Cost Analysis of COPD Exacerbations and Cardiovascular Events in SUMMIT – AJMC.com Managed Markets Network

Richard H. Stanford, PharmD, MS; Anna D. Coutinho, PhD; Michael Eaddy, PharmD, PhD; Binglin Yue, MS; and Michael Bogart, PharmD

This cost analysis using data from the Study to Understand Mortality and Morbidity in COPD (SUMMIT) trial found that fluticasone furoate/vilanterol reduced the rates and costs of combined chronic obstructive pulmonary disease (COPD) exacerbations and revascularization/cardiovascular events versus placebo.

Objectives: The Study to Understand Mortality and Morbidity in COPD (SUMMIT) trial compared the efficacy of once-daily fluticasone furoate/vilanterol (FF/VI) with placebo, FF monotherapy, and VI monotherapy on mortality in patients with moderate chronic obstructive pulmonary disease (COPD) and a history/increased risk of cardiovascular (CV) disease. We conducted a post hoc economic analysis using data from SUMMIT to evaluate the economic benefits of treating these patients with COPD and CV risk.

Study Design: Patients (aged 40-80 years, with 10 pack-years smoking history and a risk of CV events) were randomized (1:1:1:1) to receive placebo, FF 100 mcg, VI 25 mcg, or FF/VI 100 mcg/25 mcg.

Methods: This was a post hoc economic analysis to assess the rates and associated costs of the composite end point (acute COPD exacerbations and revascularization/CV composite events) in the SUMMIT trial from a US healthcare payer perspective.

Results: Overall, 16,485 patients were evaluated; of these, 5246 (31.8%) experienced an on-treatment composite end point event (28.5% experienced a COPD exacerbation, 4.2% experienced a CV event, and 2.0% underwent a revascularization procedure). The mean estimated 1-year on-treatment combined end point cost was highest for placebo and lowest for FF/VI ($4220 vs $3482, respectively). The reductions in cost versus placebo were significant for all active treatments (P <.0001). The likelihood of experiencing an on-treatment combined end point event was lower for patients treated with FF/VI versus placebo (hazard ratio, 0.81; P <.001).

Conclusions: One-year combined end point event costs were significantly lower for all active treatments versus placebo. Clinicians and payers may be able decrease costs by effectively managing patients COPD in those with CV risk.

Am J Manag Care. 2019;25(11):e320-e325

In patients with moderate chronic obstructive pulmonary disease (COPD) and cardiovascular (CV) risk, once-daily fluticasone furoate/vilanterol (FF/VI) was associated with significantly lower rates and costs of combined COPD exacerbations and revascularization/CV events versus placebo, FF monotherapy, and VI monotherapy. COPD exacerbations were more frequent than CV events (28.5% vs 4.2% experienced an event, respectively).

Of the comorbidities commonly seen in patients with COPD, the most clinically significant is cardiovascular (CV) disease. Individuals with COPD have an increased risk of CV-related hospitalization and/or mortality compared with those without COPD.5-8 In patients with COPD, more deaths are caused by CV disease (eg, coronary heart disease, stroke) than by respiratory-related COPD effects,9,10 and the increased hospitalization and emergency visit rates associated with comorbid CV disease in COPD result in costs that are 2.5 times higher than in patients with COPD without CV comorbidities.11 Therefore, treatments that reduce the incidence of COPD exacerbations and CV events may have the potential for generating cost savings and reducing the economic burden of COPD.

Limited evidence is available on the impact of COPD treatment on CV events and mortality, and current guidelines from the Global Initiative for Chronic Obstructive Lung Disease recommend that patients COPD and comorbid CV diseases be treated independently.12 Results from secondary analyses of 2 large-scale clinical trials suggest that COPD maintenance therapies consisting of inhaled corticosteroid/long-acting 2 agonist (ICS/LABA) combinations may reduce patients risk of CV events and respiratory and CV-related mortality.13,14

The Study to Understand Mortality and Morbidity in COPD (SUMMIT) was a prospective, randomized, phase 3 trial that compared the efficacy of once-daily ICS/LABA fluticasone furoate/vilanterol 100 mcg/25 mcg (FF/VI) combination therapy, and its individual components FF 100 mcg once-daily monotherapy and VI 25 mcg once-daily monotherapy, versus placebo on mortality in patients with moderate COPD and a heightened risk of CV disease.15 The primary end point of SUMMIT was the incidence of all-cause mortality, which was unaffected by combination FF/VI therapy or the individual components compared with placebo.15 Outcomes assessed in the SUMMIT trial included the rate of moderate and severe COPD exacerbations15 and the number of patients experiencing a first composite CV event (CV death, myocardial infarction, stroke, unstable angina, or transient ischemic attack). All active treatments significantly reduced moderate and severe exacerbations versus placebo (all P <.025), whereas no differences were observed in composite CV events.15

This post hoc analysis used patient-level event data from the SUMMIT trial to examine the combined economic burden of acute COPD exacerbations and CV events and to evaluate the costs (US$) associated with these events, stratified by treatment (FF/VI, FF monotherapy, VI monotherapy, and placebo) from a US payer perspective. The primary objective of our analysis was to evaluate the incremental costs related to the combined end point (COPD exacerbation or revascularization/CV event) between treatment cohorts. Our secondary objectives were to evaluate the likelihood of experiencing the combined end point between treatment cohorts and to quantify the incremental number of events related to the combined end point between treatment cohorts.

METHODS

Study Design

This was a retrospective, post hoc economic analysis of within-trial acute COPD exacerbation and CV event data from the SUMMIT trial, conducted from the US payer perspective. The SUMMIT trial was a multicenter, randomized, double-blind, placebo-controlled, event-driven, international clinical trial of FF/VI in patients with COPD with heightened CV risk (ClinicalTrials.gov identifier, NCT01313676; GSK study number, HZC113782). Details of the main SUMMIT study design have been reported previously.15,16

The SUMMIT trial was conducted in accordance with Good Clinical Practice guidelines and the Declaration of Helsinki and was approved by local ethics committees. All patients provided written informed consent. Employees of the study sponsor were involved in the design and data interpretation of this economic analysis and had the right to approve or disapprove the publication of the finished manuscript.

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Cost Analysis of COPD Exacerbations and Cardiovascular Events in SUMMIT - AJMC.com Managed Markets Network