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

Physician 1:  The patient is a 42-year-old man diagnosed with Merkel cell cancer in July 2005. He has been treated with radiation therapy and multiple courses of chemotherapy, including limb perfusion therapy. Currently his disease is worsening, but because of low blood counts and the multiple side effects he has had from chemotherapy, it has been proposed that he be treated with insulin potentiated therapy along with low-dose chemotherapy. The Health Plan has denied coverage for the proposed therapy on the basis that it is experimental/investigational.Insulin potentiated therapy consists of giving insulin to lower the blood glucose; this would supposedly make the cancer cell susceptible to low doses of chemotherapy. There is currently no credible evidence that there is benefit to such therapy. Therefore, at best, it must be considered investigational and of no proven benefit. 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. The Health Plans denial should be upheld.Physician 2:  The patient is a 42-year-old man with refractory, heavily pre-treated Merkel cell cancer. It has been suggested that he begin treatment with insulin potentiation therapy along with low dose chemotherapy. The Health Plan has denied authorization for the requested therapy indicating it is considered experimental.Insulin potentiation therapy with low dose chemotherapy has not been proven effective, even at a IIB level of evidence. It has not been the subject of scientifically adequate clinical trials for Merkel cell cancer or other malignant disease. There is no evidence that the proposed therapy is likely to result in a superior clinical outcome to conventional therapy in this setting. For these reasons, I have determined that the requested therapy is not likely to be more beneficial for treatment of the enrollees medical condition than any available standard therapy, the Health Plans denial should be upheld.Physician 3:  The patient is a 42-year-old male with Merkel cell tumor diagnosed in 2005. He is status post excision, radiation and chemotherapy. He has had multiple small recurrences. The patient is requesting authorization for insulin potentiated therapy with low dose chemotherapy. The Health Plan has denied his request citing a lack of peer-reviewed data supporting the therapy.Unfortunately, despite the fact that the patient has a rare tumor with limited options, there is inadequate scientific data regarding low dose chemotherapy with insulin. The proposed therapy remains experimental. No significant trials have been performed establishing the efficacy of the therapy. Based on currently available data, it is not possible to conclude that the proposed therapy will benefit this patient. Furthermore, there is no evidence that the effects of the proposed therapy would be better than standard treatment. 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. The Health Plans denial should be upheld.