Abstract

6548 Background: Everolimus in combination with exemestane is approved for the treatment of postmenopausal women with hormone-receptor (HR) positive, HER2-negative metastatic breast cancer (MBC). The BOLERO-2, a randomized phase 3 trial, demonstrated a significantly improved progression free survival (PFS) with everolimus plus exemestane compared to exemestane alone in patients previously treated with non-steroidal aromatase inhibitors. In order to better inform U.S. policymakers, this study aimed to assess the cost-effectiveness, from a payer perspective, of everolimus in combination with exemestane. Methods: We created decision analytical and Markov models using published data from the BOLERO-2 trial. Utilities were derived from available literature. Costs were obtained from the Center for Medicare Services drug payment table and physician fee schedule and were represented in 2012 U.S. dollars. The quality-adjusted life-years (QALY) and incremental cost-effectiveness ratio (ICER) were calculated. One way and probabilistic sensitivity analyses were performed. Results: Everolimus added 0.42 years of progression-free survival (PFS) by central radiographic assessment with an incremental cost of $33,103, an overall cost of $62,751.54 per year of PFS gained, and an ICER of $79,376/QALY. By local assessment, everolimus added 0.29 years PFS years with an incremental cost of $31,873, an overall cost of $83,222 per year of PFS gained, and an ICER of $108,131/QALY. The results of the model were robust in sensitivity analyses. The primary drivers in this model were found to be: PFS duration, progression free probability on therapy, and overall everolimus cost. Conclusions: Everolimus plus exemestane appears to be cost-effective in the treatment of metastatic breast cancer. Based on efficacy and value, this newly approved combination should be considered to be a viable option in treating patients with HR+/HER2- MBC upon progression on non-steroidal aromatase inhibitors.

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