Clinical and Economic Evaluation of Fluticasone Furoate/Umeclidinium/Vilanterol Versus Tiotropium/Olodaterol Therapy in Maintenance Treatment-Naive Patients with COPD in the US.

Abstract

Purpose: Long-acting bronchodilator (LABD) therapy is recommended for maintenance treatment in most patients with chronic obstructive pulmonary disease (COPD). However, triple therapy (TT; dual LABDs + inhaled corticosteroid [ICS]) is often used as first-line maintenance treatment. The benefits of TT versus dual LABDs as first-line treatments are unknown, necessitating an evaluation of its effectiveness and costs versus non-ICS alternatives.

Patients and methods: This retrospective study assessed administrative claims of maintenance treatment-naive patients in the United States with COPD aged ≥40 years initiating single-inhaler fluticasone furoate+umeclidinium+vilanterol (FF+UMEC+VI) or tiotropium+olodaterol (TIO+OLO). Patients were propensity score-matched (1:1) and followed for up to 12 months. The primary outcome was time to first COPD exacerbation. Secondary outcomes included time to first pneumonia diagnosis, pneumonia-related hospitalization, healthcare resource utilization (HCRU), and costs. COPD exacerbation and pneumonia risk were assessed using Cox proportional hazards regression.

Results: A total of 5,121 and 3,996 patients met the eligibility criteria for the FF+UMEC+VI and TIO+OLO groups, respectively. Outcomes were assessed among 2,951 matched pairs. The risk of moderate or severe COPD exacerbation was not significantly different between FF+UMEC+VI and TIO+OLO groups (hazard ratio [HR] [95% confidence interval {CI}]: 1.13 [0.99-1.29]; P=0.064). The risks of pneumonia (HR [95% CI]: 1.04 [0.85-1.27]; P=0.723) and pneumonia-related hospitalization (HR [95% CI]: 1.18 [0.78-1.79]; P=0.429) were also not significantly different between the groups. There were no significant differences in HCRU events or all-cause costs; however, FF+UMEC+VI initiators incurred greater COPD- and/or pneumonia-related pharmacy costs than TIO+OLO initiators (FF+UMEC+VI: $2,934 [$2,827-$3,041], TIO+OLO: $1,994 [$1,915-$2,073]; P<0.001).

Conclusion: In maintenance treatment-naive patients, FF+UMEC+VI offered no reduction in COPD exacerbation risk over TIO+OLO and resulted in higher pharmacy costs related to COPD and/or pneumonia treatment. These results support treatment recommendations for LAMA+LABA as initial maintenance therapy.

Trial registration: ClinicalTrials.gov identifier - NCT05169424.