This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.
The Oncotype DX DCIS Breast Score is considered experimental/investigational (E/I), and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.
- Experimental/investigational (E/I) molecular and genomic (MolGen) tests refer to assays involving chromosomes, DNA, RNA, or gene products that have insufficient data to determine the net health impact, which typically means there is insufficient data to support that a test accurately assesses the outcome of interest (analytical and clinical validity), significantly improves health outcomes (clinical utility), and/or performs better than an existing standard of care medical management option. Such tests are also not generally accepted as standard of care in the evaluation or management of a particular condition.
- In the case of MolGen testing, FDA clearance is not a reliable standard given the number of laboratory developed tests that currently fall outside of FDA oversight and FDA clearance often does not assess clinical utility.
- The National Comprehensive Cancer Network (NCCN, 2016) breast cancer treatment guidelines include Oncotype DX Breast ("21-gene RT-PCR assay") in their treatment algorithm for hormone receptor-positive, HER2-negative breast cancer.
- They recommend considering the Oncotype DX assay in the following circumstances:
- Histology: Ductal, Lobular, Mixed, Metaplastic
- Tumor >0.5 cm (T1b-T3)
- pN0 or pN1mi (<2mm axillary node metastasis)
- In the discussion, NCCN guidelines state: "Pending the results of prospective trials, the Panel considers the 21-gene RT-PCR assay [Oncotype DX] as an option when evaluating patients with primary tumors characterized as 0.6-1.0cm with unfavorable features or >1cm, and node-negative, hormone receptor positive and HER2-negative (category 2A). In this circumstance, the recurrence score may be determined to assist in estimating likelihood of recurrence and benefit from chemotherapy." (Category 2B: The recommendation is based on lower level evidence and there is non-uniform NCCN consensus, but no major disagreement).
- The 14th St Gallen International Breast Cancer Conference (2015) Expert Panel confirmed previously published recommendations:
- Regarding Oncotype DX, the 2011 recommendations stated: “Several tests are available which define prognosis. These may indicate a prognosis so good that the doctor and patient decide that chemotherapy is not required. A strong majority of the Panel agreed that the 21-gene signature (Oncotype DX) may also be used where available to predict chemotherapy responsiveness in an endocrine responsive cohort where uncertainty remains after consideration of other tests..."
- In 2015, the Panel “considered the role of multiparameter molecular marker assays for prognosis separately in years 1-5 and beyond 5 years and their value in selecting patients who require chemotherapy.” The Panel concluded that “only Oncotype DX commanded a majority in favor of its value in predicting the usefulness of chemotherapy.”
- The Evaluation of Genomic Applications in Practice and Prevention Working Group (EGAPP, 2009 and updated in 2016) found:
- "Insufficient evidence to make a recommendation for or against the use of tumor gene expression profiles to improve outcomes in defined populations of women with breast cancer. In the updated 2016 publication, “evidence of clinical validity for Oncotype DX was confirmed as adequate. With regard to clinical utility, although there was evidence from prospective retrospective studies that the Oncotype DX test predicts benefit from chemotherapy, and there was adequate evidence that the use of Oncotype DX gene expression profiling in clinical practice changes treatment decisions regarding chemotherapy, no direct evidence was found that the use of Oncotype DX testing leads to improved clinical outcomes. Until definitive evidence for clinical utility is available, clinicians must decide on a case-by-case basis whether to offer the test to patients."
- The 2007 evidence-based guidelines from the American Society of Clinical Oncology (ASCO) about breast cancer tumor marker use state:
- "In newly diagnosed patients with node-negative, estrogen-receptor positive breast cancer, the Oncotype DX assay can be used to predict the risk of recurrence in patients treated with tamoxifen. Oncotype DX may be used to identify patients who are predicted to obtain the most therapeutic benefit from adjuvant tamoxifen and may not require adjuvant chemotherapy. In addition, patients with high recurrence scores appear to achieve relatively more benefit from adjuvant chemotherapy (specifically (C)MF) than from tamoxifen. There are insufficient data at present to comment on whether these conclusions generalize to hormonal therapies other than tamoxifen, or whether this assay applies to other chemotherapy regimens."
- In 2016, the American Society of Clinical Oncology (ASCO), stated “If a patient has ER/PgR-positive, HER2-negative (node-negative) breast cancer, the clinician may use the 21-gene recurrence score (RS; Oncotype DX; Genomic Health, Redwood City, CA) to guide decisions on adjuvant systemic chemotherapy. Type: evidence based. Evidence quality: high. Strength of recommendation: strong.”
- Literature Review
- Rakovitch et al. (2015) conducted a population cohort study (n=3320 women with DCIS) with a median follow-up period of 9.6 years.19 Study authors demonstrated that the DCIS Score independently predicted the risk of local recurrence in women with DCIS treated with breast conserving surgery (HR, 2.15; 95% CI, 1.43-3.22). Patients considered low risk via the DCIS Score (62%) had 10-year local recurrence of 13%; intermediate risk (17%) patients had 10-year local recurrence of 33%; and high risk (21%) patients had 10-year local recurrence of 28%. The DCIS Score is intended to provide a quantified risk score for local recurrence to help clinicians guide treatment decisions and potentially reduced the effects of overtreatment with radiotherapy.
- Study results of this trial and others indicate that despite the ability of Oncotype DX to reclassify patients into different risk groups, it is not clear if the risk estimation is accurate enough to induce changes in treatment strategies or disease management, or if the 10-year local recurrence of approximately 13% is still low enough for patients to successfully avoid radiation therapy and the risk of its associated complications.
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Experimental/Investigational (E/I) services are not covered regardless of place of service.
OncotypeDX Breast DCIS Score is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.
Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.
