Cost-Effectiveness of Single-Inhaler Triple Therapy (FF/UMEC/VI) versus Tiotropium Monotherapy in Patients with Symptomatic Moderate-to-Very Severe COPD in the UK

Abstract

Purpose

For patients with chronic obstructive pulmonary disease (COPD) who remain symptomatic despite maintenance treatment, clinical management guidelines recommend a stepwise escalation from monotherapy to dual therapy, and from dual therapy to triple therapy. However, in clinical practice, patients are often escalated directly from monotherapy to triple therapy based on disease severity. This study evaluated the cost-effectiveness of once-daily, single-inhaler fluticasone furoate, umeclidinium, and vilanterol (FF/UMEC/VI) triple therapy compared with long-acting muscarinic antagonist monotherapy with once-daily tiotropium (TIO) in patients with symptomatic moderate-to-very severe COPD, from a UK National Health Service perspective.

Patients and Methods

The validated GALAXY-COPD disease progression model was populated with patient baseline characteristics and treatment effect data from the 12-week GSK Study 207626 comparing FF/UMEC/VI with TIO in patients with moderate-to-very severe COPD. UK unit costs and drug costs (British Pound, 2021) were applied to healthcare resource utilization and treatments. The base case analysis was conducted over a lifetime horizon, and costs and health outcomes (except for life years [LYs]) were discounted at 3.5% per year. Model outputs included exacerbation rates, healthcare costs, LYs, quality-adjusted LYs (QALYs), and incremental cost-effectiveness ratios.

Results

Overall, treatment with FF/UMEC/VI resulted in increased clinical benefit (reduction in total exacerbations and increased overall survival and QALYs), coupled with cost savings (derived from lower maintenance and exacerbation healthcare costs) compared with TIO monotherapy. In the base case analysis, FF/UMEC/VI provided an additional 0.393 LYs (95% range: 0.176, 0.655) and 0.443 QALYs (0.246, 0.648), at a cost saving of £880 (£54, £1608) versus TIO. FF/UMEC/VI remained the cost-effective (dominant) treatment option across sensitivity and scenario analyses.

Conclusion

FF/UMEC/VI offers greater clinical benefits and is a cost-effective treatment option compared with TIO for the treatment of adult patients with COPD with persistent symptoms and/or who are at risk of exacerbation in the UK.

Keywords:

• chronic obstructive pulmonary disease
• health technology assessment
• economic evaluation
• real-world
• single-inhaler triple therapy

Abbreviations

6MWT, 6-minute walk test; BMI, body mass index; CAT, COPD Assessment Test; CI, confidence interval; COPD, chronic obstructive pulmonary disease; CVD, cardiovascular disease; ECLIPSE, Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points; EMAX, Early MAXimisation of bronchodilation for improving COPD stability; FEV₁, forced expiratory volume in 1 second; FF, fluticasone furoate; FULFIL, Lung Function and Quality of Life Assessment in Chronic Obstructive Pulmonary Disease with Closed Triple Therapy; GBP, British Pound; ICER, incremental cost-effectiveness ratio; ICS, inhaled corticosteroid; IMPACT, InforMing the PAthway of COPD Treatment; INTREPID, INvestigation of TRelegy Effectiveness: usual PractIce Design; ITT, intent-to-treat; LABA, long-acting β₂-agonist; LAMA, long-acting muscarinic antagonist; LY, life year; mMRC, modified Medical Research Council; NHS, National Health Service; NICE, National Institute for Health and Care Excellence; OCS, oral corticosteroid; PPPY, per person per year; QALY, quality-adjusted life year; RRR, relative risk reduction; SD, standard deviation; SE, standard error; SGRQ, St George’s Respiratory Questionnaire; SITT, single-inhaler triple therapy; TIO, tiotropium; UMEC, umeclidinium; VI, vilanterol.

Data Sharing Statement

Anonymized individual participant data and study documents for Study 207626 can be requested for further research from www.clinicalstudydatarequest.com.

Ethics Approval and Informed Consent

Ethics committee approval and patient informed consent was not required for this analysis. The analysis was conducted using patient characteristics and treatment effects from a previously published study; therefore, no direct patient contact or primary collection of individual patient data were required.

Acknowledgments

Editorial support (in the form of writing assistance, including preparation of the draft manuscript under the direction and guidance of the authors, collating and incorporating authors’ comments for each draft, assembling tables and figures, grammatical editing, and referencing) was provided by Rebecca Cunningham and Abigail Marmont of Aura, a division of Spirit Medical Communications Group Limited, and was funded by GSK. The abstract of this paper was presented at the International Society of Pharmacoeconomic and Outcomes Research (ISPOR) 25th European Congress 2021 as a poster presentation with interim findings: Martin A, Shah D, Shukla S, et al. Cost-effectiveness of single-inhaler triple therapy (FF/UMEC/VI) versus tiotropium monotherapy in patients with COPD in the UK. Value Health. 2022; 25 (Suppl 1): S40.

Author Contributions

All authors made a significant contribution to the work reported, whether that was in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising, or critically reviewing the manuscript; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

AAM, SS, CC, and ASI are GSK employees. AAM, CC, and ASI hold shares in GSK. ASI is also an unpaid part-time professor at McMaster University, Hamilton, ON, Canada. RK and DS are ICON employees. ICON received funding from GSK to conduct this analysis, but not for manuscript development.

Additional information

Funding

This study was funded by GSK (GSK Study 212889). GSK-affiliated authors were involved in study conception and design, data analysis, data interpretation, and the decision to submit the article for publication. The sponsor funded the article processing charges and open access fee.