Figures
- FIGURE 1
Conceptual COPD disease progression model. Moderate COPD (forced expiratory volume in 1 s (FEV1) % pred 50 to <80%); severe COPD (FEV1 % pred 30 to <50%); very severe COPD (FEV1 % pred <30%). A recent exacerbation history is defined as an exacerbation occurring within the previous year. QALY: quality-adjusted life year.
- FIGURE 2
One-way sensitivity analysis plot (quality-adjusted life years (QALYs); intent to treat (ITT) population). FF: fluticasone furoate; UMEC: umeclidinium; VI: vilanterol; BUD: budesonide; FOR: formoterol; ICER: incremental cost-effectiveness ratio.
- FIGURE 3
Incremental cost-effectiveness of fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) versus budesonide (BUD)/formoterol (FOR): (a) life year (LY) plane; (b) quality-adjusted life year (QALY) plane; (c) QALY cost-effectiveness acceptability curves (intent to treat (ITT) population; probabilistic analysis).
Tables
- TABLE 1
Baseline patient characteristics
Parameter Value Source Age at baseline years 63.90±6.39 FULFIL [4] Height m 1.69±0.08 FULFIL [4] Sex Male 75.8 TORCH [10] Age category years <55 11.5 TORCH [10] 55 to <65 32.3 TORCH [10] 65 to <75 43.7 TORCH [10] ≥75 12.6 TORCH [10] Exacerbation history (moderate or severe, in the previous 12 months) 0 43.0 TORCH [10] 1 24.8 TORCH [10] ≥2 32.3 TORCH [10] BMI kg·m−2 <20 13.5 TORCH [10] 20 to <25 37.6 TORCH [10] 25 to <29 26.9 TORCH [10] ≥29 22.0 TORCH [10] SGRQ total score <38 28.8 TORCH [10] 38 to <50 25.7 TORCH [10] 50 to <62 22.9 TORCH [10] ≥62 22.6 TORCH [10] FEV1 % pred, baseline# <30% 12.9 FULFIL [4] 30 to <50% 54.5 FULFIL [4] 50 to <80% 32.6 FULFIL [4] ≥80% <1.0 FULFIL [4] Data are presented as mean±sd or %. #: forced expiratory volume in 1 s (FEV1) % pred at baseline was not included in the model and is provided only as information describing lung function status at study entry. BMI: body mass index; SGRQ: St. George's Respiratory Questionnaire; TORCH: Towards a Revolution in COPD Health; FULFIL: Lung Function and Quality of Life Assessment in Chronic Obstructive Pulmonary Disease with Closed Triple Therapy.
- TABLE 2
Itemised resource use and unit costs for COPD therapy and exacerbations
Cost category Resource use (per annum/per exacerbation)# Unit cost (2017)¶ Overall cost (per annum/per exacerbation) Moderate COPD Outpatient visit, respiratory physician 0.00 £149.35 £0.00 Outpatient visit, GP 2.00 £36.68 £73.37 Spirometry 2.00 £61.57 £123.15 Influenza vaccination 0.75 £9.05 £6.79 Oxygen therapy (days) 0.00 £16.98 £0.00 Total cost of moderate COPD (per annum) £203.30 Severe COPD Outpatient visit, respiratory physician 2.00 £149.35 £298.71 Outpatient visit, GP 0.00 £36.68 £0.00 Spirometry 2.00 £61.57 £123.15 Influenza vaccination 0.75 £9.05 £6.79 Oxygen therapy (days) 14.60 £16.98 £247.86 Total cost of severe COPD (per annum) £676.51 Very severe COPD Outpatient visit, respiratory physician 4.00 £149.35 £597.42 Outpatient visit, GP 0.00 £36.68 £0.00 Spirometry 4.00 £61.57 £246.29 Influenza vaccination 0.75 £9.05 £6.79 Oxygen therapy (days) 73.00 £16.98 £1239.32 Total cost of very severe COPD (per annum) £2089.82 Moderate exacerbation ICU days 0.00 £1341.52 £0.00 Non-ICU days 1.01 £436.97 £441.34 ER visits 0.03 £200.94 £6.03 Outpatient visit, respiratory physician 0.34 £149.35 £50.78 Outpatient visit, GP 0.66 £36.68 £24.21 Visit other HCP 0.27 £98.52 £26.60 Antibiotics¶ 7.94 £0.28 £2.21 Systemic steroids¶ 7.94 £0.27 £2.11 Oxygen therapy 0.00 £16.98 £0.00 Total cost per moderate exacerbation £553.28 Severe exacerbation ICU days 0.86 £1341.52 £1153.71 Non-ICU days 11.08 £436.97 £4841.63 ER visits 0.25 £200.94 £50.24 Outpatient visit, respiratory physician 0.82 £149.35 £122.47 Outpatient visit, GP 0.70 £36.68 £25.68 Visit other HCP 0.50 £98.52 £49.26 Antibiotics¶ 11.75 £0.56 £6.55 Systemic steroids¶ 24.08 £0.27 £6.40 Oxygen therapy 0.21 £16.98 £3.57 Total cost per severe exacerbation £6259.49 Cost per pneumonia event £6533.07 Unit costs come from Oostenbrink et al. [14], National Health Service Reference Costs 2015/16 [15] and PSSRU, 2016 [16]. GP: general practitioner; ICU: intensive care unit; ER: emergency room; HCP: healthcare professional; PSSRU: Personal Social Services Research Unit. #: Resource use estimates were based on Oostenbrink et al., 2005 [14]; ¶: unit cost represents the cost per day or visit, or per category.
