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

Physician 1: The patient is a 58-year-old male with a history of hepatocellular carcinoma. He underwent liver resection and three chemoembolization treatments. He was then evaluated for experimental chemotherapy and was found ineligible. The patient was seen by a surgeon and was found unresectable. A recent workup revealed progressive disease. It was then recommended the patient receive TheraSphere therapy. The Health Plan has denied authorization and coverage for the proposed therapy on the basis it is considered investigational.Review of the clinical evidence indicates recent CT and PET scans revealed bulky disease in both lobes of the liver and also some peritoneal implants. Though TheraSphere therapy has been recommended, it is not likely to have any effect on gross, bulky disease because it is a beta-omitting radiation treatment. Its depth of penetration is only a few millimeters. As such, TheraSphere therapy is not likely to have any meaningful clinical effect in the case of this patient. 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 58-year-old man who has long-standing cirrhosis of the liver with hepatocellular carcinoma. It has been determined he is not eligible for liver transplantation. The patient has had three sessions of chemoembolization. At the present time he has CT evidence demonstrating progression of disease into the right lobe of his liver. He was evaluated for two different single-agent chemotherapy trials, but was found to be ineligible. The patients provider has recommended the patient undergo treatment with TheraSphere. The Health Plan has denied coverage for TheraSphere therapy on the basis it is experimental in nature.TheraSphere is a preparation containing insoluble yttrium 90 in microscopic glass beads. The isotope is a pure beta emitter, which can then be delivered by intra-arterial injection into the tumor where the glass carrier beads are captured at the capillary level and deliver a precalculated dose of radiation to the generally radiosensitive hepatocellular carcinoma. This constitutes brachytherapy to the tumor. Potential complications include radiation exposure to the gastroduodenum due to problems with catheter placement and exposure of the pulmonary capillary bed to radiotoxicty from shunting through the liver. TheraSphere is approved for use in the United States by the FDA under a humanitarian device exemption (HDE). Review of the medical literature reveals no large randomized controlled trials available to compare this treatment to more established methods of treatment for hepatocellular carcinoma. The closest to a comparison between treatments cited is Steel et. al. where patients treated with TheraSphere scored higher in HRQL compared to patients treated with intra-arterial cisplatin and had similar clinical effectiveness.Given that this patient has already failed intra-arterial chemoembolization and is not resectable, there is no evidence-based literature demonstrating TheraSphere therapy is likely to be of benefit in this patient. 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 58-year-old male diagnosed with unresectable hepatocellular carcinoma status post liver resection and three chemoembolizations. He was recently evaluated for possible further resection and was deemed unresectable. He was also evaluated for two clinical trials using systemic chemotherapy and was found ineligible. A re-staging CT revealed a spread to the right side of the liver. The patients provider then recommended radiotherapeutic microsphere therapy (TheraSphere). The Health Plan has denied coverage for the proposed therapy on the basis it is considered investigational.The National Comprehensive Cancer Network (NCCN) guidelines list radiotherapeutic microsphere therapy as a treatment option for hepatocellular cancers deemed unresectable or for patients declining surgery. The other options include clinical trial, ablation, chemoembolization (patient has had in the past), chemotherapy on clinical trial (patient was deemed ineligible) and conformal radiation therapy. The literature regarding TheraSphere indicates it is an FDA approved treatment for unresectable liver cancer, and it is a viable option under current NCCN guidelines. As such, and because other options have not been successful, use of TheraSphere is medically reasonable and appropriate for this patient. Based upon the information set forth above, 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. The Health Plans denial should be overturned.