Abstract
BackgroundA 21-gene recurrence score (RS) assay may inform adjuvant systematic treatment decisions in women with early stage breast cancer. We sought to investigate the cost effectiveness of using the RS-assay versus current clinical practice (CCP) in women with early-stage estrogen- or progesterone-receptor-positive, axilliary lymph-node negative breast cancer (ER+/ PR + LN- ESBC) from the perspective of the Canadian public healthcare system.MethodsWe developed a Markov model to project the lifetime clinical and economic consequences of ESBC. We evaluated adjuvant therapy separately in post- and pre-menopausal women with ER+/ PR + LN- ESBC. We assumed that the RS-assay would reclassify pre- and post-menopausal women among risk levels (low, intermediate and high) and guide adjuvant systematic treatment decisions. The model was parameterized using 7 year follow up data from the Manitoba Cancer Registry, cost data from Manitoba administrative databases, and secondary sources. Costs are presented in 2010 CAD. Future costs and benefits were discounted at 5%.ResultsThe RS-assay compared to CCP generated cost-savings in pre-menopausal women and had an ICER of $60,000 per QALY gained in post-menopausal women. The cost effectiveness was most sensitive to the proportion of women classified as intermediate risk by the RS-assay who receive adjuvant chemotherapy and the risk of relapse in the RS-assay model.ConclusionsThe RS-assay is likely to be cost effective in the Canadian healthcare system and should be considered for adoption in women with ER+/ PR + LN- ESBC. However, ongoing assessment and validation of the assay in real-world clinical practice is warranted.
Highlights
A 21-gene recurrence score (RS) assay may inform adjuvant systematic treatment decisions in women with early stage breast cancer
In pre-menopausal women, the RS-assay led to an increase of 0.05 QALY per person and decrease in cost of $50 per person resulting in a cost saving compared to clinical practice (CCP)
In post-menopausal women, the RS-assay led to an increase of 0.062 QALY per person and an increase in cost of $3,700 per person, resulting in an incremental cost effectiveness ratio (ICER) of approximately $60,000 per QALY gained compared to CCP
Summary
A 21-gene recurrence score (RS) assay may inform adjuvant systematic treatment decisions in women with early stage breast cancer. We sought to investigate the cost effectiveness of using the RS-assay versus current clinical practice (CCP) in women with early-stage estrogen- or progesterone-receptor-positive, axilliary lymph-node negative breast cancer (ER+/ PR + LN- ESBC) from the perspective of the Canadian public healthcare system. Half of them will be diagnosed with early-stage estrogen- or progesterone-receptor-positive, axillary lymph-node negative difficult because the histopathologic measures that inform the guidelines are not accurate predictors of risk or benefits of chemotherapy [4,5,6,7,8]. The 21-gene recurrence score assay (Oncotype DX) produces a “tumour signature” reflecting tumour biology and risk of relapse [7,9]. Women with a score between 18 and 30 have an intermediate risk and do not appear to have a large benefit from chemotherapy but the uncertainty in the estimate cannot exclude a clinically important benefit [9,10]
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