Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1:  A 59-year-old female patient has requested reimbursement for an Oncotype DX tumor assay performed in June 2004 as part of the evaluation of her stage I infiltrating ductal carcinoma of the breast. Pathology revealed the tumor was ER-rich, PR-positive, without HER-2/neu gene amplification. The patients provider recommended Oncotype DX testing to assess the risk of distant recurrence and to ascertain the necessity of adjuvant chemotherapy. The results of the Oncotype DX assay indicated a low risk of recurrence and the decision was made to use Arimedix and not use adjuvant chemotherapy.  At issue in this case is whether the diagnostic procedure at issue was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.Published reports indicate the Oncotype DX assay has been used in a prospective manner for women with this type and stage of cancer to predict risk groups.  The data are impressive and convincing.  Many oncologists are using Oncotype DX to help them with when to treat and how to treat decisions. The use of Oncotype DX assays to guide therapeutic decisions is becoming more frequent in the management of a subgroup of patients. This particular patient is one in whom the use of Oncotype DX was likely to be more beneficial for evaluation of her condition than any available standard therapy. Therefore, the Health Plans denial should be overturned.Physician 2:  The patient is a 59-year-old woman who underwent bilateral mastectomies for multiple small breast cancers in January 2004. One of her cancers was a 1.5 cm invasive ductal carcinoma with negative nodes and positive estrogen receptor. Her tumor was submitted to Oncotype DX testing. The patient was found to have a low recurrence score; therefore chemotherapy was not recommended.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 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. The data that was instrumental in establishing the clinical utility of the assay did not come out to the oncologic community until late 2004. The critical paper by Paik was published in December 2004; good data was also presented that same month at the San Antonio meetings of the American Society of Clinical Oncology. At the time the patient underwent Oncotype testing in June 2004 the benefit of the assay remained unproven. 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 3:  The patient is a 59-year-old female who is requesting reimbursement for Oncotype DX testing following bilateral mastectomies secondary to three small, ER/PR+, HER2 tumors. As such, the patient was in a favorable prognostic category. She sought additional information regarding the risk of tumor recurrence through Oncotype DX testing. This testing revealed that her tumors were of low risk with a 4-8% likelihood of recurrence. The Health Plan denied coverage for this testing on the basis that it was experimental and therefore not a covered benefit.The Oncotype DX tumor assay provides prognostic groupings related to the risk of recurrence. To date, it is not sufficiently precise and has not been validated for predictions regarding the benefit of chemotherapy or the need or lack of need for a specific chemotherapeutic course. Given the lack of a definitive statement/knowledge of what level of risk prognosticated by the Oncotype DX test would serve as a triggering threshold for a practicing physician to recommend/not recommend chemotherapy, the test should be considered 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.