[Medico-economic evaluation of the PRADO-BPCO post-exacerbation support program]. / Évaluation médicoéconomique du PRADO-BPCO, programme d'accompagnement post-exacerbation.

INTRODUCTION: The "Programme d'Accompagnement du retour à Domicile" (PRADO) COPD is a home discharge support program dedicated to organizing care pathways following hospitalization for COPD exacerbation. This study aimed at assessing its medico-economic impact. METHODS: This was a retrospective database study of patients included in the PRADO BPCO between 2017 and 2019. Data were extracted from the National Health Data System. A control group was built using propensity score matching. Morbi-mortality and costs (national health insurance perspective) were measured during the year following hospitalization. RESULTS: While the proportion of patients with a care pathway complying with recommendations from the National Health Authority was higher in the PRADO group, there was no significant effect on mortality and 12-month rehospitalization. In the PRADO group, the rehospitalization rate was lower when the care pathway was optimal. Healthcare costs per patient were 670 € higher in the PRADO group. CONCLUSIONS: The PRADO COPD improves quality of care but without decreasing rehospitalizations and mortality, although rehospitalizations did decrease among PRADO group patients benefiting from an optimal care pathway.

Acute COPD exacerbations and in-hospital treatment-related problems: An observational study.

BACKGROUND: Treatment-related problems (TRPs) interfere with the ability to attain the desired goals of treatment, adding cost to healthcare systems. Patients hospitalized with acute conditions are at particular risk to experience TRPs. Data investigating such burden in patients with acute exacerbation of COPD (AECOPD) is generally scarce with no studies ever conducted in Jordan. This study aimed to investigate and categorize TRPs among patients hospitalized with AECOPD in Jordan, and to estimate their cost savings and cost avoidance. METHODS: This was a retrospective population-based cohort study. Patients' cases of AECOPD admitted to the study site from Jan 2017 to Jul 2021 were identified from the electronic clinical database and screened for eligibility. TRPs were identified/categorized using AbuRuz tool and assessed for their severity. Cost saving was estimated by calculating all the extra costs. Cost avoidance was estimated according to Nesbit method. RESULTS: A total of 1243 (mean±SD 3.1±1.5) and 503 (mean±SD 1.3±1.2) TRPs were identified during hospitalization and at discharge respectively, of which 49.4% and 66.7% were classified as "unnecessary drug therapy". In 54.5% of the cases, systemic corticosteroid was administered for a period longer than recommended. Most of the TRPs were of moderate severity. The total direct cost saving, and cost avoidance were estimated to be 15,745.7 USD and 340,455.5 USD respectively. CONCLUSION: The prevalence and cost of TRPs among AECOPD patients is a concern requiring attention. The study results implicate integrating interventions such as embracing clinical pharmacists' role in the respiratory care units to optimize patients' management.

Disease Burden and Health-Related Quality of Life (HRQoL) of Chronic Obstructive Pulmonary Disease (COPD) in the US - Evidence from the Medical Expenditure Panel Survey (MEPS) from 2016-2019.

Purpose: Chronic obstructive pulmonary disease (COPD) is a progressive disease associated with reduced life expectancy, increased morbidity, mortality, and cost. This study characterized the US COPD burden, including socioeconomic and health-related quality of life (HRQoL) outcomes. Study Design and Methods: In this retrospective, cross-sectional study using nationally representative estimates from Medical Expenditures Survey (MEPS) data (2016-2019), adults (≥18 years) living with and without COPD were identified. Adults living without COPD (control cohort) and with COPD were matched 5:1 on age, sex, geographic region, and entry year. Demographics, clinical characteristics, socioeconomic, and generic HRQoL measures were examined to include a race-stratified analysis of people living with COPD. Results: A total of 4,135 people living with COPD were identified; the matched dataset represented a weighted non-institutionalized population of 11.3 million with and 54.2 million people without COPD. Among people living with COPD, 66.3% had ≥1 COPD-related condition; 62.7% had ≥1 cardiovascular condition, compared to 33.5% and 50.5% without COPD. More people living with COPD were unemployed (56.2% vs 45.3%), unable to work due to illness/disability (30.1% vs 12.1%), had problems paying bills (16.1% vs 8.8%), reported poorer perceived health (fair/poor: 36.2% vs 14.4%), missed more working days due to illness/injury per year (median, 2.5 days vs 0.0 days), and had limitations in physical functioning (40.1% vs 19.4%) (all P<0.0001). In race-stratified analyses for people living with COPD, people self-reporting as Black had higher prevalence of cardiovascular-risk conditions, poorer socioeconomic and HRQoL outcomes, and higher healthcare expenses than White or Other races. Conclusion: Adults living with COPD had higher clinical disease burden, lower socioeconomic status, and reduced HRQoL than those without, with greater disparities among Black people living with COPD compared to White and other races. Understanding the characteristics of patients helps address care disparities and access challenges.

