Transcatheter Hepatic Arterial Chemoembolization
DESCRIPTION
Transcatheter arterial chemoembolization (TACE) of the liver is a proposed alternative to conventional systemic or intra-arterial chemotherapy and to various nonsurgical ablative techniques to treat nonresectable tumors. TACE is a minimally invasive procedure performed by interventional radiologists who inject highly concentrated doses of chemotherapeutic agents into the tumor tissues to restrict tumor blood supply. The embolic agent(s) causes ischemia and necrosis of the tumor, extending the retention of the chemotherapeutic agent and decreasing systemic toxicity. The liver is especially amenable to such an approach given its distinct lobular anatomy, the existence of two independent blood supplies, and the ability of healthy hepatic tissue to grow and thus compensate for tissue mass lost during chemoembolization.
The TACE procedure requires hospitalization for placement of a hepatic artery catheter and workup to establish eligibility for chemoembolization. Prior to the procedure, the patency of the portal vein must be demonstrated to ensure an adequate post-treatment hepatic blood supply. 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 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 or recurrent hepatocellular cancer, unresectable cholangiocarcinoma, as part of combination therapy with radiofrequency ablation for resectable or unresectable hepatocellular carcinoma, 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:
Portal venous flow to the affected area of the liver must be demonstrated prior to the procedure
Treatment is indicated for ANY ONE of the following:
Hepatocellular carcinoma when ALL of the following are met:
Tumor is surgically unresectable
Evaluation for metastases outside the liver is negative (should include negative chest x-ray, CT or MRI of the abdomen)
Child Pugh liver function score of A or B (see Additional Information below)
Liver metastases from neuroendocrine tumors when ALL of the following are met:
Symptoms persist despite systemic therapy
Individual is not a candidate for surgical resection
As a bridge to transplant in individuals with hepatocellular cancer when ALL of the following are met:
Intent is to prevent further tumor growth and to maintain candidacy for liver transplant
Child-Pugh score A or B liver function
Absence of extrahepatic disease
Absence of vascular invasion
Tumor characteristics are ANY ONE of the following:
Single tumor, 5 cm or less in diameter
No more than 3 tumors, each 3 cm (or less) in diameter
Liver-dominant metastasis from uveal (ocular) melanoma
IMPORTANT REMINDERS
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
ADDITIONAL INFORMATION
Child-Pugh score is a scoring system used to assess prognosis in individuals with chronic liver disease and cirrhosis. The score considers total bilirubin, serum albumin, INR, degree of ascites and hepatic encephalopathy.
SOURCES
American Association of Liver Disease. (2018). AASLD guidelines for the treatment of hepatocellular carcinoma. Retrieved January 24, 2020 from https://www.aasld.org. (98 articles and/or guidelines reviewed)
BlueCross BlueShield Association. Evidence Positioning System. (8:2023). Transcatheter arterial chemoembolization to treat primary or metastatic liver malignancies (8.01.11). Retrieved December 14, 2023 from www.bcbsaoca.com/eps/. (118 articles and/or guidelines reviewed)
Kulik, L., Heimbach, J., Zaiem, F., Almasri, J., Prokop, L., Wang, Z. (2018). Therapies for patients with hepatocellular carcinoma awaiting liver transplantation: a systematic review and meta-analysis. Hepatology, 67 (1), 381-400. (Level 1 evidence)
Li, L., Tian, J., Liu, P., Wang, X., & Zhu, Z. (2016). Transarterial chemoembolization combination therapy vs monotherapy in unresectable hepatocellular carcinoma: a meta-analysis. Tumori Journal, (3), 301-310. Abstract retrieved February 9, 2017 from PubMed database.
National Comprehensive Cancer Network. (2023, August). NCCN clinical practice guidelines in oncology (NCCN Guidelines®). Neuroendocrine and adrenal tumors. (V.1.2023). Retrieved December 15, 2023 the National Comprehensive Cancer Network.
National Comprehensive Cancer Network. (2023, May). NCCN clinical practice guidelines in oncology (NCCN Guidelines®). Uveal Melanoma. (V.1.2023). Retrieved December 15, 2023 the National Comprehensive Cancer Network.
National Comprehensive Cancer Network. (2023, November). NCCN clinical practice guidelines in oncology (NCCN Guidelines®). Biliary tract cancers. (V.3.2023). Retrieved December 15, 2023 the National Comprehensive Cancer Network.
ORIGINAL EFFECTIVE DATE: 6/1/2000
MOST RECENT REVIEW DATE: 2/8/2024
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Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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