OBJECTIVES : Adjuvant chemotherapy and endocrine treatment reduces risk of recurrence in patients with HR+, HER2- early breast cancer. Chemotherapy is associated with additional clinical burden and not all patients derive clinical benefit. Evidence from the long-term prospective randomized controlled trial (RCT) TAILORx confirmed that the Oncotype DX^® test predicts the likelihood of chemotherapy benefit in patients without lymph node involvement. These findings were recognized by IQWiG and reimbursement granted. Reduction in chemotherapy use will potentially lower the costs for the health-care system. This analysis quantifies the economic impact of this decision.

METHODS : This budget impact model is based on following assumptions. The costs associated with chemotherapy and their frequency were compared when using the Oncotype DX test vs. no test. The distribution of Recurrence Score^® results (RS) groups is based on the TAILORx study. Cost of standard chemotherapy regimen is based on the calculation of Lux et al. (2017) with updated cost data. For this model, the assumption is that patients tested are candidates for chemotherapy. With testing, our assumptions are: 10% of the patients with RS result <11 and 20% of 11–25 receive chemotherapy diverting from test results. 100% of the patients with RS results >25 receive chemotherapy.

RESULTS : Direct costs of standard chemotherapy (epirubicine + cyclophosphamide + paclitaxel) are estimated €12,135 including drugs, administration, monitoring and handling of complications. The reimbursed test price is €3,392. Out of 1,000 patients, based on the scenario described, approximately 681 patients can be spared chemotherapy leading to total costs saving of €8,258,964. Test costs for 1,000 patients are €3,392,860. Testing and its associated reduction of chemotherapy use generates savings of €4,866,104 for 1,000 patients.

CONCLUSIONS : Using Oncotype DX test for patients with early breast cancer provides a high potential to save costs for the German health-care system by guiding patients when to safely avoid adjuvant chemotherapy.