P1-10-04: Cost-Utility of the 21-Gene Breast Cancer Assay (Oncotype DX®) in the Irish Healthcare Setting.

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Abstract Objective: The Oncotype DX® Breast Cancer Test is a validated 21-gene assay that predicts the likelihood of benefit from adjuvant chemotherapy in early-stage, node-negative and up to 3-node-positive, ER+ breast cancer as well as the likelihood of distant recurrence at 10-years. Study objective was to investigate the cost-utility (incremental cost per QALY gained) of using Oncotype DX® in early stage, node-negative, ER+ breast cancer patients, from the perspective of the Irish Healthcare system. Methods: A cost-utility analysis was performed over the lifetime of the patient using a state transition model (Markov), which simulated the costs and quality-adjusted survival associated with and without the use of Oncotype DX® to inform adjuvant chemotherapy decisions. The model included 3 health states: no recurrence, recurrence and death. Transition probabilities between health states, utility scores associated with each of the health state, patient cohort characteristics and impact of Oncotype DX® on chemotherapy decisions data were derived from published sources. Direct medical costs associated with chemotherapy were collected from a representative panel of 5 hospitals in Ireland. Costs and outcomes were discounted at 4% per annum and the analysis was conducted over 30 years (lifetime horizon). Probabilistic and one-way sensitivity analyses were conducted. Results: Costs associated with adjuvant chemotherapy (4 cycles of TC) included the following costs: drug (€1,002); administration and monitoring (€1,646); adverse event prevention (€3,561) and adverse event management (€756). The average total cost of chemotherapy across hospitals therefore summed up to €6,965. The base case incremental cost per QALY gained with ODX testing was estimated to be €9,462. There was a 74% chance for ODX to be cost-effective at a willingness to pay threshold of €20,000. Conclusions: Using Oncotype DX® as a decision tool to inform adjuvant chemotherapy in node-negative, ER+ breast cancer patients, is likely to be cost-effective in the Irish healthcare setting. This estimate is probably conservative as the cost and disutility associated with long-term impact of chemotherapy related adverse events (i.e. such as cardiotoxicity, secondary leukaemia and potential cognitive impairment) have not been considered. Citation Information: Cancer Res 2011;71(24 Suppl):Abstract nr P1-10-04.

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