Appeal type: Experimental/Investigational
Decision: Overturned

Physician 1: The patient is a 56-year-old woman with recurrent breast cancer, Stage IV with inflammatory histopathology. She is appealing denial of coverage for therapy with Avastin in combination with paclitaxel (Taxol). At issue is whether immunotherapy with Avastin is likely to be more beneficial than any available standard therapy.The data addressing the role of Avastin in breast cancer is encouraging yet incomplete. It is clear from single institution and cooperative group trials that Avastin, in combination with chemotherapy, has important activity in advanced breast cancer. However, the timing and combinations that best exploit this activity in the breast cancer treatment algorithm remains to be determined. The issue at hand is whether there is evidence that the safety and efficacy of Avastin in advanced breast cancer is superior in terms of benefit as compared to the available standard therapy. In this patients case, with disease that is recurrent despite anthracycline, Navelbine, and taxane therapy, and the aggressive biology known to characterize the inflammatory breast cancer subtype, standard therapeutic options are very limited. Based on the recent report of both significant activity and acceptable tolerability of Avastin plus Taxol in a large, multi-institutional, chemo-naive advanced breast cancer population, this regimen is a reasonable choice in a well-informed patient with a good performance status. The requested therapy is likely to have greater benefit than existing standard regimens in this pre-treated patient. Furthermore, Taxol and Avastin therapy is listed as an option for patients with refractory/recurrent breast cancer in the NCCN guidelines. 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.Physician 2: The patient is a 56-year-old female who was diagnosed with infiltrating ductal carcinoma of the right breast in July 2003. She underwent lumpectomy and lymph node dissection.  She had a second resection due to close margins and then received adjuvant chemotherapy.  A recurrence was noted in January 2005 and she was diagnosed with inflammatory breast cancer.  The patient received carboplatin and Taxotere and was treated with Navelbine and Xeloda in October 2005.  The patients oncologist has recommended combination chemotherapy with Avastin and Taxol. The Health Plan has denied authorization and coverage for Avastin on the basis it is considered investigational for patients such as this patient.Unfortunately, it is unlikely that any chemotherapy will produce a significant response in the patients cancer. The combination of Taxol with Avastin is being recommended based on a study that was recently reported at the ASCO annual meeting. In that study, Taxol alone was compared with Taxol plus Avastin. The results indicated a superior overall and progression-free survival in the patients receiving the combination regimen. However, this was a study of drug use as first-line chemotherapy for metastatic breast cancer. The results are not applicable to this setting, which involves a patient who not only has had multiple chemotherapies, but also has had aggressive therapy with Taxol itself. Accordingly, 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: This patient is a 56-year-old woman with metastatic breast cancer. In January 2005 she was assessed with Stage IV inflammatory breast cancer. She has been treated with: carboplatin/Taxotere and Navelbine/Xeloda. She is requesting coverage for treatment with Avastin and Taxol. The Health Plan indicates the use of Avastin for treatment of the patients breast cancer is considered investigational.Based on the results of the EZ100 clinical trial presented at the ASCO meeting in 2005 and again at the San Antonio Breast Cancer Conference there was improvement in progression-free survival and overall survival in patients with metastatic breast cancer who were treated with Avastin and Taxol. In light of these results and given the fact that there is no other available therapy that is likely to have clinical value in this setting, the proposed regimen is medically reasonable and appropriate and should be authorized.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.