Appeal type: Experimental/Investigational
Decision: Upheld

Physician 1:The patient is a 51-year-old woman with a history of melanoma presenting in 2003 as a pulmonary mass, which was resected. No primary site was found. She received brief adjuvant alpha interferon, which was discontinued for poor tolerance. She suffered an isolated brain recurrence, which was resected in May 2004. She received post-operative whole brain irradiation and is currently without evidence of disease and in good clinical condition. The patients provider has recommended the patient undergo immune treatment on a Phase II clinical trial. The Health Plan has denied authorization for this treatment on the basis that it is considered investigational.Metastatic melanoma lacks good therapy. To date, chemotherapy, alpha interferon, and IL-2 have offered benefit to a minority of patients. Melanoma cells can be immunogenic; hence, immunologic approaches have hope of benefiting patients with melanoma. Immunotherapies can be effective in low volume metastatic disease. Dr. Webbers vaccine trial addresses just this situation. His trial is both NCI and FDA approved. Based upon this evidence and in the absence of any effective conventional therapy, I have determined that the requested therapy is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should be overturned.Physician 2:The patient is a 51-year-old female with resected metastatic melanoma. The patient wishes to participate in a study of the immunologic endpoints of multi-peptide and vaccine adjuvant that include CpG ODN, a promising but unproven component of an unproven form of treatment for this disease. The Health Plan has denied coverage for the patients participation in the clinical trial.There is insufficient evidence of clinical benefit to recommend the requested therapy. Though there are many reports of immunologic responses to various melanoma vaccines, and occasional clinical response noted with metastatic disease, there is no data for patients with no evidence of disease. As such, there is no evidence the requested therapy will result in a superior clinical outcome to standard therapies. 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:The patient is a 51-year-old woman who had a pulmonary lesion resected in 2003, which proved to be metastatic melanoma with no known primary site. She then developed a left-sided brain mass that was resected in May 2004, which also proved to be metastatic melanoma. This was then followed by whole brain irradiation with concomitant chemotherapy with Temodar.In November 2004, the patient was seen by an oncologist at USC who noted she was now with no evidence of melanoma. It was recommended the patient undergo immune treatment on a Phase II clinical trial. The Health Plan has denied authorization for the patients participation in this trial on the basis that it is considered investigational.The patient is at significant risk for recurrence of her melanoma. For many years there have been multiple attempts to treat melanoma and/or prevent recurrence of melanoma with a wide variety of immune treatments. In general, randomized studies have not shown such treatments to be of significant benefit. These attempts have included non-specific immune stimulants, such as BCG, and a very large variety of more tumor-specific vaccines using various antigens. This current study falls into the latter line of research. The trial proposed is a Phase II trial with as yet no proven benefit to patients such as this patient. The protocol itself focuses mostly on possible stimulation of the patients immune system with the hope that this will reduce her chance of recurrence. Within the body of the protocol the only clinical data included refers to some demonstration that the immune system might be stimulated; however, there is no data to suggest any actual clinical benefit is likely.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.