Appeal type: Experimental/Investigational
Decision: Upheld

Physician #1:  The patient is a 57-year-old woman with unresectable cholangiocarcinoma. She has been started on a regimen of FOLFOX and Avastin. The Health Plan has denied coverage for Avastin indicating there is insufficient evidence of its efficacy in this clinical context. In cases such as this involving a rare disease, data from randomized clinical trials is not available. Thus, therapy is traditionally derived by analogy. There is Phase III data showing survival benefit with Avastin added to standard first-line treatment in patients with metastatic colon cancer, non-squamous cell lung cancer and breast cancer. The proposed regimen in this case represents first-line treatment for metastatic disease using a chemotherapy regimen that has been shown to be active in colon cancer and enhanced by Avastin. As such, there is sufficient data by extrapolation to support the use of Avastin in this clinical context.Accordingly, 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 57-year-old female who was diagnosed with an intrahepatic cholangiocarcinoma in March 2006. The cancer was quite locally advanced, and measured 9cm. Surgical consult found that the tumor was unresectable and the patient was referred to medical oncology. The patient was seen at UCLA where it was proposed she be treated with combination chemotherapy - FOLFOX along with Avastin. The Health Plan has denied coverage for the use of Avastin in this situation on the basis that it is considered experimental/investigational.Avastin is one of a new class of chemotherapeutic agents that attack the epithelial growth receptor of tumors and, hopefully, will interfere with their blood supply. Avastin has been found useful (when combined with chemotherapy) in certain cancers such as colon and lung cancer. Though it is being evaluated in many other types of cancer, as yet there is no reliable scientific literature that suggests Avastin has clinical value in cholangiocarcinoma. Thus, it is considered unproven in this setting and, as such, is not likely to be of greater benefit than standard therapy.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 #3:  A 57-year-old female patient has requested reimbursement and continued authorization and coverage for Avastin therapy to treat intrahepatic cholangiocarcinoma, which was diagnosed in March 2006. A 9cm central tumor was found encasing the portal vein and was considered not resectable. The patients provider has recommended an intensive treatment regimen with FOLFOX and Avastin.  The Health Plan has denied coverage for Avastin on the basis that it is considered experimental.The use of Avastin in combination with chemotherapy for tumors is currently early in its clinical investigational phase with significant and serious side effects that may lead to complications. There does not yet appear to be generalized principles for guiding treatment with Avastin for rare tumors not yet studied in clinical trials. Thus, currently there are insufficient data to indicate that the use of Avastin in this tumor setting is likely to be superior to standard therapy.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.