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Managed Care Considerations in COPD: Value-Based Strategies and Updated Guidance From GOLD

Leveraging GOLD Guidance and Value-Based Strategies in the Management of COPD

To advance the management of chronic obstructive pulmonary disease (COPD), the Global Initiative for Chronic Obstructive Lung Disease (GOLD) issues annual reports.1 However, as few as 25% of US primary care physicians use COPD guidelines to guide clinical decision-making.2 This low rate of guideline concordance may contribute to a rate of COPD underdiagnosis in the United States of approximately 70% that has remained steady for 2 decades.2-4 Improving guideline concordance and implementing other value-based health care (VBH) strategies can help to optimize care and mitigate the substantial clinical and economic burden associated with this disease.5-7 Citing the GOLD 2024 report, this article summarizes key updates from the GOLD 2023 annual report, reviews challenges faced by providers and payers in the management of COPD, and explores value-based solutions related to the diagnosis and management of this serious chronic medical condition.

Recent Guidance From GOLD

The GOLD 2024 report is an update to the GOLD 2023 report, which was a major revision.8 Authors of the GOLD 2023 report highlight 17 “novel and important” changes to GOLD definitions, recommendations, and paradigms. These include a revision of the tool for initial COPD assessment, revised guidance regarding initial and follow-up pharmacologic treatment, and new information on choice of inhaler device.1

Revised COPD Assessment Tool

Authors of the GOLD 2023 report revised the COPD assessment tool to underscore that exacerbations are clinically significant regardless of patient symptoms.1 The GOLD 2024 report retains this revision.8 Since 2011, GOLD reports have proposed disease severity classification systems to guide initial pharmacologic treatment.1 In its 2022, 2023, and 2024 reports, GOLD counsels that classification requires spirometry results and assessments of airflow limitation, exacerbation history, and symptoms.1,8,9 According to the 3 reports, patients who have had 1 or fewer moderate or severe exacerbations of the disease with no episode leading to hospital admission should be included in the group A classification if their symptoms are mild and the group B classification if their symptoms are more severe.1,8,9 The 2022 report also classified disease in patients who experienced 2 or more of these exacerbations according to symptom severity; they would be in group C if their symptoms were mild and group D if their manifestations of the disease were more severe.9 However, authors of the 2023 and 2024 reports combine patients in the C and D groups into a single group E (Figure).1,8

Revised Guidance for Initial and Follow-Up Pharmacologic Treatment: Triple Therapy

The GOLD 2023 and 2024 reports recommend that health professionals consider triple therapy (TT) entailing combined use of a long-acting β2 agonist (LABA), a long-acting muscarinic antagonist (LAMA), and an inhaled corticosteroid (LABA+LAMA+ICS) in instances when LABA+ICS dual therapy had been recommended. Whereas the GOLD 2022 report noted the efficacy of LABA+ICS in patients with moderate to very severe COPD and exacerbations, the GOLD 2023 and 2024 reports underscore, “Use of LABA+ICS in COPD is not encouraged. If there is an indication for an ICS, then LABA+LAMA+ICS has been shown superior to LABA+ICS and is therefore the preferred choice.”1,8,9

In removing recommendations for LABA+ICS dual therapy, the GOLD 2023 report authors note that the results of several trials (eg, TORCH [NCT00268216], SUMMIT [NCT01313676], and UPLIFT [NCT00144339]) failed to demonstrate the efficacy of LABA+ICS vs placebo in reducing mortality.1,8,10-12 Thus, to initiate pharmacotherapy in patients with COPD in group E whose blood eosinophil count is at least 300 cells/µL, the GOLD 2023 and 2024 reports recommend that TT be considered. Further, if initial pharmacotherapy with LABA or LAMA after a COPD exacerbation does not elicit an appropriate patient response and if guideline concordance, inhaler technique, and comorbidities do not interfere with treatment, TT should be considered for patients whose eosinophil count is at least 300 cells/µL.1,8


In recommending TT over LABA+ICS, the GOLD 2023 and 2024 reports cite results of the large, randomized IMPACT (NCT02164513) and ETHOS (NCT02465567) clinical trials, which involved patients with symptomatic COPD and a history of frequent and/or severe exacerbations. Authors of both reports highlighted that in both trials, TT reduced all-cause mortality compared with LABA+ICS and LABA+LAMA dual therapy.1,8,13,14

