Appeal type: Experimental/Investigational
Decision: Upheld Decision of Health Plan

Physician 1: The patient is a 59-year-old man with advanced gastric cancer who presented with an ulcerated mass below the gastroesophageal (GE) junction. He has had palliation with radiation therapy and with Xeloda, oxaliplatin, and Taxotere. His tumor was tested for and shows high levels of EGFR (epidermal growth factor receptor). The patients oncologist has proposed the use of cetuximab (Erbitux). The Health Plan has denied authorization and coverage for Erbitux on the basis that it is investigational for the treatment of gastric cancer.Advanced gastric cancer is present at the time of diagnosis in about half of all patients with the disease and the rates of recurrence are similarly very high after potentially curative resection. Various palliative endoscopic and surgical techniques may improve patient comfort, but in general do not lengthen survival. Accordingly, many patients will be eligible and turn to chemotherapy, which has been shown to increase survival at four months. A current common regimen is ECF (epirubicin, cisplatin and infusional 5-FU), which has been established as superior to FAMTX (fluorouracil, doxorubicin, and methotrexate).Erbitux is currently employed in a Phase II trial evaluation of its use in the treatment of unresectable or metastatic esophageal and gastric cancer, which began in July 2005 and is expected to enroll 36 patients. Review of the scientific literature reveals no published, peer-reviewed studies demonstrating that the use of Erbitux for gastric cancer is superior to available regimens at this time. 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 59-year-old male who has been diagnosed with gastroesophageal junction (GE) cancer. He has been treated with oxaliplatin and Xeloda. Radiation therapy is also being started. The treating physician has requested authorization and coverage for the addition of Erbitux to the patients regimen. At issue is whether Erbitux is likely to be more beneficial for treatment of gastric cancer than any available standard therapy.There are no peer-reviewed studies regarding the use of Erbitux in combination with any other agents currently being used for the treatment of GE junction cancer. Thus, the addition of Erbitux to the patients regimen is of unproven efficacy and is not likely to result in a superior clinical outcome to standard therapy. 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: A 59-year-old male patient with dysphagia and abdominal discomfort was found to have locally advanced adenocarcinoma at the gastro-esophageal (GE) junction. The majority of the mass is gastric with regional lymphadenopathy, but no distant metastases. Therapy was initiated with oxaliplatin and Xeloda; the addition of Erbitux (an antibody to the EGFR) was recommended based on an approximate 40% expression level of EGFR in the tissue section. Coverage was denied by the Health Plan based on the experimental/investigational status of Erbitux in the treatment of gastric carcinoma.Erbitux has been shown to benefit patients with colorectal carcinoma, and head and neck cancers. Although the toxicity of Erbitux therapy is acceptable, the data concerning activity in gastric carcinoma or GE junction tumor activity fails to reveal convincing evidence for empiric off-label use of this drug, even in poor prognosis tumors such as this one. The available evidence suggests a need for prospective studies in gastric carcinoma, and there are several ongoing studies in both single and intergroup settings. Based on the clinical data available at this time, the off-label use of Erbitux for locally advanced gastric carcinoma remains unproven. 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. Therefore, the Health Plans denial should be upheld.