OBJECTIVES

The budget impact of the Oncotype DX® test in the UK was estimated compared to clinical risk tools only and other commercially available multigene assays (MGAs) used to guide adjuvant chemotherapy in ER+/HER2- node-negative early breast cancer. The model was informed by a systematic literature review of clinical studies of MGAs, including TAILORx and MINDACT randomised controlled studies.

METHODS

The analysis included the cost of genomic testing, chemotherapy and distant recurrence over a 5-year period in the UK. Reduction in chemotherapy use conditional on genomic risk was derived from decision impact studies. Distant recurrence-free intervals were derived from TAILORx and B-20 trials for the Oncotype DX® test, TransATAC for EPClin® and Prosigna® and MINDACT for MammaPrint®. Cost of chemotherapy and distant recurrence was informed by literature and expert opinion.

RESULTS

Compared to clinical risk tools alone, testing all patients with the Oncotype DX® test had a budget impact of £10.6 million assuming MGA list prices. The analysis showed cost savings of £25.0 million and £16.3 million compared to MammaPrint® and Prosigna®, respectively, and an additional cost of £2.2 million compared to EPClin®. The Oncotype DX® test reduced costs of chemotherapy (£10.8-£31.9 million) and distant recurrence (£12.4-£15.1 million) compared to other MGAs. The Oncotype DX® test was cost-saving against all comparators assuming discounts to the list price of >16% for all tests.

CONCLUSIONS

The Oncotype DX® test reduces over-treatment costs by identifying patients who are not expected to benefit from chemotherapy, and crucially identifies a minority of patients for whom targeted adjuvant chemotherapy reduces distant recurrence and associated treatment costs. The choice of MGA to guide adjuvant treatment in early breast cancer needs to consider both its impact on short-term chemotherapy-related costs and downstream costs of distant recurrence, which have increased in recent years with the approval of novel treatments such as CDK4/6 inhibitors.