Appeal type: Experimental/Investigational
Decision: Overturned

Physician 1: The patient is a 55-year-old woman diagnosed with breast cancer in September 2004. At that time she was found to have a 1.5 cm poorly differentiated invasive ductal adenocarcinoma with four sentinel nodes being negative. The estrogen and progesterone receptors were positive, and HER2 was negative.  To aid in making the decision as to the usefulness of adjuvant chemotherapy, an Oncotype analysis was performed. This revealed a recurrence score that predicted a 27% chance of recurrence of the patients cancer. Because of the high predicted risk of recurrence, the patient accepted the need for adjuvant chemotherapy. The use of the Oncotype tumor assay test was considered investigational by the Health Plan, and therefore excluded from coverage.The decision to use adjuvant chemotherapy is a difficult one in patients with small cancers that are node-negative and estrogen receptor-positive. The Oncotype assay is very often used in this situation to aid in decision making for the patient and the physician. Though further studies of the Oncotype assays impact on survival are needed, the literature supports a relatively good validation of the accuracy of its prognostic results. It is fast becoming the medical standard to perform this assay in women such as this patient.  The Oncotype analysis was indeed likely to be of clinical benefit and was medically appropriate and necessary in this case.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 2: This 55-year-old female patient was diagnosed with a breast cancer that was poorly differentiated, ductal invasive, hormone receptor positive and HER2 negative.  Her lymph node biopsies were negative.  The patient received aggressive chemotherapy then Taxol, which she stated was based on the Oncotype assay.  She was also treated with radiation therapy.  The Health Plan denied authorization for the Oncotype assay due to their determination that this diagnostic procedure was investigational.The prospective data on this tumor assay may be validated in the near future, but as of now data showing a patient outcome benefit with this stratification have not been validated.  Additionally, the standard for a 55-year-old female with breast cancer would have been chemotherapy, plus hormone therapy, plus radiation.  In effect, the Oncotype assay was not required to make a decision as to the best course of treatment for this patient. Based upon the information set forth above, 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 55-year-old female with stage I infiltrating ductal carcinoma of the breast. Estrogen and progesterone receptors were positive, HER2-neu was negative by FISH, and zero of four sentinel lymph nodes were involved.  The Oncotype DX assay indicated a 27% chance of a recurrence of the patients cancer if she was treated with Tamoxifen alone. The patient appeared to be in otherwise good health and she elected to be treated with chemotherapy followed by radiation and hormonal therapy.  Coverage for the Oncotype assay has been denied by her Health Plan as an experimental or investigational procedure.It is often difficult to decide whether to use adjuvant chemotherapy in patients with negative nodes or relatively small cancers.  This case is a classic example of the utility of the Oncotype assay.  It showed the patient would have a 27% chance of recurrence if she were treated with Tamoxifen alone for systemic management. The patient suggested she would not have chosen to have chemotherapy had it not been for this test.  Given the risk of recurrence predicted by the Oncotype assay, an appropriately more aggressive course of treatment with chemotherapy, radiation, and hormonal therapy was pursued.  There is an expectation of additional diminution of her recurrence risk. 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.