OBJECTIVES : Single inhaler, once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100μg/62.5μg/25μg was compared to twice-daily budesonide/formoterol (BUD/FOR) 400μg/12μg for patients with moderate/severe COPD in a phase III trial (FULFIL, Lipson 2017). A de novo model was developed to assess the cost-effectiveness of FF/UMEC/VI vs BUD/FOR from a UK NHS perspective, using results from FULFIL.

METHODS : The model combines a decision-tree for the trial period, with longer-term outcomes extrapolated via a Markov model with health states reflecting COPD severity; disease progression and exacerbation rates are determined by risk equations based on the Towards a Revolution in COPD Health study (Calverley 2007). Baseline characteristics, efficacy and medication use were taken from FULFIL, with medication and healthcare resource use costed using UK unit costs and drug prices. Costs and health outcomes were discounted at 3.5% and modelled out to a lifetime horizon.

RESULTS : With FF/UMEC/VI vs BUD/FOR there were fewer moderate and severe exacerbations (5.793, 1.422 vs 5.804, 1.434 respectively), greater life-years (LYs) and quality-adjusted life years (QALYs) and higher total costs (9.094, 6.638 and £26,237 vs 8.561, 6.132 and £25,566, respectively). Patients receiving FF/UMEC/VI gained an additional 0.533 LYs and 0.506 QALYs, for an additional cost of £671, compared to BUD/FOR, to give ICERs of £1,257 per LY and £1,325 per QALY. Results were most sensitive to drug acquisition costs, utility associated with moderate COPD, mortality risk with very severe COPD and exacerbation treatment effect, with ICERs ranging from dominant to £3,253 per QALY in deterministic analyses. The probability of FF/UMEC/VI being cost-effective vs BUD/FOR was 100% at cost-effectiveness thresholds above £10,000 per QALY. The ICERs for key clinical subgroups ranged from £21 to £1,397 per QALY.

CONCLUSIONS : Treatment with FF/UMEC/VI was predicted to improve health outcomes and to be a cost-effective option for treatment of moderate/severe COPD compared to BUD/FOR, in the UK.

Funding: GSK (HO1613835)