Transcatheter Hepatic Arterial Chemoembolization
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 unresectable 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.
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.
Transcatheter hepatic arterial chemoembolization is considered medically appropriate if ALL of the following criteria are met:
Documented diagnoses for ANY ONE of the following:
Surgically unresectable hepatocellular carcinoma
Liver metastases from neuroendocrine tumors when ALL of the following:
Symptoms persist despite systemic therapy
Individual 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
Treatment is needed when ALL of the following criteria are met:
Severe chronic liver failure as indicated by ANY ONE of the following:
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)
Tumor(s) and 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
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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.
American Association for the Study of Liver Diseases. (2011). AASLD practice guideline. Management of hepatocellular carcinoma: An update. Retrieved May 29, 2013 from: http://www.aasld.org/practiceguidelines.
American College of Radiology. (2015) ACR appropriateness criteria® radiologic management of hepatic malignancy. Received March 17, 2016 from: http://www.guideline.gov. (NCG#010833)
BlueCross BlueShield Association. Medical Policy Reference Manual. (8:2016). Transcatheter arterial chemoembolization to treat primary or metastatic liver malignancies (8.01.11). Retrieved February 7, 2017 from BlueWeb. (57 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.
Choe, W., Kin, Y., Park, H., Park, H., Kim, J., and Kwon, S. (2014, September). Short-term interval combined chemoembolization and radiofrequency ablation for hepatocellular carcinoma. World Journal of Gastroenterology, 20 (35), 12588-12594. (Level 4 evidence)
Choi, W., Jeong, W., Kim, Y., Song, S., Lee, S., Kim, Y., et al. (2014). Assessment of treatment success and short-term effectiveness using C-arm CT immediately after hepatic chemoembolization of HCC. Hepatogastroenterology, 61 (133), 1353-8. Abstract retrieved December 31, 2014 from PubMed database.
Dhand, S., & Gupta, R. (2011). Hepatic transcatheter arterial chemoembolization complicated by postembolization syndrome. Seminars in Interventional Radiology, 28 (2), 207-211. (Level 5 evidence)
Li, L., Tian, J., Liu, P., Wang, X., & Zhu, Z. (2016, June). Transarterial chemoembolization combination therapy vs monotherapy in unresectable hepatocellular carcinoma: a meta-analysis. Tumori Journal, 2016 (3), 301-310. Abstract retrieved February 9, 2017 from PubMed database.
Murata, S., Mine, T., Ueda, T., Nakazawa, K., Onozawa, S., Yasui, D., et al. (2013). Transcatheter arterial chemoembolization based on hepatic hemodynamics for hepatocellular carcinoma. The Scientific World Journal, 2013 (479805), 1-8. (Level 5 evidence)
National Comprehensive Cancer Network. (2016, February). NCCN clinical practice guidelines in oncology. Hepatobiliary cancers. (V.2.2016). Retrieved February 7, 2017 the National Comprehensive Cancer Network.
Özçınar, B., Güven, K., Poyanlı, A., & Özden, I. (2009). Necrotizing pancreatitis after transcatheter arterial chemoembolization for hepatocellular carcinoma. Diagnostic and Interventional Radiology, 15 (1), 36-38. (Level 5 evidence)
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)
Sun, J. J., Wang, K., Zhang, C. Z., Guo, W. X., Shi, J., Cong, W. M., et al. (2016). Postoperative adjuvant transcatheter arterial chemoembolization after R0 hepatectomy improves outcomes of patients who have hepatocellular carcinoma with microvascular invasion. Annals of Surgical Oncology, 23 (4), 1344-1351. Abstract retrieved February 9, 2017 from PubMed database.
Wang, K., Liu, G., Ki, J., Yan, Z., Xia, Y., Wan, X., et al. (2014). Early intrahepatic recurrence of hepatocellular carcinoma after hepatectomy treated with re-hepatectomy, ablation or chemoembolization: A prospective cohort study. European Journal of Surgical Oncology. S0748-7983 (14) 01200-1. Abstract retrieved December 31, 2014 from PubMed database.
Zacharias, A. J., Jayakrishnan, T. T., Rajeev, R., Rilling, W. S., Thomas, J. P., George, B., et al. (2015). Comparative effectiveness of hepatic artery based therapies for unresectable colorectal liver metastases: a meta-analysis. PloS One, 10 (10), 1-10. (Level 1 evidence - Independent)
Zhou, Y., Zhang, X, Wu, L., Ye, F., Su, X., Shi, L., et al. Meta-analysis: Preoperative transcatheter arterial chemoembolization does not improve prognosis of patients with resectable hepatocellular carcinoma. BMC Gastroenterology, 13 (51), 1-11. (Level 2 evidence - Independent study)
ORIGINAL EFFECTIVE DATE: 6/1/2000
MOST RECENT REVIEW DATE: 4/13/2017
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