Cost-Effectiveness of Once-Daily Single-Inhaler COPD Triple Therapy in Spain: IMPACT Trial

Abstract

Purpose

Given between-country differences in healthcare systems, treatment costs, and disease management guidelines, country-specific cost-effectiveness analyses are important. This study evaluated the cost-effectiveness of once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) versus FF/VI and UMEC/VI among patients with symptomatic chronic obstructive pulmonary disease (COPD) at risk of exacerbations from a Spanish healthcare system perspective.

Patients and Methods

Baseline data and treatment effects from the IMPACT trial were populated into the validated GALAXY COPD progression model. Utilities were estimated using Spanish observational data. Direct healthcare costs (2019 €) were informed by Spanish public sources. A 3% discount rate for costs and benefits was applied. The time horizon and treatment duration were 3 years (base case). One-way sensitivity, scenario, and probabilistic sensitivity analyses were performed.

Results

FF/UMEC/VI treatment resulted in fewer exacerbations over 3 years (4.130 vs 3.648) versus FF/VI, with a mean (95% confidence interval [CI]) incremental cost of €444 (€149, €713) per patient and benefit of 0.064 (0.053, 0.076) quality-adjusted life years (QALYs), resulting in an incremental cost-effectiveness ratio (ICER) of €6887 per QALY gained. FF/UMEC/VI was a dominant treatment strategy versus UMEC/VI, resulting in fewer exacerbations (4.130 vs 3.360), with a mean (95% CI) incremental cost of –€450 (–€844, –€149) and benefit of 0.054 (0.043, 0.064) QALYs. FF/UMEC/VI was cost-effective versus FF/VI and UMEC/VI across all analyses.

Conclusion

FF/UMEC/VI was predicted to be a cost-effective treatment option versus FF/VI or UMEC/VI in symptomatic COPD patients at risk of exacerbations in Spain, across all scenarios and sensitivity analyses.

Keywords:

• chronic obstructive pulmonary disease
• cost-effectiveness
• single-inhaler triple therapy
• Spain
• triple inhaled therapy

Abbreviations

BUD, budesonide; CAT, COPD Assessment Test; CI, confidence interval; FEV_1, forced expiratory volume in 1 second; FF, fluticasone furoate; FOR, formoterol; GOLD, Global Initiative for COPD; ICER, incremental cost-effectiveness ratio; ICS, inhaled corticosteroid; ITT, intent-to-treat; LABA, long-acting β₂-agonist; LAMA, long-acting muscarinic antagonist; LY, life years; mMRC, modified Medical Research Council; PSA, probabilistic sensitivity analysis; QALY, quality-adjusted life years; UMEC, umeclidinium; VI, vilanterol.

Data Sharing Statement

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

Ethics Approval and Informed Consent

Ethical approval and patient informed consent were not applicable for this analysis as anonymized patient aggregated (summary) data were used for a subset of patients from the IMPACT primary trial. For the IMPACT primary trial, all patients provided written informed consent; the study was conducted in accordance with Good Clinical Practice guidelines and the provisions of the Declaration of Helsinki and received approval by local ethics review boards of the participating sites (Supplementary Table 6).

Acknowledgments

Editorial support in the form of preparation of the first draft based on input from all authors, and collation and incorporation of author feedback to develop subsequent drafts, was provided by Chrystelle Rasamison, of Fishawack Indicia Ltd. part of Fishawack Health, UK, and was funded by GSK. ELLIPTA is owned by or licensed to the GSK Group of Companies.

Author Contributions

All authors made a significant contribution to the work reported, whether that is 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 article; 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

LA Vallejo-Aparicio, A Martin, and AS Ismaila are employees of GSK and A Martin and AS Ismaila own stocks/shares in GSK. AS Ismaila is an unpaid part-time professor at McMaster University. VF Paly and C Abreu are ICON employees and C Biswas was an ICON employee at the time of this analysis. ICON received funding from GSK to conduct this study but not payment for manuscript development. JL Izquierdo, JA Riesco and JJ Soler-Cataluña received consulting fees from GSK to conduct this study but did not receive payment for manuscript development. JJ Soler-Cataluña also reports grant and personal fees from GSK; grant, personal fees and non-financial support from Boehringer Ingelheim and Laboratorios Esteve; personal fees and non-financial support from Bial, Menarini and Novartis; and personal fees from AstraZeneca, Chiesi, Faes, Rovi and Ferrer. The authors report no other conflicts of interest in this work.

Additional information

Funding

This study (GSK ID: HO-17-17596) was funded by GSK. The funders of the study had a role in study design, data analysis, data interpretation, and writing of the report. The corresponding author had full access to all the data and the final responsibility to submit for publication.