Transcatheter Hepatic Arterial Chemoembolization
DESCRIPTION
Transcatheter arterial chemoembolization (TACE) was developed as an alternative to conventional systemic or intra-arterial chemotherapy. Transcatheter hepatic arterial chemoembolization has been investigated as a treatment of isolated liver metastases and for hepatocellular carcinoma.
The rationale for TACE is that infusions of viscous material will occlude arterial blood, causing an infarct and subsequent necrosis of tumors in the infarcted region. The cytotoxic effect of arterial occlusion can be potentiated by labeling the infusion with radioactive isotopes or by adding cytotoxic drugs. The liver is especially amenable to such an approach given the distinct lobular anatomy of the liver, the existence of two independent blood supplies, and the ability of healthy hepatic tissue to compensate for tissue mass lost during chemoembolization. Another rationale is that TACE provides for effective local dose intensity while avoiding systemic toxicities associated with intravenous chemotherapy. However, TACE of the liver is associated with its own constellation of potentially life-threatening toxicities and complications, such as severe postembolization syndrome, hepatic insufficiency, abscess, or infarction.
The chemoembolization procedure requires hospitalization. Prior to the procedure, the patency of the portal vein must be demonstrated in order to ensure an adequate post-treatment hepatic blood supply. Under local anesthesia and mild sedation, a superselective catheter is inserted via the femoral artery and threaded into the hepatic artery. Angiography is then performed to delineate the hepatic vasculature, followed by injection of the embolic chemotherapy mixture. Embolic material varies, but may include a viscous collagen agent, polyvinyl alcohol particles, or ethiodized oil. Typically, only one lobe of the liver is treated during a single session, with subsequent embolization procedures scheduled from 5 days to 6 weeks later. In addition, since the embolized vessel recanalizes, chemoembolization can be repeated as many times as necessary.
Note: This policy does not apply to requests for venous occlusion of the portal vein.
POLICY
Transcatheter hepatic arterial chemoembolization for the treatment of surgically unresectable hepatocellular carcinoma is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Transcatheter hepatic arterial chemoembolization for the treatment of metastatic neuroendocrine tumors is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Transcatheter hepatic arterial chemoembolization for the treatment of liver-dominant metastatic uveal melanoma is considered medically necessary.
Transcatheter hepatic arterial chemoembolization as a bridge to transplant in individuals with hepatocellular cancer where the intent is to prevent further tumor growth and to maintain an individual’s candidacy for liver transplant is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Transcatheter hepatic arterial chemoembolization for all other conditions including, but not limited to, resectable hepatocellular cancer, unresectable cholangiocarcinoma and any other tumors is considered investigational.
MEDICAL APPROPRIATENESS
Transcatheter hepatic arterial chemoembolization is considered medically appropriate if ALL of the following criteria are met:
ANY ONE of the following:
For the treatment of surgically unresectable hepatocellular carcinoma
For the treatment of liver metastases from neuroendocrine tumors with ALL of the following:
Symptoms persist despite systemic therapy
Is not a candidate for surgical resection
As a bridge to transplant in individual’s with hepatocellular cancer where the intent is to prevent further tumor growth and to maintain an individual’s candidacy for liver transplant
ALL of the following criteria are met:
ANY ONE of the following:
A Child-Pugh score A or Child-Pugh score B liver function
MELD (Model for End-Stage Liver Disease) score 6 through 40
Evaluation for metastases outside the liver is negative (should include negative chest x-ray, CT or MRI of the abdomen)
ANY ONE of the following:
Single tumor, 5 cm or less in diameter
No more than 3 tumors, each 3 cm in diameter
Portal venous flow to the affected area of the liver must be demonstrated prior to the procedure
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
Child-Pugh score is a scoring system for liver function based on the presence of encephalopathy and/or ascites, and laboratory measures of bilirubin, albumin, and prothrombin time.
MELD (Model for End-Stage Liver Disease) is a scoring system for liver function based on a numerical scale. The scale ranges from 6 (less ill) to 40 (gravely ill). It is used for liver transplant candidates’ age 12 years and older. It gives an individual score based on how urgently a liver transplant is needed within the next three months. The number is calculated using the most recent laboratory tests for bilirubin, INR (formerly known as the prothrombin time) and serum creatinine.
There is lack of randomized controlled trials that provide evidence of the efficacy of transcatheter hepatic arterial chemoembolization for other indications.
SOURCES
Alba, E., Valls, C., Dominquez, J., Martinez, L., Escalante, E., Llado, L., et al. (2008). Transcatheter arterial chemoembolization in patients with hepatocellular carcinoma on the waiting list for orthotopic liver transplantation. American Journal of Roentgenology, 190 (5), 1341-1348. (Level 2 Evidence - Independent study)
American Association for the Study of Liver Diseases. (2005). AASLD practice guideline. Management of hepatocellular carcinoma. Retrieved March 10, 2009 from http://www.aasld.org/practiceguidelines/Documents/Bookmarked%20Practice%20Guidelines/hepatocellular%20carenoma.pdf.
Augsburger, J. J., Correa, Z. M., & Shaukh, A. H. (2008). Quality of evidence about effectiveness of treatments for metastatic uveal melanoma. Transactions of the American Ophthalmological Society, 106, 128-135. (Level 2 Evidence - Independent study)
Battula, N., Madanur, M., Priest, O., Srinivasan, P., O’Grady, J., Heneghan, M. A., et al. (2009). Spontaneous rupture of hepatocellular carcinoma: A Western experience. The American Journal of Surgery, 197 (2), 164–167. (Level 1 Evidence - Independent study)
Befeler, A. S. (2005). Chemoembolization and bland embolization: A critical appraisal. Clinics in Liver Disease, 9, 287-300.
BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2010). Transcatheter arterial chemoembolization to treat primary or metastatic liver malignancies (8.01.11). Retrieved October 11, 2011 from BlueWeb. (38 articles and/or guidelines reviewed)
BlueCross BlueShield of Tennessee network providers. April 2009.
BlueCross BlueShield of Tennessee network providers. July-August 2005.
BlueCross BlueShield of Tennessee network providers. June-August 2000.
Boursier, J., Cesbron, E., Tropet, A. L., & Pilette, C. (2009). Comparison and improvement of MELD and Child-Pugh score accuracies for the prediction of 6-month mortality in cirrhotic patients. Journal of Clinical Gastroenterology, 43 (6), 580-585. (Level 3 Evidence - Independent study)
Choh, M. S., & Madura, J. A. (2009). The role of minimally invasive treatments in surgical oncology. The Surgical Clinics of North America, 89 (1), 53-77.
Choi, S. B., Kim, K. S., Park, Y. N., Choi, J. S., Seong, J., et al. (2009). The efficacy of hepatic resection after neoadjuvant transarterial chemoembolization (TACE) and radiation therapy in hepatocellular carcinoma greater than 5 cm in size. Journal of Korean Medical Science, 24 (2), 242-247. (Level 2 Evidence - Independent study)
Decaens, T., Roudot-Thoraval, F., Bresson-Hadni, S., Meyer, C., Gugenheim, J., Durand, F., et al. (2005). Impact of pretransplantation transarterial chemoembolization on survival and recurrence after liver transplantation for hepatocellular carcinoma. Liver Transplantation, 11 (7), 767-775. (Level 3 Evidence - Independent study)
El-Serag, H. B., Marrero, J. A., Rudolph, L., & Reddy, K., R. (2008). Diagnosis and treatment of hepatocellular carcinoma. Gastroenterology, 134 (6), 1752-1763.
Fiorentini, G., Aliberti, C., Del Conte, A., Tilli, M., Rossi, S., Ballardini, P, et al. (2009). Intra-arterial hepatic chemoembolization (TACE) of liver metastases from ocular melanoma with slow-release Irinotecan-eluting beads. Early results of a phase II clinical study. In Vivo, 23, 131-138. (Level 3 Evidence -Independent study)
Greten, T. F., Papendorf, F., Bleck, J. S., Kirchhoff, T., Wohlberedt, T., Kubicka, S., et al. (2005). Survival rate in patients with hepatocellular carcinoma: A retrospective analysis of 389 patients. British Journal of Cancer, 92 (10), 1862-1868. (Level 1 Evidence - Independent study)
Hoffmann, K., Glimm, H., Radeleff, B., Richter, G., Heining, C., Schenkel, I., et al. (2008). Prospective, randomized, double-blind, multi-center, phase III clinical study on transarterial chemoembolization (TACE) combined with Sorafenib versus TACE plus placebo in patients with hepatocellular cancer before liver transplantation - HeiLivCa [ISRCTN24081794]. BMC Cancer, 8, 349. (Level 2 Evidence - Industry sponsored)
Johnson, P. J. (2005). Non-surgical treatment of hepatocellular carcinoma. HPB, 7 (1), 50-55.
Marrero, J. A., & Pelletier, S. (2006). Hepatocellular carcinoma. Clinics in Liver Disease, 10 (2), 339-351.
National Comprehensive Cancer Network. (2011). NCCN clinical practice guidelines in oncology®. Hepatobiliary cancers. (V.1.2012). Retrieved October 11, 2011 from http://www.nccn.org/professionals/physician_gls/PDF/hepatobiliary.pdf. (292 articles and/or guidelines reviewed)
National Guideline Clearinghouse. (2005, November). Management of hepatocellular carcinoma. Retrieved March 10, 2009 from http://www.guidelines.gov.
Ozcınar, B., Guven, K., Poyanlı, A., & Ozden, I. (2009). Necrotizing pancreatitis after transcatheter arterial chemoembolization for hepatocellular carcinoma. Diagnostic and Interventional Radiology, 15 (1), 36-38.
Polson, J., & Lee, W. M. (2005). AASLD position paper: The management of acute liver failure. Hepatology, 41 (5), 1179-1197.
Reso, A., Ball, C. G., Sutherland, F. R., Bathe, O, & Dixon, E. (2009). Rupture and intra-peritoneal bleeding of a hepatocellular carcinoma after a transarterial chemoembolization procedure: A case report. Cases Journal, 2 (1), 68. (Level 4 Evidence - Independent study)
Sherman, M., & Takayama, Y. (2004). Screening and treatment for hepatocellular carcinoma. Gastroenterology Clinics of North America, 33, 671-691.
Townsend, C. M., Jr., Beauchamp, R. D., Evers, B. M., & Mattox, K. L. (Eds.). (2008). Sabiston Textbook of Surgery (18th ed., Chapter 52). Philadelphia: W. B. Saunders Company.
UNOS. Talking about transplantation. Questions and answers for transplant candidates about MELD and PELD. Retrieved November 8, 2011 from http://www.unos.org/docs/MELD_PELD.pdf.
Varela, M., Sanchez, W., Bruix, J., & Gores, G. J. (2006). Hepatocellular carcinoma in the setting of liver transplantation. Liver Transplantation, 12, 1028-1036.
Yoo, H. Y., Edwin, D., & Thuluvath, P. J. (2003). Relationship of the model for end-stage liver disease (MELD) scale to hepatic encephalopathy, as defined by electroencephalography and neuropsychometric testing, and ascites. The American Journal of Gastroenterology, 98 (6), 1395-1399.
MOST RECENT REVIEW DATE: 11/10/2011
ID_BT
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