Appeal type: Experimental/Investigational
Decision: Upheld

The patient is a 47-year-old man who was diagnosed with rectal cancer metastatic to his liver in April 2004. He was treated with aggressive chemotherapy including oxaliplatin, and 5-FU and leucovorin along with Avastin, and had a complete response to the therapy. The chemotherapy itself has been discontinued. It has been proposed that the patient be continued on Avastin alone for six months. The Health Plan has denied coverage for Avastin on the basis it is considered investigational in this clinical setting. Avastin is a monoclonal antibody that binds to vascular endothelial growth, and presumably, inhibits tumor angiogenesis. It has been shown to be beneficial when added to chemotherapy, specifically chemotherapy including 5-FU. Its efficacy as a single-agent without chemotherapy is entirely unproven. It has only been approved for use along with 5-FU chemotherapy. Thus, there is no data to indicate its usefulness alone in this patients case. 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 47-year-old male with a history of rectal cancer with liver metastasis, presumed to be diagnosed concurrently. He has had an apparent complete remission with two chemotherapies, the second containing Avastin. He is in good clinical condition, but has suffered neurotoxicity from the oxaliplatin. Surgical resection of the liver metastasis was considered and now possibly deferred. A request has been made for authorization and coverage for Avastin. The Health Plan has denied the request on the basis Avastin is considered experimental for treatment of the patients condition. The patient has stage IV cancer of the rectum with liver metastasis. Curability with chemotherapy alone is a remote possibility; surgery and chemotherapy can cure a subset of patients with small volume liver metastasis. While complete remissions are increasingly described with newer chemotherapy regimens (with or without Avastin), there is no evidence of the efficacy of single-agent adjuvant Avastin in colorectal or other cancers. Therefore, continued use of single-agent Avastin cannot be recommended. 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: The patient is a 47-year-old man with stage IV rectal cancer who has had a complete clinical and radiographic response to sequential chemotherapy and chemo-immunotherapy regimens. The patients referring physician has recommended maintenance Avastin therapy. The Health Plan has classified this regimen as experimental. Review of the current medical literature reveals no support for the use of single-agent Avastin in this setting. Phase I and Phase II clinical trials in the early drug development stages supported use of this drug in combination with chemotherapy (as is the current standard). The only immunotherapy that appears to be useful as a single-agent is anti-EGFR with cetuximab, which, unlike Avastin, has been validated in second and third-line therapy settings. Outside of a clinical trial, in the absence of supporting literature, and with alternative approaches available for second-line therapy, the proposed therapy with Avastin cannot be considered more beneficial for treatment of the patients condition than any available standard therapy. Therefore, the Health Plans denial should be upheld.