Cost-effectiveness analysis of fluticasone furoate/umeclidinium bromide/vilanterol and umeclidinium bromide/vilanterol in the management of moderate and severe COPD in China.

OBJECTIVE: A study has analyzed the long-term cost-effectiveness of fluticasone furoate/umeclidinium bromide/vilanterol combination therapy (FF/UMEC/VI) versus umeclidinium bromide/vilanterol dual therapy (UMEC/VI) in the treatment of moderate or severe chronic obstructive pulmonary disease (COPD), providing evidence for decision-making in COPD treatment. METHODS: From the perspective of the whole society, a Markov model based on the severity of COPD was established, consisting of four states: moderate, severe, very severe, and death. The cycle of the model is three months, and the time frame of the study is 20 years. Data such as initial states, transition probabilities, costs, and utilities were collected from published literature, the National Institute for Health and Care Excellence (NICE) COPD economic report, Yaozh database, and the National Statistics Office. The discount rate is 5 %, and the willingness to pay threshold is set at three times the per capita GDP of China in 2022. TreeAge Pro 2011 was used to obtain the results of multiplication analyses, and one-way factor analysis and probability sensitivity analysis were conducted. RESULTS: The study findings demonstrate that for patients treated with FF/UMEC/VI and UMEC/VI, the 20-year treatment costs amount to $10,126.46 and $10,685.74, respectively. Similarly, the effectiveness is 32.94 quality-adjusted life years (QALYs) and 32.19 QALYs, respectively. The incremental cost-effectiveness ratio is $-745.70/QALY, which is lower than the willingness to pay threshold. The tornado plot from one-way factor analysis indicates that the first two factors impacting the results are the utility values for severe COPD of UMEC/VI and FF/UMEC/VI. Probability sensitivity analysis indicates that FF/UMEC/VI compared to UMEC/VI can be considered a more cost-effective treatment at the willingness to pay threshold of $35,806.96. CONCLUSION: The triple therapy (FF/UMEC/VI) is more affordable than dual therapy (UMEC/VI) when compared to China's three times GDP per capita criterion.

Pulmonary Rehabilitation Reimbursement Challenges.

Pulmonary rehabilitation (PR) is a highly effective intervention for persons with chronic respiratory diseases, resulting in improvement in exercise capacity, dyspnea, health-related quality of life, mood, reduced hospitalization, and improved survival and cost savings post-COPD hospitalization. Despite demonstrated effectiveness, PR is underutilized in part due to lack of awareness, limited access, and inadequate PR reimbursement. Poor payment is a long-standing barrier to PR's financial stability and access. Addressing PR payment, access, and utilization is a complex challenge and requires strategic, collaborative long-term approaches to meaningful solutions. Strategies to overcome payment disparities begin with legislative approaches to address limitations of Centers for Medicare and Medicaid Services coverage. Additional priorities include permanent approval for remote physician and advanced practice provider (APP) PR supervision, PR referrals by APPs, telerehabilitation using two-way audio/video technology, and elimination of the PR lifetime maximum limit of 72 h or units/patient. Methods are needed to effectively link appropriate PR prescribing and encouragement with primary care providers, hospitalists, case managers, and hospital navigators to optimize PR referrals. There is an important need to address inadequate PR access in rural settings. Potential opportunities to improve PR referrals and access include exploration of PR synergies with value-based care models that emphasize high-quality care and cost savings. Development and use of effective PR provider tools and resources may help address the above challenges as well as financially benefit PR programs.

Review of the Evidence for Pulmonary Rehabilitation in COPD: Clinical Benefits and Cost-Effectiveness.

COPD is a common and lethal chronic condition, recognized as a leading cause of death worldwide. COPD is associated with significant morbidity and disability, particularly among older adults. The disease course is marked by periods of stability and disease exacerbations defined by worsening respiratory status resulting in a high burden of health care utilization and an increased risk of mortality. Treatment is focused on pharmacologic therapies, but these are not completely effective. Pulmonary rehabilitation (PR) represents a key medical intervention for patients with chronic respiratory diseases, including COPD. PR provides individualized and progressive exercise training, education, and self-management strategies through a comprehensive and multidisciplinary program. PR has been associated with improvement in exercise capacity, health-related quality of life, and dyspnea in patients living with COPD. Moreover, PR has been associated with improvements in hospital readmission and 1-y survival. In addition to the clinical benefits, PR is estimated to be a cost-effective medical intervention. Despite these benefits, participation in PR remains low. We will review the evidence for PR in each of these benefit domains among patients with stable COPD and in those recovering from a COPD exacerbation.

