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

doi:10.5246/jcps.2026.03.020

Abstract

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:

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.

Figures/Tables 19

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).

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.

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

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