Introduction:Chronic obstructive pulmonary disease (COPD) poses a substantial burden on individuals and the U.S. health care system. Up-to-date information describing individuals with COPD and their acute hospital-based health care utilization at the state level and by insurance type is lacking. Methods:Individuals with COPD aged 40 and older were identified from large databases of Medicare fee-for-service, Medicaid, and commercial health insurance claims, and counts were extrapolated to the U.S. health insurance market. Demographics and outcome metrics were quantified between January 1 and December 31, 2021, and summarized by state and insurance type. Results:Approximately 11.7 million insured individuals had COPD in 2021. The largest share were covered by Medicare (79.4%), followed by commercial insurance (11.3%) and Medicaid (9.3%). COPD prevalence varied among states, ranging from 44 (Utah) to 143 (West Virginia) per 1000 insured individuals. Nationwide, annual all-cause mortality for individuals with COPD covered by Medicare (11.5%) was more than double that of Medicaid (5.1%). There were 1.8 million COPD-related acute inpatient hospitalizations nationwide, with the largest share among individuals covered by Medicare (86.4%), followed by Medicaid (9.0%) and commercial insurance (4.6%). COPD-related hospitalization rates also varied among states, ranging from 97 (Idaho) to 200 (District of Columbia) per 1000 individuals with COPD. There were 1.4 million COPD-related emergency department/observation encounters not resulting in acute inpatient admissions nationwide. Conclusion:There is substantial state and payer variation in COPD prevalence and burden. Understanding this variation provides valuable insights into populations with unmet needs that can inform public health strategies to address gaps.

Background: Patient perception of medication onset of effect is important for adherence. Although the Onset of Effect Questionnaire (OEQ) has been validated in patients with asthma, it has not been evaluated in patients with chronic obstructive pulmonary disease (COPD). This study evaluated the COPD-OEQ- OEQ in patients with COPD. Methods: Two analyses (qualitative and quantitative) were conducted to assess the content validity and psychometric properties of the COPD-OEQ- OEQ in participants with COPD. In the qualitative analysis, interviews assessed content validity by concept elicitation (CE) and cognitive interviewing (CI). CE included questions to understand the patient experience related to onset of medication effect. CI included completion of the COPD-OEQ- OEQ and assessment of the COPD-OEQ- OEQ items, response options, and instructions. During the 2- week quantitative analysis, 2 versions of the COPD-OEQ- OEQ (Weekly and Daily) were administered to assess test- retest reliability, construct validity, and known- groups validity. Results: The qualitative analysis demonstrated that 3 of the 5 COPD-OEQ- OEQ items were relevant and understood as intended. Qualitative findings demonstrated inconsistent evidence that the COPD-OEQ- OEQ Weekly and Daily were reliable and valid measures in participants with COPD. Test- retest reliability was observed for the COPD-OEQ- OEQ Weekly and Daily; however, construct validity was weak and demonstrated inconsistent correlations among COPD-OEQ- OEQ items. Overall, known- groups validity was not demonstrated. Conclusion: The weak evidence from the quantitative analysis of the COPD-OEQ- OEQ Weekly and Daily tools does not support use of the OEQ in general COPD. Although the OEQ produced inconsistent results, the content validity surrounding the perception of medication onset remained valid in patients with COPD.

BACKGROUND: Despite the signi fi cant burden posed by COPD to health care systems, there is a lack of up-to-date information quantifying the general COPD burden, costs, and long-term projections to various stakeholders in the United States. RESEARCH QUESTION: What are the updated state -speci fi c and nationwide estimates of the COPD disease burden and direct costs in 2019, along with projections of COPD-attributable medical costs through 2029? STUDY DESIGN AND METHODS: A cross-sectional, retrospective study design using the 2016 to 2019 Medical Expenditure Panel Survey, 2019 American Community Survey, and 2019 Behavioral Risk Factor Surveillance System data was applied to generate COPD-attributable expenditure estimates. Cost projections for the years 2020 to 2029 were based on 2017 national population projections reported by the US Census Bureau, and all costs were adjusted to 2019 US dollars. RESULTS: In total, 4,135 people living with COPD were included; a higher proportion had other concurrent conditions such as cardiovascular -related conditions compared with people without COPD (n 1 / 4 86,021). Overall, in 2019, COPD-attributable medical costs after adjusting for demographic characteristics and 19 concurrent conditions (including COPD-related and non-COPD-related conditions) were estimated at $31.3 billion, with state -speci fi c cost estimates reporting wide variation, from $44.8 million in Alaska to $3.1 billion in Florida. Nationwide COPD-attributable medical costs borne by payer type were as follows: private insurance, $11.4 billion; Medicare, $10.8 billion; and Medicaid, $3.0 billion. Projections of national medical costs attributable to COPD are reported to increase to $60.5 billion in 2029. INTERPRETATION: Understanding the current disease and economic burden of COPD in the United States, along with the projected costs attributable to COPD in the next decade, will highlight unmet needs and gaps in care that help inform health care decision -makers in planning future actions to alleviate this disease burden. CHEST 2024; 165(5):1093-1106

Purpose: This study estimated the magnitude and duration of risk of cardiovascular events and mortality following acute exacerbations of chronic obstructive pulmonary disease (AECOPD), and whether risks varied by number and severity of exacerbation in a commercially insured population in the United States. Methods: This was a retrospective cohort study of newly diagnosed COPD patients >= 40 years old in the Healthcare Integrated Research Database from 2012 to 2019. Patients experiencing exacerbations comprised the "exacerbation cohort". Moderate exacerbations were outpatient visits with contemporaneous antibiotic or glucocorticoid administration; severe exacerbations were emergency department visits or hospitalizations for AECOPD. Follow-up started on the exacerbation date. Distribution of time between diagnosis and first exacerbation was used to assign index dates to the "unexposed" cohort. Cox proportional hazards models estimated risks of a cardiovascular event or death following an exacerbation adjusted for medical and prescription history and stratified by follow-up time, type of cardiovascular event, exacerbation severity, and rank of exacerbation (first, second, or third). Results: Among 435,925 patients, 170,236 experienced >1 exacerbation. Risk of death was increased for 2 years following an exacerbation and was highest during the first 30 days (any exacerbation hazard ratio (HR)=1.79, 95% CI=1.58-2.04; moderate HR=1.22, 95% CI=1.04-1.43; severe HR=5.09, 95% CI=4.30-6.03). Risks of cardiovascular events were increased for 1 year following an AECOPD and highest in the first 30-days (any exacerbation HR=1.34, 95% CI=1.23-1.46; moderate HR=1.23 (95% CI 1.12-1.35); severe HR=1.93 (95% CI=1.67-2.22)). Each subsequent AECOPD was associated with incrementally higher rates of both death and cardiovascular events. Conclusion: Risk of death and cardiovascular events was greatest in the first 30 days and rose with subsequent exacerbations. Risks were elevated for 1-2 years following moderate and severe exacerbations, highlighting a sustained increased cardiopulmonary risk associated with exacerbations.

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.

Background: The US population includes 24 million to 29 million people with diagnosed and undiagnosed chronic obstructive pulmonary disease (COPD). Studies have demonstrated the safety and efficacy of single-inhaler triple therapy (SITT) in reducing COPD exacerbations. Long-term population implications of SITT use have not been quantified. Objectives: This simulation-based projection aimed to estimate the potential impact of widespread SITT use on the US COPD population. Methods: Exacerbation and all-cause mortality reductions reported in the Efficacy and Safety of Triple Therapy in Obstructive Lung Disease trial (ETHOS; NCT02465567) were used to project clinical outcomes in US patients meeting ETHOS trial eligibility criteria (ETHOS-Eligible) and patients meeting a practical definition of SITT eligibility (Expanded ETHOS-Eligible). The US COPD population was modeled with 1000 simulations of patient progression over 10 years. Agent characteristics were based on literature and claims analysis of the 2016-2018 Medicare 100% fee-for-service and IBM MarketScan® databases. Agent annual characteristics reflected incident cases, changes in COPD severity, treatment, mortality, and exacerbations under status quo treatment patterns and scenarios for the adoption of SITT. The scenarios assumed the reduced exacerbation and mortality rates associated with SITT according to ETHOS trial outcomes mean values. Results: Higher than current SITT adoption over 10 years would be expected to substantially reduce COPD exacerbation-associated hospitalizations by 2 million. Applying mean improvements reported in ETHOS for SITT would extend average patient life expectancy 2.2 years for ETHOS-Eligible patients and 1.7 years for Expanded ETHOS-Eligible patients. The number needed to treat to extend the average patient life by 1 year was 8 for the ETHOS-Eligible population and 10 for the Expanded ETHOS-Eligible population. Discussion: Widespread SITT adoption may be impeded by competitive pressures from generic treatments and nonadherence, and efficacy observed in clinical trials may not occur in real-world populations. Conclusions: Assuming ETHOS treatment effects and adherence translate to clinical practice, higher than current use of SITT can substantially reduce COPD exacerbations and hospitalizations and extend survival. These results should be viewed cautiously, because the improved outcomes for SITT in the ETHOS final retrieved vital statistics data were not statistically significant for all comparator therapy groups.

Background In this study, we compare management of patients with high-risk chronic obstructive pulmonary disease (COPD) in the United States to national and international guidelines and quality standards, including the COllaboratioN on QUality improvement initiative for achieving Excellence in STandards of COPD care (CONQUEST). Methods Patients were identified from the DARTNet Practice Performance Registry and categorized into three high-risk cohorts in each year from 2011 to 2019: newly diagnosed (& LE;12 months after diagnosis), already diagnosed, and patients with potential undiagnosed COPD. Patients were considered high-risk if they had a history of exacerbations or likely exacerbations (respiratory consult with prescribed medication). Descriptive statistics for 2019 are reported, along with annual trends.Findings In 2019, 10% (n = 16,610/167,197) of patients met high-risk criteria. Evidence of spirometry for diagnosis was low; in 2019, 81% (n = 1228/1523) of patients newly diagnosed at high-risk had no record of spirometry/peak expiratory flow in the 12 months pre-or post-diagnosis and 43% (n = 651/1523) had no record of COPD symptom review. Among those newly and already diagnosed at high-risk, 52% (n = 4830/9350) had no evidence of COPD medication.Interpretation Findings suggest inconsistent adherence to evidence-based guidelines, and opportunities to improve identification, documentation of services, assessment, therapeutic intervention, and follow-up of patients with COPD.

Introduction: A twice-daily single inhaler triple therapy consisting of budesonide/glycopyrrolate/formoterol fumarate (BGF) was approved by the US Food and Drug Administration (FDA) in July 2020 as a maintenance treatment for patients with chronic obstructive pulmonary disease (COPD). The objective of this AURA study is to describe patient characteristics, exacerbation and treatment history, and healthcare resource utilization (HCRU) before BGF initiation to better inform treatment decisions for prescribers. Methods: This retrospective cohort study leveraged data of all payer types from IQVIA’s Longitudinal Prescription Data (LRx) linked to Medical Data (Dx). Patients with COPD who had ⩾1 LRx claim for BGF between 1 October 2020 and 30 September 2021 were included. The date of first BGF claim was the index date. Patient demographic and clinical characteristics, history of COPD exacerbation or related event, treatment history, and HCRU were assessed during the 12 months before index (baseline). Results: We identified 30,339 patients with COPD initiating BGF (mean age: 68.2 years; 57.1% female; 67.6% Medicare). Unspecified COPD (J44.9; 74.0%) was the most commonly coded COPD phenotype. The most prevalent respiratory conditions/symptoms were dyspnea (50.8%), lower respiratory tract infection (25.3%), and sleep apnea (19.0%). Uncomplicated hypertension (58.8%), dyslipidemia (43.9%), cardiovascular disease (41.4%), and heart failure (19.9%) were the most prevalent nonrespiratory conditions. During the 12-month baseline, 57.9% of patients had evidence of a COPD exacerbation or related event, and 14.9% had ⩾1 COPD-related emergency department (ED) visit; 21.0% of patients had evidence of prior triple therapy use, while 54.3% had ⩾1 oral corticosteroid (OCS) fill. Among OCS users, 29.9% had cumulative exposures >1000 mg [median [Q1–Q3] exposure: 520 (260–1183) mg]. Conclusion: This real-world data analysis indicates that BGF is being initiated in patients with COPD experiencing symptoms and exacerbations despite current therapy, and among patients who have various chronic comorbidities, most often cardiopulmonary-related.

Purpose:Triple therapy to prevent exacerbations from chronic obstructive pulmonary disease (COPD) is associated with improved health compared to single and dual-agent therapy in some populations. This study assessed the benefits of prompt administration of budesonide/glycopyrrolate/formoterol fumarate (BGF) following a COPD exacerbation. Patients and methods:EROS was a retrospective analysis of people with COPD using the MORE2 Registry®. Inclusion required ≥1 severe, ≥2 moderate, or ≥1 moderate exacerbation while on other maintenance treatment. Within 12 months following the index exacerbation, ≥1 pharmacy claim for BGF was required. Primary outcomes were the rate of COPD exacerbations and healthcare costs for those that received BGF promptly (within 30 days of index exacerbation) versus delayed (31-180 days) and very delayed (181-365 days). The effect of each 30-day delay in initiation of BGF was estimated using a multivariable negative binomial regression model. Results:2409 patients were identified: 434 prompt, 1187 delayed, and 788 very delayed. The rate (95% CI) of total exacerbations post-index increased as time to BGF initiation increased: prompt 1.52 (1.39-1.66); delayed 2.00 (1.92-2.09); and very delayed 2.30 (2.20-2.40). Adjusting for patient characteristics, each 30-day delay in receiving BGF was associated with a 5% increase in the average number of subsequent exacerbations (rate ratio, 95% CI: 1.05, 1.01-1.08; p<0.05). Prompt initiation of BGF was also associated with lower post-index annualized COPD-related costs ($5002 for prompt vs $7639 and $8724 for the delayed and very delayed groups, respectively). Conclusion:Following a COPD exacerbation, promptly initiating BGF was associated with a reduction in subsequent exacerbations and reduced healthcare utilization and costs.

PURPOSE: Acute exacerbation of chronic obstructive pulmonary disease (AECOPD) has been associated with an increased risk of acute cardiovascular (CV) events and healthcare resource use (HCRU); however, data are limited.This study evaluated healthcare costs and HCRU following an AECOPD and assessed the contribution of CV-related care. METHODS:Patients $40 years old with an incident COPD diagnosis between January 1, 2012-December 31, 2019, were identified using the HealthCare Integrated Research Database, a large US healthcare claims database.AECOPD was defined as an outpatient COPD diagnosis with a prescription for antibiotics or glucocorticoids (moderate), inpatient or emergency department (ED) diagnosis of COPD (severe), or an inpatient or ED diagnosis of lower respiratory infection with secondary diagnosis of COPD (severe).The index date was the date of first AECOPD; follow-up ended at disenrollment, subsequent AECOPD, death, or end of study period.Costs (plan and patient-paid) and HCRU (inpatient hospitalization, outpatient and ED visits, and prescriptions) were measured 1 month and 2-12 months post-index.Data were analyzed overall and by subgroup (patients with or without an acute CV event #12 months post-index).RESULTS: 145,838 patients (41% of cohort) experienced at least one AECOPD; 85.3% moderate and 14.6% severe.Mean (median) costs at 1-month post-AECOPD were 5.6x higher for those with a severe AECOPD ($36,273 [$11,210]) vs. moderate ($6,474 [$824]) and were primarily driven by inpatient hospitalization (5.2% of patients with moderate and 52.3% of patients with severe AECOPD had $1 hospitalization).Overall, 12-month mean (median) costs were 1.8x more for patients with versus those without a CV event ($16,340 [$5,474] vs. $9,195 [$898]).CONCLUSIONS: HCRU was higher among patients experiencing severe AECOPD and subsequent CV events.These results highlight the burden of AECOPD events and the subsequent increased cost and HCRU associated with this cardiopulmonary risk. CLINICAL IMPLICATIONS:The high HCRU and costs associated with AECOPD should inform COPD management approaches for both payers and providers and highlight the importance of indexing cardiovascular risk in all subjects with COPD prone to acute exacerbations.

PURPOSE: Exacerbations of chronic obstructive pulmonary disease (COPD) cause significant morbidity and mortality.Global Initiative for Obstructive Lung Disease (GOLD) guidelines recommend considering initial treatment with, or escalation to, triple therapy in patients who have experienced exacerbations and have elevated blood eosinophil levels.This study examined whether prompt initiation of budesonide/glycopyrrolate/formoterol fumarate (BGF) triple therapy after an exacerbation is associated with lowered costs and healthcare resource utilization (HCRU) compared to patients for whom therapy is delayed. METHODS:The EROS study was a retrospective analysis of patients with COPD in the MORE 2 RegistryÒ claims database.Patients were required to present with either: $1 severe exacerbation, $2 moderate exacerbations, or $1 moderate exacerbation while on non-triple maintenance treatment (earliest qualifying exacerbation ¼ index date).In the 12-month period following the index exacerbation, all patients were required to have $1 pharmacy claim for BGF.Patients were required to be $40 years old on the index date, continuously enrolled for 12 months before and $3 months after index, and did not present use of single inhaler triple therapy (SITT) in the 12-month pre-index period.Unadjusted mean (median) annualized healthcare costs (all-cause, COPD related) and HCRU (inpatient [INP], emergency department [ED] and office visits [OV]) were presented and stratified by the timing of post-index BGF initiation: prompt (#30 days), delayed (31-180 days), and very delayed (181-365 days), and analyzed using the Kruskal-Wallis test.RESULTS: 2,409 patients qualified for the study: 434 prompt, 1,187 delayed, and 788 very delayed initiation of BGF.Annualized all-cause mean (median) healthcare costs were $25,289 ($15,446), $31,404 ($17,277) and $28,901 ($18,653) for prompt, delayed and very delayed BGF initiation, respectively (P <0.05 overall).Similar associations were observed for COPD-related HCRU, with healthcare costs of $5,002 ($2,235), $7,639 ($3,786) and $8,724 ($5,076) for prompt, delayed and very-delayed patients, respectively (P <0.01).Additionally, the mean annualized hospitalization rate was 0.53 per patient for the prompt group, approximately 36% lower than the delayed (0.83) and very delayed (0.83) groups (P <0.01 for both).CONCLUSIONS: Among patients with COPD, promptly initiating BGF following a moderate or severe exacerbation was associated with a 19.4% and 12.4% reduction in annualized all-cause healthcare costs and a 34.5% and 42.6% reduction in annualized COPD related costs compared to "delayed" and "very delayed" BGF initiation, respectively.CLINICAL IMPLICATIONS: Proactive COPD management, including use of triple therapies, may be both clinically and economically effective for patients, providers, and plans.

PURPOSE: Several treatments, including triple therapies (inhaled corticosteroid/long-acting muscarinic antagonist/long-acting b 2 -agonist [ICS/LAMA/LABA]), are approved as maintenance therapy for chronic obstructive pulmonary disease (COPD).However, there is limited knowledge regarding the proportion of patients not receiving appropriate treatment posthospitalization.To address this unmet need, we examined maintenance therapy use during the 12 months pre/post-discharge in patients not on triple therapy hospitalized for COPD in the US and assessed patient demographic and clinical characteristics, and post-discharge outcomes.METHODS: A linked dataset was created from the US-based Premier PINC AIÔ Healthcare Database and IQVIA longitudinal prescription and medical claims databases.The study period was January 1, 2018-December 31, 2021 (index date: first COPD hospitalization discharge date).Eligible patients had $1 COPD hospitalization (primary or secondary discharge diagnosis), were $40 years old at the index date, discharged to home or home care, and had data for $12 months before and after the index date.Key exclusion criteria included triple therapy use in the 3 months before the index date and biologic use or lung surgery in the 12 months before the index date.

PURPOSE: Blood eosinophil count (BEC) is a useful marker of exacerbation risk and inhaled corticosteroid (ICS) response in patients with chronic obstructive pulmonary disease (COPD).The Global Initiative for Chronic Obstructive Lung Disease (GOLD) 2023 report recommends switching to triple therapy (ICS/long-acting muscarinic antagonist [LAMA]/long-acting b 2agonist [LABA]) in patients with recurrent exacerbations despite LAMA/LABA use when BEC $100 cells/mL or ICS/LABA use.Though clinically useful, BEC may fluctuate in response to medication use or comorbidities, and may not be routinely collected.As such, the best way to characterize BEC continues to be debated.We evaluated BEC levels and data availability in patients hospitalized for a COPD exacerbation.

SESSION TITLE: COPD Medications and Treatment Outcomes SESSION TYPE: Rapid Fire Original Inv PRESENTED ON: 10/19/2022 11:15 am - 12:15 pm PURPOSE: Moderate COPD exacerbations are associated with risks of future exacerbations and higher healthcare costs, however many patients may not receive timely escalation of therapy following these events. This analysis of the PRIMUS study assessed whether prompt initiation of triple therapy (TT) following a second moderate exacerbation within 12 months was associated with a lower risk of subsequent COPD exacerbations. METHODS: Using the IBM MarketScan databases between 1/1/2010 and 12/31/2019, adult patients aged ≥ 40 years with a diagnosis of COPD were identified. For study inclusion, all patients must have had open or closed TT (earliest prescription fill=index treatment date), ≥ 2 moderate (i.e., outpatient COPD visit (office or ED) followed by treatment with steroids or antibiotics within 7 days) COPD exacerbation events within 12 months before index treatment, 12 months of continuous enrollment preceding/following the index exacerbation (2nd moderate event), and an absence of select respiratory diseases and cancer during the study period. Patients were stratified based on the timing of their TT prescription following the index exacerbation: prompt (within 30 days), delayed (31-180 days), and very delayed (181+ days). The number and severity of exacerbations during the 12 months following the initial index exacerbation with prompt, delayed, or very delayed TT were assessed using chi-square tests and ANOVA. RESULTS: 17,998 TT patients (4,609 prompt [25.6%]; 7,678 delayed [42.7%]; 5,711 very delayed [31.7%]) met inclusion. The mean (±SD) age of the sample was 61.3.0±10.9 years, of which 61.5% were female and 98% had baseline mono- or dual-therapy. The proportion of patients with ≥1 exacerbation was 66.6%, 81.3%, and 88.5% respectively in the prompt, delayed, and very delayed TT (p< 0.001). The mean number of moderate or severe exacerbations was 1.5 ± 1.7 vs. 2.1 ± 1.8 vs. 2.9 ± 2.2 for prompt, delayed, and very delayed TT, respectively (p< 0.001). Similarly, the proportion of patients with a severe exacerbation also increased respectively across study groups: 8.4%, 12.6%, and 17.2% (p< 0.001). CONCLUSIONS: Patients with ≥2 moderate exacerbations in the prior 12-months are indicative of being high-risk. Delaying initiation of TT following 2nd moderate event was associated with increased occurrence of future exacerbations, including severe exacerbations; prompt initiation of TT presented a lower percent of patients exacerbating, the lowest mean number of total exacerbations and fewer severe exacerbations. CLINICAL IMPLICATIONS: Delays in starting triple therapy may introduce avoidable risks of future exacerbations including hospitalizations. These results support a more proactive approach to the management of COPD following moderate exacerbation events, particularly initiation of triple therapy. DISCLOSURES: Consultant relationship with Multiple pharmaceutical and biotech companies Please note: 6.5 years Added 04/01/2022 by Kristin Evans, value=Grant/Research Support Employee relationship with IBM Watson Health Please note: 6.5 years Added 04/01/2022 by Kristin Evans, value=Salary Employee relationship with AstraZeneca Pharmaceuticals LP Please note: >$100000 by Norbert Feigler, value=Salary Employee relationship with AstraZeneca Please note: March 2019 by Sushma Patel, value=Salary Employee relationship with AstraZeneca Please note: >$100000 by Michael Pollack, value=Salary Advisory Committee Member relationship with AstraZeneca Please note: 9/1/2020-6/1/2021 by Edward Portillo, value=Consulting fee Employee relationship with AstraZeneca Please note: 4/2/2018 to present by Anthony Staresinic, value=Salary Consultant relationship with Uptake Medical Please note: 2019-2020 by Charlie Strange, value=Consulting fee Consultant relationship with AstraZeneca Please note: 2019-Present by Charlie Strange, value=Consulting fee Consultant relationship with Glaxo Smith Kline Please note: 2019- Present by Charlie Strange, value=Consulting fee Grant relationship with Novartis Please note: 2019-2020 by Charlie Strange, value=Grant/Research Support Removed 06/06/2022 by Charlie Strange Consultant relationship with CSA Medical Please note: 2019-Present by Charlie Strange, value=Grant/Research Support Research Grant to institution relationship with NuVaira Please note: 2020-Present by Charlie Strange, value=Grant/Research Research monies paid to University relationship with Grifols Please note: Current Added 06/06/2022 by Charlie Strange, value=Grant/Research Support Employee relationship with AlphaNet Please note: Current Added 06/06/2022 by Charlie Strange, value=Salary Scientific Medical Advisor relationship with Vertex Please note: Current Added 06/06/2022 by Charlie Strange, value=Grant/Research Support Grant to University relationship with Adverum Please note: Current Added 06/06/2022 by Charlie Strange, value=Grant/Research Support Consultant relationship with Takeda Please note: Current Added 06/06/2022 by Charlie Strange, value=Consulting fee Consultant relationship with Inhibrx Please note: Current Added 06/06/2022 by Charlie Strange, value=Travel Consultant relationship with Morair Please note: Current Added 06/06/2022 by Charlie Strange, value=Consulting fee Consultant relationship with Pulmanage Please note: Current Added 06/06/2022 by Charlie Strange, value=Consulting fee Grant to University relationship with Arrowhead Please note: Current Added 06/06/2022 by Charlie Strange, value=Grant/Research Support Consultant relationship with AstraZeneca Please note: 1/1/2020 to current Added 04/16/2022 by Joseph Tkacz, value=Consulting fee Consultant relationship with Astra Zeneca Please note: Oct 2020- present by Daniel Touchette, value=Consulting fee Consultant relationship with Monument Analytics Please note: Jul 2019-present by Daniel Touchette, value=Consulting fee

1Life Sciences, IBM Watson Health, Cambridge, MA, USA; 2Center for Pharmacoepidemiology and Pharmacoeconomic Research, University of Illinois College of Pharmacy, Chicago, IL, USA; 3Pharmacy Practice Division, University of Wisconsin-Madison School of Pharmacy, Madison, WI, USA; 4Division of Pulmonary, Critical Care, Allergy and Sleep Medicine, Medical University of South Carolina, Charleston, SC, USA; 5BioPharmaceuticals, US Medical Affairs, AstraZeneca, Wilmington, DE, USA

Purpose:We analyzed population-level administrative claims data for Medicare fee-for-service (FFS) beneficiaries to provide insights on systemic oral corticosteroid (OCS) use patterns and associated health conditions and acute events among patients newly diagnosed with chronic obstructive pulmonary disease (COPD).Background:COPD is a progressive inflammatory disease of the lungs, characterized by acute exacerbations that may lead to increased mortality. Short courses of systemic corticosteroids (SCS) are recommended to reduce recovery time from exacerbations, although SCS use has been associated with increased risk of adverse events.Methods:This study used 2013-2019 Medicare 100% FFS research identifiable files, which contain all Medicare Parts A, B, and D paid claims incurred by 100% of Medicare FFS beneficiaries. Descriptive statistics for patients newly diagnosed with COPD were analyzed, including OCS use, select health conditions and acute events, and COPD exacerbations. Statistical models were used to analyze the relationship between the incidence of select health conditions and events and cumulative OCS dosage.Results:Of Medicare FFS patients newly diagnosed with COPD, 36% received OCS in the 48 months following diagnosis, and 38% of OCS episodes lasted longer than the recommended 5-7 days. Patients had a variety of health conditions or acute events in the 24-month period prior to new COPD diagnosis, such as hypertension, depression/anxiety, type 2 diabetes, or osteoporosis, that could heighten the risks of OCS use. Patients treated with >1000 mg of prednisolone equivalent OCS in the 48 months following COPD diagnosis had a higher incidence of new conditions or events, including cardiovascular disease, heart failure, hypertension, obesity, dyspepsia, infections, and depression/anxiety, than patients with no OCS use.Conclusion:These results highlight the potential risks of OCS in COPD treatment, including prolonged use among complex Medicare patients, and reinforce the importance of preventive treatment strategies and therapy optimization early in the disease course.

BACKGROUND: Severe exacerbations requiring hospitalization contribute a substantial portion of the morbidity and costs of chronic obstructive pulmonary disease (COPD). Triple therapy (inhaled corticosteroid + long-acting β-agonist + long-acting muscarinic antagonist) is a recommended option for patients who experience recurrent COPD exacerbations or persistent symptoms. Few real-world studies have specifically examined the effect of prompt initiation of triple therapy, specifically among patients hospitalized for a COPD exacerbation. OBJECTIVE: To assess whether prompt initiation of triple therapy following a severe COPD exacerbation was associated with lower risk of subsequent exacerbations and lower health care use and costs and the effects of each 30-day delay of initiation. METHODS: Adults aged 40 years or older with COPD were identified in the Merative MarketScan Databases between January 1, 2010, and December 31, 2019, and were required to meet the following criteria: open or closed triple therapy (date of first closed prescription or last component of open=index treatment date), more than 1 inpatient admission with a primary COPD diagnosis (ie, severe exacerbation) in the prior 12 months (index exacerbation), 12 months of continuous enrollment before (baseline) and after (follow-up) index exacerbation, and absence of select respiratory diseases and cancer. Patients were stratified based on timing of open or closed triple therapy after the index exacerbation: prompt (≤30 days), delayed (31-180 days), or very delayed (181-365 days). Multivariable regression controlled for baseline characteristics (age, sex, insurance type, index year, comorbidities, prior treatment, and prior exacerbations) and estimated the odds of subsequent exacerbations, change in the number of exacerbations, and change in health care costs during 12-month follow-up associated with each 30-day delay of triple therapy initiation. RESULTS: A total of 6,772 patients met inclusion criteria (2,968 [43.8%] prompt, 1,998 [29.5%] delayed, and 1,806 [26.7%] very delayed). The adjusted odds of any exacerbation and a severe exacerbation during 12-month follow-up increased by 13% (odds ratio [95% CI]: 1.13 [1.11-1.15]) and 10% (1.10 [1.08-1.12]), respectively, for each 30-day delay in triple therapy initiation, and the mean number of exacerbations increased by 5.4% (95% CI = 4.7%-6.1%). There was a 3.0% increase (95% CI = 2.2%-3.8%) in mean all-cause costs and a 3.7% increase (95% CI = 2.9%-4.6%) in total COPD-related costs for each 30-day delay of triple therapy initiation. CONCLUSIONS: Longer delays in triple therapy initiation after a COPD hospitalization result in greater risk of subsequent exacerbations and higher health care resource use and costs. Adequate post-discharge follow-up care and earlier consideration of triple therapy may improve clinical and economic outcomes among patients with COPD. DISCLOSURES: This study was funded by AstraZeneca. Dr Evans is employed by Merative, formerly IBM Watson Health, and Mr Tkacz was employed by IBM Watson Health at the time of this study; Merative/IBM Watson Health received funding from AstraZeneca to conduct this study. Mr Pollack, Dr Staresinic, Dr Feigler, and Dr Patel are employed by AstraZeneca. Dr Touchette, Dr Portillo, and Dr Strange are paid consultants to AstraZeneca. Dr Strange also participates in research grants paid to the Medical University of South Carolina by AstraZeneca, CSA Medical, and Nuvaira, and is a consultant to GlaxoSmithKline, Morair, and PulManage regarding COPD.

SESSION TITLE: COPD Assessment Tools and ComorbiditiesSESSION TYPE: Rapid Fire Original InvPRESENTED ON: 10/17/2022 12:15 pm - 1:15 pmPURPOSE: Chronic obstructive pulmonary disease (COPD) exacerbations, particularly severe exacerbations, cause significant morbidity and mortality. This study sought to describe the burden of severe exacerbations in the Medicare Fee-for-Service (MFFS) COPD population and assess risks of experiencing severe events among patients with a history of experiencing no or only moderate events.METHODS: This study used claims data from MFFS patients from the Inovalon MORE2 Registry®. Patients were aged ≥40 years, continuously enrolled and had a COPD diagnosis. Year 1 (Y1, baseline) exacerbation rates were used to classify patients into mutually exclusive categories (0 exacerbations, 1 moderate event, >1 moderate event); patients with severe events in Y1 were excluded. Moderate exacerbations are defined as COPD-related outpatient/ED visits with a corticosteroid/antibiotic claim within ±7 days of the visit. Severe exacerbations are hospitalizations with a primary COPD diagnosis. Exacerbations occurring ≤14 days apart were considered one episode, with highest severity assigned. Rate ratios (RR) for Year 2 (Y2) and Year 3 (Y3) were compared to patients having 0 baseline events using generalized linear model (GLM) unadjusted and adjusted for relevant covariates (p<0.05).RESULTS: A total of 1,392,002 patients met selection criteria; 66.2% of patients had 0 exacerbations during baseline year, 22.9% had 1 moderate, 10.9% had >1 moderate exacerbation. Across Y2 and Y3, 1.3M events were observed, 13% (168,289) events were identified as being severe; severe events per 100 person-years (PYs) was 5.29 and 6.79, respectively. Among those with 0 baseline events, 3.2% of patients (29,784) had a severe event in Y2 and 4.1% (37,899) in Y3, and 14.4% (77,776) of all events were severe. Patients with 1 moderate-only baseline event: 5.4% (17,346) and 6.6% (21,109) experienced severe events in Y2 and Y3 with 12.5% (45,988) of all events being severe. Among those with >1 moderate-only events during baseline, 10.6% (16,043) and 12.2% (18,577) had a severe event in Y2 and Y3, respectively; 11.0% (44,525) of all events were severe. 46% of all severe events occurred among those with 0 baseline events. After adjustment, compared to patients with no baseline events, patients with 1 moderate event and >1 moderate were 1.32 and 1.96 times more likely to have a severe event in Y2; adjusted RRs were 1.29 and 1.92 for Y3.CONCLUSIONS: Among COPD patients with no history of a severe event in the past year, a striking proportion of patients experienced ≥1 severe event over the next 2 years (4.5% Y2, 5.6% Y3); rates and risks were fairly consistent over the 2 year period with 13% of all events being severe.CLINICAL IMPLICATIONS: Providers should consider future risk of severe exacerbations even in patients without a recent history of a severe event; risks should be assessed particularly when treatment decisions are being made.DISCLOSURES: no disclosure on file for Jill Dreyfus;Employee relationship with AstraZeneca Pharmaceuticals LP Please note: >$100000 by Norbert Feigler, value=SalaryConsultantGrant relationship with NHLBI Please note: 2022 Added 04/14/2022 by Barry Make, value=Grant/Research SupportRemoved 04/14/2022 by Barry MakeGrant relationship with American Lung Association Please note: current Added 04/14/2022 by Barry Make, value=Grant/Research SupportRemoved 04/14/2022 by Barry MakeGrant relationship with Department of Defense Please note: 2021 Added 04/14/2022 by Barry Make, value=Grant/Research SupportRemoved 04/14/2022 by Barry MakeScientific Medical Advisor relationship with NHLBI Please note: Current Added 04/14/2022 by Barry Make, value=Grant/Research SupportRemoved 04/14/2022 by Barry MakeScientific Medical Advisor relationship with American Lung Association Please note: Current Added 04/14/2022 by Barry Make, value=Grant/Research SupportRemoved 04/14/2022 by Barry Makeunknown relationship with Department of Defense Please note: 2021 Added 04/14/2022 by Barry Make, value=Grant/Research SupportRemoved 04/14/2022 by Barry MakeScientific Medical Advisor relationship with NHLBI Please note: current Added 04/14/2022 by Barry Make, value=Grant/Research SupportRemoved 04/14/2022 by Barry MakeScientific Medical Advisor relationship with American Lung Association Please note: current Added 04/14/2022 by Barry Make, value=Grant/Research SupportRemoved 04/14/2022 by Barry MakeScientific Medical Advisor relationship with Department of Defense Please note: 2021 Added 04/14/2022 by Barry Make, value=Grant/Research SupportRemoved 04/14/2022 by Barry MakeAdvisory Committee Member relationship with Astra Zeneca Please note: current Added 04/14/2022 by Barry Make, value=Grant, Personal, Consulting, HRemoved 04/14/2022 by Barry MakeAdvisory Committee Member relationship with Glaxo Smith Kline Please note: April 2020 Added 04/14/2022 by Barry Make, value=Personal, Data Safety MonitorRemoved 04/14/2022 by Barry MakeScientific Medical Advisor relationship with NHLBI Please note: current Added 04/14/2022 by Barry Make, value=Grant/Research SupportScientific Medical Advisor relationship with American Lung Association Please note: current Added 04/14/2022 by Barry Make, value=Grant/Research SupportScientific Medical Advisor relationship with Department of Defense Please note: 2021 Added 04/14/2022 by Barry Make, value=Grant/Research SupportAdvisory Committee Member relationship with Astra Zeneca Please note: current Added 04/14/2022 by Barry Make, value=Grant, Personal, Consulting, HAdvisory Committee Member relationship with Glaxo Smith Kline Please note: April 2020 Added 04/14/2022 by Barry Make, value=Personal, Data Safety MonitorCME activity relationship with Novartis Please note: March 2020 Added 04/14/2022 by Barry Make, value=Personal, HonorariaAdvisory Committee Member relationship with Boehringer Ingelheim Please note: Oct 2021 Added 04/14/2022 by Barry Make, value=Personal, Data Safety MonitorAdvisory Committee Member relationship with Mylan Please note: Nov 2019 Added 04/14/2022 by Barry Make, value=Personal, Data Safety MonitorConsultant relationship with Third Pole Please note: 2019 Added 04/14/2022 by Barry Make, value=Consulting feeConsultant relationship with Wolters Kluwer Health (Up-To-Date) Please note: current Added 04/14/2022 by Barry Make, value=RoyaltyScientific Medical Advisor relationship with Pearl Please note: 2019 Added 04/14/2022 by Barry Make, value=Grant/Research SupportNo relevant relationships by Chad MoretzEmployee relationship with AstraZeneca Please note: >$100000 by Michael Pollack, value=SalaryNo relevant relationships by Dakota Powellno disclosure on file for Scott Robinson;Research funds to institution relationship with Regeneron Please note: 2021 Added 04/06/2022 by Sanjay Sethi, value=Grant/Research SupportSpeaker/Speaker's Bureau relationship with Boerhinger Ingelheim Please note: ongoing by Sanjay Sethi, value=HonorariaAdvisory Committee Member relationship with Glaxo Smith Kline Please note: ongoing by Sanjay Sethi, value=Consulting feeClinical Event adjudication committee relationship with Pulmonx Please note: ongoing Added 04/06/2022 by Sanjay Sethi, value=Consulting feeSpeaker/Speaker's Bureau relationship with Circassia Please note: 2019 by Sanjay Sethi, value=HonorariaRemoved 04/06/2022 by Sanjay SethiAdvisory Committee Member relationship with Pulmotect Please note: ongoing by Sanjay Sethi, value=Consulting feeScientific Medical Advisor relationship with Astra Zeneca Please note: ongoing by Sanjay Sethi, value=Consulting feeSpeaker/Speaker's Bureau relationship with Astra Zeneca Please note: 2019 by Sanjay Sethi, value=HonorariaScientific Medical Advisor relationship with Nuvaira Please note: ongoing by Sanjay Sethi, value=ConsultingSpeaker/Speaker's Bureau relationship with Glaxo Smith Kline Please note: ongoing by Sanjay Sethi, value=HonorariaAdvisory Committee Member relationship with Boehringer Ingelheim Please note: ongoing Added 04/06/2022 by Sanjay Sethi, value=Consulting feeAdvisory Committee Member relationship with Theravance Please note: 2019 by Sanjay Sethi, value=Consulting feeRemoved 04/06/2022 by Sanjay SethiConsultant relationship with apellis Please note: 2021 Added 04/06/2022 by Sanjay Sethi, value=Consulting feeConsultant relationship with aerogen Please note: 2021 Added 04/06/2022 by Sanjay Sethi, value=Consulting feeNo relevant relationships by Ann Xi SESSION TITLE: COPD Assessment Tools and Comorbidities SESSION TYPE: Rapid Fire Original Inv PRESENTED ON: 10/17/2022 12:15 pm - 1:15 pm PURPOSE: Chronic obstructive pulmonary disease (COPD) exacerbations, particularly severe exacerbations, cause significant morbidity and mortality. This study sought to describe the burden of severe exacerbations in the Medicare Fee-for-Service (MFFS) COPD population and assess risks of experiencing severe events among patients with a history of experiencing no or only moderate events. METHODS: This study used claims data from MFFS patients from the Inovalon MORE2 Registry®. Patients were aged ≥40 years, continuously enrolled and had a COPD diagnosis. Year 1 (Y1, baseline) exacerbation rates were used to classify patients into mutually exclusive categories (0 exacerbations, 1 moderate event, >1 moderate event); patients with severe events in Y1 were excluded. Moderate exacerbations are defined as COPD-related outpatient/ED visits with a corticosteroid/antibiotic claim within ±7 days of the visit. Severe exacerbations are hospitalizations with a primary COPD diagnosis. Exacerbations occurring ≤14 days apart were considered one episode, with highest severity assigned. Rate ratios (RR) for Year 2 (Y2) and Year 3 (Y3) were compared to patients having 0 baseline events using generalized linear model (GLM) unadjusted and adjusted for relevant covariates (p<0.05). RESULTS: A total of 1,392,002 patients met selection criteria; 66.2% of patients had 0 exacerbations during baseline year, 22.9% had 1 moderate, 10.9% had >1 moderate exacerbation. Across Y2 and Y3, 1.3M events were observed, 13% (168,289) events were identified as being severe; severe events per 100 person-years (PYs) was 5.29 and 6.79, respectively. Among those with 0 baseline events, 3.2% of patients (29,784) had a severe event in Y2 and 4.1% (37,899) in Y3, and 14.4% (77,776) of all events were severe. Patients with 1 moderate-only baseline event: 5.4% (17,346) and 6.6% (21,109) experienced severe events in Y2 and Y3 with 12.5% (45,988) of all events being severe. Among those with >1 moderate-only events during baseline, 10.6% (16,043) and 12.2% (18,577) had a severe event in Y2 and Y3, respectively; 11.0% (44,525) of all events were severe. 46% of all severe events occurred among those with 0 baseline events. After adjustment, compared to patients with no baseline events, patients with 1 moderate event and >1 moderate were 1.32 and 1.96 times more likely to have a severe event in Y2; adjusted RRs were 1.29 and 1.92 for Y3. CONCLUSIONS: Among COPD patients with no history of a severe event in the past year, a striking proportion of patients experienced ≥1 severe event over the next 2 years (4.5% Y2, 5.6% Y3); rates and risks were fairly consistent over the 2 year period with 13% of all events being severe. CLINICAL IMPLICATIONS: Providers should consider future risk of severe exacerbations even in patients without a recent history of a severe event; risks should be assessed particularly when treatment decisions are being made. DISCLOSURES: no disclosure on file for Jill Dreyfus; Employee relationship with AstraZeneca Pharmaceuticals LP Please note: >$100000 by Norbert Feigler, value=Salary Consultant Grant relationship with NHLBI Please note: 2022 Added 04/14/2022 by Barry Make, value=Grant/Research Support Removed 04/14/2022 by Barry Make Grant relationship with American Lung Association Please note: current Added 04/14/2022 by Barry Make, value=Grant/Research Support Removed 04/14/2022 by Barry Make Grant relationship with Department of Defense Please note: 2021 Added 04/14/2022 by Barry Make, value=Grant/Research Support Removed 04/14/2022 by Barry Make Scientific Medical Advisor relationship with NHLBI Please note: Current Added 04/14/2022 by Barry Make, value=Grant/Research Support Removed 04/14/2022 by Barry Make Scientific Medical Advisor relationship with American Lung Association Please note: Current Added 04/14/2022 by Barry Make, value=Grant/Research Support Removed 04/14/2022 by Barry Make unknown relationship with Department of Defense Please note: 2021 Added 04/14/2022 by Barry Make, value=Grant/Research Support Removed 04/14/2022 by Barry Make Scientific Medical Advisor relationship with NHLBI Please note: current Added 04/14/2022 by Barry Make, value=Grant/Research Support Removed 04/14/2022 by Barry Make Scientific Medical Advisor relationship with American Lung Association Please note: current Added 04/14/2022 by Barry Make, value=Grant/Research Support Removed 04/14/2022 by Barry Make Scientific Medical Advisor relationship with Department of Defense Please note: 2021 Added 04/14/2022 by Barry Make, value=Grant/Research Support Removed 04/14/2022 by Barry Make Advisory Committee Member relationship with Astra Zeneca Please note: current Added 04/14/2022 by Barry Make, value=Grant, Personal, Consulting, H Removed 04/14/2022 by Barry Make Advisory Committee Member relationship with Glaxo Smith Kline Please note: April 2020 Added 04/14/2022 by Barry Make, value=Personal, Data Safety Monitor Removed 04/14/2022 by Barry Make Scientific Medical Advisor relationship with NHLBI Please note: current Added 04/14/2022 by Barry Make, value=Grant/Research Support Scientific Medical Advisor relationship with American Lung Association Please note: current Added 04/14/2022 by Barry Make, value=Grant/Research Support Scientific Medical Advisor relationship with Department of Defense Please note: 2021 Added 04/14/2022 by Barry Make, value=Grant/Research Support Advisory Committee Member relationship with Astra Zeneca Please note: current Added 04/14/2022 by Barry Make, value=Grant, Personal, Consulting, H Advisory Committee Member relationship with Glaxo Smith Kline Please note: April 2020 Added 04/14/2022 by Barry Make, value=Personal, Data Safety Monitor CME activity relationship with Novartis Please note: March 2020 Added 04/14/2022 by Barry Make, value=Personal, Honoraria Advisory Committee Member relationship with Boehringer Ingelheim Please note: Oct 2021 Added 04/14/2022 by Barry Make, value=Personal, Data Safety Monitor Advisory Committee Member relationship with Mylan Please note: Nov 2019 Added 04/14/2022 by Barry Make, value=Personal, Data Safety Monitor Consultant relationship with Third Pole Please note: 2019 Added 04/14/2022 by Barry Make, value=Consulting fee Consultant relationship with Wolters Kluwer Health (Up-To-Date) Please note: current Added 04/14/2022 by Barry Make, value=Royalty Scientific Medical Advisor relationship with Pearl Please note: 2019 Added 04/14/2022 by Barry Make, value=Grant/Research Support No relevant relationships by Chad Moretz Employee relationship with AstraZeneca Please note: >$100000 by Michael Pollack, value=Salary No relevant relationships by Dakota Powell no disclosure on file for Scott Robinson; Research funds to institution relationship with Regeneron Please note: 2021 Added 04/06/2022 by Sanjay Sethi, value=Grant/Research Support Speaker/Speaker's Bureau relationship with Boerhinger Ingelheim Please note: ongoing by Sanjay Sethi, value=Honoraria Advisory Committee Member relationship with Glaxo Smith Kline Please note: ongoing by Sanjay Sethi, value=Consulting fee Clinical Event adjudication committee relationship with Pulmonx Please note: ongoing Added 04/06/2022 by Sanjay Sethi, value=Consulting fee Speaker/Speaker's Bureau relationship with Circassia Please note: 2019 by Sanjay Sethi, value=Honoraria Removed 04/06/2022 by Sanjay Sethi Advisory Committee Member relationship with Pulmotect Please note: ongoing by Sanjay Sethi, value=Consulting fee Scientific Medical Advisor relationship with Astra Zeneca Please note: ongoing by Sanjay Sethi, value=Consulting fee Speaker/Speaker's Bureau relationship with Astra Zeneca Please note: 2019 by Sanjay Sethi, value=Honoraria Scientific Medical Advisor relationship with Nuvaira Please note: ongoing by Sanjay Sethi, value=Consulting Speaker/Speaker's Bureau relationship with Glaxo Smith Kline Please note: ongoing by Sanjay Sethi, value=Honoraria Advisory Committee Member relationship with Boehringer Ingelheim Please note: ongoing Added 04/06/2022 by Sanjay Sethi, value=Consulting fee Advisory Committee Member relationship with Theravance Please note: 2019 by Sanjay Sethi, value=Consulting fee Removed 04/06/2022 by Sanjay Sethi Consultant relationship with apellis Please note: 2021 Added 04/06/2022 by Sanjay Sethi, value=Consulting fee Consultant relationship with aerogen Please note: 2021 Added 04/06/2022 by Sanjay Sethi, value=Consulting fee No relevant relationships by Ann Xi

