Appeal type: Experimental/Investigational
Decision: Overturned

Physician 1: The patient is a 62-year-old man who was diagnosed with a hepatocellular carcinoma by MRI in April 2004 with extensive left portal vein involvement. The patients provider determined that surgery was not an option for the patient and systemic chemotherapy was of limited value. Non-surgical ablative therapy was also ruled out. The patients provider recommended transcatheter arterial chemoembolization (TACE). The Health Plan has denied coverage for TACE indicating it is considered experimental for treatment of the patients condition. Review of the submitted records indicates the patient has had two TACE treatments. The first was in May 2004 and the second was in June 2004. Follow-up MRI of the liver has shown diminution of the size of the left portal vein mass. The patient remains asymptomatic as to abdominal pain and distension, nausea and vomiting. Thus, it appears the patient has responded favorably to previous TACE treatments. Though additional data on the efficacy of TACE is still needed, there is growing support for use of TACE in the treatment of patients such as this patient. Therefore, I have determined that TACE is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned. Physician 2: The patient is a 62-year-old man with unresectable hepatocellular carcinoma. He originally presented when he was found to have a palpable liver edge in April 2004. He was diagnosed with hepatocellular carcinoma that was deemed unresectable due to left portal vein thrombosis, evidence of cirrhosis, and the possibility of extrahepatic disease manifested by an enlarged lymph node in the gastrohepatic ligament. He was evaluated for a liver transplant and was felt not to be an appropriate candidate. Therefore, he underwent transcatheter arterial chemoembolization (TACE) in May 2004 and again in June 2004. The patient has had stable disease based on radiographic imaging including the latest MRI in January 2005. He had a dramatic response of his alpha-fetoprotein with an initial level of 4201 on 4/21/04 and values of 4.2, 4.4 and 4.9 in August 2004, October 2004, and January 2005, respectively. He currently has a stable level of function and is without significant pain or other symptoms related to the tumor. It has been recommended the patient receive repeat TACE treatments. The Health Plan has denied coverage for TACE on the basis it is considered investigational. The role of TACE in the management of hepatocellular carcinoma remains incompletely defined. For patients with unresectable disease, there is conflicting evidence as to whether TACE prolongs survival. Although some studies have demonstrated a survival advantage, others have not. There are consistent findings of significant palliation manifested by decreased pain and better control of the disease within the liver. Therefore, TACE should be considered as an acceptable palliative therapy in unresectable hepatocellular carcinoma, especially in patients with significant symptoms, though the survival benefit has not been clearly defined. Given that this patients hepatocellular carcinoma is unresectable, all treatment options are directed toward palliation. His current situation is that of stable disease without significant symptoms having undergone TACE in mid-2004. Therefore, there is no true indication for TACE at this time as it is unlikely to provide any additional benefit over continued observation. However, the patients prior TACE treatments in May 2004 and June 2004 were indicated and have provided the patient with some benefit, manifested by a decrease in alpha-fetoprotein and the maintenance of stable disease on MRI. Based upon the information set forth above, I have determined that although the Health Plan should provide coverage for the TACE treatments the patient received in May 2004 and June 2004, further TACE treatments are not likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. Therefore, the Health Plans denial should upheld. Physician 3: The patient is a 62-year-old man diagnosed with inoperable hepatocellular carcinoma in April 2004. At that time his tumor marker (AFP) was very high at 4201. In May 2004, he underwent transcatheter arterial chemoembolization (TACE) of his liver with dramatic fall in AFP to 39.9 by June 2004. MRI showed decrease in the size of the mass. He underwent a second TACE treatment in June 2004. MRI in August 2004 again showed decrease in the size of the mass. The patient was next seen in follow-up on 1/12/05, at which time he appeared to be doing well clinically. MRI showed no change in the lesion. It was noted that his AFP was 4.9. The last note states the patient will return in three months. A request has been made for coverage for additional TACE treatments. The Health Plan has denied coverage for TACE on the basis it is considered experimental. TACE is the infusion of chemotherapy drugs directly into hepatic arteries, which presumably feed a cancer. There is a great deal of variation in hepatocellar carcinoma in terms of size and number of tumors, and degree of cirrhosis in the rest of the liver. This has made randomized studies of the treatment of this condition difficult. Additionally, a wide variety of agents have been used making comparisons between studies difficult. The submitted materials include a review of many of the randomized studies of this treatment, with the conclusion that it is unclear just how efficacious chemoembolization is for hepatocellular carcinoma. However, there are many studies, which show quite good response rates, and certainly this patient has experienced a good response. It is accurate to state that the consensus in oncology at present is that TACE is the only treatment that is at all likely to be beneficial in the treatment of hepatocellular carcinoma that can neither be resected nor treated with liver transplantation. Therefore, I have determined that TACE is likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.