Cost-effectiveness analysis of LungLB for the clinical management of patients with indeterminate pulmonary nodules

Figures & data

Figure 1. Conceptual model diagram. Conceptual Markov model of 1 year cycle length for the clinical treatment pathway of patients with IPNs who enter the model in either the CDP or LungLB arm. Patients can progress to testing with biopsy and receive either a benign or malignant IPN diagnosis, stratified by diagnostic accuracy. Patients with a benign diagnosis continue in the model until they experience a non-cancer death while patients with a malignant diagnosis continue into lung cancer staging and experience a non-cancer or cancer-related death. Patients who have a false negative malignant diagnosis experience a delay in treatment (shown in grey).

Table 1. Test sensitivity and specificity.

Diagnostic test	Sensitivity (%)	Specificity (%)	Source
LungLB	77	72	LungLife Ai
Biopsy	96	98	^9
CT scan	97	56	^9
Pet scan	90	40	^10

Abbreviations: CT, computed tomography; Pet, Positron emission tomography

Table 2. Model inputs.

Parameter	Value	Source
Malignant patients (% of cohort)	0.23	^11
Proportion of presenting cohort by stage of lung cancer
Stage I	54%	^12
Stage II	11%	^12
Stage III	17%	^12
Stage IV	18%	^12
CDP diagnostic accuracy (Mayo model)
True positive	11%	^13
True negative	4%	^13
False positive	1%	^13
False negative	3%	^13
Undetermined (intermediate-risk nodule)	81%	^13
Diagnostic related AE rates
Needle biopsy
Minor complication	14%	^14
Intermediate complication	14%	^14
Major complication	4%	^14
Bronchoscopy
Minor complication	24%	^14
Intermediate complication	32%	^14
Major complication	13%	^14
Surgical diagnosis
Minor complication	47%	^14
Intermediate complication	41%	^14
Major complication	11%	^14
Expected distribution of biopsy procedures
Needle biopsy	30%	^a
Bronchoscopy	30%	^a
Surgical diagnosis	40%	^a
Distribution of lung cancer types
NSCLC	85%	^a
SCLC	15%	^a
Present value discounting
Cost discount rate	3%
Outcomes discount rate	3%

Notes: ^aAssumption based on literature.

Abbreviations: AE, adverse event; NSCLC, non-small cell lung cancer; SCLC, small cell lung cancer; CDP, Current Diagnostic Pathway.

Table 3. Cost inputs.

Model parameter	Cost (2021 USD)	Source
LungLB	$2,300.00	LungLife Ai
PET scan	$2,279.68	^15
CT scan	$1,704.48	^16
Needle biopsy
Procedure	$402.81	^14
Minor complication	$11,157.67	^14
Intermediate complication	$17,911.45	^14
Major complication	$45,369.34	^14
Bronchoscopy
Procedure	$1,126.22	^14
Minor complication	$8,781.92	^14
Intermediate complication	$22,295.37	^14
Major complication	$71,446.18	^14
Surgical diagnosis
Procedure	$9,175.92	^14
Minor complication	$12,488.23	^14
Intermediate complication	$29,172.47	^14
Major complication	$74,025.09	^14
NSCLC costs (annual)
Stage I	$37,894.49	^17
Stage II	$37,894.49	^17
Stage III	$53,790.73	^17
Stage III	$53,790.73	^17
Stage IV	$42,037.66	^17
SCLC costs (annual)
Stage I	$34,822.49	^17
Stage II	$34,822.49	^17
Stage III	$34,822.49	^17
Stage III	$34,822.49	^17
Stage IV	$29,551.79	^17

Abbreviations: NSCLC, non-small cell lung cancer; SCLC, small cell lung cancer.

Table 4. Health state utility values.

HSUV	Value	Source
No cancer	0.855	^8
Lung cancer
Stage I	0.825	^7
Stage II	0.825	^7
Stage III	0.772	^7
Stage IV	0.537	^7
Age-dependent background utility
0–24	0.919	^18
25–34	0.912	^18
35–44	0.843	^18
45–54	0.816	^18
55–64	0.817	^18
65–74	0.824	^18
75+	0.806	^18
Disutilities
Iatrogenic pneumothorax	0.023	^18
Pulmonary hemorrhage	0.014	^18

Table 5. Lung cancer disease progression 1-month transition probabilities.

	Cancer-free	Stage I (%)	Stage II (%)	Stage IIIA (%)	Stage IIIB (%)	Stage IV (%)	Death
Cancer-free		0.17	0.00	0.00	0.00	0.00	CDC^a
Stage I		76.84	13.63	1.11	0.00	2.98	5.44%
Stage II			81.95	9.06	0.20	4.50	4.28%
Stage IIIA				81.39	8.13	5.11	5.37%
Stage IIIB					92.26	1.13	6.60%
Stage IV						88.88	11.12%

Note: ^aInformed by age-dependent CDC mortality table.

Abbreviation: CDC, Center for Disease Control.

Sources: Hofer et al.¹⁹ and Life table for the total population: United States, 2017–2021²⁰.

Table 6. Lung cancer disease mortality 1-year transition probabilities.

Disease stage	Probability of death (%)
After care I	1.38
After care II	1.48
After care III	1.57
After care IV	3.64

Table 7. Model results.

	LungLB	CDP	Delta	ICER ($/QALY)
LYs	11.11	11.04	0.07	$60,187
QALYs	9.01	8.95	0.06	$75,740
Costs	$48,492	$44,310	$4182
NMB	$852,105	$850,766	$1339

Figure 2. Deterministic sensitivity analysis. Results of the deterministic analysis displayed in a tornado diagram. “Low” bars indicate if the parameter is decreased and “high” bars indicate if the parameter is increased by either its 95% confidence interval.

Figure 3. Probabilistic sensitivity analysis. Results of the probabilistic sensitivity analysis creating by a Monte Carlo simulation, where each parameter is varied simultaneously for 500 iterations and subsequently plotted.

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