Expected Monetary Impact of Oncotype DX Score-Concordant Systemic Breast Cancer Therapy Based on the TAILORx Trial

Abstract

Background TAILORx demonstrated that women with node-negative, hormone receptor-positive, HER2-negative breast cancers and Oncotype DX recurrence scores (RS) of 0–25 had similar 9-year outcomes with endocrine vs chemo-endocrine therapy; evidence for women aged 50 years and younger and RS 16–25 was less clear. We estimated how expected changes in practice following the trial might affect US costs in the initial 12 months of care (initial costs). Methods Data from Surveillance, Epidemiology, and End Results (SEER), SEER-Medicare, and SEER-Genomic Health Inc datasets were used to estimate Oncotype DX testing and chemotherapy rates and mean initial costs pre- and post-TAILORx (in 2018 dollars), assuming all women received Oncotype DX testing and score-suggested therapy posttrial. Sensitivity analyses tested the impact on costs of assumptions about compliance with testing and score-suggested treatment and estimation methods. Results Pretrial mean initial costs were $2.816 billion. Posttrial, Oncotype DX testing costs were projected to increase from $115 to $231 million and chemotherapy use to decrease from 25% to 17%, resulting in initial care costs of $2.766 billion, or a net savings of $49 million (1.8% decrease). A small net savings was seen under most assumptions. The one exception was if all women aged 50 years and younger with tumors with RS 16–25 elected to receive chemotherapy, initial care costs could increase by $105 million (4% increase). Conclusions Personalizing breast cancer treatment based on tumor genetic profiles could result in small cost decreases in the initial 12 months of care. Studies are needed to evaluate the long-term costs and nonmonetary benefits of personalized cancer care.

Chemotherapy and 21-gene recurrence score testing for older breast cancer patients: A competing-risks analysis

“…A previous SEER-Medicare study indicated that the rate of chemotherapy receipt was 3.7%, 9.5%, and 58.3% in low, intermediate, and high RS of patients aged between 65 and 74 years, respectively [33], which was similar to our results. However, the rate of chemotherapy receipt was still significantly lower than that of young patients.…”

Comparison of GenesWell BCT Score With Oncotype DX Recurrence Score for Risk Classification in Asian Women With Hormone Receptor-Positive, HER2-Negative Early Breast Cancer

“…We also assessed the concordance between the two scores according to age: ≤50 years and >50 years. Based on recent findings on the benefits of chemotherapy for patients with a RS midrange score (11–25) from TAILORx (23), patients were categorized into chemobenefit and non-chemobenefit groups using different RS ranges for each age subgroup. In patients aged ≤50 years, those with RS 0–15 and RS ≥16 were categorized into non-chemobenefit and chemobenefit groups, respectively, whereas in patients aged >50 years, the RS ranges used for the classification into non-chemobenefit and chemobenefit groups were RS 0–25 and RS ≥26, respectively.…”

“…Meanwhile, the ARR and NNT for a RS ≥26 was 25.0 and 4.0, respectively (24). A recent study showed that tailored therapy based on Oncotype DX results could result in a net cost increase in initial care of American breast cancer if women aged ≤50 years with tumors with RS of 16–25 all chose to receive chemotherapy (25).…”

Recommendations from the European Commission Initiative on Breast Cancer for multigene testing to guide the use of adjuvant chemotherapy in patients with early breast cancer, hormone receptor positive, HER-2 negative

“…Furthermore, the reported analysis suggests that data for evaluating the potentially most efficient two-step testing strategy is missing. 47 , 48 Mariotto and colleagues 49 showed that application of the 21-RS risk to decide whether or not to provide chemotherapy would produce savings in the actual US real clinical practice. Another analysis using the same data indicates that savings would be much larger if testing would be performed according to a two-step strategy.…”