Cost-Effectiveness and Impact on Health Care Utilization of Interventions to Improve Medication Adherence and Outcomes in Asthma and Chronic Obstructive Pulmonary Disease: A Systematic Literature Review.

BACKGROUND: Poor adherence to asthma and chronic obstructive pulmonary disease maintenance therapies impairs health outcomes. Proven and cost-effective programs to promote adherence and persistence are not yet in regular widespread use. Implementation costs are a potential barrier to uptake of such programs. OBJECTIVE: We undertook a systematic literature review and narrative synthesis of studies investigating the cost-effectiveness of treatment adherence-promoting programs or that determined their impact on health care budget directly or via health care resource use (HCRU). METHODS: We identified relevant publications using Medline and PreMEDLINE (PubMed), Embase (Embase.com, Elsevier), and EconLit for publications between January 2000 and July 2021. We also searched clinical trial databases and selected conference proceedings. RESULTS: Of 1,910 potentially relevant articles, 26 met prespecified inclusion criteria and underwent data extraction. Eleven reported a direct assessment of adherence, 15 included economic evaluations, and 17 described HCRU. None included an analysis of biologic medication use. When they were studied, interventions were often found to be highly cost-effective, with dominant incremental cost-effectiveness ratios in some cases. Reductions in direct costs and HCRU (health care visits, hospital admissions, and/or the use of medications, including add-on/reliever treatment and antibiotics) were frequently reported. Reported use of maintenance treatments improved in some studies. Counseling and/or digitally informed programs were used in all cases in which favorable outcomes were observed. CONCLUSIONS: Adherence-promoting interventions are mostly cost-effective and often result in reduced HCRU and associated costs. Multidisciplinary care involving one-to-one advice and digitally enhanced communications appear to offer the greatest benefit.

The overlap of chronic obstructive pulmonary disease and obstructive sleep apnea in hospitalizations for acute exacerbation of chronic obstructive pulmonary disease.

STUDY OBJECTIVES: This study examined in-hospital outcomes for patients with both chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA), also known as COPD-OSA overlap syndrome, during hospitalizations for acute exacerbation of COPD. METHODS: The National Inpatient Sample was used to examine in-hospital mortality, length of stay, costs, and utilization of supportive ventilation in patients with COPD-OSA overlap during acute exacerbation of COPD hospitalizations. A 1-to-1 matched case-control design was utilized to match patients with and without OSA. Multivariate logistic regression modeling was used to examine mortality and ventilatory support, while controlling for potentially confounding diagnoses. RESULTS: COPD-OSA overlap was associated with longer median length of stay (4 days OSA, 3 days non-OSA; P < .001), higher mean costs ($32,197 OSA, $29,011 non-OSA; P < .001), increased utilization of noninvasive positive-pressure ventilation (13.92% OSA, 6.78% non-OSA; P < .001), and when required for greater than 96 hours, earlier initiation of mechanical ventilation (2.53 days OSA, 3.35 days non-OSA; P = .001). However, COPD-OSA overlap was associated with reduced mortality (0.81% OSA, 1.05% non-OSA; P < .001). These differences in mortality (adjusted odds ratio: 0.650; 95% confidence interval: 0.624-0.678) and noninvasive positive-pressure ventilation usage (adjusted odds ratio: 1.998; 95% confidence interval: 1.970-2.026) remained when adjusted for confounders. CONCLUSIONS: Patients with COPD-OSA overlap have higher utilization of supportive ventilation and longer length of stay during acute exacerbation of COPD hospitalizations, contributing to higher costs. The diagnosis of OSA is associated with reduced mortality in these hospitalizations, which may be related to greater utilization of supportive ventilation when OSA is recognized. CITATION: De la Fuente JRO, Greenberg P, Sunderram J. The overlap of chronic obstructive pulmonary disease and obstructive sleep apnea in hospitalizations for acute exacerbation of chronic obstructive pulmonary disease. J Clin Sleep Med. 2024;20(6):863-870.

Comparison of BODE and ADO Indices in Predicting COPD-Related Medical Costs.

