Symptom Burden and GOLD Classification in Medicare Advantage Patients with COPD Initiating Umeclidinium/Vilanterol or Fluticasone Propionate/Salmeterol Therapy

Figures & data

Figure 1 Study design. ^aFour waves of data collection were required to achieve the target sample size. The dates of the baseline period were: June 1, 2017 to May 31, 2018 (Wave 1); July 1, 2017 to June 30, 2018 (Wave 2); August 1, 2017 to July 31, 2018 (Wave 3); and October 1, 2017 to September 30, 2018 (Wave 4). Due to the claims lag, fully adjudicated medical and pharmacy claims data for each wave were available approximately 6 months after the end of the baseline period.

Figure 2 Study attrition. Percentages may not sum to 100% due to rounding. ^aCOPD ICD-10 diagnosis codes were J40, J410, J411, J418, J42, J430, J431, J432, J438, J439, J440, J441, and J449; ^btriple therapy is defined as claims for ICS/LABA/LAMA, including combined monotherapy formulations and fixed-dose combinations. Patients with no evidence of triple therapy within 30 days were included; ^casthma ICD-10 diagnosis codes were J4520, J4521, J4522, J4530, J4531, J4532, J4540, J4541, J4542, J4550, J4551, J4552, J45901, J45902, J45909, J45990, J45991, and J45998; ^dfor waves in which a larger sampling frame was available than was needed to meet the current target, random sampling was implemented to derive the survey sampling frame. For Waves 2–4, patients were excluded if they had been invited to participate in the survey in a previous wave; ^efollowing a 6-month claims lag, patients were removed from the analysis if they had evidence of asthma, lung cancer (diagnosis or treatment) or if they had evidence of triple therapy during the 12-month baseline period. Continuous enrollment in the health plan was also re-assessed, and patients with <12 months of continuous enrollment in the baseline period were excluded. Patients that self-reported a medication that was different from the claims-based medication cohort were also excluded from the analysis (n=29).

Abbreviations: COPD, chronic obstructive pulmonary disease; ICD-10, International Classification of Diseases, 10th Edition; ICS, inhaled corticosteroids; FP/SAL, fluticasone propionate/salmeterol; LABA, long-acting β₂-agonist; LAMA, long-acting muscarinic antagonist; MA, Medicare Advantage; UMEC/VI, umeclidinium/vilanterol.

Table 1 Patient Demographics by Treatment Cohort

Baseline Characteristics	Pre-IPTW			Post-IPTW
	UMEC/VI N=392	FP/SAL N=397	ASD^a (%)	UMEC/VI N=392	FP/SAL N=397	ASD^a (%)
Age category, years, n (%)
65–69	58 (14.8)	64 (16.1)	−3.7	61 (15.6)	60 (15.0)	1.6
70–74	132 (33.7)	130 (32.8)	2.0	123 (31.3)	132 (33.2)	−4.0
75–79	108 (27.6)	108 (27.2)	0.8	111 (28.4)	111 (27.9)	1.2
80+	94 (24.0)	95 (23.9)	0.1	97 (24.7)	95 (23.9)	1.8
Female, n (%)	201 (51.3)	222 (55.9)	−9.3	209 (53.3)	214 (54.0)	−1.4
White^b, n (%)	355 (90.6)	343 (86.4)	13.1	350 (89.3)	354 (89.2)	0.4
Residence^b, n (%)
Urban/city	117 (29.9)	121 (30.5)	−1.4	115 (29.4)	119 (30.0)	−1.4
Suburban	156 (39.8)	141 (35.5)	8.8	154 (39.4)	153 (38.5)	1.7
Rural	119 (30.4)	135 (34.0)	−7.8	123 (31.3)	125 (31.5)	−0.4
Smoking pack-years^b, mean (SD)	47.1 (30.6)	42.7 (33.0)	13.8	45.1 (28.9)	45.7 (34.7)	−1.9
Time since COPD diagnosis^b, n (%)
<1 year	69 (17.6)	41 (10.3)	21.1	55 (14.1)	58 (14.6)	−1.5
1–5 years	170 (43.4)	152 (38.3)	10.4	158 (40.4)	159 (40.1)	0.7
6–10 years	83 (21.2)	106 (26.7)	−13.0	92 (23.5)	96 (24.3)	−1.9
11–19 years	49 (12.5)	58 (14.6)	−6.2	55 (14.1)	53 (13.4)	2.1
≥20 years	21 (5.4)	40 (10.1)	−17.8	31 (8.0)	31 (7.7)	1.0
COPD-related emergency room visits, mean (SD)	0.2 (0.6)	0.2 (0.5)	−10.2	0.2 (0.8)	0.2 (0.5)	5.4
COPD-related ambulatory visits, mean (SD)	3.2 (2.9)	2.4 (3.0)	28.1	2.8 (2.8)	2.8 (3.3)	2.1
Baseline COPD exacerbations, mean (SD)	0.7 (1.1)	0.8 (1.0)	−5.2	0.8 (1.2)	0.7 (1.0)	5.1

Notes: ^aASD for UMEC/VI vs FP/SAL; ^bimputation of missing values for ordinal categorical and continuous variables was implemented using the mean value of non-missing values. Imputed values for ordinal categorical variables were rounded to nearest whole number. Patients with missing values for Race were categorized as “White”. Patients with missing values for Residence were categorized as “Suburban”. To calculate smoking pack-years, patients were asked to self-report smoking status, and the number of cigarettes smoked per day was multiplied by the total number of years smoked, then divided by 20; never smokers were assigned a value of zero. Two patients had missing smoking status, and were also assigned a pack years value of zero. To determine time since COPD diagnosis, patients were asked to self-report the length of time since a healthcare provider had told them they had COPD; one patient with a missing value was categorized as “6–10 years”.

Abbreviations: ASD, absolute standardized difference; COPD, chronic obstructive pulmonary disease; FP/SAL, fluticasone propionate/salmeterol; IPTW, inverse probability of treatment weighting; SD, standard deviation; UMEC/VI, umeclidinium/vilanterol.

Figure 3 Mean CAT scores among patients receiving UMEC/VI or FP/SAL before IPTW.

Abbreviations: CAT, COPD Assessment Test; COPD, chronic obstructive pulmonary disease; FP/SAL, fluticasone propionate/salmeterol; IPTW, inverse probability of treatment weighting; SD, standard deviation; UMEC/VI, umeclidinium/vilanterol.

Figure 4 GOLD classification according to symptom burden (assessed by CAT and mMRC) and exacerbation history.

Abbreviations: CAT, COPD Assessment Test; COPD, chronic obstructive pulmonary disease; FP/SAL, fluticasone propionate/salmeterol; GOLD, Global Initiative for Obstructive Lung Disease; mMRC, modified Medical Research Council dyspnea scale; UMEC/VI, umeclidinium/vilanterol.

Figure 5 Comparison of GOLD classification according to different patient-reported measures of symptom burden (CAT or mMRC).

Abbreviations: CAT, COPD Assessment Test; COPD, chronic obstructive pulmonary disease; GOLD, Global Initiative for Obstructive Lung Disease; mMRC, modified Medical Research Council dyspnea scale.