Cost-Effectiveness Analysis of -MammaPrint® to Guide the Use of Endocrine Therapy in Patients with Early-Stage Breast Cancer

Background Gene expression profiling tests can predict the risk of disease recurrence and select patients who are expected to benefit from therapy, while allowing other patients to forgo therapy. For breast cancers, these tests were initially designed to tailor chemotherapy decisions, but recent evidence suggests that they may also guide the use of endocrine therapy. This study evaluated the cost effectiveness of a prognostic test, -MammaPrint((R)), to guide the use of adjuvant endocrine therapy in patients eligible according to Dutch treatment guidelines. Methods We constructed a Markov decision model to calculate the lifetime costs (in 2020 Euros) and effects (survival and quality- adjusted life-years) of -MammaPrint((R)) testing versus usual care (endocrine therapy for all patients) in a simulated cohort of patients. The population of interest includes patients for whom -MammaPrint((R)) testing is currently not indicated, but for whom it may be possible to safely omit endocrine therapy. We applied both a health care perspective and a societal perspective and discounted costs (4%) and effects (1.5%). Model inputs were obtained from published research (including randomized controlled trials), nationwide cancer registry data, cohort data and publicly available data sources. Scenario and sensitivity analyses were conducted to explore the impact of uncertainty around input parameters. Additionally, threshold analyses were performed to identify under which circumstances -MammaPrint((R)) testing would be cost effective. Results Adjuvant endocrine therapy guided by -MammaPrint((R)) resulted in fewer side effects, more (quality- adjusted) lifeyears ( 0.10 and 0.07 incremental QALYS and LYs, respectively) and higher costs (epsilon 18,323 incremental costs) compared with the usual care strategy in which all patients receive endocrine therapy. While costs for hospital visits, medication costs and productivity costs were somewhat higher in the usual care strategy, these did not outweigh costs of testing in the -MammaPrint((R)) strategy. The incremental cost-effectiveness ratio was epsilon 185,644 per QALY gained from a healthcare perspective and epsilon 180,617 from a societal perspective. Sensitivity and scenario analyses showed that the conclusions remained the same under changed input parameters and assumptions. Our results show that -MammaPrint ((R)) can become a cost-effective strategy when either the price of the test is reduced (> 50%), or the proportion of patients for which treatment is altered (i.e. those with ultra-low risk) increases to > 26%. Conclusion Standard -MammaPrint((R)) testing to guide the use of endocrine therapy in our simulated patient population appears not to be a cost-effective strategy compared with usual care. The cost effectiveness of the test can be improved by reducing the price or preselecting a population more likely to benefit from the