Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1The patient is a 56-year-old woman who underwent surgery for ovarian cancer, stage III-B in 2002. She then underwent six cycles of carboplatinum-taxol. She was well until January 2004 when a rising CA-125 was noted. The patient was then apparently treated with cisplatin-cytoxan and subsequently underwent secondary cytoreductive surgery. She now apparently has progressive disease.It has been noted the results of a chemosensitivity assay suggest resistance to many of the further chemotherapy drugs that might be tried in this situation.  It has now been proposed that the patient be treated with Avastin. The Health Plan has denied authorization for the requested therapy on the basis it is considered investigational.Avastin (bevacizumab) is an antibody that inhibits epithelial growth factors and presumably acts by inhibiting cancer-related new blood vessel development and therefore, progression of the cancer. It has been shown to have some efficacy when combined with chemotherapy in the treatment of metastatic colon cancer. The patients provider references data from an unpublished and unreviewed study in a few patients with ovarian cancer. This does not meet accepted criteria for approval of a new therapy. Thus, the use of Avastin in ovarian cancer is of no proven benefit. As such, 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 56-year-old female with refractory ovarian cancer, which is progressive after optimal first-line chemotherapy. The patient progressed approximately six months after completion of initial chemotherapy. Subsequent chemotherapy has been guided by a chemosensitivity assay, which demonstrated broad chemotherapy resistance to multiple second- and third-line agents. Further treatment with cytoxan and platinum provided a minor response and stabilization. The patient now has progressive disease. Her provider has recommended the patient begin treatment with Avastin. The Health Plan indicates Avastin for treatment of metastatic ovarian carcinoma is considered investigational.The patient has progressive, refractory carcinoma of the ovary. She has been appropriately treated and would appear to have exhausted any conventional chemotherapy treatment of potential benefit. As such, investigational treatment in an NCI approved trial for any agent would be appropriate given her good performance status. It does not appear that Avastin is being offered as part of an approved trial. In the absence of any evidence demonstrating the efficacy of Avastin for patients with metastatic ovarian cancer, there is no data to conclude Avastin is likely to be of benefit to the patient. 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 56-year-old female. She has a stage III-B serous papillary cystadenocarcinoma (high grade). She underwent optimal tumor debulking surgery in August 2002. This was followed by six cycles of carboplatin and Taxol. She recently had a recurrence with liver metastases and rising CA-125. There is tumor progression status post four cycles of platin-based therapy. Carboplatin, cisplatin, Taxol, and cyclophosphamide were unsuccessful. The tumor is resistant to doxorubian, topotecan, gemcitabine, and etoposide. The patients provider has recommended treatment with Avastin.  This patient has recurrent ovarian cancer. She underwent cytoreductive surgery two times and has failed multiple chemotherapy treatments. Most recently, her tumor progressed during chemotherapy. In summary, the patient has failed or progressed through all available and appropriate traditional therapies. The patients provider indicates Avastin is showing promise in the treatment of resistant ovarian cancer. Avastin is a human monoclonal antibody agonist vascular endothelial growth factor. This substance is currently undergoing phase II trials to study treatment in recurrent or persistent epithelial ovarian cancer. Avastin appears active with evidence of response rates and delay in tumor progression. Phase III trials may be initiated soon. In light of these results and given that the patient has exhausted all traditional therapies, Avastin is medically reasonable and appropriate in the treatment of this patient.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.