Appeal type: Experimental/Investigational
Decision: Overturned

Physician 1: The patient is a 43-year-old woman who recently was diagnosed with stage I breast cancer. She underwent a diagnostic breast biopsy in October 2004, which revealed a 6 mm intermediate grade (grade II) invasive ductal carcinoma (DCIS). The tumor is ER positive, PR positive, and Her2/neu 2+ (but FISH negative). She underwent a second excision for a positive DCIS margin as well as a sentinel lymph node biopsy in November 2004. This revealed additional DCIS, but with a narrowly negative margin. Two sentinel lymph nodes were excised, both are negative by routine histopathology as well as immunohistochemistry. A post-op MRI did not reveal any additional disease. The patients family history is important in that she is of Ashkenazi Jewish heritage. She has multiple family members affected by breast cancer on her paternal side, including aunts and cousins, totaling four affected individuals.The patient was evaluated for consideration of adjuvant therapy of the stage I breast cancer. Based on the ER-positive nature, adjuvant endocrine therapy was recommended. However, the specific role of adjuvant chemotherapy remains controversial. Although the patient is stage I, she has a mixed prognostic panel and therefore, may sustain some benefit from chemotherapy. Current prognostic markers are inadequate to fully define appropriate groups of stage I breast cancer patients who are mostly likely (as well as unlikely) to benefit from adjuvant chemotherapy. In light of this, the patients provider has recommended Oncotype DX testing to assist with the patients treatment plan. The Health Plan has denied coverage for Oncotype DX testing on the basis it is considered investigational.No specific guidelines from the NIH are available for the role of adjuvant chemotherapy in the treatment of patients such as this patient. That is, no standard of care for the provision of chemotherapy exists, as there is no way to accurately define the subgroup of patients who will and will not benefit.The Oncotype DX Breast Cancer Assay is a 21-gene profile of breast cancers that has been applied to ER-positive, node-negative invasive breast cancer. This test has been found to predict the likelihood of recurrence and has been validated by retrospective analysis of a large, NSABP trial (B-14). This has been reported in the New England Journal of Medicine (December 2004). Furthermore, this test has been validated to predict response to chemotherapy, identifying the group of women with ER-positive, node-negative breast cancer who will and who will not benefit from chemotherapy (reported as a conference presentation at the 2004 San Antonio Breast Cancer Symposium). It is clear that current criteria of selection of adjuvant therapy in breast cancer are inaccurate, leading to both over and under treatment with chemotherapy. In a large analysis of prospectively randomized patients and data acquisition, Oncotype DX testing has been shown to be more powerful than other currently accepted criteria for selection of patients in whom chemotherapy can be safely omitted. Given the recent data from two national conferences (2004 San Antonio Breast Cancer Symposium and the 2005 American Society of Clinical Oncology Annual Meeting), there is sufficient evidence Oncotype DX testing is efficacious. Furthermore, therapy dictated by the results (omission of adjuvant chemotherapy) are likely to be beneficial to the patient as she will not be subjected to the short and long-term toxicities of unnecessary chemotherapy. Based upon the information set forth above, I have determined that the requested services are 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 patient is a young woman with a family history of breast cancer. She was diagnosed in late 2004 with a small breast cancer (node-negative, ER/PR-positive). Her provider has recommended Oncotype DX testing to ascertain whether chemotherapy is warranted. The Health Plan has denied coverage for Oncotype DX testing indicating its efficacy has not been established.The patients clinical situation is such that the NIH guidelines for adjuvant chemotherapy do not provide clear guidance. Oncotype DX testing is a validated assay, which assesses for risk of distant relapse. It enables clinicians to decide if chemotherapy is or is not warranted. The Oncotype DX breast cancer assay includes the analysis of MRNA from 21 genes. It allows characterization of tumor tissue at the molecular level and can potentially avoid the administration of chemotherapy if the recurrence score is low. The results of the test are very likely to have a role in the ongoing care and management of the patient. Accordingly, I have determined that the requested services are 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 43-year-old female with a strong family history of breast cancer. She has early stage ER positive, pre-menopausal breast cancer in the setting of recurrent DCIS. The patient requests coverage for risk-assessment using Oncotype DX testing. The Health Plan has denied this request citing the investigational nature of this approach. Gene expression profiling is a relatively new tool in the setting of therapeutic decision-making, and in the case of predictive values in early stage breast cancer, prospective trials to validate the approach are not yet available for analysis. However, there is some peer-reviewed and compelling data regarding usefulness in the specific setting of patients such as this patient. Given the decisions regarding further therapy that are at stake in this clinical setting where there are not clear-cut guidelines, Oncotype DX testing is likely to be more beneficial than decisions that are not guided by data that informs the physician via risk assessment and gene profiles.Accordingly, I have determined that the requested services are likely to be more beneficial for evaluation of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.