Appeal type: Experimental/Investigational
Decision: Overturned

Physician 1:  The patient is a 61-year-old woman diagnosed with breast cancer in June 2005. At that time she was found to have a 4.5 cm lobular invasive cancer with negative nodes and positive estrogen receptor. The tumor was submitted for Oncotype DX assay, returning a recurrence score of 20, which correlates to a 13% chance of recurrence by ten years if treated with hormonal therapy alone.Based on the results of the Oncotype DX assay, the patient elected to forgo adjuvant chemotherapy. She is currently on hormonal treatment alone. At issue is whether the Oncotype DX assay was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.Oncotype DX assay is a 21-gene analysis of breast cancer cells, which produces a recurrence score that predicts quite accurately the risk of distance recurrence of the cancer by ten years if the patient is treated with hormonal therapy as the sole systemic treatment. There is good literature support for its reliability. The assay has been shown to be valid only in node-negative, estrogen receptor positive tumors. It has become very important particularly in this group of breast cancer patients in which it is very difficult to make recommendations about adding adjuvant chemotherapy. Therefore, I have determined that the diagnostic procedure at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.Physician 2:  The patient is a 61-year-old female with a history of stage II invasive lobular carcinoma of the breast. Her cancer was ER positive, PR negative and HER2/neu negative. An Oncotype DX assay was performed, which revealed a 13 % risk of distant recurrences. The patient avoided chemotherapy and was treated with hormonal therapy only. The Health Plan has denied coverage for the Oncotype assay on the basis that it is considered investigational.Oncotype assay is a validated test published in peer-reviewed journals and presented in various oncological meetings. This test has been shown to be clinically useful and in this case assisted the physician in the care and management of the patient. Furthermore, recent results from Berry and colleagues published in the Journal of American Medicine indicate that ER positive patients benefit less from chemotherapy, thus lending further support for the use of the Oncotype assay in cases such as this. Therefore, I have determined that the diagnostic procedure at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.Physician 3:  The patient is a 61-year-old woman with stage II ER positive, PR negative, HER2/neu negative invasive lobular carcinoma of the breast. She is seeking reimbursement for the Oncotype DX assay that predicted a low recurrence risk and was used in the decision not to undergo adjuvant chemotherapy. The Health Plan indicates there is insufficient evidence to support the use of the Oncotype DX assay.Medicare in California has now begun to cover the Oncotype DX assay and the assay is now widely used based on positive validation studies using the NSABP database and a prospective study. In addition, the American Society of Clinical Oncology and the NCCN practice guidelines endorse the use of this study as a part of the decision-making process in patients with the same clinical parameters as the patient in this case.Extensive data now supports the omission of adjuvant chemotherapy in a select group of early-stage breast cancer patients and the use of the Oncotype DX assay in weighing this decision has become a reasonable practice. As compared to the available standard treatment (chemotherapy), which carries a risk of short and long-term exposure to agents associated with neutropenia, neuropathy, and cardiomyopathy, this test and the therapeutic decision facilitated by the results should be considered more beneficial than any available standard treatment.As set forth above, I have determined that the diagnostic procedure at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.