Appeal type: Experimental/Investigational
Decision: Overturned

Physician 1:  The patient is a 53-year-old woman diagnosed with infiltrating lobular carcinoma in July 2000 and subsequently diagnosed with ipsilateral invasive ductal cancer in January 2005. She was found to have a 1.4cm tumor with positive estrogen receptors and negative axillary nodes. The patient underwent an Oncotype DX assay and had a recurrence score of 17 which predicts an 11% chance of recurrence if the patient is not treated with chemotherapy. On that basis, the decision was made to forgo adjuvant chemotherapy. The patients request for reimbursement was denied by the Health Plan based upon a determination that the use of the Oncotype DX assay is experimental/ investigational.Oncotype DX assay is a 21 gene analysis of breast cancer cells, allowing for the development of a Recurrence Score that predicts, quite accurately, the risk of distant recurrence of the cancer if the patient is treated with hormonal therapy as the sole systemic treatment. There is good literature support for its reliability. The test has only been validated for node negative, estrogen receptor positive cancers. The assay has become very important, as it is in this group of breast cancer patients in particular, that it is very difficult to make recommendations about adding adjuvant chemotherapy. Indeed, this assay has been rapidly adopted by many oncologists as part of their standard evaluation of such patients and Medicare has approved of its use. The Oncotype assay should no longer be considered investigational as its clinical value has been clearly established. 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.Phsyician 2:  The patient is a 53-year-old woman with a 1.4cm, node negative, ER/PR positive stage I breast cancer diagnosed in January 2005. She also had an infiltrating lobular carcinoma diagnosed in 2000 and treated with lumpectomy. She did not receive adjuvant therapy following the earlier diagnosis. The Oncotype DX assay performed in August 2005 predicted a low recurrence risk (Recurrence Score = 17) and was a factor in the decision to forgo adjuvant chemotherapy. The patient is now requesting reimbursement for the diagnostic procedure. The Health Plan considers the Oncotype DX assay experimental/ investigational and has denied coverage.Given the patients small tumor and the other characteristics of her cancer, she may or may not be best treated with chemotherapy plus hormonal therapy. Clinical studies have not been particularly helpful in directing the best clinical approach or predicting an outcome under these circumstances. With the Oncotype assay, physicians and clinicians are now able to determine the benefit of chemotherapy therapy based on the risk of distant metastasis. The research supporting Oncotype DX has been published in peer-reviewed journals and has been presented at various meetings such as the American Society of Clinical Oncology; the assay is not experimental or investigational. For these reasons, 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 53-year-old women with a prior history of a right T1cN0 infiltrating lobular carcinoma in July 2000 treated surgically (lumpectomy and axillary node dissection). The patient was well until she re-presented in January 2005 with a recurrent breast lump. She was ultimately diagnosed with a T2Nx infiltrating ductal carcinoma, treated by partial mastectomy. Given the prior axillary node dissection, no further nodal excision was performed. The patients oncologist ordered an Oncotype DX assay for risk stratification and this returned with a Recurrence Score of 17; translating into an 11% recurrence risk at 10 years. The patient is now requesting reimbursement for the Oncotype DX testing. The Health Plan deemed the procedure investigational and her request for reimbursement was denied.The Oncotype DX is a 21-gene expression assay which was developed retrospectively using tissue analysis from women treated on NSABP B-14, a trial that tested five years versus ten years of adjuvant tamoxifen. The individuals handling the tissue specimens were blinded to patient outcomes and Paik and colleagues reported that at a mean follow-up of 10.9 years, the Recurrence Score accurately predicted the risk of disease recurrence. The ten-year rate of recurrence was found to be 6.8% in the low risk group (Recurrence Score less than 18) and 30.5% in the high-risk group. (Recurrence Score greater than 31). These results demonstrated that the Recurrence Score was a more powerful predictor of distant recurrence than primary tumor size and patient age. The data was confirmed in another retrospective dataset from patients treated at Kaiser-Permanente in California (Habel, et al). With a growing body of data supporting its validity in predicting recurrence risk, the Oncotype DX assay is relied upon by many oncologists to make adjuvant treatment recommendations. The assay helps to identify women who should receive chemotherapy and, more importantly those who may not need chemotherapy. It can be reasonably concluded that the use of the Recurrence Score in risk stratification has become the standard of care. The Oncotype DX assay is not experimental or investigational for any woman with node negative, hormone receptor positive breast cancer.However, all of this data points to a very specific group of women: those with surgically proven node-negative breast cancer. The dilemma here is that the patient has had a second diagnosis of breast cancer within the same breast, raising suspicion of recurrent breast cancer, versus a second primary. Assuming this is a recurrence, the Oncotype DX assay is not validated in this situation. Additionally, the patient had previously undergone an axillary node dissection in 2000, and further axillary surgery was not technically feasible. Although one can clinically assume she was node-negative, one cannot be as assured of this, especially in the absence of pathologic confirmation. Therefore she has Nx disease, as opposed to N0 (node-negative). Again, Oncotype DX has only been validated in women with node-negative breast cancer and therefore, the data from Oncotype DX cannot be extrapolated to this situation. In the context of recurrent breast cancer and/or Nx disease, the Oncotype DX assay is experimental/investigational.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.