Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1: The patient is a 52-year-old female who was diagnosed with invasive ductal carcinoma of the breast found to be T2N0M0, ER positive, PR positive, and HER2 positive.  The Oncotype DX assay was performed to help guide her choice of therapy.  The patient now requests reimbursement for the diagnostic procedure.  The Health Plan considers the Oncotype DX experimental/investigational and has denied reimbursement and coverage.There are no prospective clinical trials that have demonstrated that this assay can be used to select a specific therapy that will provide the individual patient with a better therapeutic outcome than would be achieved with the current guidelines for selection of therapy. Such studies are currently in progress, and until such data are available, use of this test is investigational.  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 52-year-old woman diagnosed with breast cancer in September 2005. At that time she was found to have a 2.1 cm Grade II infiltrating ductal carcinoma. Her lymph nodes were negative, Estrogen and Progesterone receptors were positive, and her tumor over expressed HER2.  The patients provider submitted her cancer to Oncotype for evaluation, which resulted in a Recurrence Score of 53.  This means that if the patient were treated with hormonal manipulation alone she would have a 34% risk of distant recurrence. Apparently, based on those results the decision was made to have her undergo chemotherapy. The Health Plan has denied the patients request for reimbursement of the cost for the Oncotype DX, citing the investigational/experimental nature of the procedure.The Oncotype DX is a relatively new assay wherein 21 genes in a breast cancer are analyzed allowing for the development of a prognostic score. This score then allows the placement of a patient into a risk category for recurrence (low, intermediate or high). Thus far, the test only applies to women with negative lymph nodes and estrogen receptor positive cancers.  Although the test itself is fairly new, data from older studies has been applied retrospectively and there is a rapidly growing body of data showing the assay to be quite reliable in terms of prognosis and the potential usefulness of 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 still however, 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 to aid in the decision-making process and has transitioned beyond a purely investigational status.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 52-year-old female with breast cancer, diagnosed in September 2005.  She was node negative with a 2.1cm tumor that was ER/PR positive and HER2/neu positive. The Oncotype DX assay was performed to assess her risk of distant recurrence and she is now seeking reimbursement. The Health Plan deemed the diagnostic procedure experimental/investigational and reimbursement was denied.The usefulness of the Oncotype assay is case specific.  It was not beneficial for this patient because HER2/neu positive disease indicates an aggressive cancer. As shown by the results of Intergroup Study 9831 presented at ASCO 2005, this woman should be offered chemotherapy. The Oncotype assay was not required to make a clinical judgment in this case. Regardless of the Oncotypes prediction, the patients disease requires chemotherapy/herceptin and local treatment.  Therefore, 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.