Background and Objectives:The ADO (age, dyspnea, and airflow obstruction) and BODE (body mass index, airflow obstruction, dyspnea, and exercise capacity) indices are often used to evaluate the prognoses for chronic obstructive pulmonary disease(COPD); however, an index suitable for predicting medical costs has yet to be developed. Materials and Methods: We investigated the BODE and ADO indices to predict medical costs and compare their predictive power. A total of 396 patients with COPD were retrospectively enrolled. Results: For hospitalization frequencies, BODE was R2 = 0.093 (p < 0.001), and ADO was R2 = 0.065 (p < 0.001); for hospitalization days, BODE was R2 = 0.128 (p < 0.001), and ADO was R2 = 0.071 (p < 0.001); for hospitalization expenses, BODE was R2 = 0.020 (p = 0.047), and ADO was R2 = 0.012 (p = 0.179). BODE and ADO did not differ significantly in the numbers of outpatient visits (BODE, R2 = 0.012, p = 0.179; ADO, R2 = 0.017, p = 0.082); outpatient medical expenses (BODE, R2 = 0.012, p = 0.208; ADO, R2 = 0.008, p = 0.364); and total medical costs (BODE, R2 = 0.018, p = 0.072; ADO, R2 = 0.016, p = 0.098). In conclusion, BODE and ADO indices were correlated with hospitalization frequency and hospitalization days. However, the BODE index exhibits slightly better predictive accuracy than the ADO index in these items.

Associations of self-reported chronic obstructive pulmonary disease with indicators of economic instability and stress - 16 states, 2017.

OBJECTIVES: To examine the association between chronic obstructive pulmonary disease status and indicators of economic instability and stress to better understand the magnitude of these issues in persons with chronic obstructive pulmonary disease. METHODS: Analyzed 2017 Behavioral Risk Factor Surveillance System data from 16 states that administered the 'Social Determinants of Health' module, which included economic instability and stress measures (N = 101,461). Associations between self-reported doctor-diagnosed chronic obstructive pulmonary disease status and each measure were examined using multinomial logistic models. RESULTS: Adults with chronic obstructive pulmonary disease were more likely (p < 0.001) than adults without to report not having enough money at month end (21.0% vs. 7.9%) or just enough money (44.9% vs. 37.2%); being unable to pay mortgage, rent, or utility bills (19.2% vs. 8.8%); and that often or sometimes food did not last or could not afford to eat balanced meals (37.9% vs. 20.6%), as well as stress all or most of the time (27.3% vs. 11.6%). Associations were attenuated although remained significant after adjustments for sociodemographic and health characteristics. DISCUSSION: Financial, housing, and food insecurity and frequent stress were more prevalent in adults with chronic obstructive pulmonary disease than without. Findings highlight the importance of including strategies to address challenges related to economic instability and stress in chronic obstructive pulmonary disease management programs.

Clinical and economic burden of comorbid coronary artery disease in patients with acute exacerbation of chronic obstructive pulmonary disease: sex differences in a nationwide cohort study.

BACKGROUND: Coronary artery disease (CAD) is a common comorbidity of chronic obstructive pulmonary disease (COPD). However, data related to the impact of CAD on outcomes of acute exacerbation of COPD (AECOPD) are limited and whether the relationship depends on sex remains unknown. Our aim was to determine the impact of comorbid CAD on clinical outcomes among men and women with AECOPD. METHODS: We used data from the acute exacerbation of chronic obstructive pulmonary disease inpatient registry (ACURE) study, which is a nationwide observational real-world study conducted between September 2017 and February 2020 at 163 centers in patients admitted with AECOPD as their primary diagnosis. Patients were stratified according to the presence or absence of CAD in men and women. The primary outcomes were the length of hospital stay and economic burden during hospitalization. RESULTS: Among 3906 patients included in our study, the prevalence of CAD was 17.0%, and it was higher in women than in men (19.5% vs. 16.3%; P = 0.034). Age and other cardiovascular diseases were common factors associated with comorbid CAD in men and women, while body-mass index, cerebrovascular disease, and diabetes were determinants in men and pre-admission use of long-acting beta-adrenoceptor agonist and home oxygen therapy were protective factors in women. Only in men, patients with CAD had a longer length of hospital stay (median 10.0 vs. 9.0 days, P < 0.001), higher total cost during hospitalization (median $1502.2 vs. $1373.4, P < 0.001), and more severe COPD symptoms at day 30 compared to those without CAD. No significant difference was found in women. Comorbid CAD showed no relationship with 30-day readmission or death regardless of sex. In our real-world study, mortality/readmission risk within 30 days increased in patients with previous frequent hospitalizations and poorer pulmonary function. CONCLUSIONS: In hospitalized AECOPD patients, comorbid CAD was significantly associated with poorer short-term outcomes in men. Clinicians should have heightened attention for men with comorbid CAD to achieve an optimal management of AECOPD patients.

Humanistic and socioeconomic burden of COPD patients and their caregivers in Malaysia.

