Appeal type: Experimental/Investigational
Decision: Overturned

Physician 1: The patient is a 56-year-old woman diagnosed with cancer in the left breast.  The tumor was ER positive and HER-2/neu amplified. The Oncotype DX assay was reportedly performed to help decide whether or not adjuvant chemotherapy was warranted.  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 role of the Oncotype gene expression assay in patients whose tumors are HER-2/neu amplified has not been established. The Paik publication reported that less than 10% of the tumors in the sample population were HER-2/neu positive. Of those that were, there was a 25% relapse rate which was nearly equal to the relapse rate in the sample group with the highest overall score. This high risk HER-2/neu positive subset could not be further divided by the Oncotype DX assay and chemotherapy was indicated regardless of the Oncotype score.  Therefore, 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. The Health Plans denial should be upheld.Physician 2: The patient is a 56-year-old woman diagnosed with breast cancer in early 2005. At that time she was found to have a 1.4cm mixed lobular-ductal invasive adenocarcinoma, moderately differentiated. The estrogen receptor was positive, nodes were negative, and HER-2/neu was positive. Her cancer was submitted for the Oncotype assay and the testing indicated a high recurrence probability.  She apparently went ahead with adjuvant chemotherapy based on those results. The Health Plan deemed the diagnostic procedure experimental/investigational and the patients request for reimbursement was denied.The Oncotype DX is a relatively new assay wherein 21 genes are analyzed in a breast cancer, allowing for the development of a prognostic score. This score then allows one to place a patient into a risk category for recurrence (low, intermediate or high). The test thus far only applies to women with node negative (or micrometastatic positive), estrogen receptor positive cancers.Though the test itself is fairly new, there is a rapidly growing body of data based on the retrospective application of the assay to older studies. It appears to be quite reliable in terms of prognosis and has potential usefulness in decisions regarding adjuvant chemotherapy.  Specifically, there is data to suggest that those in the low risk group get no benefit from adjuvant chemotherapy, and those in the high risk group get significant benefit from adjuvant chemotherapy. There is a great deal of controversy about those who fall into the intermediate risk category.  In any case, the test is being used by many oncologists in their decision-making process and has moved beyond an investigational status.  The use of the Oncotype DX assay should be supported.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. The Health Plans denial should be overturned.Physician 3: The patient is a 56-year-old woman with breast cancer. The Oncotype DX assay was done to help guide her choice of therapy for T2N0M0, ER positive, PR positive, and HER-2/neu positive invasive ductal carcinoma of the left breast.  The patient is requesting reimbursement for the Oncotype DX assay. Her request was denied by the Health Plan based on their determination that the diagnostic procedure is experimental/ investigational.The article in the New England Journal of Medicine reports results from a study where the Oncotype DX was used in a prospective manner to predict risk groups for women with this type and stage of cancer. The data are impressive and convincing. Many oncologists are using the Oncotype DX assay to help them with when to treat decisions. The use of Oncotype DX assays to guide therapeutic decisions should now be considered as within the standard of care for breast cancer diagnosis and treatment. This particular patient is one in whom the use of Oncotype DX was likely to be more beneficial for evaluation of her medical condition than any available standard therapy. The Health Plans denial should be overturned.