caa a22 4500 445332166 CHVBK 20180317142740.0 cr unu---uuuuu 170323e20111201xx s 000 0 eng 10.1007/s10198-010-0272-0 doi (NATIONALLICENCE)springer-10.1007/s10198-010-0272-0 Cost-effectiveness of zoledronic acid in the prevention of skeletal-related events in patients with bone metastases secondary to advanced renal cell carcinoma: application to France, Germany, and the United Kingdom [Elektronische Daten] [M. Botteman, M. Meijboom, I. Foley, J. Stephens, Y. Chen, S. Kaura] Background: The use of zoledronic acid (ZOL) has recently been shown to significantly reduce the risk of new skeletal-related events (SREs) in renal cell carcinoma (RCC) patients with bone metastases. The present exploratory study assessed the cost-effectiveness of ZOL in this population, adopting a French, German, and United Kingdom (UK) government payer perspective. Materials and methods: This cost-effectiveness model was based on a post hoc retrospective analysis of a subset of patients with RCC who were included in a larger randomized clinical trial of patients with bone metastases secondary to a variety of cancers. In the trial, patients were randomized to receive ZOL (n=27) or placebo (n=19) with concomitant antineoplastic therapy every 3weeks for 9months (core study) plus 12months during a study extension. Since the trial did not collect costs or data on the quality-adjusted life years (QALYs) of the patients, these outcomes had to be assumed via modeling exercises. The costs of SREs were estimated using hospital DRG tariffs. These estimates were supplemented with literature-based costs where possible. Drug, administration, and supply costs were obtained from published and internet sources. Consistent with similar economic analyses, patients were assumed to experience quality of life decrements lasting 1month for each SRE. Uncertainty surrounding outcomes was addressed via multivariate sensitivity analyses. Results: Patients receiving ZOL experienced 1.07 fewer SREs than patients on placebo. Patients on ZOL experienced a gain in discounted QALYs of approximately 0.1563 in France and Germany and 0.1575 in the UK. Discounted SRE-related costs were substantially lower among ZOL than placebo patients (−€ 4,196 in France, −€ 3,880 in Germany, and −€ 3,355 in the UK). After taking into consideration the drug therapy costs, ZOL saved € 1,358, € 1,223, and € 719 in France, Germany, and the UK, respectively. In the multivariate sensitivity analyses, therapy with ZOL saved costs in 67-77% of simulations, depending on the country. The cost per QALY gained for ZOL versus placebo was below € 30,000 per QALY gained threshold in approximately 93-94% of multivariate sensitivity analyses simulations. Conclusions: The present analysis suggests that ZOL saves costs and increases QALYs compared to placebo in French, German, and UK RCC patients with bone metastases. Additional prospective research may be needed to confirm these results in a larger sample of patients. The Author(s), 2010 Renal cell carcinoma nationallicence Bone health nationallicence Cost-effectiveness nationallicence Bone metastases nationallicence Bisphosphonates nationallicence Botteman M. Health Economics, Pharmerit International, 4530 East-West Highway, #430, 20814, Bethesda, MD, USA aut Meijboom M. Health Economics, Pharmerit International, Rotterdam, The Netherlands aut Foley I. Health Economics, Pharmerit International, 4530 East-West Highway, #430, 20814, Bethesda, MD, USA aut Stephens J. Health Economics, Pharmerit International, 4530 East-West Highway, #430, 20814, Bethesda, MD, USA aut Chen Y. Health Economics, Novartis Pharmaceuticals Corp, East Hanover, NJ, USA aut Kaura S. Health Economics, Novartis Pharmaceuticals Corp, East Hanover, NJ, USA aut The European Journal of Health Economics Springer-Verlag 12/6(2011-12-01), 575-588 1618-7598 12:6<575 2011 12 10198 https://doi.org/10.1007/s10198-010-0272-0 text/html Onlinezugriff via DOI 1 research-article jats NATIONALLICENCE 856 40 https://doi.org/10.1007/s10198-010-0272-0 text/html Onlinezugriff via DOI NATIONALLICENCE 700 1- Botteman M. Health Economics, Pharmerit International, 4530 East-West Highway, #430, 20814, Bethesda, MD, USA aut NATIONALLICENCE 700 1- Meijboom M. Health Economics, Pharmerit International, Rotterdam, The Netherlands aut NATIONALLICENCE 700 1- Foley I. Health Economics, Pharmerit International, 4530 East-West Highway, #430, 20814, Bethesda, MD, USA aut NATIONALLICENCE 700 1- Stephens J. Health Economics, Pharmerit International, 4530 East-West Highway, #430, 20814, Bethesda, MD, USA aut NATIONALLICENCE 700 1- Chen Y. Health Economics, Novartis Pharmaceuticals Corp, East Hanover, NJ, USA aut NATIONALLICENCE 700 1- Kaura S. Health Economics, Novartis Pharmaceuticals Corp, East Hanover, NJ, USA aut NATIONALLICENCE 773 0- The European Journal of Health Economics Springer-Verlag 12/6(2011-12-01), 575-588 1618-7598 12:6<575 2011 12 10198 Metadata rights reserved Springer special CC-BY-NC licence nationallicence BK010053 XK010053 XK010000 NATIONALLICENCE NATIONALLICENCE NL-springer