Appeal type: Experimental/Investigational
Decision: Overturned

Physician 1:  The patient is a 47-year-old female who was first diagnosed with breast cancer in 1998. She was initially treated with adjuvant chemotherapy including Adriamycin, Cytoxan, and Taxol. This was followed by five years of tamoxifen. In 2004 the patient was found to have bone metastases and was treated with other hormonal therapies.  In April 2006 she was found to have progressive disease in bone, and liver and her oncologist recommended treatment with Taxol and Avastin. The providers request for authorization was denied as the Health Plan has deemed the therapy experimental/ investigational in this clinical context.Avastin is within a class of new drugs that presumably inhibit angiogenesis. It has been approved for use in combination with chemotherapy in several types of cancer. There is essentially only one applicable study in metastatic breast cancer. This study, conducted by the Eastern Cooperative Oncology Group, has been reported in abstract form at both the 2005 ASCO and the San Antonio Breast Cancer meetings.In that study, 722 patients were randomized to either Taxol alone or Taxol with Avastin, as a first line chemotherapeutic treatment for their metastatic breast cancer. This situation is analogous to this patients clinical status. The group receiving the Avastin had an improved response rate (29.9% vs. 13.8%). There was also an improvement in the median time of progression free survival, (11.4 months vs. 6.11 months). It is not clear as yet whether this will eventuate in improved survival for the group receiving the Avastin, however there is a trend in that direction. Though this is only one study, it did appear to be of sufficient size to allow a conclusion that Avastin was of some value in this situation when combined with Taxol. The NCCN has in fact, included Avastin in their current guidelines for therapy.  Based upon the clinical outcomes achieved with Avastin and Taxol, I have determined that the requested therapy is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.Physician 2:  The patient is a 47-year-old female with metastatic breast cancer. After several rounds of hormonal manipulation her cancer has progressed. The patients oncologist has recommended therapy with Avastin followed by Taxol. The patient has requested authorization for the Avastin therapy. The Health Plan denied her request on the basis that Avastin has not been shown to be efficacious in the treatment of metastatic breast cancer.Based on the results of the Miller study, Avastin and Taxol is a reasonable treatment option for this patients metastatic disease. The proposed treatment regimen may potentially extend the period of progression free survival.  Therefore, I have determined that the requested therapy is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.Physician 3:  The patient is a 47-year-old woman who was originally diagnosed with breast cancer in 1998.  She now presents with advanced metastatic disease for which she has apparently not been treated.  The patients clinician has requested authorization for a treatment regimen of Avastin and Taxol. The Health Plan denied authorization for Avastin citing the investigational nature of the therapy in this clinical setting.The patient is the ideal candidate for the recommended treatment plan of Avastin added to Taxol. She is the type of patient most likely to benefit in terms of progression free survival.  The proposal for first line therapy with Avastin added to Taxol has been presented at the large cancer symposiums and has been adopted by the NCCN.  Based upon the information set forth above, I have determined that the requested therapy is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.