Appeal type: Experimental/Investigational
Decision: Overturned

Physician 1: The patient was a 36-years old male with widely metastatic cholangiocarcinoma. He failed conventional systemic chemotherapy and transcatheter arterial chemoembolization (TACE) was utilized as a salvage regimen.  The patient survived seven more months, albeit with pain and illness, and succumbed to advanced disease.  The patients widow requested reimbursement for the chemoembolization, but her request was denied based upon the Health Plans determination that the therapy was experimental/investigational.Considering all of the circumstances, TACE appears to be a reasonable option in this clinical context. The patient had already failed conventional chemotherapy. Although the bulk of the literature deals with hepatoma, there is some data that suggests chemoembolization may be beneficial in cholangiocarcinoma.  This treatment likely slowed the progression of the disease in a setting with few reasonable alternatives.  Therefore, I have determined that the therapy at issue was 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: This was a 36-year-old male patient who was diagnosed with an unresectable cholangiocarcinoma. He failed all the standard available chemotherapeutic agents. TACE was used for its potential benefits in prolonging his life. The Health Plan deemed the therapy experimental/investigation and denied the request for reimbursement.This is a difficult question to answer since the patient has passed away. The use of TACE has been studied in peer-reviewed journals, and it is a therapy that is primarily used to prolong survival. This patient was a young man with very aggressive disease and required the benefit of all available therapies to prolong his life.  As all other treatments had failed to slow the progress of his disease, I have determined that the chemoembolization was 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 3: This patient was a 36-year-old man with locally advanced unresectable cholangiocarcinoma, stage 4a, with a large right liver mass. He was status post exploratory laparotomy and status post several cycles of chemotherapy when he underwent chemoembolization (TACE) as a palliative therapy.  He apparently responded to the therapy and expired approximately seven months after the TACE procedure.  Reimbursement was requested for the procedure, but denied by the Health Plan as chemoembolization is considered experimental/investigational.Since the patient had unresectable cholangiocarcinoma, his prognosis overall was poor. Palliative therapy was the only option left for him to improve his quality of life, and median survival. Although in the past most randomized controlled trials failed to show a survival benefit with TACE, more recently two well-designed, randomized trials have shown that TACE can have a positive impact on survival. An RCT by Lo et al, showed increased survival in the chemoembolization groups verses the control groups. A second RCT by Lloret et al, randomized 112 patients to TAE, TACE or supportive care. The trial was stopped early since TACE and TAE demonstrated a clear survival benefit yielding one and two year survival rates of 82% and 62% for TACE vs. 63% and 27% for the controls. While TACE is not a cure for patients with hepatocellular and cholangiocarcinoma, it is an effective therapy and has become the mainstay of treatment.Based upon the information set forth above, I have determined that the therapy at issue was likely to be more beneficial for treatment of the patients medical condition than any available standard therapy. The Health Plans denial should be overturned.