Cost-Effectiveness Analysis of the Oncotype DX Breast Recurrence Score^® Test from a US Societal Perspective

Figures & data

Figure 1 In the decision-tree component of the model, RS result subgroups were defined using cut-offs used in the TAILORx study for N0 (0–10, 11–25, 26–100) and RxPONDER for N1 (0–13, 14–25, 26–100). In the 21-gene assay alternative of the model, chemotherapy assignment was dependent on the subgroup. In the clinical-pathological risk alternative of the model, it differed according to patient age, clinical risk, and menopausal status. Once patients have been assigned their RS result and assigned adjuvant treatment, they proceed to the respective part of the Markov model.

Figure 2 Markov model structure. The model included five health states; the arrows depict patient movement between health states in each model cycle. Patients can move to death from any health state. Patients enter the Markov portion in the “Recurrence-free” health state, and the probability of transition to distant recurrence, AML and CHF is conditional on the assigned adjuvant treatment, clinical risk, and RS category (if known).

Table 1 Chemotherapy-Related Adverse Events

Adverse event	Probability	Unit cost	Source
Febrile neutropenia	4.0%	$7765.00	Wang et al 2019^Citation8
Arthralgia	2.2%	$4949.00
Fatigue	2.3%	$105.02
Neutrophil count decreased	7.3%	$7765.00
White blood cell decreased	3.2%	$7765.00

Table 2 Incremental Cost-Effectiveness of the 21-Gene Assay Compared to Clinical-Pathological Risk Alone N0 Population

Comparator	Oncotype DX	Clinical-Pathological Risk Alone
Absolute values
Total cost (healthcare payer perspective)	$61,331	$70,173
Total cost (societal perspective)	$80,089	$93,485
Total QALYs	13.97	13.72
Total life-years	17.52	17.23
Incremental values vs clinical risk alone
Total cost (healthcare payer perspective)	-$8842	–
Total cost (societal perspective)	-$13,395	–
QALYs	0.25	–
Life-years	0.29	–
ICER per QALY (societal and healthcare payer perspective)	Dominant	–
ICER per life-year (societal and healthcare payer perspective)	Dominant	–

Table 3 Incremental Cost-Effectiveness of the 21-Gene Assay Compared to Clinical-Pathological Risk Alone Combined N1 Population

Comparator	Oncotype DX	Clinical Risk Alone
Absolute values
Total cost (healthcare payer perspective)	$77,858	$78,311
Total cost (societal perspective)	$102,556	$105,082
Total QALYs	13.69	13.61
Total life-years	17.21	17.12
Incremental values vs clinical risk alone
Total cost (healthcare payer perspective)	-$453	–
Total cost (societal perspective)	-$2526	–
QALYs	0.08	–
Life-years	0.09	–
ICER per QALY (societal and healthcare payer perspective)	Dominant	–
ICER per life-year (societal and healthcare payer perspective)	Dominant	–

Table 4 Breakdown of Cost for the 21-Gene Assay Compared to Clinical-Pathological Risk Alone N0 Population

	Oncotype DX	Clinical risk alone	Incremental cost
MGA cost	$3873	$0	$3873
Chemo-endocrine therapy	$4387	$4200	$187
Short-term AEs	$345	$327	$19
Recurrence-free	$8536	$8333	$202
Local recurrence	$256	$332	-$76
Distant recurrence	$41,882	$54,460	-$12,578
AML	$56	$54	$2
CHF	$681	$657	$24
Terminal care	$1314	$1810	-$496
Patient out-of-pocket (OOP) expenses*	$972	$918	$53
Lost productivity cost*	$17787	$22,393	-$4607

Note: *Included in societal cost perspective analysis only.

Table 5 Breakdown of Cost for the 21-Gene Assay Compared to Clinical-Pathological Risk Alone Combined N1 Population

	Oncotype DX	Clinical risk alone	Incremental cost
MGA cost	$3873	$0	$3873
Chemo-endocrine therapy	$6757	$8890	-$2133
Short-term AEs	$439	$606	-$167
Recurrence-free	$8312	$8248	$65
Local recurrence	$339	$349	-$10
Distant recurrence	$55,390	$56,954	-$1564
AML	$71	$99	-$28
CHF	$857	$1199	-$342
Terminal care	$1820	$1967	-$147
Patient out-of-pocket (OOP) expenses*	$1283	$1770	-$487
Lost productivity cost*	$23,416	$25,002	-$1586

Note: * Included in societal cost perspective analysis only.

Figure 3 Tornado diagram reporting the results of one-way sensitivity analyses for the combined N0 population. The endpoint of interest for the one-way sensitivity analyses was net monetary benefit (NMB), which is the product of the threshold willingness-to-pay per QALY in the US ($100,000) and incremental QALYs gained, less incremental cost. NMB is a more appropriate endpoint to measure uncertainty in the presence of negative ICERs, which are difficult to interpret as they can represent both a dominant (higher incremental QALYs and lower incremental cost) and dominated (lower incremental QALYs and higher incremental cost) result.

Figure 4 Tornado diagram reporting the results of one-way sensitivity analyses for the combined N1 population.

Wang SY, Chen T, Dang W, Mougalian SS, Evans SB, Gross CP. Incorporating tumor characteristics to maximize 21-gene assay utility: a cost-effectiveness analysis. J Natl Compr Cancer Netw. 2019;17(1):39–46. doi:10.6004/JNCCN.2018.7077

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Data Sharing Statement

Data parameters used in the model are specified in the article and appendices, alongside literature references to allow a reader to re-create the model if needed. For any questions related to the methodology or parameters used in the model, please contact the lead author.