Cost-Effectiveness of Triple Therapy with Budesonide/Glycopyrronium/Formoterol Fumarate Dihydrate versus Dual Therapies in Moderate-to-Very Severe Chronic Obstructive Pulmonary Disease: United Kingdom Analysis Using the ETHOS Study

Enrico de Nigris,1 Catrin Treharne,2 Nick Brighton,2 Ulf Holmgren,3 Andrew Walker,4 John Haughney5 1Formerly of Global Product and Portfolio Strategy, AstraZeneca, Cambridge, UK; 2Formerly of Health Economic Modelling, Regulatory and Access, Parexel International, London, UK; 3Real World Science and Digital, BioPharmaceuticals Medical, AstraZeneca, Gothenburg, Sweden; 4Salus Alba, Glasgow, UK; 5Clinical Research Facility, Queen Elizabeth University Hospital, Glasgow, UKCorrespondence: Ulf Holmgren, AstraZeneca, Pepparedsleden 1, Gothenburg, SE-431 83, Sweden, Tel +46 0 317 761 424, Email ulf.holmgren@astrazeneca.comBackground: In the 52-week ETHOS study (NCT02465567), fixed-dose triple therapy with budesonide/glycopyrronium/formoterol fumarate dihydrate (BGF) reduced moderate or severe chronic obstructive pulmonary disease (COPD) exacerbations versus fixed-dose long-acting muscarinic antagonist (LAMA)/long-acting β2-agonist (LABA) or inhaled corticosteroid (ICS)/LABA dual therapies. Here, ETHOS data were used to estimate the long-term cost-effectiveness of BGF versus LAMA/LABA and ICS/LABA dual therapies in the United Kingdom.Methods: Costs, exacerbations, quality-adjusted life-years (QALYs), and LYs were extrapolated using a Markov model that considered disease severity progression, risk of moderate and severe exacerbations, adverse events, and treatment discontinuation in patients with moderate-to-very severe COPD receiving BGF 320/14.4/10 μg, the LAMA/LABA glycopyrronium/formoterol fumarate dihydrate 14.4/10 μg (GFF), or the ICS/LABA budesonide/formoterol fumarate dihydrate 320/10 μg (BFF). Utilities for COPD severity states were estimated using EuroQol 5-dimension 5-level data from ETHOS. Exacerbation disutilities were sourced from published literature. Healthcare resource utilization was based on ETHOS data, published literature, key external experts’ input, and informed assumptions. Unit costs came from the UK National Health Service Schedule of Reference Costs, Unit Costs of Health and Social Care from the Personal Social Services Research Unit, and published literature. A lifetime horizon was considered, with costs, QALYs, and LYs discounted at 3.5% per annum.Results: The incremental cost–utility ratio (ICUR; per QALY gained) was £ 9901 for BGF versus GFF and £ 2164 for BGF versus BFF. The probability of treatments being cost-effective at the conventional UK-adopted willingness-to-pay threshold of ICUR