Abstract P5-15-04: CTX and CTX-related direct medication costs saved by testing biomarkers uPA and PAI-1 in primary breast cancer: Results of a prospective multi-center study at Certified Breast Centers in Germany

Abstract

Abstract Background: Biomarkers uPA and PAI-1 are guideline recommended by ASCO, USA, and AGO, Germany, to be used in primary breast cancer to avoid unnecessary CTX in medium risk recurrence patients [G2, N−, HR+, HER2neu−, >35 years]. This study was performed to verify in normal clinical settings how many CTX cycles and how much CTX-related direct medication costs can be avoided by uPA/PAI-1 testing. Methods: Prospective, non-interventional, multi-center study over two years among six Certified Breast Centers in Germany to analyze application of uPA/PAI-1 and consecutive decision making in the clinical setting for AOK Bayern-insured patients. CTX regimen and cycles avoided were identified for each case and direct costs for CTX and CTX-related medication costs for concomitant medication calculated for each patient individually according to body weight and body surface as well as potential FN prophylaxis according to physicians' decision. All medication costs were taken from the pharmaceutical price list for Germany Rote Liste of 2012. EURO [€] to US Dollar conversion rate as of June 12 2012: € 1.00 = US$ 1.25. Results: In n=93 breast cancers n=35 CTX (37.6%; FEC n=25, FEC+DOC n=8 and TC n=2) were avoided according to uPA/PAI-1 test result. Consecutively 210 CTX cycles or 12.1 years of CTX application were saved improving patients' quality of life. uPA/PAI-1 testing saved direct medication costs for avoided CTX of US$ 221.816, CTX-related concomitant medication of US$ 34.353 and G-CSF prophylaxis of US$ 25.749, overall US$ 281.918. At process costs for a single uPA/PAI-1 test calculated at US$ 359, uPA/PAI-1 testing resulted in additional costs of US$ 33.387 for all breast cancer cases. Overall, testing of uPA/PAI-1 has been proven to be cost-effective regarding direct medication costs alone at a return-on-investment ratio of 8.4:1. Indirect cost savings further increase this ROI. Conclusions: Innovative and individual cancer diagnostics like biomarkers uPA/PAI-1 can decrease need of CTX and increase patients' quality of life and thereby reduce costs for health care systems. Since application of this test is inadequate at present time measures are suggested to fully implement such cost-effective diagnostics. Citation Information: Cancer Res 2012;72(24 Suppl):Abstract nr P5-15-04.