Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1The patient is a 60-year-old woman diagnosed with medullary cancer of the thyroid at least three years ago. She has been documented to have metastases to liver, lung, and bone. She has been treated in the past with hepatic chemoembolization, radiation therapy, and a variety of chemotherapeutic agents. It has been proposed that she be treated with Avastin. The Health Plan has denied authorization and coverage for Avastin on the basis that it is considered experimental.Avastin is a monoclonal antibody that binds to and inhibits the biologic activity of human vascular endothelial growth factor (VEGF). It has recently been approved by the Food and Drug Administration for use in combination with chemotherapy in the treatment of metastatic colon cancer. While Avastin is being studied for treatment of other cancers, it has thus far shown little activity in other cancers. There has been no published data to indicate efficacy in any form of thyroid cancer. Thus, there is no evidence that Avastin would offer the patient any significant clinical benefit. Therefore, I have determined that the requested medication 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 60-year-old woman with stage IV medullary carcinoma of the thyroid (MCT). She has requested authorization and coverage for Avastin, an anti-angiogenesis agent. The patient was originally diagnosed in 2001 and has been treated in the past with topotecan, ifosfamide/carboplatin/VP-16, chemoembolization, radiation, and 5FU plus interferon. She has recently been on thalidomide. The Health Plan has denied authorization and coverage for Avastin on the basis that it is an experimental use in this setting. Avastin is not an entirely benign drug, and has a significant risk of hemostatic complications. Its use empirically in this situation, outside of a clinical trial, does not meet reasonable criteria for off-label drug use. There is no peer-reviewed literature that provides support for the proposed therapeutic approach. Thus, there is insufficient evidence that Avastin is likely to be of any benefit to the patient. Though it appears the patient has exhausted available standard treatments, aggressive supportive care remains an option, as does exploring avenues related to modifying signals elaborated by over-expression of the RET oncogene if the patients tumor has this relatively common lesion found in sporadic MCT. Therefore, I have determined that the requested medication 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 60-year-old woman with metastatic medullary carcinoma of the thyroid to multiple sites. She was initially diagnosed in 2001. She has received multiple modalities and lines of systemic, local, and regional treatment including chemotherapy, radiation, chemoembolization and immunomodulation with partial responses. Her disease while widespread is relatively indolent and she remains in good condition. A request has been made for Avastin. The Health Plan has denied authorization and coverage for Avastin on the basis that it is considered experimental.While the patient remains in good condition and is a candidate for further treatment, she has already received exhaustive therapy for an uncommon neoplasm, for which there are few, if any, standard systemic therapies. The rationale for use of Avastin in this case is unclear and there is no evidence that Avastin would be potentially beneficial despite known low toxicity. Therefore, I have determined that the requested medication 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.