) and logistic regression were used, controlling for sociodemographics and smoking. RESULTS: There were 6666 completed surveys (1799 individuals completed all three survey waves). After controlling for covariates, each one-point increase in ACQ-5 was associated with a decrease of 0.066, 0.058, 0.074 and 6.12 in EQ-5D(US), EQ-5D(UK), AQL-5D and VAS scores. Uncontrolled asthma (ACQ-5 > 1.5) was associated with a decrease of 0.15, 0.17, 0.11 and 10, respectively (vs. ACQ ≤ 1.5). AQL-5D scores were statistically significantly different across categories of ACQ-5 scores of 0.5 (the minimum clinically important difference [MCID]), while EQ-5D scores were not significant across most categories. The AQL-5D appeared more robust to changes in control over time (responsiveness) compared to EQ-5D-3L. CONCLUSION: The AQL-5D appears more responsive to changes in asthma control over time and more sensitive to detecting differences corresponding to the ACQ-5 MCID than the EQ-5D-3L. Using the EQ-5D-3L without an asthma-specific measure such as the AQL-5D may miss clinically important changes in asthma control.

Outcomes before and after treatment escalation to Global Initiative for Asthma steps 4 and 5 in severe asthma.

BACKGROUND: Little is known about health outcomes in severe asthma reflected by Global Initiative for Asthma steps 4 and 5. OBJECTIVE: To analyze control, risk, economic, and health resource use (HRU) outcomes associated with treatment escalation to Global Initiative for Asthma steps 4 and 5. METHODS: This was a before-vs-after retrospective cohort study of patients (12-75 years old) with asthma newly initiated to omalizumab, high-intensity corticosteroids (HICS; ≥1,000 µg/day of inhaled fluticasone equivalent or oral prednisone), or high-dose inhaled corticosteroid (HDICS; ≥500 to <1,000 µg/day of fluticasone equivalent) using 2002 to 2011 MarketScan data. Poisson regression was used to model HRU outcomes; Tobit regression was used to model medical expenditures. RESULTS: Of 19,227 patients, 856 initiated omalizumab, 6,926 initiated HICS, and 11,445 initiated HDICS. Use of ß-agonist increased for the HDICS and HICS cohorts and decreased for the omalizumab cohort; acute care visits and oral corticosteroid use decreased during follow-up for the HDICS and omalizumab cohorts. Annual health care expenditures, polypharmacy burden, and outpatient visits were high for all cohorts and increased in the follow-up year (baseline to follow-up; general health care expenditures: omalizumab $14,071 to $34,887, HICS $12,030 to $15,557, HDICS $7,570 to $9,826; annual number of asthma prescriptions: omalizumab 11.74 to 19.46, HICS 7.8 to 12.44, HDICS 5.17 to 9.69; outpatient visits: omalizumab 26.79 to 34.06, HICS 18.78 to 21.37, HDICS 15.06 to 16.64). CONCLUSION: Omalizumab use was associated with improvements in risk and control accompanied by large increases in expenditures per HRU. Patients on HDICS and HICS showed improvements in risk but worsening control and increased expenditures per HRU. Innovations in disease management and available treatment options are needed to more optimally achieve treatment goals.