Abstract

16085 Background: Previous European analyses have shown that zoledronic acid (ZOL) is cost effective in patients with bone metastases secondary to breast cancer, lung cancer, and other solid tumors. A recent analysis suggests that ZOL significantly reduce the risk of new skeletal related events (SREs) such as spinal cord compression, pathological fracture, radiation or surgery to bone, in renal cell carcinoma (RCC) patients with bone metastases. The present study assessed the cost effectiveness of ZOL in this population, adopting a French health care payer perspective. Methods: This analysis was based on a retrospective analysis of a trial of ZOL which randomized RCC patients with bone metastases to ZOL (n=27) or placebo (n=19) plus concomitant antineoplastic therapy for 9 months. A model was developed to simulate the costs and quality-adjusted life-years (QALYs) of the trial patients. SRE costs were estimated by pooling data from SRE studies in the Netherlands and Portugal. These estimates were supplemented with literature-based costs. Drug costs were obtained from French tariffs. Consistent with similar economic analyses, it was assumed that quality of life decreased for 1 month after each SRE experienced. Uncertainty was addressed via bootstrapping and multivariate probabilistic sensitivity analyses (PSA), which involved 10,000 model simulations using input values drawn from probability distributions. Results: ZOL and placebo patients experienced an estimated 0.527 vs. 0.402 discounted QALYs, respectively. Discounted SRE-related costs were substantially lower among ZOL than placebo patients (€3,754 v. €10,531, respectively). After taking into consideration drug therapy costs, ZOL saved €4,732 and increased QALYs by 0.125. Thus, ZOL is preferred over placebo both in terms of costs and quality of life. In the PSA, therapy with ZOL saved costs in 93% of simulations. The cost per QALY gained was below the €50,000 per QALY gained threshold in 97% of PSA simulations. Conclusions: The present analysis suggests that ZA is cost saving and increases QALYs compared to placebo in RCC patients with bone metastases in France. These results may need to be confirmed via a larger prospective clinical trial. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Novartis Novartis

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