Cost-Effectiveness Analysis from a Societal Perspective of Recurrence Index for Distant Recurrence (RecurIndex) in Women with Hormone Receptor-Positive and HER2-Negative Early-Stage Breast Cancer

Abstract

Nicolas Pennarun,1 Jian-Ying Chiu,2 Hsun-Chen Chang,3 Sean-Lin Huang,1 Skye Hung-Chun Cheng4,5 1Amwise Diagnostics Pte. Ltd., Singapore; 2Department of Medical Operation, Amwise Diagnostics Pte. Ltd., Singapore; 3Institute of Epidemiology and Preventive Medicine, College of Public Health, National Taiwan University, Taipei, Taiwan; 4Department of Radiation Oncology, Koo Foundation Sun Yat-Sen Cancer Center, Taipei, Taiwan; 5Cancer Center, Taitung Christian Hospital, Taitung, TaiwanCorrespondence: Skye Hung-Chun Cheng, Department of Radiation Oncology, Koo Foundation Sun Yat-Sen Cancer Center, 125, Lide Road, Beitou District, Taipei, 112, Taiwan, Tel [phone], ext. 1302, Email [email protected]: A clinical-genomic prognostic multigene panel (RI-DR assay, RecurIndex®), predicting the risk level of distant recurrence (DR) in early-stage breast cancer (EBC) patients with an Asian background, has been validated as a valuable tool for identifying high-risk patients to develop distant recurrence (metastasis). Although the clinical benefit of adjuvant chemotherapy from the assay’s prediction is already proved, its affordability remains uncertain. This study is the first time in which the long-term cost-effectiveness of the RI-DR assay is evaluated.Patients and Methods: A lifetime Markov decision-analytic model was developed from a societal perspective to estimate the life-years gained (LYGs), quality-adjusted life-years (QALYs), medical costs, and incremental cost-effectiveness ratios (ICERs), comparing EBC women with and without RI-DR genomic testing. A decision tree was used to classify patients in one of the fifteen end nodes (by order, each arm was stratified by a patient being tested or not with the RI-DR assay, being treated or not with adjuvant chemotherapy and had no, minor, major, or fatal toxicity after adjuvant chemotherapy). Health utilities, costs, transition probabilities, and survival data were extracted from the scientific literature. Deterministic sensitivity analysis (DSA) and probabilistic sensitivity analysis (PSA) were performed on variables to assess the robustness of the model. A willingness-to-pay (WTP) threshold of 790,000 NT$ per QALY gained was considered as a cost-effectiveness criterion.Results: The incremental cost per QALY gained under base-case assumptions of the model was 173,842 NT$. Findings on the variation in model input parameters were robust and confirmed that every key variable was cost-effective for the benefit of RI-DR testing.Conclusion: The clinical-genomic RI-DR assay is cost-effective in guiding adjuvant chemotherapy decisions compared to current clinical practice guidelines.Keywords: economic evaluation, gene signature, Markov model, decision making, RI-DR assay

Keywords

• economic evaluation
• gene signature
• markov model
• decision making
• ri-dr assay