Tuesday, October 21, 2014: 11:45 AM

Vakaramoko Diaby, PhD, Florida A&M University, Tallahassee, FL, Georges Adunlin, MA, Florida A & M University, Tallahassee, FL, Simon Zeichner, MD, Department of Internal Medicine, Mount Sinai Medical Center, Miami Beach, FL, Kiran Avancha, PhD, RPh, Cancer Clinical Research, Hartford Healthcare Cancer Institute, Hartford, CT, Gilberto Lopes, MD, Centro Paulista de Oncologia, So Paulo, Brazil, Stefan Glck, MD, PhD, University of Miami, Miami, FL and Alberto Montero, M.D., MBA, Cleveland Clinic, Taussig Cancer Center Department of Solid Tumor Oncology, Cleveland, OH
Purpose: Everolimus in combination with exemestane is Food and Drug Administration-approved for the treatment of postmenopausal women with hormone-receptor positive and HER2-negative metastatic breast cancer, based on the interim results of the BOLERO-2 trial. As part of this trial, Everolimus in combination with exemestane significantly improved progression-free survival compared to exemestane alone in patients previously treated with non-steroidal aromatase inhibitors. A cost-effectiveness analysis was conducted to determine whether everolimus represents good value for money, utilizing data from BOLERO-2.

Method: A decision-analytic model was used to estimate the incremental cost-effectiveness ratio (ICER) between treatment arms of the BOLERO-2 trial according to a public payer perspective and time horizon matching the duration of the clinical trial. The population studied was composed of postmenopausal women with hormone-receptor positive (HR+) and HER2-negative metastatic breast cancer. Costs were obtained from the Center for Medicare Services drug payment table and physician fee schedule. Benefits were expressed as quality-adjusted progression-free survival weeks and quality-adjusted progression-free years, with utilities/disutilities derived from the literature. Deterministic and probabilistic sensitivity analyses were performed.

Result: Everolimus/exemestane had an incremental benefit of 11·88 QAPFW compared to exemestane or 0·22 QAPFY, and an incremental cost of $60,574. This translates into an ICER of $265,498·5/QAPFY. Key drivers of our model, by order of importance include: health utility value for stable disease, everolimus acquisition costs, and transition probabilities from the stable to the progression states. The Monte-Carlo simulation showed results that were similar to the base-case analysis.

Conclusion: Everolimus plus exemestane in postmenopausal women with hormone-receptor positive and HER2-negative metastatic breast cancer is not cost-effective compared to exemestane alone. Further research investigating the cost-effectiveness of the combination versus the monotherapy, in sub-groups of the population studied in BOLERO-2, will be beneficial.