Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1The patient is a 51-year-old woman who is surgically post-menopausal. The patient is a BRCA-1 carrier with a poorly differentiated carcinoma of the left breast post modified radical mastectomy. Laboratory results indicate ER/PgR negative, HER-2 negative by IHC and FISH. The patient is post adjuvant four cycles of FEC chemotherapy and weekly cycles of Taxotere. The patient has experienced an isilateral local recurrence in a lymph node. She is in good clinical condition.The patients provider has recommended high-dose chemotherapy followed by autologous stem cell rescue. The Health Plan has determined the requested therapy is considered investigational for treatment of the patients medical condition.The literature regarding high-dose chemotherapy and autologous stem cell transplantation for recurrent breast cancer is, at best, mixed. Available data is not yet valuable with regard to a survival benefit. While there are aspects of this patients status that are attractive for such an approach (e.g., low tumor volume), the history suggests a chemo-resistant tumor is not likely to be overcome by such an approach. To date, there is insufficient evidence that the requested therapy is likely to be more beneficial than regional radiation therapy with/without additional empiric systemic chemotherapy. Therefore, I have determined that the requested therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 2The patient is a 51-year-old woman with left breast cancer who underwent modified radical mastectomy in January 2004. This was followed by FEC therapy then weekly Taxotere. The patient experienced a recurrence in her axilla, which was treated surgically in June 2004. She then received additional therapy of one cycle of gemcitabine and carboplatin, complicated by thrombocytopenia. Repeat staging studies including a CT scan and PET scan do not document additional metastatic breast cancer. Her oncologist has recommended high-dose chemotherapy (HDC) with stem cell rescue as consolidation therapy, noting that in some patients a 30-40% relapse-free five-year survival can be obtained. The Health Plan has denied authorization for the requested therapy on the basis it is considered experimental.The patients oncologist is correct in assuming that the rapid recurrence of the patients axilla disease (or more accurately persistent disease given the short time frame) reflects anthracycline and taxane resistance, which bodes poorly for the patient in terms of rapid relapse. Unfortunately, there is no data to suggest the superiority of HDC with stem cell support in this situation. Much of the information available regarding HDC is either in the metastatic setting or in the adjuvant setting in high-risk patients. The patient does not fit into either group. In either case, however, the data suggest equivalence between HDC and conventional chemotherapy (but perhaps some superiority in high-risk patients in the adjuvant setting when examined by endpoints other than overall survival). The optimal treatment for locally recurrent breast cancer remains surgery and potentially radiation therapy. Even the efficacy of the addition of systemic chemotherapy is unclear. HDC with stem cell support would not be expected to be more beneficial than current options of radiation therapy and additional standard chemotherapy. Based upon the information set forth above, I have determined that the requested therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.Physician 3The patient is a 51-year-old woman diagnosed with breast cancer in January 2004. She underwent mastectomy, followed by chemotherapy with four cycles of FEC followed by weekly Taxotere. While receiving chemotherapy the patient developed palpable adenopathy in her left axilla. Surgery demonstrated multiple positive nodes, which were all resected. She was then treated with chemotherapy including carboplatin and Gemzar. Recent re-evaluation has not demonstrated any residual or recurrent breast cancer. It has been proposed that the patient now be treated with high-dose chemotherapy (HDC) and autologous stem cell transplant. The Health Plan indicates such therapy is considered experimental in this clinical setting.The use of HDC in breast cancer has been the subject of ongoing controversy for many years. Though initial, non-randomized studies suggested there might be efficacy to such treatments, randomized studies reported in the past five years have not corroborated this. These randomized studies have strongly indicated that HDC is not more clinically beneficial than more conventional therapies. There are still ongoing clinical trials of HDC, as some investigators believe there is a sub-group of women with breast cancer who might benefit from HDC. However, thus far it has not been established what sub-group this might entail or if such a sub-group exists at all. Given that the efficacy of HDC in the treatment of this patients cancer has not been established, I have determined that the requested therapy is not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be upheld.