BlueCross BlueShield of Tennessee Medical Policy Manual

Radioembolization for Primary Tumors and Metastatic Tumors to the Liver

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 under a Humanitarian Device Exemption to treat unresectable hepatocellular carcinoma. SIR-Spheres® have premarket approval for use in combination with hepatic artery infusion chemotherapy to treat unresectable hepatic metastatic colorectal cancer.

POLICY

MEDICAL APPROPRIATENESS

IMPORTANT REMINDERS

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)

Bhooshan, N., Sharma, N., Badiyan, S., Kaiser, A., Moeslein, F., Kwok, Y., et al. (2016). Pretreatment tumor volume as a prognostic factor in metastatic colorectal cancer treated with selective internal radiation to the liver using yttrium-90 resin microspheres. Journal of Gastrointestinal Oncology, 7 (6), 931-937. Abstract retrieved May 3, 2017 from PubMed database.

BlueCross BlueShield Association. Evidence Positioning System. (7:2018). Radioembolization for primary and metastatic tumors of the liver (8.01.43). Retrieved April 18, 2019 from https://www.evidencepositioningsystem.com/. (74 articles and/or guidelines reviewed)

Cucchetti, A., Cappelli, A., Mosconi, C., Zhong, J., Cescon, M., