Appeal type: Experimental/Investigational
Decision: Overturned

Physician #1:  The patient is a 51-year-old woman diagnosed with breast cancer in July 2005. At that time she was found to have a 1.1cm poorly differentiated ductal cancer with negative nodes. The estrogen receptor was positive and HER-2/neu was negative. In an effort to aid in the decision-making process regarding the usefulness of adjuvant chemotherapy, her cancer was submitted for Oncotype DX analysis. On the basis of that test, she was found to have a relatively high risk of recurrence and, therefore, chemotherapy was recommended. The patients request for reimbursement was denied by the Health Plan based upon a determination that the use of the Oncotype DX assay is experimental/ investigational.Oncotype DX assay 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 the clinician 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, such that it appears to be quite reliable not only in terms of prognosis, but 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 remains a great deal of controversy about those who fall into the intermediate risk category. This assay has proven reliable, and is now being used by many oncologists in their decision-making process.  It is no longer considered investigational in the oncology community. 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 51-year-old female with infiltrating ductal carcinoma of the left breast, diagnosed in July 2005.  She had a 1.1cm tumor, ER/PR positive, HER-2/neu negative and sentinel node negative. The Oncotype DX testing score was 31, indicative of an intermediate to high risk of recurrence.  In this case the patient and her clinician chose to treat her cancer aggressively.  The patient is requesting reimbursement for the Oncotype DX testing. 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 assay 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 the Oncotype DX assay was likely to be more beneficial than any available standard therapy. Therefore, the Health Plans denial should be overturned.Physician #3:  The patient is a 51-year-old woman with a 1.1cm breast cancer, node negative, ER/PR positive and HER-2/neu negative. The Oncotype DX assay predicted an intermediate to high 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. Given the patients small tumor in this instance, in the absence of the assay single agent hormonal manipulation would have been a valid option. The assay returned a score of 31 suggesting that indeed there was a benefit to chemotherapy and hormonal therapy.  The assay definitely played a role in outlining the treatment course for this patient.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.