Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1: The patient is a 51-year-old male with recurrent gastroesophageal (GE) junction adenocarcinoma post neoadjuvant cisplatin with a small volume of liver metastases. Taxotere and Xeloda have been tried. In June 2005, it was recommended the patient receive carboplatin and CPT-11 along with Avastin. The Health Plan has denied coverage for Avastin on the basis it is considered investigational in this clinical setting.The patient has conventionally incurable metastatic GE junction adenocarcinoma. Despite significant prior therapy to which he has had some documented response, he has symptomatic recurrent disease in his liver and possibly elsewhere. Additional conventional therapy is not likely to be effective. There is significant phase II activity of CPT-11, platinum and Avastin in such tumors reported in ASCO abstract #4025. Given the patients neurotoxicity, carboplatinum is a rational substitution. While it is third-line therapy, there is evidence Avastin has added benefit in non first-line metastatic solid tumor situations (i.e., colon and breast cancer). For this reason, and given the lack of conventional treatment options, I have determined that the requested medication 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 51-year-old male with metastatic, chemo-refractory esophageal cancer who now is being considered for partially non-cross-resistant treatment and the addition of Avastin. The Health Plan has denied coverage for Avastin indicating there is no evidence of the efficacy of the proposed combination regimen. Though there has been some success with combinations of Avastin with carboplatin and taxol in lung cancer, and with 5FU/leucovorin and CPT-11 (or with oxaliplatin) in colon cancer, there is no data yet demonstrating the efficacy of the proposed regimen for esophageal cancer. There is no evidence that the addition of Avastin to the patients regimen will result in a superior outcome to standard therapy. Thus, there is insufficient data to support the inclusion of Avastin in this patients regimen. 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 3:The patient is a 51-year-old man who was diagnosed with adenocarcinoma of the gastroesophageal (GE) junction in early 2004. He was initially treated with cisplatin and CPT-11, and then surgery. He was noted to have liver metastases in October 2004, at which time he was treated with Taxotere and Xeloda. The patient was seen in consultation in June 2005 and it was recommended that he be treated with carboplatin and CPT-11, along with Avastin. The Health Plan has denied authorization for the use of Avastin on the basis it is considered investigational for treatment of gastric adenocarcinoma. Avastin has been approved for use along with chemotherapy in metastatic colon cancer, in certain situations. It also appears to have activity in other cancers, including lung and renal cancer. As yet, there are no reported studies of its usefulness in gastric adenocarcinoma, though such studies are underway. In the absence of any data to support its efficacy in gastric adenocarcinoma, Avastin remains of unproven value. 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.