Economic evaluation of the 21-gene signature (Oncotype DX®) in lymph node-negative/positive, hormone receptor-positive early-stage breast cancer based on Japanese validation study (JBCRG-TR03)

Abstract

The 21-gene signature is validated as a good predictor of recurrence for lymph node-negative/positive, hormone receptor-positive, early-stage breast cancer in Japanese patient population. This study evaluates the cost-effectiveness of two scenarios designed to include the assay into Japan's social health insurance benefit package: one for LN-, ER+, ESBC and another for LN-/+, ER+, ESBC. An economic decision tree and Markov model under Japan's health system from the societal perspective is constructed with new evidence from the Japanese validation study. Incremental cost-effectiveness ratios are estimated as ¥384,828 (US$3,848) per QALY for the indication for LN- scenario and ¥568,533 (US$5,685) per QALY for the indication for LN-/+ scenario. Both are not more than the suggested social willingness-to-pay for one QALY gain from an innovative medical intervention in Japan, ¥5,000,000/QALY (US$50,000/QALY). Sensitivity analyses show that this result is plausibly robust, since ICERs do not exceed the threshold by various changes of assumptions made and values employed. In conclusion, the inclusion of the assay in Japan's social health insurance benefit package for not only LN- diseases but also LN+ diseases is cost-effective. Such a decision can be justifiable as an efficient use of finite resources for health care.

OPTIMA prelim: a randomised feasibility study of personalised care in the treatment of women with early breast cancer

“…74,113,115,116 Two studies 112,113 assessed populations that included only patients with lymph node-positive disease, both of which evaluated Oncotype DX. Four studies reported specific details of patients' level of lymph node involvement; 112,113,115,116 most restricted their populations to patients with low levels (1-3) of lymph node involvement, with only one study 111 including patients with higher (1-9) lymph node involvement.…”

“…116 Of the six studies assessing Oncotype DX, 74,111,115 two estimated that the test would dominate standard care strategies, with Oncotype DX found to produce a gain in QALYs and a reduction in costs. 112,113 Both of these studies were funded by the manufacturer.…”

“…The remaining four studies 74,111,114,115 found Oncotype DX to be more costly and more effective than standard care. The highest incremental cost-effectiveness ratio (ICER) value was estimated in the only study that included patients with high levels of lymph node involvement (1-9 positive nodes).…”

“…They found that there was almost a 100% probability of Oncotype DX-guided treatment being cost-effective, but that the results for the lymph node-positive group were more sensitive to one-way sensitivity analyses than the results in a lymph node-negative population. For the remaining three studies (which assessed mixed lymph node populations), the ICER results were £6232/QALY, 74 JP¥568,533/QALY (equivalent to US$5685) 115 and AUD$9986/QALY.…”

Gene Expression Profiling in Breast Cancer and Its Effect on Therapy Selection in Early-Stage Breast Cancer

“…Even though these tests are costly, studies performed have shown that they are actually cost-efficient (42,43). They are included in reimbursement schemes in the USA and Europe whereas they are not included in the reimbursement program in Turkey and many other countries.…”