Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1The patient is 67-year-old man with chemo-refractory metastatic colon cancer. The patient wishes to undergo a combination of insulin potentiation therapy and additional chemotherapy. The Health Plan has denied authorization for insulin potentiation therapy indicating that the efficacy of the requested procedure has not been shown.There is not adequate data in support of insulin potentiation therapy. The proposed treatment is not part of a clinical trial in a Food and Drug Administration-approved protocol. This modality has not been tested in rigorous trials with favorable results and is not likely to result in any improvement in the patients condition. 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 2The patient is a 67-year-old man with a history of metastatic colon cancer. The patient has undergone multiple chemotherapeutic options. He has progressive disease to his lungs and liver. The patient has requested authorization for insulin potentiation therapy. The Health Plan has denied the patients request.The Health Plans denial should be upheld. There is no scientific literature demonstrating that insulin potentiation therapy results in improved outcomes for patients with metastatic colon cancer. There is no evidence to support the safety or efficacy of the requested therapy. Furthermore, there are other types of proven effective therapy available for treatment of this patients condition. 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 3The patient is a 67-year-old man diagnosed with metastatic colon cancer in April 2002. At that time, he had a hernia operation and was found to have adenocarcinoma in the hernia sac. Further evaluation revealed metastic lung and liver nodules, as well as a primary colon cancer in the transverse colon. The patient underwent resection of the primary along with a splenectomy. He was then treated with chemotherapy including 5-FU with leucovorin, oxaliplatin, CPT-11, and Xeloda. Chemotherapy was continued until August 2003, at which time there may have been some progression of his disease. In January 2004, the patients oncologist suggested restarting chemotherapy. At that time, the patient indicated he wanted to pursue insulin potentiation therapy.Insulin potentiation therapy (IPT) is a form of treatment for a variety of disease states that has been around for many years. It involves the injection of insulin, thereby lowering the blood sugar. Once the blood sugar is lowered, chemotherapy is infused. The theory is that lowered sugar levels make the cancer cells more sensitive to the chemotherapy so that the doses of chemotherapy need only be 10-15% of the usual dosage. It is unclear how safe IPT is, as low blood sugar states carry risks.There is no scientific published data to verify that IPT 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 requested therapy may be effective. This patient is more likely to benefit from further chemotherapy, perhaps combined with C-225, which has recently been approved for use in colon cancer.Based upon the information set forth above, 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.