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Cost-effectiveness analysis of a single-inhaler triple therapy for COPD in the UK

Elisabeth Fenwick, Alan Martin, Melanie Schroeder, Stuart J. Mealing, Oyinkansola Solanke, Nancy Risebrough, Afisi S. Ismaila
ERJ Open Research 2021 7: 00480-2020; DOI: 10.1183/23120541.00480-2020
Elisabeth Fenwick
1ICON Health Economics, ICON plc., Abingdon, UK
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Alan Martin
2Value Evidence and Outcomes, GlaxoSmithKline plc., Uxbridge, UK
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Melanie Schroeder
3Value Evidence and Outcomes, GlaxoSmithKline plc., Brentford, UK
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Stuart J. Mealing
1ICON Health Economics, ICON plc., Abingdon, UK
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Oyinkansola Solanke
4ICON Health Economics, ICON plc., London, UK
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Nancy Risebrough
5ICON Health Economics, ICON plc., Toronto, ON, Canada
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Afisi S. Ismaila
6Value Evidence and Outcomes, GlaxoSmithKline plc., Collegeville, PA, USA
7Dept of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, ON, Canada
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  • For correspondence: afisi.s.ismaila@gsk.com
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  • FIGURE 1
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    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
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    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
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    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

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  • TABLE 1

    Baseline patient characteristics

    ParameterValueSource
    Age at baseline years63.90±6.39FULFIL [4]
    Height m1.69±0.08FULFIL [4]
    Sex
     Male75.8TORCH [10]
    Age category years
     <5511.5TORCH [10]
     55 to <6532.3TORCH [10]
     65 to <7543.7TORCH [10]
     ≥7512.6TORCH [10]
    Exacerbation history (moderate or severe, in the previous 12 months)
     043.0TORCH [10]
     124.8TORCH [10]
     ≥232.3TORCH [10]
    BMI kg·m−2
     <2013.5TORCH [10]
     20 to <2537.6TORCH [10]
     25 to <2926.9TORCH [10]
     ≥2922.0TORCH [10]
    SGRQ total score
     <3828.8TORCH [10]
     38 to <5025.7TORCH [10]
     50 to <6222.9TORCH [10]
     ≥6222.6TORCH [10]
    FEV1 % pred, baseline#
     <30%12.9FULFIL [4]
     30 to <50%54.5FULFIL [4]
     50 to <80%32.6FULFIL [4]
     ≥80%<1.0FULFIL [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 categoryResource use (per annum/per exacerbation)#Unit cost (2017)¶Overall cost (per annum/per exacerbation)
      Moderate COPD
       Outpatient visit, respiratory physician0.00£149.35£0.00
       Outpatient visit, GP2.00£36.68£73.37
       Spirometry2.00£61.57£123.15
       Influenza vaccination0.75£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 physician2.00£149.35£298.71
       Outpatient visit, GP0.00£36.68£0.00
       Spirometry2.00£61.57£123.15
       Influenza vaccination0.75£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 physician4.00£149.35£597.42
       Outpatient visit, GP0.00£36.68£0.00
       Spirometry4.00£61.57£246.29
       Influenza vaccination0.75£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 days0.00£1341.52£0.00
       Non-ICU days1.01£436.97£441.34
       ER visits0.03£200.94£6.03
       Outpatient visit, respiratory physician0.34£149.35£50.78
       Outpatient visit, GP0.66£36.68£24.21
       Visit other HCP0.27£98.52£26.60
       Antibiotics¶7.94£0.28£2.21
       Systemic steroids¶7.94£0.27£2.11
       Oxygen therapy0.00£16.98£0.00
       Total cost per moderate exacerbation£553.28
      Severe exacerbation
       ICU days0.86£1341.52£1153.71
       Non-ICU days11.08£436.97£4841.63
       ER visits0.25£200.94£50.24
       Outpatient visit, respiratory physician0.82£149.35£122.47
       Outpatient visit, GP0.70£36.68£25.68
       Visit other HCP0.50£98.52£49.26
       Antibiotics¶11.75£0.56£6.55
       Systemic steroids¶24.08£0.27£6.40
       Oxygen therapy0.21£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#UtilityLower 95% CIUpper 95% CI
        Moderate COPD0.7870.7710.802
        Severe COPD0.7500.7310.768
        Very severe COPD0.6470.5980.695
        EventQALY loss per eventLower 95% CIUpper 95% CI
        Moderate exacerbation¶0.0110.0060.020
        Severe exacerbation¶0.0200.0200.030
        Pneumonia+0.0110.0060.020

        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/VIBUD/FORIncremental
          Outcomes
           Predicted cumulative exacerbations
            Moderate exacerbations5.7935.804–0.011
            Severe exacerbations1.4221.434–0.012
           Any moderate and/or severe exacerbation7.2167.238–0.023
           Total LYs (discounted)9.0948.5610.533
           Total QALYs (discounted)6.6386.1320.506
          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£1042Referent
           ICER per QALY£1098Referent

          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 caseScenarioFF/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 mortalityOnOff£1011
            Post-trial treatment effectOffOn – 1 year£255
            Post-trial treatment effectOffOn – 3 yearsDominant
            Post-trial treatment effectOffOn – 5 yearsDominant
            Post-trial treatment effect – waningOffOn – 5 yearsDominant
            Overall treatment discontinuationOnOff£1414
            Post-trial treatment discontinuationOnOff£1414
            Time horizonLifetimeTrial follow-upDominant
            Replacement therapyBy treatment armBy overall trial£1098
            PerspectiveHealth service perspectiveSocietal perspective£886

            FF: fluticasone furoate; UMEC: umeclidinium; VI: vilanterol; BUD: budesonide; FOR: formoterol; ICER: incremental cost-effectiveness ratio; QALY: quality-adjusted life year.

            Supplementary Materials

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              Supplementary material 00480-2020.SUPPLEMENT

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            Cost-effectiveness analysis of a single-inhaler triple therapy for COPD in the UK
            Elisabeth Fenwick, Alan Martin, Melanie Schroeder, Stuart J. Mealing, Oyinkansola Solanke, Nancy Risebrough, Afisi S. Ismaila
            ERJ Open Research Jan 2021, 7 (1) 00480-2020; DOI: 10.1183/23120541.00480-2020

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            Cost-effectiveness analysis of a single-inhaler triple therapy for COPD in the UK
            Elisabeth Fenwick, Alan Martin, Melanie Schroeder, Stuart J. Mealing, Oyinkansola Solanke, Nancy Risebrough, Afisi S. Ismaila
            ERJ Open Research Jan 2021, 7 (1) 00480-2020; DOI: 10.1183/23120541.00480-2020
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