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Clinical Evidence Supporting the Evolving COPD Treatment Paradigm: Considerations for Managed Care and Evidence-Based Recommendations for Appropriate Utilization of COPD Treatment Strategies

Clinical Evidence Supporting the Evolving COPD Treatment Paradigm: Considerations for Managed Care and Evidence-Based Recommendations for Appropriate Utilization of COPD Treatment Strategies

In a key Academy of Managed Care Pharmacy (AMCP) Science and Innovation Theater Webinar, experts provided insights into the considerations for managed care in the evolving chronic obstructive pulmonary disease (COPD) treatment paradigm and the clinical evidence supporting the use of dual bronchodilation with long-acting muscarinic receptor antagonist (LAMA)/ long-acting beta2 agonist (LABA) combination therapies compared with LABA/inhaled corticosteroid (ICS) therapies for the management of patients with COPD. A substantial change was introduced in the 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) recommendations, based on high-quality supporting evidence, which highlighted LABA/LAMA as the preferred combination treatment over LABA/ICS, and provided limitations to ICS-containing treatment use in the management of COPD.1 The expert discussion highlighted managed care perspectives and clinical implications following the implementation of this substantial update in the 2018 GOLD report for the second year.2

The Growing Burden of COPD

According to the CDC, an estimated 15.7 million Americans have been diagnosed with COPD.3 Although COPD is often perceived as a disease of the elderly, more than half (67.0%) of all patients diagnosed with COPD are 64 years and younger.3

COPD is a treatable disease characterized by persistent respiratory symptoms that typically include breathlessness (dyspnea), chronic cough and/or sputum production, and airflow limitation due to airway and alveolar abnormalities attributed to toxic environmental gases and particles.2 Patients with COPD are also subject to periods of symptom worsening, or exacerbations, which negatively impact health status, increase hospitalization rates and readmissions, and contribute to disease progression.2 Chronic airflow limitations may be caused by a mixture of small airway disease and parenchymal destruction, which vary from patient to patient and may evolve at different rates and at different times.2

Co-leading the webinar discussion was Sanjay Sethi, MD, professor of medicine, chief in the Division of Pulmonary, Critical Care and Sleep Medicine, assistant vice president for Health Sciences, and medical director of the University of Buffalo Clinical Research Office. He addressed key challenges in diagnosing and treating patients with COPD, given its wide variability in presentation: “There is a substantial proportion of patients who have COPD in their so-called working years, and therefore that can have a substantial impact on their productivity.”

Economic Impact of COPD

COPD is responsible for substantial economic burdens on healthcare systems in the United States.COPD exacerbations and associated hospitalizations account for the greatest proportion of the cost burden, with a clear relationship between disease severity and cost of care.4 Total national medical costs attributable to COPD were estimated at $32.1 billion in 2010 and are projected to reach $49 billion in 2020.5 In 2010, nearly 700,000 patients were hospitalized for COPD, while 10.3 million were treated as outpatients and 1.5 million visited an emergency department (ED).The same data set from 2010 demonstrated that indirect COPD-attributable costs due to absenteeism were estimated at $3.9 billion (in 2012 dollars).5

Chronic conditions associated with COPD may interfere with disease management and contribute to hospitalizations.2 Factors driving the rising economic burden of COPD can be attributed to the aging US population coupled with the overall increase in healthcare utilization from COPD complicated by comorbidities and the growth of total medical costs.5

Andrew Cournoyer, RPh, MBA, vice president of formulary access solutions, Precision for Value, and former senior director of Formulary and Utilization Management, co-lead of the presentation, reemphasized the distribution of COPD patients by age and Medicare eligibility. Cournoyer noted that both age groups (ie, those younger than 65 years and the Medicare population) “should have equal weight across all lines of business [Medicare and commercial].” Although rising costs attributable to an aging population keep Medicare as a priority in COPD discussions, the total costs for both medical and pharmacy benefits need to be considered across age groups. Utilization management may offer opportunities to mitigate cost inflations due to rising medical and pharmacy costs.

