OBJECTIVES: DiviTum^®TKa, a blood-based biomarker assay developed to monitor and predict treatment response in hormone receptor positive metastatic breast cancer (HR+ mBC), may decrease traditional disease monitoring assessments and avoid prolongation of futile treatments. Our objective was to estimate the diagnostic- and treatment budget impact of the assay on a postmenopausal HR+ mBC population in a one-million-member U.S. health plan.

METHODS: We developed a budget impact model comparing inclusion and exclusion of DiviTum^®TKa to standard care under which DiviTum^®TKa 1) reduces frequency of traditional mBC monitoring tools, and 2) predicts treatment futility in advance of radiological disease progression. Traditional disease monitoring assessment schedules were based on guidelines and expert opinion. DiviTum^®TKA’s impact on therapy utilization was based on published literature and expert opinion. Modeled costs included DiviTum^®TKa, NCCN-recommended treatments, imaging, biomarker testing, and adverse events. Unit costs were based on CMS fee schedules and wholesale acquisition costs. Annual rates of incident and recurrent postmenopausal HR+ mBC were estimated from SEER and publicly available data. We calculated total and per-member per-month (PMPM) costs with a 3-year time horizon.

RESULTS: Inclusion of DiviTum^®TKa resulted in total cost-savings of $439,700, equaling PMPM cost-savings of $0.013. Looking at 3-year diagnostic and treatment impacts separately, addition of DiviTum^®TKa (+$166,400) to monitoring was offset by reductions to other tests (-$144,800): CT scans (-203), bone scans (-93), and biomarker tests (-180), with a PMPM of +$0.001. Treatment-related cost-savings were $465,300. Results were most sensitive to DiviTum^®TKa cost, population parameters, and treatment costs.

CONCLUSIONS: Clinical use of DiviTum^®TKa is expected to decrease traditional imaging and monitoring and may reduce overall costs of managing mBC if it leads to clinical decisions to avoid futile therapy. Post-coverage, real world monitoring of palliative therapies among postmenopausal mBC populations is needed to better categorize cost savings over time.