SESSION TITLE: COPD Medications and Treatment Outcomes SESSION TYPE: Rapid Fire Original Inv PRESENTED ON: 10/19/2022 11:15 am - 12:15 pm PURPOSE: Short courses of systemic corticosteroids (SCS) are recommended for patients with chronic obstructive pulmonary disease (COPD) to shorten recovery time from exacerbations. However, SCS use has been associated with adverse effects. The purpose of this study is to assess real-world patterns of oral corticosteroid (OCS) use among Medicare fee-for service (FFS) patients newly diagnosed with COPD. METHODS: Patients newly diagnosed with COPD in 2015 (index date) were identified from the Medicare 100% FFS claims data and followed from 24 mos pre-index (baseline) through 48 mos post-index. Exclusion criteria: age <40, COPD diagnosis or claim for SCS in the baseline period, eligibility for Medicare based on end-stage renal disease, and diagnosis for conditions for which SCS may be commonly prescribed. OCS use included oral betamethasone, cortisone, dexamethasone, hydrocortisone, methylprednisolone, prednisolone, and prednisone, with dosage converted to prednisolone equivalents. OCS episodes were defined as groups of OCS prescription fills with days supply within 14 days. Inpatient COPD exacerbation events were identified as acute inpatient hospital facility claims with COPD-related diagnosis codes in the principal position. Analyses were descriptive. RESULTS: 183,637 patients newly diagnosed with COPD in 2015 were identified. 36% filled >=1 OCS prescription in the 48 mos post-index. Of patients with OCS prescription fills, 73% had a cumulative dose of <=500 mg, 17% >500- <=1,000 mg, and 11% >1,000 mg. The mean cumulative OCS dose was 526 mg, and the median was 300 mg. Among OCS episodes, 93% were shorter than 30 days, with an average of 7.6 days supplied and an average dose of 222 mg. The remaining 7% of episodes extending at least 30 days had an average of 84.8 days supplied and an average dose of 1,053 mg. 62% of episodes had 7 days or fewer of OCS supplied, and 90% had 19 days or fewer supplied. 20% of patients had at least one inpatient COPD exacerbation in the 48 mos post-index, where additional SCS was likely provided. CONCLUSIONS: Over a third of patients with COPD received OCS within 48 mos after initial diagnosis, with 11% of those patients receiving >1,000 mg. The total amount of SCS provided is likely higher than captured in the analysis due to SCS treatment during inpatient COPD exacerbations not being reported on claims. 38% of OCS episodes exceeded the maximal length of 7 days recommended by the Global Initiative for Chronic Obstructive Lung Disease (GOLD). CLINICAL IMPLICATIONS: OCS use is observed in over one-third of Medicare FFS patients newly diagnosed with COPD in the 4 years post-diagnosis. In clinical practice, more than one-third of OCS treatment courses in patients with newly diagnosed COPD are longer than the GOLD recommendations, which may result in higher risk of adverse OCS-related effects with no additional clinical benefit. DISCLOSURES: Consultant relationship with AstraZeneca Please note: 2020-present Added 03/30/2022 by Maggie Alston, value=Consulting fee Consultant relationship with AstraZeneca Please note: 2018 to present Added 03/30/2022 by Carol Bazell, value=Consulting fee Consultant relationship with AstraZeneca Please note: 10/20/2020-present Added 03/29/2022 by Melissa Caplen, value=Consulting fee Employee relationship with Milliman Please note: 9/5/2017-present Added 03/29/2022 by Melissa Caplen, value=Salary Consultant relationship with VIDA Diagnostics Please note: 2012 to today Added 04/01/2022 by Alejandro Comellas, value=software support Consultant relationship with GlaxoSmithKline Please note: June 2018 to today Added 04/01/2022 by Alejandro Comellas, value=Consulting fee Consultant relationship with AstraZeneca Please note: 01-01-2021 to today Added 04/01/2022 by Alejandro Comellas, value=Consulting fee Consultant relationship with Elli Lilly Please note: 01-01-2022 to today Added 04/01/2022 by Alejandro Comellas, value=Consulting fee Consultant relationship with Respira Lab Please note: 12-2021 to today Added 04/01/2022 by Alejandro Comellas, value=Consulting fee Employee relationship with AstraZeneca Pharmaceuticals LP Please note: >$100000 by Norbert Feigler, value=Salary Consultant relationship with AstraZeneca Please note: 11/2020 - present Added 03/30/2022 by Dane Hansen, value=Consulting fee Employee relationship with AstraZeneca Please note: >$100000 by Michael Pollack, value=Salary Consultant relationship with AstraZeneca Please note: 11/2020-present Added 04/11/2022 by Bruce Pyenson, value=Consulting fees Research funds to institution relationship with Regeneron Please note: 2021 Added 04/06/2022 by Sanjay Sethi, value=Grant/Research Support Speaker/Speaker's Bureau relationship with Boerhinger Ingelheim Please note: ongoing by Sanjay Sethi, value=Honoraria Advisory Committee Member relationship with Glaxo Smith Kline Please note: ongoing by Sanjay Sethi, value=Consulting fee Clinical Event adjudication committee relationship with Pulmonx Please note: ongoing Added 04/06/2022 by Sanjay Sethi, value=Consulting fee Speaker/Speaker's Bureau relationship with Circassia Please note: 2019 by Sanjay Sethi, value=Honoraria Removed 04/06/2022 by Sanjay Sethi Advisory Committee Member relationship with Pulmotect Please note: ongoing by Sanjay Sethi, value=Consulting fee Scientific Medical Advisor relationship with Astra Zeneca Please note: ongoing by Sanjay Sethi, value=Consulting fee Speaker/Speaker's Bureau relationship with Astra Zeneca Please note: 2019 by Sanjay Sethi, value=Honoraria Scientific Medical Advisor relationship with Nuvaira Please note: ongoing by Sanjay Sethi, value=Consulting Speaker/Speaker's Bureau relationship with Glaxo Smith Kline Please note: ongoing by Sanjay Sethi, value=Honoraria Advisory Committee Member relationship with Boehringer Ingelheim Please note: ongoing Added 04/06/2022 by Sanjay Sethi, value=Consulting fee Advisory Committee Member relationship with Theravance Please note: 2019 by Sanjay Sethi, value=Consulting fee Removed 04/06/2022 by Sanjay Sethi Consultant relationship with apellis Please note: 2021 Added 04/06/2022 by Sanjay Sethi, value=Consulting fee Consultant relationship with aerogen Please note: 2021 Added 04/06/2022 by Sanjay Sethi, value=Consulting fee Employee relationship with AstraZeneca Please note: 4/2/2018 to present by Anthony Staresinic, value=Salary Employee relationship with AztraZeneca Please note: 5/4/2020 - Present Added 04/11/2022 by John Styczynski, value=Salary