Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1:  The patient is a 59-year-old woman diagnosed with breast cancer in November 2005. At that time she was found to have multiple foci of invasive ductal breast cancer, the largest of which was 1.9cm. It was of intermediate grade histologically. Estrogen receptor was strongly positive and HER-2 was negative. The patient underwent an Oncotype DX tumor assay for which she has requested reimbursement. The Health Plan has denied her request on the basis that the Oncotype DX assay is considered investigational.Oncotype DX assay is a 21-gene analysis of breast cancer cells, which produces a recurrence score that predicts quite accurately the risk of distant recurrence of the cancer by ten years if the patient is treated with hormonal therapy alone.However, thus far all the validated data has been only in patients with estrogen receptor positive, node-negative tumors. There is essentially no substantiated data about the usefulness of the test in women such as this patient, who had positive nodes. Accordingly, the use of Oncotype DX analysis in decision-making in patients such as this patient is of no proven clinical benefit. As such, I have determined that the diagnostic procedure at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be upheld.Physician 2:  The patient is a 59-year-old female who has invasive breast cancer in the left breast. She has multifocal carcinoma. She had a tumor that was 1.0cm and 3 of 14 nodes were positive. She was HER-2 negative, and the cancer was ER/PR positive. The patient has requested reimbursement for an Oncotype DX tumor assay performed in January 2005. The Health Plan has denied this request citing a lack of peer-reviewed evidence demonstrating the efficacy of Oncotype testing in this clinical scenario.Although the Oncotype assay is a validated assay, it is not appropriate for patients such as this individual as she had a node negative breast cancer in which case the standard of care is chemotherapy. The Oncotype assay was not clinically useful under these circumstances and did not add any value to the care and management of the patients treatment. Therefore, I have determined that diagnostic procedure at issue was not likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 3:  The patient is a 59-year-old woman with lobular carcinoma of the left breast, multi-focal, with three axillary lymph nodes involved. She has requested reimbursement for an Oncotype DX assay used to make a decision to forego chemotherapy in the setting of a HER-2 negative, ER/PR+ tumor. The Health Plan has classified this test as experimental/investigational and has denied reimbursement.The referring physicians rationale is outlined as a low-proliferative (good prognosis histopathology) tumor despite the presence of axillary lymph node metastases.  Although the Oncotype DX tumor assay has been validated for help in decision-making, the clinical scenario in which the data has been validated does not include patients with lymph node disease. The standard of care for patients in this clinical setting is systemic chemotherapy in light of multi-focal disease and lymph node involvement. Review of the literature does not reveal data that supports the utility of performing this test in this particular clinical scenario (compared to patients with no axillary lymph node involvement). Therefore, this diagnostic procedure cannot be considered more beneficial for evaluation of the patients medical condition compared to the standard of care and available standard therapy. Thus, the Health Plans denial should be upheld.