Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1: This patient is a 55-year-old woman diagnosed with breast cancer in September 2005. At that time she was found to have a 1.5 cm invasive ductal carcinoma, intermediate grade, with negative nodes. The estrogen receptor was positive and HER2 was positive.  Her tissue was submitted for Oncotype DX assay. This assay gave her a risk of recurrence of 34%. Accordingly, she underwent adjuvant chemotherapy.  The Health Plan deemed the diagnostic procedure experimental/investigational and denied her request for reimbursement.The decision as to the appropriateness of adjuvant chemotherapy is a difficult one in Stage I breast cancer. The Oncotype DX assay does appear to add meaningful prognostic information in this situation. Though there is as yet no convincing data that using adjuvant chemotherapy in women who have a high risk of recurrence, based on their Oncotype DX score, will improve outcome, it seems quite likely. The data has been compelling enough that the medical oncology community is increasingly incorporating the assay in the appropriate clinical situation, in making recommendations about adjuvant chemotherapy and such appears to have been this case for this patient. 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 patient is a 55-year-old female with T1c invasive ductal carcinoma of the right breast. The tumor was hormone receptor positive with Her-2 amplification. The Oncotype assay indicated a high risk of recurrence and the patient proceeded with chemotherapy on the recommendation of her oncologist. The Health Plan denied coverage for the Oncotype assay and the patient now requests reimbursement for the diagnostic procedure.Although the December 2004 Paik paper published in the New England Journal of Medicine asserts that the Oncotype recurrence score predicts better than the HER-2/neu status, the validation of the chemotherapy vs. no chemotherapy protocol has not been published. Furthermore, new data on Herceptin expression will probably alter practice even for node negative patients in favor of providing appropriately chosen chemotherapy treatment with Herceptin overexpression.  The patient was HER-2/neu positive and her oncologist discussed overall survival with her and recommended adjuvant chemotherapy prior to the results of the Oncotype assay.  The contribution of Oncotype DX to the chemotherapy vs. no chemotherapy decision-making process was likely minimal.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:  This case involves a 55-year-old female with a 1.5 cm, node negative, hormone-receptor (ER/PR) positive tumor that was also shown to express the Her-2 neu oncoprotein. The study in question was performed as part of a risk-stratification to decide whether the patient would benefit from adjuvant chemotherapy following aggressive local therapy.  The patient now requests reimbursement for the Oncotype assay. The Health Plan considers the diagnostic procedure experimental/investigational and has denied her request.The Oncotype DX study is somewhat controversial, but two large studies (NSABP and Kaiser Permanente) have validated the predictive value of this test in patients with early stage, ER/PR+, node negative disease. Although the issue of Her-2 neu expression by immunostaining was not specifically addressed in these studies, this prognostic feature is measured as part of the Oncotype profile.However, it is generally accepted that Her-2 neu positive patients would benefit from an anthracycline-based chemotherapy, as these patients tend to have a worse prognosis than patients who do not overexpress Her-2 neu.  Similarly, it is not considered the standard of care to recommend omitting adjuvant chemotherapy for breast cancer patients with tumors greater than 1 cm who also have the poorer prognostic feature of Her-2 neu overexpression. Indeed, this patient did go on to receive therapy. Given the clinical scenario, this patient would have been considered, according to generally accepted standards, a definite candidate for adjuvant chemotherapy, and therefore, the contribution of the Oncotype DX score cannot be considered necessary for making this decision. 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.