Appeal type: Experimental/Investigational
Decision: Overturned

Physician 1: The patient is a 55-year-old woman diagnosed with breast cancer in May 2005.  At that time she was found to have a 2.5 cm invasive ductal carcinoma, which was node negative and estrogen receptor positive.  She had the Oncotype DX assay performed to assist in her decision making as to whether she should receive adjuvant chemotherapy. This analysis yielded a score of 8, which placed her at very low risk of recurrence.  Accordingly, she did not receive chemotherapy.  The Health Plan, based upon their determination that Oncotype DX testing is experimental/investigational in nature, denied coverage for the diagnostic procedure.As additional data is accumulated, there is increasing evidence that for appropriate patients with breast cancer (node negative, estrogen receptor positive), the Oncotype DX assay is a reliable prognostic test.  Not only does it predict risk of recurrence, but it also demonstrates that the low risk group of patients does not benefit from chemotherapy.  This patient fell into such a group and therefore the test was very helpful in the decision making of the patient and her provider.  There is sufficient data, in qualified studies, to indicate that for a patient with specific characteristics, this is a valuable and worthwhile test.   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 55-year-old woman with Stage II (T2 N0 MX) breast cancer that is estrogen receptor positive, progesterone receptor positive and HER2 negative. The Oncotype DX assay was performed to determine if chemotherapy was warranted.  The identified risk of recurrence for this patient was low, and in consultation with her physician, she elected to forgo chemotherapy.  The Health Plan deemed the Oncotype DX assay an experimental/investigational procedure, and denied the patients request for reimbursement.The Oncotype DX is a valid assay with study results published in the New England Journal of Medicine and multiple major oncology meetings.  With a low recurrence score of 8, as with this patient, adjuvant chemotherapy has not been found to provide a benefit over hormonal therapy alone.  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 3: The patient is a 55-year-old woman with early stage, hormone receptor positive breast cancer. She is seeking reimbursement for use of the Oncotype DX tumor assay in therapeutic decision-making vis-a-vis the addition of chemotherapy.  In addition to the evaluation of her prognostic and tumor features for recurrence in the absence of chemotherapy, the Oncotype DX assay supported the low-risk assessment, and chemotherapy was not given.  The Health Plan has denied reimbursement for the Oncotype DX assay on the basis that it is experimental/investigational.The Oncotype DX assay has been validated in prospective studies as a predictor of distant recurrence in patients with the same profile as the patient in this case. As stated in the 2005 NCCN guidelines, the Oncotype DX assay has been cited as an option in helping to decide about the necessity for chemotherapy.  In addition, the ASCO website discusses the use of the Oncotype DX assay for this clinical scenario, based on a presentation at the ASCO meeting by Paik, et al. These sources, among others, support the use of this assay as standard of care for patients with early stage breast cancer. The Oncotype DX assay is used to make a significant decision regarding the administration of systemic chemotherapy; this therapy is not without significant risk for infection and organ/nerve damage.