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.

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.

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.

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).

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.

The impact of fluticasone furoate/vilanterol on healthcare resource utilisation in the Salford Lung Study in chronic obstructive pulmonary disease.

AIM: The Salford Lung Study (SLS) in chronic obstructive pulmonary disease (COPD) was a randomised controlled trial evaluating the effectiveness and safety of initiating fluticasone furoate/vilanterol (FF/VI) 100/25 µg versus continuing usual care (UC) in patients with COPD and a history of exacerbations. Here, we investigate the impact of initiating FF/VI on healthcare resource utilisation (HRU) in SLS COPD. METHODS: HRU and interventions were determined from patients' electronic health records. Annual rates of on-treatment all-cause and COPD-related secondary care contacts (SCCs) and primary care contacts (PCCs) for FF/VI versus UC were analysed using a general linear model. Costs were derived from national data sources. RESULTS: Least-squares (LS) mean annual rates of all-cause (9.81 versus 9.36) and COPD-related (1.57 versus 1.48) SCCs were similar for FF/VI and UC, as were rates of all-cause hospitalisations (0.87 versus 0.82). Mean duration of hospital stay/patient was 4.5 and 4.2 days, respectively. COPD-related SCC mean total cost/patient was £484 FF/VI and £475 UC. LS mean annual rates of all-cause PCCs were significantly higher for FF/VI (21.20 versus 18.88 UC; p < 0.001). LS mean annual rates of COPD-related PCCs were similar for FF/VI and UC (2.42 versus 2.46). All-cause PCC mean total cost/patient was £900 FF/VI versus £811 UC, but COPD-related PCC costs were similar (£116 versus £114). Direct COPD-related total medical costs/patient were significantly lower for FF/VI (LS geometric mean £806 versus £963 UC; p < 0.001). DISCUSSION: In patients with COPD and exacerbation history, FF/VI may represent a less costly alternative to current therapies.GlaxoSmithKline plc. study HZC115151; ClinicalTrials.gov NCT01551758.The reviews of this paper are available via the supplemental material section.

Using the Medication Adherence Reasons Scale (MAR-Scale) in asthma and chronic obstructive pulmonary disease to determine the extent and identify the reasons for non-adherence.

INTRODUCTION: Adherence to medications for asthma and COPD can reduce exacerbation rates, decrease healthcare costs, and improve health-related quality of life. In spite of the advantages to treatment adherence, individuals with asthma and COPD often fail to take medicines as prescribed. The objectives of this study were to determine the extent of non-adherence with asthma and COPD medicines and to describe the reasons for non-adherence in these conditions. MATERIALS AND METHODS: Data from the National Health and Wellness Study (NHWS), a self-administered, annual, internet-based cross-sectional survey of US adults from 2018 was used. NHWS participants who self-reported taking daily prescription medication(s) to treat asthma and COPD responded to the 19 reasons for non-adherence and one global item in the Medication Adherence Reasons Scale (MAR-Scale). Frequencies were used to identify the reasons for non-adherence. RESULTS: The non-adherence rate in asthma (N = 2810) was 38.4% and 28.4% in COPD (N = 1632). For both conditions, "simply missing the medicine" was the most common cause of non-adherence. Additionally, for both conditions, there was a difference between the non-adherence reason reported by more individuals and the reason for which the medicine was missed for the most number of days. CONCLUSION: The MAR-Scale identified the most frequent reasons for non-adherence with asthma and COPD in a nationwide sample in the US. The MAR-Scale can be used as a tool in a clinic setting or at a population level to measure the extent and the reasons for non-adherence.

National Trends and Disparities in Health Care Access and Coverage Among Adults With Asthma and COPD: 1997-2018.