- TABLE 3
Health-state utilities and QALY loss associated with each event
Health state# Utility Lower 95% CI Upper 95% CI Moderate COPD 0.787 0.771 0.802 Severe COPD 0.750 0.731 0.768 Very severe COPD 0.647 0.598 0.695 Event QALY loss per event Lower 95% CI Upper 95% CI Moderate exacerbation¶ 0.011 0.006 0.020 Severe exacerbation¶ 0.020 0.020 0.030 Pneumonia+ 0.011 0.006 0.020 QALY: quality-adjusted life year; NICE: National Institute for Health and Care Excellence. #: source Rutten-van Mölken et al. [20]; ¶: source NICE Guidelines, 2010 [22]; +: assumption: equivalent to moderate exacerbation.
- TABLE 4
Base-case results (lifetime horizon#), intent to treat population
FF/UMEC/VI BUD/FOR Incremental Outcomes Predicted cumulative exacerbations Moderate exacerbations 5.793 5.804 –0.011 Severe exacerbations 1.422 1.434 –0.012 Any moderate and/or severe exacerbation 7.216 7.238 –0.023 Total LYs (discounted) 9.094 8.561 0.533 Total QALYs (discounted) 6.638 6.132 0.506 Costs Maintenance £7531 £8495 –£965 Moderate exacerbation £2459 £2484 –£25 Severe exacerbation £6874 £6974 –£100 Pneumonia £4261 £3927 £334 Treatment £4887 £3339 £1549 Discontinuation £404 £641 –£237 Total costs £26 416 £25 860 £556 ICER per LY £1042 Referent ICER per QALY £1098 Referent FF: fluticasone furoate; UMEC: umeclidinium; VI: vilanterol; BUD: budesonide; FOR: formoterol; LY: life year; QALY: quality-adjusted life year; ICER: incremental cost-effectiveness ratio. #: Outcomes and costs observed over the complete period (trial-based and Markov models).
- TABLE 5
Scenario analyses (FF/UMEC/VI versus BUD/FOR), intent to treat population
Base case Scenario FF/UMEC/VI ICER (cost per QALY gained) Base case £1098 Discount rate (costs, benefits) 3.5% 0.0% £1547 Discount rate (costs, benefits) 3.5% 5.0% £900 Within-trial mortality On Off £1011 Post-trial treatment effect Off On – 1 year £255 Post-trial treatment effect Off On – 3 years Dominant Post-trial treatment effect Off On – 5 years Dominant Post-trial treatment effect – waning Off On – 5 years Dominant Overall treatment discontinuation On Off £1414 Post-trial treatment discontinuation On Off £1414 Time horizon Lifetime Trial follow-up Dominant Replacement therapy By treatment arm By overall trial £1098 Perspective Health service perspective Societal perspective £886 FF: fluticasone furoate; UMEC: umeclidinium; VI: vilanterol; BUD: budesonide; FOR: formoterol; ICER: incremental cost-effectiveness ratio; QALY: quality-adjusted life year.
Supplementary Material
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Supplementary material 00480-2020.SUPPLEMENT
