Cost-effectiveness analysis of the Oncotype DX Breast Recurrence Score test in node-positive early breast cancer

Abstract

Aims

Given the high rate of adverse events and high cost of adjuvant chemotherapy, it is optimal to avoid its use when endocrine therapy is equally effective at preventing distant recurrence of early breast cancer. The Oncotype DX test is a predictive and prognostic multigene assay used to guide adjuvant chemotherapy decisions in early breast cancer based on a Recurrence Score (RS) result. A model-based cost-effectiveness analysis compared the Oncotype DX test to clinical risk tools alone for HR+/HER2– node-positive (1–3 axillary lymph nodes) early breast cancer patients based on results from the RxPONDER trial.

Materials and methods

A decision-tree and Markov model was developed in Microsoft Excel. Distributions of patients and distant recurrence probabilities with endocrine and chemo-endocrine therapy were derived from the RxPONDER trial, TransATAC and SWOG-8814. Chemotherapy assignment data were obtained from the Clalit registry. The cost of adjuvant chemotherapy was based on the distribution of treatments used in the UK combined with published drug unit costs in the UK. The cost of distant recurrence and health state utility values were obtained from literature.

Results

The Oncotype DX test was found to be more effective (with an estimated 0.02 additional QALYs) at a lower estimated cost (–£989) compared to clinical risk tools alone. The results did not substantially change with more conservative clinical and cost scenarios. The RxPONDER trial was restricted to RS 0–25, and data synthesis with other studies was required to inform the analysis, which increased uncertainty.

Conclusions

The Oncotype DX test is highly likely to be cost-effective in node-positive early breast cancer. The results were driven by reduction in the use of chemotherapy with consequence avoidance of the costs and harmful effects of chemotherapy. Targeted treatment of a minority (11%) of women with RS 26–100 who benefit from chemotherapy reduced cost and improved survival.

Keywords:

• Cost-effectiveness
• multigene assay
• breast cancer
• chemotherapy
• the Oncotype DX test
• 21-gene assay

JEL CLASSIFICATION CODES:

• C63
• C6
• C
• D61
• D6
• D

Transparency

Declaration of financial/other relationships

Steve Millen, Andrew Paramore, Sarah Reynia and Nina Fryer are employees of Exact Sciences. Peer reviewers on this manuscript have received an honorarium from JME for their review work but have no other relevant financial relationships to disclose.

Authors contributions

VB: conceptualization, formal analysis, methodology, writing – original draft, review and editing; SM: conceptualization, writing – original draft, review and editing; AP: conceptualization, methodology, writing – original draft, review and editing; PH: methodology, writing – original draft, review and editing; TP: methodology, writing – original draft, review and editing; RB: data curation, writing – original draft, review and editing; JG: writing – original draft, review and editing; SR: writing – original draft, review and editing; NF: writing – original draft, review and editing; LL: writing – original draft, review and editing.

Acknowledgements

We would like to acknowledge the expert input of Dr. Mark Verrill, Prof. Robert Coleman, Prof. Carlo Palmieri and Dr. Richard Simcock to validate model assumptions and identify model inputs.

Data availability statement

The parameter inputs used in the model were identified from sources in the open domain or peer-reviewed journal articles. All parameter values and their sources are reported in the article and appendix. The Excel data traces used to generate the results of the cost-effectiveness model can be obtained upon written request to the corresponding author.

Previous presentations

An exploratory analysis for postmenopausal women with node-positive early breast cancer based on the model described in this article was presented at the 2021 ASCO Annual Meeting: J Clin Oncol. 2021;39(15_suppl):534. DOI: 10.1200/JCO.2021.39.15_suppl.534.

Additional information

Funding

This work was funded by Exact Sciences, who are the manufacturers of the Oncotype DX test. Exact Sciences contributed to the design and reporting of the analysis.