Chronic obstructive pulmonary disease (COPD) is associated with substantial humanistic and socioeconomic burden on patients and their caregivers. COPD is expected to be 7th leading cause of disease burden till 2030. The objective of the current study was to assess the humanistic and socioeconomic burden of COPD patients and their caregivers in Malaysia. The burden includes the cost of management of COPD, QOL of COPD patients and their caregivers, work productivity and activity impairment of COPD patients and their caregivers due to COPD. One hundred and fifty COPD patients and their caregivers from the chest clinic of Penang Hospital were included in the study from August 2018 to August 2019. Caregiving cost was estimated using the replacement cost approach, while humanistic and social burden was assessed with the help of health status questionnaires. Overall, 64.66% and 7.1% of COPD patients reported to depend on informal caregivers and professional caregivers respectively. COPD patients reported dyspnoea score as 2.31 (1.31), EQ-5D-5L utility index 0.57 (0.23), CCI 2.3 (1.4), SGRQ-C 49.23 (18.61), productivity loss 31.87% and activity impairment 17.42%. Caregivers reported dyspnoea score as 0.72 (0.14), EQ-5D-5L utility index 0.57 (0.23), productivity loss 7.19% and social activity limitation as 21.63% due to taking care of COPD patients. In addition to the huge direct cost of management, COPD is also associated with substantial burden on society in terms of compromised quality of life, reduced efficiency at the workplace, activity impairment and caregiver burden.

Health expenditures of asthma-COPD overlap in Northern Jordan.

OBJECTIVE: To investigate the characteristics and medical expenditures of patients with Asthma- chronic obstructive pulmonary disease (COPD) overlap (ACO) compared to asthma and COPD patients. METHODS: This was a retrospective cohort study involving patients diagnosed with ACO, asthma or COPD as of January 2016. Medical records for patients attending King Abdullah University Hospital (KAUH), in northern Jordan, during the years 2015-2016 were used to identify eligible patients and all relevant clinical characteristics. Both respiratory and all-cause charges were extracted from KAUH billing system during the year 2016. Total, inpatient, outpatient, and pharmacy charges were described and compared across the three disease categories. Charges were measured in Jordanian Dinar (JOD, equal to 1.41 US Dollar). RESULTS: Of a total of 761, 87 ACO patients, 494 asthmatic patients and 180 COPD patients were identified and included in this study. The average total respiratory-related charges were significantly higher in patients with ACO compared to patients with asthma (601.4 versus 354.3 JODs; P value < 0.001). Average all-cause charges were higher in case of ACO and COPD compared to patients with asthma (1830.8 and 1705.4 versus 1251.7 JODs; P value < 0.001). ACO was a significant predictor of higher respiratory and all-cause related charges. Respiratory charges were also higher in older patients and those with higher disease severity. CONCLUSIONS: ACO is a risk factor for incurring higher health expenditures in Jordan. Higher respiratory expenditures are also associated with older ages and higher disease severity.

Time-to-first exacerbation, adherence, and medical costs among US patients receiving umeclidinium/vilanterol or tiotropium as initial maintenance therapy for chronic obstructive pulmonary disease: a retrospective cohort study.

BACKGROUND: Adherence to chronic obstructive pulmonary disease (COPD) maintenance medication is important for managing symptoms and exacerbation risk, and is associated with reduced mortality, hospitalizations, and costs. This study compared on-treatment exacerbations, medical costs, and medication adherence in patients with COPD initiating treatment with umeclidinium/vilanterol (UMEC/VI) or tiotropium (TIO). METHODS: This retrospective matched cohort study selected patients from Optum's de-identified Clinformatics Data Mart database who initiated maintenance treatment with UMEC/VI or TIO between 01/01/2014 and 12/31/2017 (index date defined as the first dispensing). Eligible patients were ≥ 40 years of age and had ≥ 12 months continuous health plan coverage pre- and post-index; ≥ 1 medical claim for COPD pre-index or on the index date; no moderate/severe COPD-related exacerbations on the index date; no asthma diagnosis pre- or post-index; no maintenance medication fills containing inhaled corticosteroids, long-acting ß2-agonists, or long-acting muscarinic antagonists pre-index or on the index date; and no fills for both UMEC/VI and TIO on the index date. Outcomes included time-to-first (Kaplan-Meier analysis) and rates of on-treatment COPD-related moderate/severe exacerbations, medication adherence (proportion of days covered [PDC] and proportion of adherent patients [PDC ≥ 0.8]), and COPD-related medical costs per patient per month (PPPM). Propensity score matching was used to adjust for potential confounders. RESULTS: Each cohort included 3929 matched patients. Kaplan-Meier rates of on-treatment COPD-related exacerbations were similar between cohorts (hazard ratio at 12 months; overall: 0.93, moderate: 0.92, severe: 1.07; all p > 0.05). UMEC/VI versus TIO initiators had significantly higher adherence (mean PDC: 0.44 vs 0.37; p < 0.001; proportion with PDC ≥ 0.8: 22.0% vs 16.4%; p< 0.001) and significantly lower mean on-treatment COPD-related total medical costs ($867 vs $1095 PPPM; p = 0.028), driven by lower outpatient visit costs. CONCLUSIONS: These findings provide valuable information for physicians considering UMEC/VI or TIO as initial maintenance therapy options for patients with COPD.