In the IMPACT trial, investigators compared a TT of once-daily fluticasone furoate (an ICS), umeclidinium (a LAMA), and vilanterol (a LABA) (FF+UMEC+VI) with dual therapies of VI+FF and VI+UMEC across 52 weeks. The international, double-blind, phase 3 study enrolled 10,355 adults at least 40 years of age who had symptomatic COPD, at least 1 moderate or severe exacerbation in the previous year, and diminished forced expiratory volume in 1 second (FEV1). Compared with LABA+ICS dual therapy, TT was associated with a 15% lower rate of moderate or severe exacerbations per year (1.07 vs 0.91 annual exacerbations; 95% CI, 10%-20%; P < .001); further, the risk of moderate or severe exacerbations during treatment was reduced by 15% (95% CI, 9%-20%; P < .001). Compared with risk for all-cause mortality associated with LABA+LAMA dual therapy, the risk related to TT was reduced by 42% (95% CI, 12%-62%; unadjusted P = .01). In general, the adverse events (AEs) associated with TT closely resembled those noted with the dual therapies, and there were no novel safety observations linked to the concurrent use of an ICS, LAMA, or LABA in combination. Rates of AEs that led to discontinuation of treatment and of serious AEs (SAEs), respectively, were 6% and 22% for TT, 8% and 21% for LABA+ICS dual therapy, and 9% and 23% for LABA+LAMA dual therapy.13 (Note: The IMPACT and ETHOS study investigators did not define serious AE in their published findings.13,15,16 However, independent committees adjudicated all reported SAEs in the IMPACT trial and safety data throughout the ETHOS trial.13,16)

In the ETHOS study, twice-daily use of TT with the ICS budesonide, the LAMA glycopyrrolate, and the LABA FF at 2 dosages was compared with administration of dual therapy with glycopyrrolate plus FF or budesonide plus FF across 52 weeks. The international, double-blind, phase 3 study enrolled 8588 adults aged 40 to 80 years who had symptomatic COPD, at least 1 moderate or severe exacerbation in the previous year, diminished FEV1, low ratio of FEV1 to forced vital capacity (FVC) (FEV1:FVC ratio), and a history of smoking equivalent to at least 1 pack of cigarettes a day for 10 years; patients were taking 2 or more inhaled maintenance therapies at screening. Compared with LABA+ICS dual therapy, TT involving 320 µg of budesonide was associated with a 13% lower rate of moderate or severe exacerbations per year (1.24 vs 1.08 annual exacerbations; 95% CI, 5%-21%; P = .003).16 Compared with LABA+LAMA dual therapy, TT including 320 µg of budesonide was associated with a risk for all-cause mortality that was reduced by 49% (95% CI, 20%-67%; unadjusted P = .0035) when all patient vital status data were considered.14 There were no novel safety observations associated with concurrent use of an ICS, LAMA, or LABA in combination. Rates of AEs that led to discontinuation of treatment and rates of SAEs, respectively, were 5.6% and 19.9% for TT with 320 µg of budesonide, 6.6% and 20.6% for LABA+ICS dual therapy, and 6.9% and 20.4% for LABA+LAMA dual therapy.16

Patients With COPD and Asthma

Guideline authors emphasize the distinction between asthma and COPD, departing from the previous asthma and COPD overlap model. They stress that if a patient with COPD is presumed to have asthma as well, the primary approach to pharmacotherapy should align with asthma guidelines.1,8 In the 2020 focused updates to the Asthma Management Guidelines from the National Asthma Education and Prevention Program Coordinating Committee (NAEPPCC), LABA+ICS is recommended in stepwise treatment approaches to asthma.17 However, the NAEPPCC guidance does not take into account more recent evidence favoring TT use in certain populations of patients with asthma.18-20 Moreover, for patients with simultaneous disease, guideline authors emphasize that COPD may need to be managed separately, which may require TT.1,8

Current Information on Choice of Inhaler Device

The authors of the GOLD 2023 and 2024 reports note that use of 1 inhaler may improve both patient adherence with treatment and outcomes in TT compared with use of multiple inhalers. The authors also highlight that the choice of inhaled therapeutic delivery system should be individualized for each patient and should account for patient goals, abilities, and preferences along with device features. According to the authors, selecting a device through shared decision-making between patient and provider is likely to improve outcomes for patients with COPD.1,8

Identifying Challenges Faced by Providers and Payers in COPD Management

In 2018, chronic lower respiratory disease ranked as the fourth leading cause of death in the United States, and COPD was the primary driver of this mortality.5,21 As a chronic and progressive medical condition, COPD is associated with greater disability, increased emergency department (ED) visits and hospital admissions, and heightened risk of premature death.5,22 In 2018, about 15.7 million individuals in the United States—some 6.4% of the population—reported having received a diagnosis of COPD. However, over half of adults with low pulmonary function may be unaware of their COPD diagnosis, and the prevalence of this disease may be substantially greater.5


