Does not apply to Medicare members, please refer to the Medicare policy addressing this topic.
DESCRIPTION
Radioembolization (also referred to as selective internal radiotherapy or transarterial radioembolization [TARE]) delivers small beads (microspheres) impregnated with yttrium-90 intra-arterially via the hepatic artery. The microspheres, which become permanently embedded, are delivered to tumors preferentially because the hepatic circulation is uniquely organized, whereby tumors greater than 0.5 cm rely on the hepatic artery for blood supply while the normal liver is primarily perfused via the portal vein. Yttrium-90 is a pure beta-emitter with a relatively limited effective range and a short half-life that helps focus the radiation and minimize its spread. Radioembolization has been proposed as a therapy for multiple types of primary and metastatic tumors.
Currently, two commercial forms of yttrium-90 impregnated microspheres are available: TheraSphere® is FDA approved to treat unresectable hepatocellular carcinoma and SIR-Spheres® is approved for use in combination with hepatic artery infusion chemotherapy to treat unresectable hepatic metastatic colorectal cancer.
POLICY
Radioembolization for the treatment of primary and metastatic tumors of the liver is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
MEDICAL APPROPRIATENESS
Radioembolization of primary and metastatic tumors of the liver is considered medically appropriate if ALL of the following are met:
Adequate liver function as measured by ECOG (Eastern Cooperative Oncology Group) score 0-2
Adequate liver reserves as measured by Child-Pugh score A or B
A diagnosis of ANY ONE of the following:
Primary hepatocellular carcinoma if ANY ONE of the following criteria are met:
Unresectable tumor greater than 3 cm that is limited to the liver
Performed as a bridge to liver transplantation
Primary intrahepatic cholangiocarcinoma (bile duct cancer) when tumors are unresectable
Hepatic metastasis from neuroendocrine tumor (carcinoid or non-carcinoid) with ALL of the following:
Diffuse and symptomatic disease (excess hormone production)
Systemic therapy has failed to control symptoms
Hepatic metastasis from colorectal carcinoma, melanoma (ocular or cutaneous) or breast cancer when ALL of the following are met:
Liver dominant disease
Tumors are unresectable
Systemic therapy has failed or individual is not a candidate for chemotherapy
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.
Does not apply to Medicare members, please refer to the Medicare policy addressing this topic.
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.
Eastern Cooperative Oncology Group (ECOG) performance scales assess how an individual’s disease is progressing, how the disease affects the daily living abilities of the individual and guides appropriate treatment and prognosis.
SOURCES
Al-Adra, D.P., Gill, R.S., Axford, S.J., Shi, X., Kneteman, N., & Liau, S.S. (2015). Treatment of unresectable intrahepatic cholangiocarcinoma with yttrium-90 radioembolization: a systematic review and pooled analysis. European Journal of Surgical Oncology, 41 (1), 120-127. (Level 2 evidence)
BlueCross BlueShield Association. Evidence Positioning System. (8:2023). Radioembolization for primary and metastatic tumors of the liver (8.01.43). Retrieved March 21, 2024 from www.bcbsaoca.com/eps/. (95 articles and/or guidelines reviewed)
National Comprehensive Cancer Network. (2023, August). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Neuroendocrine and adrenal tumors. V.1.2023. Retrieved March 21, 2024 from 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 March 21, 2024 from the National Comprehensive Cancer Network.
National Comprehensive Cancer Network. (2023, September). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Hepatocellular Carcinoma. V.2.2023. Retrieved March 21, 2024 from the National Comprehensive Cancer Network.
National Comprehensive Cancer Network. (2024, January). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Colon cancer. V.1.2024. Retrieved March 21, 2024 from the National Comprehensive Cancer Network.
National Institute for Health and Care Excellence. (2013, July). Selective internal radiation therapy for primary hepatocellular carcinoma. Retrieved April 22, 2019 from www.nice.org.uk.
National Institute for Health and Care Excellence. (2018, October). Selective internal radiation therapy for unresectable primary intrahepatic cholangiocarcinoma. Retrieved April 22, 2019 from www.nice.org.uk.
National Institute for Health and Care Excellence. (2020, March). Selective internal radiation therapy for nonresectable colorectal metastases in the liver. Retrieved January 8, 2021 from www.nice.org.uk.
National Institute for Health and Care Excellence. (2021, March). Selective internal radiation therapies for treating hepatocellular carcinoma. Retrieved December 21, 2021 from www.nice.org.uk.
Salem, R., Gordon, A., Mouli, S., Hickey, R., Kallini, J., Gabr, A., et al. (2016). Y90 radioembolization significantly prolongs time to progression compared with chemoembolization in patients with hepatocellular carcinoma. Gastroenterology, 151 (6), 1155-1163. (Level 2 evidence)
Salem, R., Johnson, G.E., Kim, E., Riaz, A., Bishay, V., Boucher, E., et al. (2021). Yttrium-90 radioembolization for the treatment of solitary, unresectable HCC: the legacy study. Hepatology, 74 (5), 2342 – 2352. (Level 3 evidence)
U. S. Food and Drug Administration. (2002, March). Center for Devices and Radiological Health. Pre-market approval decision for March 2002 P990065A. Retrieved June 7, 2016 from http://www.fda.gov.
Venerito, M., Pech, M., Canbay, A., Donghia, R., Guerra, V., Chatellier, G., et al. (2020). NEMESIS: Noninferiority, individual-patient metaanalysis of selective internal radiation therapy with 90Y resin microspheres versus sorafenib in advanced hepatocellular carcinoma. Journal of Nuclear Medicine, 61 (12), 1736–1742. (Level 2 evidence)
Winifred S. Hayes, Inc. Medical Technology Directory. (2019, June; last update search June 2022). Radioactive Yttrium-90 microspheres for treatment of primary unresectable liver cancer. Retrieved February 1, 2023 from www.Hayesinc.com/subscribers. (77 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Medical Technology Directory. (2019, September; last update search September 2022). Radioactive Yttrium-90 microspheres for treatment of primary unresectable liver cancer for downstaging or as a bridge to transplantation or surgery. Retrieved February 1, 2023 from www.Hayesinc.com/subscribers. (78 articles and/or guidelines reviewed)
Yang, B., Liang, J., Qu, Z., Yang, F., Liao, Z., & Gou, H. (2020). Transarterial strategies for the treatment of unresectable hepatocellular carcinoma: A systematic review. PloS One, 15 (2), e0227475. (Level 2 evidence)
ORIGINAL EFFECTIVE DATE: 1/1/2005
MOST RECENT REVIEW DATE: 4/11/2024
ID_BA
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.
This document has been classified as public information.