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

Figures & data

Table 1 Model Input Parameters for the Spanish Population of the IMPACT Trial

	Spanish Base Case Population	Data Source
Baseline demographics and clinical characteristics
Age (years), mean (SD)	66.9 (8.06)	IMPACT data for Spain subgroup (N=499)^a
Female, %	21	IMPACT data for Spain subgroup (N=499)^a
BMI (kg/m^2), %		IMPACT data for Spain subgroup (N=499)^a
<21	7
21–30	58
>30	35
Height (cm), mean (SD)	166.2 (8.18)	IMPACT data for Spain subgroup (N=499)^a
Smoking status (current smokers), %	27	IMPACT data for Spain subgroup (N=499)^a
Any cardiovascular comorbidity, %	44	IMPACT ITT
Any other comorbidity, %	57	IMPACT ITT
mMRC dyspnea score ≥2, %	37^b	IMPACT ITT
History of exacerbation, ≥1 moderate or severe in past year, %	99.9	IMPACT ITT
Number of exacerbations in previous year, mean (SE^c)	1.71 (0.01)	IMPACT ITT
Number of severe exacerbations in previous year, mean	0.30	IMPACT ITT
Starting FEV1% predicted, mean (SD)	45.5 (0.15)	IMPACT ITT
Starting FEV1, L, mean	1.195	Based on FEV1% reported in IMPACT and formulae based on ECLIPSE to back-calculate the starting FEV1 value
Fibrinogen (µg/dL), mean (SE)	486.3 (2.37)	Derived from GALAXY risk equation using ECLIPSE data
Starting SGRQ total score, mean (95% CI)	44.1 (42.7, 45.5)	IMPACT data for Spanish population
6MWD (m), mean (SE)	358.4 (2.74)	Derived from GALAXY risk equation using ECLIPSE data
Treatment effects		IMPACT ITT (N=10,355)
		FF/UMEC/VI vs FF/VI	FF/UMEC/VI vs UMEC/VI
Difference FEV1 incremental change from baseline, mL (95% CI)		97 (85, 109)	54 (39, 69)
Difference SGRQ total score change from baseline (95% CI)		–1.8 (–2.4, –1.1)^d	–1.8 (–2.6, –1.0)^d
Moderate exacerbation reduction, rate ratio (95% CI)		0.84 (0.79, 0.90)	0.77 (0.71, 0.84)
Severe exacerbation reduction, rate ratio (95% CI)		0.87 (0.76, 1.01)	0.66 (0.56, 0.78)

Notes: ^aPatients received FF/UMEC/VI (n=194), FF/VI (n=207) or UMEC/VI (n=98); ^bapproximated using the proportion of patients with a CAT score ≥21 in the IMPACT ITT; ^cSE assumed to be 10% of mean; ^dvalues in the table are SGRQ, which is transformed into SGRQ-C in the model by dividing by 0.9.

Abbreviations: 6MWD, 6-minute walk distance; BMI, body mass index; CAT, chronic obstructive pulmonary disease assessment test; CI, confidence interval; FEV₁, forced expiratory volume in 1 second; FF, fluticasone furoate; ITT, intent to treat; mMRC, modified Medical Research Council; SD, standard deviation; SE, standard error; SGRQ, St George’s Respiratory Questionnaire; SGRQ-C, St George’s Respiratory Questionnaire for patients with COPD; UMEC, umeclidinium; VI, vilanterol.

Table 2 Costs by Health State and Exacerbation Event

Exacerbation Event Costs		Annual General Disease Management Costs
Moderate exacerbation marginal cost per event	Severe exacerbation marginal cost per event	With dyspnea symptoms most days per week	With dyspnea symptoms several days per week	Without dyspnea symptoms
€74.85	€4594.46	€952.46	€720.10	€539.96

Note: Costs were sourced from the literature,^9,14,20 inflated to 2019 values, and assumed to be the same irrespective of disease severity, as measured by FEV₁% predicted.

Abbreviation: FEV₁, forced expiratory volume in 1 second.

Table 3 Base Case Results with FF/UMEC/VI versus FF/VI and versus UMEC/VI (Spanish IMPACT Population)

	FF/UMEC/VI vs FF/VI		FF/UMEC/VI vs UMEC/VI
	FF/UMEC/VI	FF/VI	FF/UMEC/VI	UMEC/VI
Cumulative number of exacerbations (3-year time frame)
Moderate exacerbations	3.061	3.481	2.874	3.481
Severe exacerbations	0.587	0.650	0.485	0.650
Total exacerbations	3.648	4.130	3.360	4.130
Severe exacerbations PPPY	0.207	0.230	0.172	0.230
Total exacerbations PPPY	1.289	1.464	1.187	1.464
Outcomes at the end of the 3-year time frame
LYs (undiscounted)	2.831	2.821	2.829	2.821
QALYs	2.063	1.999	2.053	1.999
Costs per patient at the end of the 3-year time frame
Drug costs	€2754	€1990	€2752	€2420
Non-drug costs	€5183	€5503	€4720	€5503
Total costs	€7937	€7493	€7472	€7923
Incremental results (FF/UMEC/VI vs comparator)
Costs per patient (95% CI)^a	€444 (€149, €713)		–€450 (–€844, –€149)
QALYs (95% CI)^a	0.064 (0.053, 0.076)		0.054 (0.043, 0.064)
ICER (€ per QALY gained) (95% CI)^a	€6887 (€2219, €12,059)^b		Dominant^b

Notes: ^a95% CI based on 5000 Monte Carlo probabilistic analysis simulations; ^b95% CI based on upper and lower limits of ICERs for each simulation.

Abbreviations: CI, confidence interval; FF, fluticasone furoate; ICER, incremental cost-effectiveness ratio; LY, life year; PPPY, per patient per year; QALYs, quality-adjusted life years; UMEC, umeclidinium; VI, vilanterol.

Figure 1 Sensitivity (A) and scenario (B) analyses for FF/UMEC/VI versus FF/VI in the Spanish IMPACT population.

Notes: ^aSensitivity analyses setting the 95% CI for the SGRQ treatment effect to the upper and lower bounds did not alter the base case ICER. Vertical line represents the base case. Orange/grey bars represent the ICER per QALY gained for each sensitivity/scenario analysis when the variable is adjusted to the low/high value.

Abbreviations: CI, confidence interval; FEV₁, forced expiratory volume in 1 second; FF, fluticasone furoate; HRQoL, health-related quality of life; ICER, incremental cost-effectiveness ratio; QALYs, quality-adjusted life years; SGRQ, St George’s Respiratory Questionnaire; SGRQ-C, St George’s Respiratory Questionnaire for patients with chronic obstructive pulmonary disease; UMEC, umeclidinium; VI, vilanterol.

Figure 2 PSA results FF/UMEC/VI versus FF/VI: (A) incremental cost-effectiveness plane; (B) net benefit acceptability curve (Spanish IMPACT population).

Abbreviations: FF, fluticasone furoate; QALYs, quality-adjusted life years; UMEC, umeclidinium; VI, vilanterol.

Figure 3 PSA results incremental cost-effectiveness plane for FF/UMEC/VI versus UMEC/VI (Spanish IMPACT population).

Abbreviations: FF, fluticasone furoate; QALYs, quality-adjusted life years; UMEC, umeclidinium; VI, vilanterol.

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