唑来膦酸用于绝经后早期乳腺癌患者辅助治疗的成本效果与预算影响分析

doi:10.5246/jcps.2026.03.020

中国药学(英文版) ›› 2026, Vol. 35 ›› Issue (3): 292-314.DOI: 10.5246/jcps.2026.03.020

唑来膦酸用于绝经后早期乳腺癌患者辅助治疗的成本效果与预算影响分析

朱祎潇¹^,^#, 吴文华²^,^#, 林丽¹, 张丽蓉¹, 蔡加琴², 孙红²^,^*(), 魏晓霞²^,^*()

^1. 福建医科大学药学院, 福建福州 350122
^2. 福建医科大学省立临床医学院药学部, 福州大学附属省立医院, 福建医科大学药学院, 福建福州 350001

收稿日期:2025-12-27 修回日期:2026-01-12 接受日期:2026-02-26 出版日期:2026-04-04 发布日期:2026-04-03
通讯作者: 孙红, 魏晓霞

The cost-effectiveness and budget impact of zoledronic acid as adjuvant therapy in postmenopausal women with early breast cancer

Yixiao Zhu¹^,^#, Wenhua Wu²^,^#, Li Lin¹, Lirong Zhang¹, Jiaqing Cai², Hong Sun²^,^*(), Xiaoxia Wei²^,^*()

^1. School of Pharmacy, Fujian Medical University, Fuzhou 350122, Fujian, China
^2. Department of Pharmacy, Shengli Clinical Medical College of Fujian Medical University, Fujian Provincial Hospital, Fuzhou University Affiliated Provincial Hospital, School of Pharmacy, Fujian Medical University, Fuzhou 350001, Fujian, China

Received:2025-12-27 Revised:2026-01-12 Accepted:2026-02-26 Online:2026-04-04 Published:2026-04-03
Contact: Hong Sun, Xiaoxia Wei
About author:
^# Yixiao Zhu and Wenhua Wu contributed equally to this work.
Supported by:
Wu Jieping Medical Foundation (Grant No. 320.6750.2025-06-272)

摘要/Abstract

摘要：

绝经后早期乳腺癌(EBC)是全球经济负担沉重的主要疾病亚型之一, 其中骨微环境在疾病进展和治疗中发挥关键作用。作为一种骨改良药物, 唑来膦酸具有明确的临床获益, 但其经济价值仍存在不确定性。本研究基于ABCSG-12和 AZURE临床试验数据, 结合中国医疗成本与效用值, 采用Markov模型评估唑来膦酸联合辅助内分泌治疗用于绝经后EBC的成本效果性及预算影响。以质量调整生命年(QALY)为主要结局计算增量成本效果比(ICER), 并与支付意愿(WTP)阈值进行比较, 同时开展单因素、概率敏感性分析及情景分析, 并构建预算影响模型预测2025–2029年国家医保支出变化。在集中带量采购价格下, 唑来膦酸在诱导性绝经组和自然绝经组均表现为优势策略, 分别节约成本7762.97元和5982.96元, 并增加0.34和0.35QALY; 敏感性分析结果表明模型稳健, 概率敏感性分析显示在所有 WTP 阈值下均具有100%的成本效果性概率。在进口价格情景下, ICER仍显著低于WTP阈值, 并且随着价格下降经济性进一步改善; 预算影响分析提示国家医保增量支出占比极低(集中采购为0.0017%–0.0082%, 进口定价为0.0028%–0.0117%)。总体而言, 唑来膦酸是绝经后EBC的高成本效果辅助治疗药物, 支持其优先纳入临床路径和医保支付范围; 集中采购制剂更适合广泛推广, 而通过价格谈判有望提升进口产品的可负担性。

关键词: 早期乳腺癌, 唑来膦酸, 成本效果分析, 药物经济学, 预算影响分析

Abstract:

