Cost-effectiveness analysis of umeclidinium/vilanterol for the management of patients with moderate to very severe COPD using an economic model

Figures & data

Figure 1 Structure of the decision model used.

Notes: ^aWithin the health states, patients may experience either a severe or a nonsevere exacerbation. ^bDeath could occur from any health status.
Abbreviation: FEV₁, forced expiratory volume in 1 second.

Table 1 Clinical efficacy, including change in trough FEV₁, exacerbations, and AEs

Parameter	Values	Source/assumption
Mean change in trough FEV1 in the first 24–26 weeks of treatment (L)
UMEC/VI	0.200	Decramer et al (2014)^Citation9 and Maleki-Yazdi et al (2014)^Citation11
TIO	0.112	Decramer et al (2014)^Citation9 and Maleki-Yazdi et al (2014)^Citation11
No long-acting bronchodilatora	0.033	Jones (2013)^Citation17 and Donohue et al (2013):^Citation10 the placebo arm in this study was shown to have some effect on FEV1, believed to be due to short-term treatment
Open dual LAMA + LABA	0.200	Assumed same as UMEC/VIb
Exacerbations per year (by disease severity)
Total
Moderate COPD	0.85	Hurst et al (2010)^Citation13
Severe COPD	1.34
Very severe COPD	2.00
Severe
Moderate COPD	0.11	Hurst et al (2010)^Citation13
Severe COPD	0.25
Very severe COPD	0.54
Nonsevere
Moderate COPD	0.74	Hurst et al (2010)^Citation13
Severe COPD	1.09
Very severe COPD	1.46
AE rates (%);c Decramer et al (2014),^Citation9 Donohue et al (2013),^Citation10 Maleki-Yazdi et al (2014),^Citation11 and Celli et al (2014)^Citation19
	UMEC/VI	TIO (absolute difference: UMEC/VI – TIO)	No long-acting bronchodilator treatment (absolute difference: UMEC/VI – no long-acting bronchodilator)
N	1,296	874	555
Headache	8.95	6.29 (2.66)	10.45 (−1.50)
Musculoskeletal (back) pain	3.09	3.20 (−0.11)	3.60 (−0.51)
Nasopharyngitis	7.87	7.21 (0.66)	8.65 (−0.78)
Upper respiratory tract infection	2.31	2.97 (−0.66)	3.78 (−1.47)

Notes:

a Mean change in FEV₁ for no long-acting bronchodilator treatment compared with UMEC/VI was extracted from Donohue et al.¹⁰

b This was one of the key assumptions made for this model.

c AEs are not shown for open dual LAMA + LABA therapy as they were assumed to be the same as for UMEC/VI.

Abbreviations: AE, adverse event; FEV₁, forced expiratory volume in 1 second; LABA, long-acting β₂-agonist; LAMA, long-acting muscarinic antagonist; TIO, tiotropium; UMEC, umeclidinium; VI, vilanterol.

Table 2 Costs included as model inputs and the utility values for COPD severity and exacerbation severity

Parameter	Value	Source/assumption
Exacerbation costs	Quarterly costs
Severe exacerbation	$8,116.88	Yu et al (2011)^Citation24 and US BLS (2015)^Citation27
Nonsevere exacerbation	$1,401.56	Yu et al (2011)^Citation24 and US BLS (2015)^Citation27
No exacerbation	$527.76	Yu et al (2011)^Citation24 and US BLS (2015)^Citation27
AE	Costsa (per reported AE)
Headache	$73.99	Physician visit at $73.99 (RBRVS, [Ingenix, 2013]^Citation26); US BLS (2015)^Citation27
Musculoskeletal (back) pain	$73.99	Physician visit at $73.99 (RBRVS, [Ingenix, 2013]^Citation26); US BLS (2015)^Citation27
Nasopharyngitis	$73.99	Physician visit at $73.99 (RBRVS, [Ingenix, 2013]^Citation26); US BLS (2015)^Citation27
Upper respiratory tract infection	$75.36	Physician visit at $73.99 (RBRVS, [Ingenix, 2013]^Citation26) and penicillin V antibiotic treatment at $13.00 applied to 10% of patients with strep-positive diagnosis (CDC);^Citation25 US BLS (2015)^Citation27
Drug costs	Monthly prescription costs (WAC)
UMEC/VI	$297.81	Medi-Span (2015)^Citation23
TIO	$315.68	Medi-Span (2015)^Citation23
No long-acting bronchodilator	$295.71	Assumed price of ipratropium/albuterol^Citation23
LAMA	$315.68	Assumed price of TIO^Citation23
LABA	$261.74	Assumed price of salmeterol and formoterol^Citation23
Add-on drug costs
ICS	$179.70	Assumed price of fluticasone propionate; applied to UMEC/VI and open dual after 1 year of primary treatment
ICS/LABA	$309.84	Assumed price of fluticasone propionate/salmeterol; applied to TIO and no long-acting bronchodilator after 1 year of primary treatment
Add-on uptake	%
Moderate COPD	27	GSK, data on file
Severe COPD	40
Very severe COPD	45
Disease severity	Utility (SE)b	By exacerbation: mean modeled utility (SE)b
		Requiring primary care treatment with oral corticosteroids and/or antibacterials (nonsevere)	Requiring hospital admission (severe)
Moderate COPD	0.810 (0.02)	0.720 (0.02)	0.519 (0.02)
Severe COPD	0.720 (0.03)	0.658 (0.03)	0.447 (0.07)
Very severe COPD	0.670 (0.05)	0.475 (0.05)	0.408 (0.05)

Notes:

a The physician visit cost was estimated to be $73.99 using CPT code 99213, which is described as in RBRVS, Ingenix, 2013.²⁶ CPT codes were obtained from the American Medical Association (2013).³⁹

b Disease severity and exacerbation-specific utilities were derived by Spencer (2005) et al.¹⁸ Costs are presented in US dollars based on 2015 prices.

