Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Physician 1: The patient is a 50-year-old female, apparently first diagnosed with breast cancer in 1997. In 2001, she developed contralateral breast cancer, treated with chemotherapy with further recurrence in 2003. In early 2004, the patient was noted to have widespread metastases, including to liver, bones, lungs, and brain. Since that time, she has been treated with multiple types of chemotherapy. Her disease is apparently progressing and it is now proposed that the patient be treated with Avastin and Taxol.Avastin is a drug in a new class of compounds, which inhibit epithelial growth factors. Avastin and similar drugs have found some usefulness and approval in very specific situations. There was one recent study reported at ASCO in 2005 suggesting that Avastin may increase the potency of Taxol when used as first-line treatment for metastatic breast cancer. As yet, this is an unconfirmed study and furthermore, it is not directly related to the case of this patient. In this case, Avastin has been requested as third or forth-line treatment, which is entirely unproven. Thus, 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 2: The patient is a 50-year-old female who has metastasized cancer. In addition, the patient has a history of deep vein thrombosis (DVT). She was originally diagnosed in 1997 with breast cancer. It has been recommended she receive Avastin and Taxol therapy. The Health Plan has denied coverage for the requested therapy on the basis it is considered experimental in this clinical setting.The efficacy of Avastin is not supported by the literature. There is no data demonstrating Avastin is beneficial for patients such as this patient. In addition, in this case the risks of Avastin are higher than reported in the literature because the patient has a history of deep vein thrombosis and is taking Coumadin. 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 3: The patient is a 50-year-old female with a history of metastatic breast cancer who has received multiple chemotherapeutic agents. She presently has a history of widely metastatic breast cancer. She is requesting approval for Avastin and Taxol therapy. The Health Plan indicates the proposed regimen is considered experimental for treatment of patients such as this patient. Therefore, the Health Plan has denied coverage for Avastin and Taxol.Recent data suggests use of Avastin and Taxol in patients who have not been heavily pre-treated has a disease free and overall survival benefit. However, there are also known toxicities associated with this agent such as bleeding, clotting, hypertension, proteinuria and stroke. Furthermore, it is contraindicated in individuals with brain metastases and is not beneficial in patients with multiple lines of treatment. Given the patients heavy premedication state and her history of brain metastases, this agent is not likely to be of clinical value. 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.