ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Drugs Outcomes Research and Policies
Cost-Effectiveness Analysis of First-Line Versus Second-Line Use of CDK4/6 Inhibitors Combined With Endocrine Therapy in Advanced HR+/HER2-Breast Cancer in China: Based on the SONIA Trial
Provisionally accepted
- 1Affiliated Hospital of Nantong University, Nantong, China
- 2Affiliated Hospital 2 of Nantong University (Nantong First People's Hospital), Nantong, China
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Background: The optimal sequencing of CDK4/6 inhibitors combined with endocrine therapy for advanced hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer remains uncertain, particularly in resource-limited settings such as China. This study evaluated the cost-effectiveness of first-line versus second-line CDK4/6 inhibitor use based on the SONIA trial. Methods: A partitioned survival model was developed to compare costs and effectiveness of first-line (CDK4/6i-first) versus second-line (CDK4/6i-second) CDK4/6 inhibitor strategies among Chinese women with advanced HR+/HER2-breast cancer. Model inputs were derived from the SONIA trial and Chinese healthcare data. Outcomes included total costs, life years (LYs), quality-adjusted life years (QALYs), and incremental cost-effectiveness ratios (ICERs). Both deterministic and probabilistic sensitivity analyses were performed. Scenario analyses incorporated generic drug pricing. Results: The base-case analysis showed that the CDK4/6i-first strategy yielded 3.07 QALYs at a lifetime cost of CNY 372,420.21, compared to 2.86 QALYs and CNY 366,445.93 for the CDK4/6i-second strategy. The ICER for first-line CDK4/6 inhibitor use was CNY 28,126.33 per QALY, well below the willingness-to-pay (WTP) threshold of CNY 287,247/QALY. Scenario analysis with generics showed an ICER of CNY 198,439.62 per QALY. Sensitivity analyses confirmed the robustness of these results. Conclusions: This study supports the early use of CDK4/6 inhibitors combined with endocrine therapy as a cost-effective strategy for advanced HR+/HER2-breast cancer in China. Continued real-world monitoring is needed to adapt to changes in drug pricing and clinical practice.
Keywords: cost-effectiveness analysis, CDK4/6 inhibitors, Endocrine therapy, HR+/HER2- breast cancer, Sonia
Received: 06 Sep 2025; Accepted: 17 Nov 2025.
Copyright: © 2025 Jin and Li. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Zhifeng Li, 2013510032@stmail.ntu.edu.cn
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