Appeal type: Experimental/Investigational
Decision: Overturned

Physician #1:  The patient is a 59-year-old woman diagnosed with breast cancer in February 2005. At that time she was found to have a 1.4cm invasive ductal carcinoma with negative axillary nodes. Her estrogen receptor was positive and HER2 was negative. She underwent an Oncotype DX assay and was found to have a low recurrence score. On the basis of that assay the decision was made to forgo adjuvant chemotherapy.At issue is whether the use of the Oncotype DX assay was likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy.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. Though the test itself is fairly new, there is a rapidly growing body of data based on applying it to older studies retrospectively, 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. The use of Oncotype DX assay in this clinical setting was medically appropriate and clinically useful in the care and management of this patients condition. 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 59-year-old woman with breast cancer. The Oncotype DX assay was performed to help guide her choice of therapy for T1N0M0, ER positivie PR positive, HER2 negative invasive ductal carcinoma of the breast. The patient is requesting reimbursement for the Oncotype DX assay. 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 assays 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 59-year-old woman with early-stage node-negative ER/PR+ Her-2-neu negative breast cancer. She is seeking reimbursement for the Oncotype DX assay that predicted a low recurrence risk and was used in the decision not to undergo adjuvant chemotherapy. At issue is whether the procedure at issue was likely to be more beneficial for treatment of the patients condition than any available standard therapy, which would have been at least four cycles of cytotoxic chemotherapy in this case.Medicare in California has now begun to cover the Oncotype DX assay and the assay is now widely used based on positive validation studies using the NSABP database and a prospective study. In addition, the American Society of Clinical Oncology and the NCCN practice guidelines endorse the use of this study as a part of the decision-making process in patients with the same clinical parameters as the patient in this case.Extensive data now supports the omission of adjuvant chemotherapy in a select group of early-stage breast cancer patients and the use of the Oncotype DX assay in weighing this decision has become a reasonable practice. As compared to the available standard treatment, which carries a risk of short and long-term exposure to agents associated with neutropenia, neuropathy, and cardiomyopathy, this test and the therapeutic decision facilitated by the results should be considered more beneficial than any available standard treatment.As 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.