Frequently, COPD is diagnosed only after the disease has progressed substantially. A cross-sectional analysis of 2007-2012 National Health and Nutritional Examination Survey (NHANES) data for 1636 patients aged 20 to 79 years found that obstructive lung disease (asthma or COPD) was undiagnosed in 1173 patients (71.7%) who met established spirometric criteria for the disease. Results of a comparative analysis with 1988-1994 NHANES data for a matched population of 1927 patients demonstrated that 1410 patients (73.2%) remained undiagnosed, showing that this high rate had remained constant for 2 decades.3

Factors in Underdiagnosis

Lack of familiarity with treatment guidelines among primary care providers may contribute to underdiagnosis of COPD. In an analysis of 2006 survey data drawn from 784 active US primary care physicians, only 45% were aware of COPD guidelines issued by either GOLD or the American Thoracic Society/European Respiratory Society. Further, only 46% of physicians who were aware of the COPD guidelines reported using the guidelines in clinical practice. Of all surveyed physicians, 1 in 3 reported that they would not order spirometry to evaluate a middle-aged patient who smokes, exhibits chronic sputum production, and has no dyspnea, for whom spirometry was indicated by GOLD guidelines.2

According to the GOLD 2023 and 2024 reports, COPD diagnosis is confirmed by spirometric measurement of airflow limitation that is not fully reversible (ie, FEV1:FVC ratio < 0.7 postbronchodilation).1,8 However, limited access to spirometers and limited proficiency with spirometric testing contributes to underdiagnosis of COPD, particularly in primary care.1,4 In a retrospective study of Veterans Affairs Corporate Data Warehouse administrative data for 24,300 patients newly diagnosed with COPD between January 2012 and December 2015 who received primary care in a Veterans Administration facility with advanced specialized services, only 59.7% were given confirmatory spirometry results in the 2 years following initial COPD diagnosis. Patients who did not have a visit with a pulmonary specialist were less likely to undergo spirometry (adjusted odds ratio [aOR], 0.38; 95% CI, 0.35-0.41).23

Economic Impact of COPD

Direct expenditures related to COPD in the United States were estimated to be $30 billion in 2010, with indirect costs (eg, related to lost workdays) amounting to an extra $20 billion.24 Adjusted for inflation, this represents $70.5 billion in direct and indirect costs in 2023.25 (Note: These adjusted numbers are based only on the dollar amount without consideration of other factors, such as new therapies. In this article, all remaining costs have been inflated in the same manner to 2023 US$.) In a modeling study using US-based data from publicly available data sets and published literature, the estimated discounted direct medical costs associated with COPD from 2019-2038 were projected to be approximately $960.08 billion (2023 US$; 95% credible interval, $677.64 billion to $1.3 trillion).25,26

Exacerbations, health care resource utilization (HCRU), and costs increase with increased disease severity. In a retrospective study of US-based medical and pharmacy claims and medical record data from the HealthCore Integrated Research Database (HIRD) from January 2012 through November 2013, 1505 patients with COPD were identified. Patients were categorized by contemporary GOLD classification, with GOLD 1 representing mild disease and GOLD 4 signifying very severe disease.27 The mean (SD) annual COPD-related medical costs for patients with GOLD 1 severity was $7690 ($17,295) and for GOLD 4 severity was $23,374 ($20,624) (all 2023 US$).25,27

Patients with more severe disease exhibited higher rates of moderate to severe COPD exacerbations, with incidences of 40.4 per 100 person-years (95% CI, 35.8-45.4 per 100 person-years) and 89.1 per 100 person-years (95% CI, 68.1-110.5 per 100 person-years) for patients with GOLD 1 and GOLD 4 severity, respectively. Relative to patients with GOLD 1 severity, patients with GOLD 4 severity had higher rates of all-cause inpatient admission (38% vs 75%, respectively), COPD-related inpatient admission (23% vs 72%), COPD-related ED visits (11% vs 31%), and mean (SD) COPD-related office visits (1.93 [2.2] vs 2.64 [2.4]) during the study period.27


