Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1:  The patient is a 41-year-old woman with long-standing granulosa cell tumor of the ovary. She was treated with a long sequence of systemic therapies including cytoxics and other biologicals and hormonal interventions. She has also had extensive surgical debulking. She is receiving thalidomide and Celebrex. Her oncologist has recommended the use of Avastin. The Health Plan has denied this request on the basis that Avastin is investigational in this clinical setting.There is no data regarding the use of Avastin for treatment of this rare disease. Although there is a basis for considering the disease a vascular tumor (it does have a propensity to hemorrhage as it tends to grow very bulky metastases) there is no evidence that it is likely to respond to Avastin. Furthermore, there is no evidence that the effects of the proposed therapy would be better than standard treatment. 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 2:  The patient is a 41-year-old woman who has a history of a sex cord tumor, now refractory to standard chemotherapy including bleomycin, etoposide and cisplatin in 1996, thalidomide from 1998 through 2000, followed by Arimidex, Celebrex, Taxol, and Revlimid. She is requesting authorization for Avastin, which is considered experimental for treatment of the patients disease by the Health Plan.Though there are clinical reports of the activity of Avastin in epithelial ovarian cancer, with response rates hovering around 10-16%, at present there is no evidence Avastin is clinically efficacious in sex cord tumors of the ovary. Furthermore, there is concern over Avastins potential side effects, which include an increase in gastrointestinal perforation, bleeding, hypertension and clotting. Avastin remains investigational in ovarian cancer and has no proven efficacy in cases involving sex cord tumors. 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 41-year-old woman with a history of granulosa cell tumor of the ovary. She has had several previous treatments, but still has progressive disease. Her physician has recommended Avastin therapy. The Health Plan has denied authorization for the proposed therapy citing a lack of scientific evidence establishing its efficacy.Avastin therapy is a humanized monoclonal antibody targeting VEGF. It is approved for use for the treatment of colon and lung cancer and has shown significant activity in breast cancer. Although phase II studies of Avastin have been reported in abstracts and demonstrate some activity in ovarian cancer, there is potentially high toxicity. To date, there is insufficient evidence that Avastin is of clinical value in the treatment of ovarian cancer. As such, it remains investigational for the patients disease and is not likely to be superior to other available options. For the reasons 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.