Postmenopausal early breast cancer (EBC) constitutes a major clinical subtype that imposes a considerable global economic burden, in which the bone microenvironment plays a pivotal therapeutic role. Zoledronic acid, a bone-modifying agent, confers meaningful clinical benefits; however, its overall economic value remains insufficiently defined. This study aimed to evaluate the cost-effectiveness and budgetary impact of combining zoledronic acid with adjuvant endocrine therapy for postmenopausal EBC using a Markov model informed by data from the ABCSG-12 and AZURE trials, alongside Chinese healthcare costs and utility parameters. Quality-adjusted life-years (QALYs) were applied to derive incremental cost-effectiveness ratios (ICERs) relative to established willingness-to-pay (WTP) thresholds and were supplemented by one-way, probabilistic sensitivity, and scenario analyses. In parallel, a budget impact model was developed to estimate national insurance expenditures from 2025 to 2029. At centralized procurement prices, zoledronic acid was dominant in both induced and natural menopause cohorts, generating cost savings (¥7762.97 and ¥5982.96, respectively) and incremental QALY gains (0.34 and 0.35, respectively). Sensitivity analyses consistently confirmed the robustness of these outcomes, and probabilistic analyses indicated a 100% probability of cost-effectiveness across all WTP thresholds. When imported pricing was applied, ICERs remained well below the WTP threshold and further improved with incremental price reductions. Budget impact projections revealed minimal increases in national healthcare expenditures (0.0017%–0.0082% under centralized procurement and 0.0028%–0.0117% under imported pricing). Overall, zoledronic acid represented a highly cost-effective adjuvant intervention for postmenopausal EBC, supporting its prioritization in clinical pathways and reimbursement frameworks. Centralized procurement formulations are preferable for widespread implementation, while pricing negotiations for imported products are recommended to enhance national affordability.

Key words: Early breast cancer, Zoledronic acid, Cost-effectiveness analysis, Pharmacoeconomics, Budget impact analysis

Supporting:

朱祎潇, 吴文华, 林丽, 张丽蓉, 蔡加琴, 孙红, 魏晓霞. 唑来膦酸用于绝经后早期乳腺癌患者辅助治疗的成本效果与预算影响分析[J]. 中国药学(英文版), 2026, 35(3): 292-314.

Yixiao Zhu, Wenhua Wu, Li Lin, Lirong Zhang, Jiaqing Cai, Hong Sun, Xiaoxia Wei. The cost-effectiveness and budget impact of zoledronic acid as adjuvant therapy in postmenopausal women with early breast cancer[J]. Journal of Chinese Pharmaceutical Sciences, 2026, 35(3): 292-314.

图/表 19

Figure 1. Markov model: (A) bubble diagram; (B) tree diagram.

Table 1. AIC and BIC values of DFS curve-fitting distributions in the no-zoledronic acid group.

Table 2. Transition probability-related parameters of the Markov model.

Table 3. Model parameters and sensitivity analysis ranges.

Table 4. Components of treatment cost items by disease state of breast cancer (¥/year).

Figure 2. Research process for the budget impact analysis of zoledronic acid adjuvant therapy for postmenopausal EBC.

Table 5. Projected number of medical insurance participants from 2024 to 2029.

Table 6. Number of the target population from 2024 to 2029.

Table 7. Results of base-case analysis.

Figure 3. Results of one-way sensitivity analysis: (A) induced menopause population; (B) natural menopause population.

Figure 4. Incremental cost-effectiveness scatterplot: (A) induced menopause population; (B) natural menopause population.

Figure 5. Cost-effectiveness acceptability curve: (A) induced menopause population; (B) natural menopause population.

Table 8. Results of scenario analysis for the import price of zoledronic acid.

Figure 6. Cost-effectiveness acceptability curve: (A) induced menopause population; (B) natural menopause population.

Figure 7. One-way sensitivity analysis of the import price of zoledronic acid: (A) induced menopause population; (B) natural menopause population.

Figure 8. Budget impact analysis of off-label zoledronic acid use under centralized procurement before and after national medical insurance inclusion (2025–2029).

Figure 9. Budget impact analysis of off-label use of imported zoledronic acid before and after national medical insurance inclusion (2025–2029).

Figure 10. One-way sensitivity analysis of the centralized procurement pricing budget impact model.

Figure 11. One-way sensitivity analysis of the imported pricing budget impact model.

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唑来膦酸用于绝经后早期乳腺癌患者辅助治疗的成本效果与预算影响分析

The cost-effectiveness and budget impact of zoledronic acid as adjuvant therapy in postmenopausal women with early breast cancer

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