Appeal type: Experimental/Investigational
Decision: Overturned

Physician 1:  The patient is a 46-year-old female with a history of breast cancer. The tumor was noted as less than 1cm in size, node negative, and ER/PR positive. An Oncotype DX assay predicted an average recurrence risk and was used in reaching the decision to undergo adjuvant chemotherapy. The patient is now requesting reimbursement for the diagnostic procedure. The Health Plan considers the Oncotype DX assay experimental/ investigational and has denied coverage.The Oncotype DX assay is used to help predict the rate of distant recurrences. The test was instrumental and medically necessary in guiding this patients care. At first review of the case, one could have argued for hormonal manipulation only given the small size of the tumor and the ER/PR state. However, the results of the Oncotype assay significantly changed the management of this case. 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 46-year-old woman who was diagnosed with breast cancer in 2004.  She was found to have a 0.5cm invasive ductal carcinoma, with negative nodes and positive estrogen receptor. HER2 was negative. Her tissue was submitted for an Oncotype DX assay. This revealed a recurrence score of 37, which predicts a 25% chance of distant recurrence within 10 years if she were to be treated with Tamoxifen alone. On the basis of this test, adjuvant chemotherapy was recommended. 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.The 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 10 years if the patient is treated with hormonal therapy as the sole systemic treatment. There is good literature supporting its reliability. The assay has been shown to be valid only in node-negative, estrogen receptor positive tumors. The assay has become very important as it is particularly in this group of breast cancer patients that it is very difficult to make recommendations about adding adjuvant chemotherapy. Although in this case the assay was performed in early 2004 and the data demonstrating the validity and value of this assay was not published until late 2004, the data itself was presented at national meetings in 2003 in abstract form. The patients oncologist was aware of this data and it was on that basis that he ordered the test. Though it was early on in its use, the data available in early 2004 was sufficient to demonstrate the efficacy of the Oncotype DX assay even at that time.Based upon the information 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. Therefore, the Health Plans denial should be overturned.Physician 3:  The patient is a 46-year-old pre-menopausal woman with early stage breast cancer, ER/PR positive, node negative disease. She requests reimbursement for the Oncotype DX tumor assay, which was used in making the decision to proceed with adjuvant chemotherapy after initial breast conservation therapy. The test predicted an unacceptably high rate of recurrence and the patient and her physician opted for subsequent chemotherapy. As additional data is accumulated, there is increasing evidence that the Oncotype DX assay is a reliable prognostic test for appropriate patients with breast cancer (node negative, estrogen receptor positive). When used in the appropriate clinical setting in which the risk/benefit ratio of cytotoxic chemotherapy is unclear, the Oncotype DX score is a medically necessary piece of data used to guide therapeutic decision making. There is sufficient data to indicate that this is a valuable and worthwhile test for patients such as this patient. 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.