Home-based versus outpatient pulmonary rehabilitation program for patients with chronic obstructive pulmonary disease: A protocol for systematic review and meta-analysis.

BACKGROUND: Although home-based pulmonary rehabilitation programs have been shown in some studies to be an alternative and effective model, there is a lack of consensus in the medical literature due to different study designs and lack of standardization among procedures. Therefore, the purpose of this study was to compare the efficacy of a home-based versus outpatient pulmonary rehabilitation program for patients with chronic obstructive pulmonary disease (COPD). METHODS: Five electronic databases including Embase, PubMed, Scopus, Science Direct, and Cochrane Library will be searched in May 2021 by 2 independent reviewers. The reference lists of the included studies will be also checked for additional studies that are not identified with the database search. There is no restriction on the dates of publication or language in the search. The randomized controlled trials focusing on comparing home-based and outpatient pulmonary rehabilitation for COPD patients will be included in our meta-analysis. The following outcomes should have been measured: functional exercise capacity, disease-specific health-related quality of life, and cost-effectiveness measures. Risk ratio with a 95% confidence interval or standardized mean difference with 95% CI is assessed for dichotomous outcomes or continuous outcomes, respectively. RESULTS: It was hypothesized that these 2 methods would provide similar therapeutic benefits. REGISTRATION NUMBER: 10.17605/OSF.IO/5CV48.

[Real-world analysis of obstructive respiratory tract disorders: characterization, health care and costs.] / Analisi real-world dei disturbi ostruttivi delle vie respiratorie: caratterizzazione, assistenza sanitaria e costi.

INTRODUCTION: This analysis has described the burden of patients with asthma, chronic obstructive pulmonary disease (COPD), asthma/COPD mixed conditions or undefined obstructive diseases (UODs), from the Italian National Health System point of view. METHODS: In the accrual period (2015), starting from the ReS database, a record linkage among demographic, pharmaceuticals, hospitalizations and outpatient specialist services databases has identified patients affected by only asthma, only COPD, asthma/COPD and UODs. From the less recent date of identification, each patient was analyzed in one previous year and in two years of follow-up (at most up to 12/31/2017). In the accrual period, in the previous one and in 2-year follow-up sinus polyps was researched. One-year free filled respiratory (ATC code R03) and concomitant prescriptions, outpatient specialist services, hospitalizations were described. Two-year costs were assessed annually. RESULTS: In 2015, 110,453 subjects with asthma (16.6 x1000 ≥12 years old), 229,747 with COPD, 8828 with asthma/COPD (55.5 x1000 and 2.1 x1000 ≥40 years, respectively) and 75,072 with UODs (27.2 x1000 subjects aged 40 to 65) were selected. Sinus polyps was found in 753 patients with asthma, 181 with COPD and 122 with asthma/COPD. A very high use of inhaled corticosteroids - ICS (R03AB) as monotherapy and as fixed association ICS/LABA and of cardiovascular drugs was highlighted among patients with COPD and asthma/COPD. The spirometry test was used in 21.4% patients with asthma/COPD, in 9.2% with asthma, in 8.6% with COPD and in 5.8% with UODs. Subjects with COPD and asthma/COPD were the most frequently hospitalized, mainly due to respiratory and cardiovascular causes, and those with the longest in-hospital stay. On average, the mean overall one-year expenditure per COPD or asthma/COPD patient was three times higher than per asthma or UOD one (€3508/€3613 vs €942/€1394, respectively). CONCLUSIONS: Concomitant drugs and hospitalizations due to other causes than respiratory ones accounted for the highest expenses. In general, comorbidities and cardiopulmonary complications played a key role in obstructive airway disease managing and controlling, by determining unsustainable socio-economic impacts.

Content validity of preference-based measures for economic evaluation in chronic obstructive pulmonary disease.

