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

Physician 1: The patient is a 47-year-old woman diagnosed with breast cancer in 1998. She was initially treated with CMF chemotherapy, but then experienced a recurrence in her bones. She has had a variety of chemotherapeutic agents, including carboplatinum, taxotere, cisplatinum and Taxol.The patient experienced long-lasting myelosuppression and has most recently been treated with Herceptin. Her oncologist has requested authorization for Avastin and has proposed adding it to Herceptin in the treatment of the patients metastatic disease. The Health Plan has denied coverage for Avastin on the basis that it is considered investigational in this setting.Avastin is a member of a new class of drugs that presumably inhibit angiogenesis. It has been approved for use, in combination with chemotherapy, in a few cancer types. In breast cancer, there is one study showing that if Avastin is added to Taxol in first-line treatment of metastatic breast cancer, there is an improved response rate as well as improvement in time to progression of disease. However, there is no data as yet that Avastin is useful in any other clinical setting in the treatment of metastatic breast cancer. Specifically, it does not appear to be useful when used alone, and there is no data that it adds to the impact of Herceptin. Accordingly, the use of Avastin in this situation has no known clinical benefit.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 2:  The patient is a 47-year-old woman with breast cancer that has metastasized to the bone. She has been heavily pre-treated. The patient has been receiving radiation therapy and has been on Herceptin, which was continued through the radiation therapy. The patients provider has recommended the addition of Avastin and 5FU/LV. The Health Plan has denied this request on the basis that it remains unproven in this context.The efficacy of Avastin in this clinical setting is not supported by the literature. There is no data demonstrating Avastin is beneficial for patients with breast cancer that has metastasized to the bone and who have been heavily pre-treated. There is insufficient evidence of activity to warrant the use of Avastin in this setting, especially to palliate bone pain. 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 47-year-old woman with a history of metastatic breast cancer. She was initially treated with CMF chemotherapy/adjuvant and upon documentation of metastatic disease has undergone several regimens including Herceptin plus several agents including carboplatin, and Taxotere. The patient has required pelvic radiation therapy and now has chronic neutropenia. Her provider has recommended Avastin along with 5FU/LV. He also discusses combining Avastin and Herceptin. The Health Plan has denied authorization for Avastin on the basis that it is investigational.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 for a patient who has previously been treated, which is entirely unproven. Furthermore, numerous other options exist for this patient including single agent Doxil, Herceptin plus Xeloda or Navelbine. 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.