Abbreviations: AE, adverse event; BLS, Bureau of Labor Statistics; CDC, Centers for Disease Control and Prevention; CPT, current procedural terminology; ICS, inhaled corticosteroids; LABA, long-acting β₂-agonist; LAMA, long-acting muscarinic antagonist; RBRVS, Resource Based Relative Value Scale; SE, standard error; TIO, tiotropium; UMEC, umeclidinium; VI, vilanterol; WAC, wholesale acquisition cost.

Table 3 Base-case analysis results over a lifetime horizon

Parameter	UMEC/VI	TIO	No long-acting bronchodilator	Open dual LAMA + LABA
Costs
Drug costs	$40,229	$46,342	$43,715	$72,327
Other medical costs	$42,115	$42,480	$43,036	$42,115
Total costs	$82,344	$88,822	$86,751	$114,442
Number of exacerbations
Nonsevere	10.866	10.938	11.045	10.866
Severe	2.347	2.433	2.552	2.347
Total exacerbations	13.214	13.371	13.597	13.214
Life-years	11.843	11.687	11.493	11.843
QALYs	7.304	7.195	7.055	7.304
Incremental cost-effectiveness ratio
Cost per life-year gained	–	UMEC/VI dominates	UMEC/VI dominates	Not defineda
Cost per QALY gained	–	UMEC/VI dominates	UMEC/VI dominates	Not defineda

Notes:

a Incremental cost-effectiveness ratio not defined as the effectiveness of open dual LAMA + LABA was assumed to be the same as UMEC/VI. Costs are presented in US dollars based on 2015 prices.

Abbreviations: LABA, long-acting β₂-agonist; LAMA, long-acting muscarinic antagonist; QALY, quality-adjusted life-year; TIO, tiotropium; UMEC, umeclidinium; VI, vilanterol.

Figure 2 Cost-effectiveness of UMEC/VI treatment in patients with moderate to very severe COPD: probabilistic sensitivity analyses (A) UMEC/VI compared with TIO and (B) UMEC/VI compared with no long-acting bronchodilator.

Note: Costs are presented in US dollars based on 2015 prices.
Abbreviations: CE, cost-effectiveness; ICER, incremental cost-effectiveness ratio; QALY, quality-adjusted life-year; TIO, tiotropium; UMEC, umeclidinium; VI, vilanterol.

Table S1 Transition probabilities for UMEC/VI

From	To
	Mild base	Moderate base	Severe base	Very severe base	New moderate	New severe	New very severe	CV death	Death
Mild base	–				–				–
Moderate base		0.944				0.031			0.026
Severe base			0.922				0.030		0.048
Very severe base				0.952					0.048
New moderate					0.948	0.026			0.026
New severe						0.909	0.043		0.048
New very severe							0.952		0.048
Death								0.000	1.000

Abbreviations: CV, cardiovascular; UMEC/VI, umeclidinium/vilanterol.

Table S2 Transition probabilities for tiotropium bromide

From	To
	Mild base	Moderate base	Severe base	Very severe base	New moderate	New severe	New very severe	CV death	Death
Mild base	–				–				–
Moderate base		0.936				0.038			0.026
Severe base			0.911				0.041		0.048
Very severe base				0.952					0.048
New moderate					0.948	0.026			0.026
New severe						0.909	0.043		0.048
New very severe							0.952		0.048
Death								0.000	1.000

Abbreviation: CV, cardiovascular.

Table S3 Transition probabilities for open dual LAMA + LABA

From	To
	Mild base	Moderate base	Severe base	Very severe base	New moderate	New severe	New very severe	CV death	Death
Mild base	–				–				–
Moderate base		0.944				0.031			0.026
Severe base			0.922				0.030		0.048
Very severe base				0.952					0.048
New moderate					0.948	0.026			0.026
New severe						0.909	0.043		0.048
New very severe							0.952		0.048
Death								0.000	1.000

Abbreviations: CV, cardiovascular; LABA, long-acting β₂-agonist; LAMA, long-acting muscarinic antagonist.

Table S4 Transition probabilities for no long-acting bronchodilator

From	To
	Mild base	Moderate base	Severe base	Very severe base	New moderate	New severe	New very severe	CV death	Death
Mild base	–				–				–
Moderate base		0.925				0.0490			0.026
Severe base			0.890				0.062		0.048
Very severe base				0.952					0.048
New moderate					0.948	0.026			0.026
New severe						0.909	0.043		0.048
New very severe							0.952		0.048
Death								0.000	1.000

Abbreviation: CV, cardiovascular.

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