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

Physician 1:  The patient is a 51-year-old woman first diagnosed with an ocular melanoma in December 2001. She was also diagnosed with chronic lymphocytic leukemia in 2003. She was found to have liver metastases in September 2005, which were resected. However, in December 2005 she was found to have new liver metastases. In about March 2006, she underwent biochemotherapy with apparently some response, but a residual lesion was noted in May 2006. She underwent cryoblation for this lesion.It has now been recommended that she undergo arterial chemoembolization of her liver. The Health Plan has denied authorization for the procedure citing its investigational status in this context.Chemoembolization of the liver is a technique that exposes the cancer cells within the liver metastases to high concentrations of chemotherapy, while at the same time blocking a good part of their blood supply. It has been particularly useful in the treatment of primary liver cancer (hepatocellular carcinoma). The procedure has been used in many other types of tumors that spread to the liver, but in those other types it has been hard to provide convincing data that there is a real survival benefit, especially considering that there can be severe toxicities in some patients.The submitted literature suggests that this form of treatment has been used in a very small number of patients with ocular melanoma metastatic to the liver. Though responses have been seen, the actual clinical benefit to the patient is not clear. One of the submitted articles discusses a recent trial reported in 2004 (Agarwala, et. al.). This was admittedly noted to be a Phase I/II trial in 19 patients with metastatic ocular melanoma. The overall (partial) response rate was 16%, with no indication of survival data. There was significant toxicity in these patients. Given the data currently available, the clinical benefit of this procedure in this patient population remains unproven.For the reasons set forth above, I have determined that the requested procedure 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.Physician 2:  The patient is a 51-year-old female with metastatic melanoma. She has had multiple hepatic lesions resected and cryoablated. She has undergone interval biochemotherapy treatment. In addition, she has chronic lymphocytic leukemia (CLL). The patient now wishes to undergo hepatic arterial chemoembolization. The Health Plan has denied coverage for the procedure on the basis that there is insufficient evidence of its efficacy in this clinical setting. The level of evidence supporting hepatic artery chemoembolization is very low (2B) due to the absence of randomized trials and uniform rigorous Phase II trials. In the case of this patient, there is the presence of major contraindications to the proposed procedure as well as factors that are likely to preclude benefit. The patients liver is not symptomatic. There is no data showing improvement in survival so in the absence of palliation there is no potential benefit. Additionally, the patient has had extensive prior surgery and cryoablation, which are likely to increase the risk of complications with chemoembolization. Furthermore, she is immunosuppressed secondary to CLL and having received rituximab. All told, there is inadequate evidence demonstrating that hepatic artery chemoembolization is likely to result in an improved clinical outcome in this case.Based upon the information set forth above, I have determined that the requested procedure 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.Physician 3:  The patient is a 51-year-old woman with ocular melanoma and liver metastases. She is requesting authorization for transcatheter arterial embolization and chemoembolization of the hepatic artery. The Health Plan has denied coverage for the requested procedure on the basis that it is considered experimental.The efficacy of the proposed therapy for patients such as this patient has not been proven. Participation in a clinical trial is the recommendation, uniformly, for patients in this clinical scenario. Moreover, the risks of the proposed procedure appear to be significant. Given the lack of data demonstrating that the requested chemoembolization procedure is likely to result in any measurable benefit, it cannot be recommended for this patient. Accordingly, I have determined that the requested procedure 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.