Appeal type: Experimental/Investigational
Decision: Overturned

Physician 1: This patient is a 55-year-old woman diagnosed with breast cancer in November 2004. At that time she was found to have a 2.7 cm high-grade invasive ductal carcinoma with negative nodes. Estrogen receptor assay was positive; HER2 was negative by FISH assay.Adjuvant chemotherapy was recommended to her because of the size of her tumor. Apparently she had reservations about such treatment and had the Oncotype assay performed on her cancer cells to assist in decision making regarding chemotherapy. This assay demonstrated that she had a relatively high risk of recurrence of her cancer and therefore she decided to go ahead with the chemotherapy. Coverage for the Oncotype assay has been denied by her Health Plan as an experimental or investigational procedure.The decision to use adjuvant chemotherapy is a difficult one in patients with negative nodes or relatively small cancers. The Oncotype assay is commonly used in this situation. There has been fairly good validation in the literature as to the accuracy of its prognostications, though as yet, there is no definitive proof that the use of chemotherapy, when guided by this assay, improves survival. However, it is a very reasonable assumption that such will be the case.It is becoming the standard to perform this assay in women such as this patient, and it is very likely to be of clinical benefit and should be considered medically necessary.  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 female with stage II breast cancer. Her tumor was 2.7 cm in size, estrogen receptor positive, grade III, HER2/neu negative (FISH) and she had negative lymph nodes.  In question, was how great was the chance of distant metastases given the patients clinical history and the mixed prognostic features.  The patients physicians had recommended chemotherapy and the patient herself was somewhat reluctant. The Oncotype DX tumor assay was suggested to validate risk of metastases.  The Health Plan considered the Oncotype assay an experimental/investigational procedure and denied coverage for the procedure.This case is an excellent example of the value of the Oncotype assay in identifying that subset of women with breast cancer who are at the highest risk for relapse and ultimate death. The Oncotype assay served a substantial clinical role in determining the treatment approach for this particular patient and in assessing the benefit of adjuvant chemotherapy prior to hormonal therapy. This test has been performed on a sufficiently large population of women with infiltrating ductal breast cancer (and results confirmed in another large group from Kaiser) to unequivocally establish its worth. 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 post-menopausal female with stage II infiltrating ductal carcinoma of the left breast. She is in good clinical condition.  Her tumor, in addition to being strongly hormone receptor positive, was HER2/neu negative by FISH.  Nonetheless, the Oncotype diagnosis assay demonstrated a relatively high risk of recurrence, thus indicating the need for combined modality systemic therapy.  The Health Plan withheld authorization for the Oncotype assay due to their determination that the status of this diagnostic procedure is investigational.Oncotype testing is becoming increasingly acceptable in situations such as this. Through analysis of 21 genes, cancers can be put into a group that is characterized as low, intermediate, or high risk of recurrence. This data has been verified and appears to be reliable. This particular assay is only possible in node negative, estrogen receptor positive tumors, such as was involved in this case. The results of the Oncotype assay often serve as a valuable guide in making decisions about adjuvant chemotherapy. Without use of the Oncotype assay, such decisions are very difficult and involve a certain degree of guesswork. Though further studies are needed, there is sufficient data to appreciate the benefit and to support the use of the Oncotype assay in this particular clinical setting.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.