BACKGROUND: Generic preference-based measures (GPBMs) are health-related quality of life (HRQoL) measures commonly used to evaluate the cost-utility of interventions in healthcare. However, the degree to which the content of GPBMs reflect the HRQoL of individuals with chronic obstructive pulmonary disease (COPD) has not yet been assessed. The purpose of this study was to examine the content and convergent validity of GPBMs in people with COPD. METHODS: COPD patients were recruited from healthcare centers in Ontario, Canada. The Patient-Generated Index (PGI) (an individualized HRQoL measure) and the RAND-36 (to obtain SF-6D scores; a GPBM) were administered. Life areas nominated with the PGI were coded using the International Classification of Functioning Disability and Health and mapped onto GPBMs. RESULTS: We included 60 participants with a mean age of 70 and FEV1% predicted of 43. The mean PGI score was 34.55/100 and the top three overarching areas that emerged were: 'mobility' (25.93%), 'recreation and leisure' (25.19%) and 'domestic life' (19.26%). Mapping of the nominated areas revealed that the Quality of Well-Being scale covered the highest number of areas (84.62%), Health Utilities Indices covered the least (15.38% and 30.77%) and other GPBMs covered between 46 and 62%. A correlation of 0.32 was calculated between the SF-6D and the PGI. CONCLUSIONS: The majority of GPBMs covered approximately half of the areas reported as being important to individuals with COPD. When areas relevant to COPD are not captured, HRQoL scores generated by these measures may inaccurately reflect patients' values and affect cost-effectiveness decisions.

Effect of compliance with GOLD treatment recommendations on COPD health care resource utilization, cost, and exacerbations among patients with COPD on maintenance therapy.

BACKGROUND: The Global Initiative for Chronic Obstructive Lung Disease (GOLD) report for the management of chronic obstructive pulmonary disease (COPD) focuses on reducing existing symptoms, decreasing the risk of future exacerbations, and improving health status by recommending specific drug therapy based on exacerbation risk and symptoms. However, disparities exist between evidence-based recommendations and clinical practice. Research that quantifies the real-world effect of COPD regimen alignment with the GOLD recommendations on clinical and economic outcomes is needed. OBJECTIVE: To compare COPD-related health care resource utilization (HRU) and costs, as well as exacerbation rates, among patients with COPD on maintenance therapy based on 2017 GOLD treatment recommendation compliance status per GOLD ABCD risk group classification in a U.S. commercially insured/Medicare Advantage population. METHODS: This retrospective cohort study utilized administrative claims data in the HealthCore Integrated Research Database. The COPD population was identified using a previously validated claims-based predictive model. Among this population, patients with ≥ 1 claim for a COPD maintenance medication (earliest maintenance fill-date = index date) between January 1, 2014, and March 31, 2017, were identified. Patients were required to be aged ≥ 40 years, have ≥ 12 months of pre-index and ≥ 30 days of post-index health plan enrollment, with no diagnosis for asthma, cystic fibrosis, and/or lung cancer at any time from January 1, 2013, to March 31, 2018. Patients were categorized into exacerbation risk/symptomatology groups according to the 2017 GOLD ABCD assessment recommendations and were then classified into treatment-compliance status based on their maintenance therapy. Multivariable analyses were conducted to examine post-index COPD-related HRU, costs, and exacerbations by compliance status. RESULTS: The primary analytical study sample included 38,382 patients in the GOLD A/B group and 6,525 in the GOLD C/D group. Patients were further categorized into GOLD A (n = 19,345), B (n = 19,037), C (n = 1,865), and D (n = 4,670). GOLD-compliant regimens were observed in 32.9% of patients in the GOLD A/B group and in 58.9% of patients in the GOLD C/D group. Inhaled corticosteroid-containing regimens were the most commonly observed noncompliant regimen. Patients on compliant regimens had significantly fewer COPD-related inpatient and emergency department visits and therefore had significantly lower COPD-related medical costs in both the GOLD A/B and C/D cohorts. Similar results were observed for individual GOLD cohorts B, C, and D. These savings were offset by increased pharmacy expenditures. Being on GOLD guideline-compliant regimens significantly reduced the risk of exacerbation by 8% (hazard ratio [HR] = 0.92; P < 0.0001) in the GOLD A/B cohort and by 12% (HR = 0.88; P = 0.0005) in the GOLD C/D cohort, and was also associated with a significantly reduced exacerbation rate in the GOLD A/B (rate ratio [RR] = 0.93; P < 0.0001) and GOLD C/D (RR = 0.93; P = 0.0129) groups. CONCLUSIONS: This study suggests a continuing trend of high prevalence of suboptimal prescriber compliance to GOLD treatment recommendations. Treatment regimens compliant with GOLD recommendations were associated with improvement in exacerbations, reduced COPD-related HRU, and COPD-related medical cost offsets. DISCLOSURES: This study was funded by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI). BIPI was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations. Palli and Shaikh are employees of BIPI. Willey is an employee of HealthCore, which was contracted by BIPI to conduct this study. Zhou was an employee of HealthCore at the time of study execution. Data were presented in part during an AMCP webinar (recording not made public) held in lieu of the Spring 2020 AMCP conference, which was canceled due to the COVID-19 pandemic.

