Abstract
Background: The ABCSG-12 trial investigated the efficacy of gonadotropin-releasing hormone (GnRH)analogs in combination with tamoxifen or anastrozole ± zoledronic acid (4 mg, q6m for 3 years) in 1,803 premenopausal women with hormone receptor-positive (HR+) breast cancer. After 48 months of follow-up, there was a 36% improvement in the disease-free survival (DFS) (recurrence-free survival 35%) using zoledronic acid. Based on these data, the costutility of zoledronic acid was calculated for the German healthcare system. Materials and Methods: Costs of surveillance, adverse effects, recurrence, contralateral breast cancer, metastasis, and end-of-life care were determined based on the Einheitlicher BewertungsmaΒstab (EBM 2009) and the diagnosis-related groups (DRG) system. Utilities were surveyed with a questionnaire (n = 95). Estimation of the cost-utility was made by calculating the incremental costeffectiveness ratio (ICER) per quality-adjusted life year (QALY), using a Markov model. Results: Including zoledronic acid as adjuvant therapy for 3 years resulted in total costs of € 2,262. The use of zoledronic acid is dominant when clinical efficacy and quality of life are taken into consideration (– € 45.83/QALY) (95% confidence interval (CI) – € 1,838 to E 2,375; 0.02–0.41 QALY). The sensitivity analyses present with a probability of 90% that the cost per QALY gained are <€ 22,000. Conclusion: In the German healthcare system, zoledronic acid is a cost-effective option for premenopausal patients with HR+ breast cancer.