Budget impact analysis of the DiviTum TKa assay in postmenopausal women with hormone receptor positive metastatic breast cancer.

BACKGROUND: 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. OBJECTIVE: To estimate the diagnostic and treatment budget impact of the assay on a postmenopausal HR + HER2- 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 the 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 opinions. 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. We calculated total and per-member per-month (PMPM) costs with a 3-year time horizon. RESULTS: The inclusion of 416 DiviTum TKa assays ($166,400) was largely offset by 193 fewer CT scans, 88 fewer bone scans, and 55 fewer biomarker tests over 3 years, a savings of -$128,400, resulting in a PMPM of $0.001. In scenario analyses, adding DiviTum TKa resulted in additional treatment-related cost-savings (-$465,600), resulting in a PMPM cost-savings of -$0.013, or an average savings of -$7,400 per each patient initiating first-line cyclin-dependent kinase 4/6 inhibitor plus aromatase inhibitor therapy. Expected savings approached 3× the spend on the new test. Results were most sensitive to DiviTum TKa cost, population parameters, and treatment costs. CONCLUSIONS: Clinical use of the DiviTum TKa assay is expected to decrease traditional imaging and monitoring and may reduce the overall cost of managing mBC if it leads to clinical decisions to avoid futile therapy. Post-coverage, real-world monitoring of palliative therapies among post-menopausal mBC populations is needed to better categorize cost savings over time.

PLAIN LANGUAGE SUMMARYWhat is already known about this subject Current monitoring of therapy for hormone receptor positive metastatic breast cancer involves a combination of tumor marker testing, imaging, and other tools. Monitoring is variable in practice, and therefore relatively insensitive to evidence of tumor progression.What this study adds DiviTum TKa is a novel biomarker that may offer a more convenient and sensitive alternative to traditional monitoring of metastatic breast cancer. Factoring in cost offsets due to reduced monitoring and earlier discontinuation of futile therapies may be cost-saving to health plans that cover this technology.

Costs of Diagnostic Assessment for Lung Cancer: A Medicare Claims Analysis.

PURPOSE: To assess the diagnostic costs leading up to a lung cancer diagnosis in patients with abnormal computed tomography (CT) scans. PATIENTS AND METHODS: A retrospective cohort study using the 5% Medicare claims data (January 1, 2009, to December 31, 2011) was conducted. Patients aged 65 to 74 years with an abnormal chest CT scan were identified. Index was defined as the date of the abnormal chest CT scan. Outcomes assessed over a 12-month follow-up after index included lung cancer diagnosis rate and the use and associated costs of follow-up diagnostic tests up to diagnosis of lung cancer. RESULTS: Of 8979 patients identified with an abnormal chest CT scan (mean age, 69.3 ± 2.9 years), 13.9% were diagnosed with lung cancer over 12 months. Chest x-rays were the most common diagnostic test. Of the 19% who underwent a biopsy, 43.6% were not diagnosed with lung cancer during follow-up. The average total diagnostic assessment cost per patient was higher for those with versus without lung cancer ($7567 vs. $3558). Among patients not diagnosed with lung cancer, the median diagnostic cost per patient for those with versus without biopsy was ∼ 28 times higher. Adverse events significantly increased the average cost per biopsy (approximately 4-fold). CONCLUSION: Total lung cancer diagnostic cost was $38.3M in the defined study sample, of which 43.1% was accounted for by biopsied patients without a lung cancer diagnosis. Additional risk stratification is required to decrease unnecessary biopsy referrals and costs. Further, adverse events significantly increased costs.