Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1: This patient is a 50-year-old woman first diagnosed with colon cancer in 2003. At that time she had positive lymph nodes and was treated with chemotherapy, the Folfox-4 regimen. In May 2005 she was found to have recurrent disease, and she was started on Folfiri with Avastin. She elected to stop this treatment and sought treatment with an out-of-network provider who offered her low dose chemotherapy and insulin potentiation therapy. The Health Plan has denied coverage for this therapy on the basis it is considered experimental for the treatment of colon cancer.Insulin potentiation therapy is an unproven treatment for cancer. It consists of giving insulin in a method that supposedly makes the cancer cells susceptible to lower doses of chemotherapy. The chemotherapy drugs used are a variety of standard chemotherapy drugs. There is no data to suggest that such therapy is of any clinical value. The chemotherapy drugs offered by the out-of-network provider could have been administered by the patients in-network oncologist. Therefore, I have determined that the therapy at issue was 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 50-year-old woman who was diagnosed with colon cancer in 2003. She was treated with the Folfox-4 regimen. In May 2005 a recurrence was discovered and she was started on Folfiri with Avastin. The patient then began treatment with an out-of-network provider, which included low dose chemotherapy and insulin potentiation therapy. The Health Plan has denied authorization for the therapy the patient received indicating that such therapy has not been proven to be effective in the treatment of colon cancer.There is not adequate data in support of the therapy at issue. The regimen was not part of a clinical trial in a Food and Drug Administration-approved protocol. The regimen has not been tested in rigorous trials with favorable results and was not likely to result in any improvement in the patients condition. Therefore, I have determined that the therapy at issue was 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 50-year-old female with metastatic colon cancer. She was treated with 12 cycles of adjuvant chemotherapy with the Folfox-4 regimen. She subsequently developed a recurrence with metastatic tumor spread including a 22-mm lymph node medial to the anastomotic site and a positive perioportal lymph node. A pelvic ultrasound revealed two large, solid vascular masses within the pelvic cul-de-sac displacing the uterous anteriorly. She was started on chemotherapy using the Folfiri regimen with the VEGI inhibitor, Avastin. The patient discontinued treatment under this regimen and began a protocol devised by an out-of-network provider that included low dose chemotherapy and insulin potentiation therapy. The patient has requested reimbursement from the Health Plan for this treatment regimen.There is no scientific published data to verify that the therapy at issue results in any improvement in tumor responses or survival advantage. Indeed, there does not appear to be any data at all to even suggest that the therapy at issue is effective in this clinical setting. The patient was likely to experience greater benefit from a standard chemotherapy regimen. Accordingly, I have determined that the therapy at issue was 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.