In a retrospective study of Optum Research Database commercial and Medicare Advantage claims data for 402 US patients with COPD, the mean (SD) cost per patient of an acute exacerbation of COPD (AECOPD) was $8430 ($22,643) (all costs, 2023 US$). Using multivariate modeling, study authors projected annual exacerbation costs to total $1.40 billion per 100,000 patients.25,28 In a separate study of 2013-2014 US hospital records from the Nationwide Readmission Database, of 1,055,830 index AECOPD admissions, there were 20,300 readmissions (19.2%) within 30 days.29 Further, in an analysis of 2007-2010 administrative claims data from Truven Health commercial and Medicare databases for 61,750 patients with COPD, the impact of previous exacerbations upon future exacerbations was evaluated. Compared with patients who had not experienced exacerbations in the previous 12 months, patients who experienced 1 or at least 2 exacerbations during this time were, respectively, 2.68 (95% CI, 2.18-3.304; P < .001) and 6.60 (95% CI, 5.14-8.48; P < .001) times more likely to experience 2 or more exacerbations in the next 12 months.30

Adherence and Proper Inhaler Technique

Authors of the GOLD 2023 and 2024 reports note that rates of adherence to inhaled medication are low for patients with COPD, even among patients with severe disease. This is despite associations between non-adherence to COPD pharmacotherapy and inadequate symptom management, heightened risk of exacerbations, increased use of health care resources and cost, reduced health-related quality of life, and elevated risk of mortality. Comorbidities, socioeconomic factors, and treatment-related factors all contribute to nonadherence.1,8

Among treatment-related factors for nonadherence is the diversity of COPD pharmacotherapies and devices. GOLD 2023 and 2024 report authors cite the availability of at least 33 unique inhaled COPD therapies and at least 22 unique inhaler devices. These devices vary regarding size, ease of carrying, number of preparatory steps needed before use, force necessary for loading or activation, drug delivery time, cleaning and maintenance requirements, and specific inhalation techniques essential for effective use. An increased number of steps alone increases the likelihood that an inhaler will be used incorrectly.1,8

VBH Strategies in COPD Management

Unlike traditional health care delivery models, which compensate physicians and hospitals based upon quantity of services delivered, VBH remunerates providers according to patient health outcomes. In VBH agreements, value is placed upon improving health to reduce the incidence and impact of chronic disease. VBH models aim to promote prevention of and prompt recovery from COPD and other chronic diseases. These clinical outcomes can reduce economic costs to patients, providers, and payers.7

Patient-Centered Medical Homes and Accountable Care Organizations

Many current value-based care initiatives have their origins in the enactment of the Patients and Providers Act in 2008 and the Affordable Care Act (ACA) in 2010.31,32 The ACA frequently mentions medical homes, which are also called advanced primary care practices or patient-centered medical homes (PCMHs).33 A PCMH is not a physical location; instead, it is a coordinated approach to care guided by a primary physician that involves a clinical care team and centers around electronic medical records. PCMHs may reduce costs associated with redundant care for COPD.7,33

Accountable care organizations (ACOs) are similar to PCMHs; originally designed by CMS for patients with Medicare coverage, they share claims and clinical data with payers to demonstrate changes in outcomes. In the ACO model, hospitals and health care providers are incentivized to improve hospital readmissions, adverse events, and other costly sequelae of diseases like COPD.7 In 2021, over 1000 ACOs working with Medicare or commercial payers covered 36 million patients in the United States.32 Being highly prevalent and morbid, COPD is a candidate for ACO arrangements in multispecialty outpatient practices that include pulmonary practitioners.32,34

Guideline-Concordant Care

In a retrospective study of 2014-2017 HIRD claims data, treatment according to GOLD report recommendations was associated with lower COPD-related HCRU and COPD-related medical costs and with improvements in exacerbations when compared with treatment discordant with GOLD recommendations. Some 44,917 patients 40 years or older with at least 1 claim for COPD maintenance medication were identified and categorized according to GOLD 2017 report recommendations, and their treatments were classified as GOLD-recommendation concordant or discordant.6 Compared with 25,751 patients having the same exacerbation status who were not recommendation concordant, 12,631 patients with no or 1 moderate exacerbation and no severe exacerbations (GOLD A/B) who were recommendation concordant had 0.02 fewer hospitalizations per patient per year (95% CI, –0.03 to 0.00 hospitalizations; P = .040), adjusted mean medical costs that were $880 lower (95% CI, –$1405 to –$334; all costs, 2023 US$; P = .002), and a lower overall exacerbation rate (0.59 vs 0.54; rate ratio [RR] = 0.93; 95% CI, 0.89-0.96; P < .001).6,25 Compared with 2683 patients with the same exacerbation status who were not recommendation concordant, 3852 patients with 2 or more moderate exacerbations and/or at least 1 severe exacerbation (GOLD C/D) who were recommendation concordant had 12 fewer hospitalizations, 6 fewer ED visits, 28 fewer office visits, and 80 fewer outpatient visits per 100 patient-years (all P < .05).6 The guideline-concordant cohort, when compared with the matched discordant cohort, demonstrated $2773 lower adjusted mean medical costs (P = .005) and a lower overall exacerbation rate (1.27 vs 1.20 exacerbations, respectively) (RR, 0.94; 95% CI, 0.90-0.99; P = .028) and severe exacerbation rate (0.18 vs 0.15 exacerbations) (RR, 0.83; 95% CI, 0.71-0.96; P = .010).6,25