The GOLD report provides expert opinions and recommendations for clinicians on maintenance treatment for the short- and long-term impacts of COPD, with the goals of relieving and reducing symptom burdens and risk of future exacerbations, improving quality of life, and reducing the risk of adverse events (AEs) and disease progression.2  GOLD recommendations emphasize individualized treatment for patients based on severity of symptoms, airflow limitation, and severity of exacerbations.2

Initial assessment and diagnosis requires spirometry to confirm the presence of persistent airflow limitation in patients with COPD symptoms, including dyspnea and chronic cough with or without sputum production.2 Once diagnosis is confirmed, the severity of airflow limitation is assessed and classified as GOLD stage 1 to 4 (Table 1).2 The GOLD recommendations include a COPD assessment tool which categorizes patients based on respiratory symptoms (severity of breathlessness, nature and magnitude of symptoms) and history of exacerbations to assign categories (ABCD) of disease (Table 2).2 Pharmacologic treatment recommendations are stratified by GOLD ABCD scale classifications for each group of patients (Figure 1).2 

2018 GOLD Treatment Recommendations

Pharmacologic therapy is the cornerstone of COPD management and it is used to reduce symptoms, reduce frequency and severity of exacerbations, and improve exercise tolerance and health status.2 Many factors influence the choice of therapeutic agent, including cost, availability, and clinical response, balanced with the AE profile of the medication.2

Combination Therapy With Long-Acting Bronchodilators

Combination therapy with long-acting bronchodilators is central to the management of patients with COPD.2 For patients with GOLD groups B, C, and D disease, LAMA/LABA combination therapies are the preferred treatment in the majority of patients with symptomatic COPD.2 LAMAs bind to muscarinic receptors and block the bronchoconstrictive effects of acetylcholine binding. The cholinergic receptors are located on smooth muscle cells where activation by acetylcholine increases peripheral airway resistance.6 LABAs bind to the beta2 receptor to induce bronchodilation. Beta2-adrenergic receptors also are located on smooth muscle cells where activation by beta2 agonists results in relaxation of bronchial smooth muscle.6 By combining therapies, different mechanisms of action target multiple receptor sites, which may have additive benefits for lung function and the reduction of both symptoms and the risk of exacerbations.2 Combination LAMA/LABA bronchodilators may increase the degree of bronchodilation with a lower risk of AEs compared with increasing the dose of monotherapy.2

Evolution of Changes in GOLD Recommendations for ICS Use

GOLD recommendations for the pharmacologic management of COPD no longer include ICS-containing regimens as the first-choice maintenance therapy in any GOLD group.2 Current GOLD-recommended strategies include the use of LAMA, LABA, and combination LAMA/LABA as preferred treatments for symptomatic patients with COPD, regardless of exacerbation risk.2 The GOLD report recommends LAMA/LABA bronchodilator combination therapy as a preferred treatment over LABA/ICS therapy due to an increased risk for developing pneumonia with ICS products.2 Furthermore, this recommendation was implemented in the 2017 GOLD report and reinforced in the 2018 GOLD report based partially on evidence demonstrating that LAMA/LABA combinations are more effective at reducing the number of exacerbations compared with LABA/ICS combinations.2

LAMA/LABA/ICS triple therapy is recommended only for those patients who develop further exacerbations while on LAMA/LABA combination therapy.2 Dr Sethi emphasized the importance of adherence with recommendations: “ICS-containing regimens have a role, not as first-line therapy, but as add-ons, and triple therapy is also only recommended if you have further exacerbations beyond the use of the LAMA/LABA.”

Adverse Events With ICS Versus LAMA/LABA Therapies

AEs are to be expected with any pharmacologic treatment for COPD. However, the relative impact and/or seriousness of the AEs should be considered and weighed in the balance of treatment response. LAMA/LABA combinations are often associated with airway AEs, such as pharyngitis and nasopharyngitis.7-9 For ICS-containing products, Dr Sethi noted a range in impact from “nuisance” AEs, such as oropharyngeal candidiasis and skin bruising, to increased risk of cataracts, diabetes, and fractures.10

The most concerning AE discussed in terms of clinical and economic impact was pneumonia. Studies have demonstrated that ICS use is associated with an increased risk of pneumonia in patients with COPD. A 2016 meta-analysis of data from 29 randomized controlled trials (RCTs) and 9 observational studies assessed the risk of pneumonia in patients taking ICS-containing therapy. The analysis showed a significantly increased risk of pneumonia among ICS users in the RCTs (relative risk [RR], 1.61; 95% CI, 1.35-1.93; P <.001) and in the observational studies (odds ratio [OR], 1.89; 95% CI, 1.39-2.58; P <.001).11 

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