BACKGROUND: Racial and ethnic as well as economic disparities in access to care among persons with asthma and COPD have been described, but long-term access trends are unclear. RESEARCH QUESTION: Have health coverage and access to care and medications among adults with airways disease improved, and have disparities narrowed? STUDY DESIGN AND METHODS: Using the 1997 through 2018 National Health Interview Survey, we examined time trends in health coverage and the affordability of medical care and prescription drugs for adults with asthma and COPD, overall and by income and by race and ethnicity. We performed multivariate linear probability regressions comparing coverage and access in 2018 with that in 1997. RESULTS: Our sample included 76,843 adults with asthma and 30,548 adults with COPD. Among adults with asthma, lack of insurance rose in the first decade of the twenty-first century, peaking with the Great Recession, but fell after implementation of the Affordable Care Act (ACA). From 1997 through 2018, the uninsured rate among adults with asthma decreased from 19.4% to 9.6% (adjusted 9.27 percentage points; 95% CI, 7.1%-11.5%). However, the proportions delaying or foregoing medical care because of cost or going without medications did not improve. Racial and ethnic as well as economic disparities present in 1997 persisted over the study period. Trends and disparities among those with COPD were similar, although the proportion going without needed medications worsened, rising by an adjusted 7.8 percentage points. INTERPRETATION: Coverage losses among persons with airways disease in the first decade of the twenty-first century were reversed by the ACA, but neither care affordability nor disparities improved. Further reform is needed to close these gaps.

La EPOC en España al inicio de una nueva década / COPD in Spain at the Start of a New Decade

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Can a telemonitoring system lead to decreased hospitalization in elderly patients?

INTRODUCTION: Growing populations of elderly patients with chronic obstructive pulmonary disease (COPD) or heart failure (HF) require more healthcare. A four-year telehealth intervention - the Health Diary system based on digital pen technology - was implemented. We hypothesized that study patients with advanced COPD or HF would have lower rates of hospitalization when using the Health Diary. The aim was to investigate the effects of the intervention on healthcare costs and the number of hospitalizations, as well as other care required in COPD and HF patients. METHODS: Patients were introduced to the telemonitoring system which was supervised by a specialized hospital-based home care (HBHC) unit. Staff associated with this unit were responsible for the healthcare provided. The study included patients with COPD or HF, aged ≥ 65 years who were frequently hospitalized due to exacerbations - at least two inpatient episodes within the last 12 months. Observed number of hospitalizations and total healthcare costs were compared with the expected values, which were calculated using the generalized estimating equations (GEE) method. RESULTS: A total of 36 COPD and 58 HF patients with advanced stages of disease were included. The number of hospitalizations was significantly reduced for both HF and COPD patients participating in telemonitoring. Accordingly, hospitalization costs were significantly reduced for both groups, but the total healthcare cost was not significantly different from the expected costs. CONCLUSION: A telemonitoring system, the Health Diary, combined with a specialized HBHC unit significantly decreases the need for hospital care in elderly patients with advanced HF or COPD without increasing total healthcare costs.

Nationwide survey of the availability and affordability of asthma and COPD medicines in Nigeria.

OBJECTIVE(S): To determine the availability and affordability of asthma and COPD medicines across Nigeria. METHODS: This was a cross-sectional survey conducted in 128 pharmacies (51 in public sector hospitals, 51 private sector community pharmacies and 26 charity or big private hospitals) across the six geopolitical zones of Nigeria using the WHO/Health Action Initiative method. The proportion of pharmacies where medicines were available, the median retail prices of originator and generics and affordability were analysed. A medicine was available if found in ≥ 80% of surveyed pharmacies. Unaffordability was defined as paying> 1 day's wage (> US$1.68) for a standard 30-day supply of the medicine. RESULTS: The available medicines were oral corticosteroids and oral salbutamol which are not on the WHO Essential Medicine List. Medicines were found more frequently in private than public pharmacies and in the southern than northern zones. Inhalable corticosteroid was not available at any public pharmacy nationwide. None of the EML medicines were affordable. The least number of days' wages for a 30-day supply of any inhalable corticosteroid-containing medication was 3.5 days. CONCLUSIONS: There are very limited availability and affordability of recommended asthma and COPD medicines across Nigeria with disparity across regions. Medicines that were available and affordable are not recommended and are harmful for long-term use. This underpins the need for engagement of all stakeholders for the review of existing policies regarding access to asthma and COPD medicines to improve availability and affordability.