Early Treatment

Authors of the GOLD 2023 and 2024 reports stress the importance of early detection and treatment of COPD.1,8 In a retrospective study of 2009-2020 Merative MarketScan commercial, Medicare, and Medicaid claims data, each 30-day delay in TT after a severe COPD exacerbation was associated with an increased risk of future exacerbations and higher all-cause and COPD-related costs.35 Specifically, each 30-day delay in TT initiation was associated with a 3% increase (95% CI, 2%-4%) in mean all-cause costs that is equal to $1497 per patient per month of delay (2023 US$) and with a 4% increase (95% CI, 3%-5%) in mean COPD-related costs that is equal to $453 per patient per month of delay.25,35 In all, 6772 patients 40 years or older with COPD, a severe index exacerbation, and evidence of TT (LABA+LAMA+ICS) were identified and categorized based upon the time between their index exacerbation and index treatment dates. After multivariable adjustment for baseline patient characteristics, each 30-day delay in TT initiation was associated with a 13% (95% CI, 11%-15%) increase in the odds of any exacerbation (moderate or severe) occurring at any time in the 12 months following index and 10% (95% CI, 8%-12%) increased odds of a severe exacerbation occurring during this time. Limitations of this analysis include a lack of disease severity measures in the MarketScan databases, inherent coding limitations that may have caused outcome misclassification, an assumption that medications were used as prescribed, and a lack of accounting for treatment adherence, administration, and persistence.35

Compared with delayed initiation, prompt treatment with TT is associated with fewer exacerbations and lower all-cause and COPD-related health care costs. Investigators analyzed 2016-2019 claims data from the IQVIA PharMetrics Plus database to identify 1904 patients with COPD who were 40 years or older, had experienced an index exacerbation that was moderate or severe, and had evidence of initiating TT with FF+UMEC+VI only after index exacerbation. Patients were categorized as prompt initiators if TT commenced within 30 days of index exacerbation or as delayed initiators if TT began between 31 and 180 days after index. Results showed that compared with delayed initiators, prompt initiators had a 21% lower rate of overall exacerbations per patient-year (PPY) (1.23 vs 0.98 exacerbations PPY; 95% CI, 6%-35%; P = .004).36 Further, prompt initiators had a 43% lower PPY rate of severe exacerbations (0.20 vs 0.11 exacerbations PPY; 95% CI, 21%-63%; P = .002) and a 16% lower PPY rate of moderate exacerbations (1.03 vs 0.86 exacerbations PPY; 95% CI, 1%-31%; P = .038). Compared with delayed treatment, prompt treatment was associated with $7543 lower all-cause health care costs PPY ($38,839 vs $31,296 PPY; P = .014) and with $5929 lower COPD-related costs ($21,146 vs $15,217 PPY; P = .002) (all costs 2023 US$).25,36 Limitations of this analysis include the small percentage (< 1%) of all patients with a COPD exacerbation who met selection criteria, the possibility for bias in selecting delayed initiators, and the potential that the largely commercially insured study population may not be generalizable to the larger US population.36


Despite its high prevalence and substantial clinical and economic impact, COPD is underdiagnosed.3,5,22,26 A lack of provider familiarity with COPD guidelines, limited patient and provider access to spirometry, and costs related to management of exacerbations represent additional concerns for payers in the management of this disease.2,4,23,27-30 Identification of at-risk patients, early treatment, and concordance with guidance from the GOLD 2023 and 2024 reports can improve clinical and economic outcomes when treating patients with this disease.6,32,35 Authors of the GOLD 2023 report call attention to a revised COPD assessment that prioritizes the role of exacerbations, the recommendation of TT over LABA+ICS in appropriate patients, and the preference for treatment using a single inhaler.1,8


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