Comparison of COPD health care utilization and associated costs across patients treated with LAMA+LABA fixed-dose therapies.

BACKGROUND: There is limited clinical trial and/or real-world evidence comparing differences among currently approved fixed-dose combination (FDC) long-acting muscarinic antagonist (LAMA)/long-acting beta2-agonist (LABA) treatments. OBJECTIVE: To compare chronic obstructive pulmonary disease (COPD)-related and all-cause health care resource utilization (HCRU) and costs between COPD patients initiating tiotropium (TIO) + olodaterol (OLO) versus (a) other LAMA + LABA FDCs and (b) umeclidinium (UMEC) + vilanterol (VI), specifically. METHODS: In this retrospective observational study, patients initiating fixed-dose LAMA + LABA therapy (earliest fill date = index date) between January 1, 2014, and September 30, 2018, were identified using administrative claims data from the Optum Research Database. Patients were followed post-index for 1-12 months. Follow-up was censored at the earliest occurrence of index therapy discontinuation or switch, health plan disenrollment, study end date, or reaching the maximum 12-month allowed duration. Propensity score matching of 1:2 was used to balance differences in baseline characteristics between cohorts for each of the 2 comparisons. Annualized population averages of HCRU and costs were calculated for each cohort as [sum of visits (or costs) for all individuals during the follow-up period] ÷ [sum of follow-up on-treatment time for all individuals] × 365 days. RESULTS: After matching, compared with patients who initiated other LAMA + LABAs or UMEC + VI, patients who initiated TIO + OLO had 14.29% and 16.95% fewer mean annualized per-patient COPD-related emergency department (ED) visits (vs. other LAMA + LABAs: 0.49 vs. 0.59, P = 0.005; vs. UMEC + VI: 0.48 vs. 0.56, P = 0.026) and 3.07% and 3.14% fewer mean annualized per-patient pharmacy fills (vs. other LAMA + LABAs: 12.66 vs. 13.07, P = 0.016; vs. UMEC + VI: 12.62 vs. 13.02, P = 0.022), leading to 17.39% and 21.47% lower mean annualized per-patient COPD-related ED costs (vs. other LAMA + LABAs: $289 vs. $368, P = 0.003; vs. UMEC + VI: $285 vs. $345, P = 0.027) and 4.56% and 5.67% lower mean annualized per-patient pharmacy spending (vs. other LAMA + LABAs: $3,570 vs. $3,741, P < 0.001; vs. UMEC + VI: $3,556 vs. $3,770, P < 0.001) in the follow-up period. Similarly, patients in the TIO + OLO cohort had 15.63% and 21.17% fewer mean annualized per-patient all-cause ED visits (vs. other LAMA + LABAs: 1.08 vs. 1.37, P < 0.001; vs. UMEC + VI: 1.08 vs. 1.28, P = 0.001), 8.29% fewer mean annualized per-patient outpatient visits (vs. UMEC + VI: 13.28 vs. 14.48, P = 0.031), 3.41% fewer mean annualized per-patient pharmacy fills (vs. other LAMA + LABAs: 56.92 vs. 58.93, P = 0.028), 19.48% and 22.28% lower mean annualized per-patient all-cause ED costs (vs. other LAMA + LABAs: $755 vs. $971, P < 0.001; vs. UMEC + VI: $749 vs. $930, P < 0.001), and 10.86% lower mean annualized per-patient outpatient setting costs (vs. UMEC + VI: $3,348 vs. $3,756, P = 0.050). There were no statistically significant differences for the other outcome measures. CONCLUSIONS: In a real-world setting, differences in HCRU and costs were observed between FDC LAMA + LABAs, with patients initiating TIO + OLO having lower ED visits/costs, COPD-related pharmacy fills/costs, and all-cause pharmacy use and outpatient visits/costs than those initiating other FDC LAMA + LABAs or UMEC + VI specifically. The remaining HCRU and cost measures were not significantly different. DISCLOSURES: This study was sponsored by Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI; Ridgefield, CT). BIPI was given the opportunity to review the manuscript for medical and scientific accuracy, as well as intellectual property considerations. Palli is an employee of BIPI. Xie, Chastek, Elliott, and Bengtson are employees of Optum, which was contracted by BIPI to conduct this study. The authors received no direct compensation related to the development of the manuscript. Part of the results of this study were accepted and presented at the 30th European Respiratory Society (ERS) International Congress (September 7-9, 2020; virtual).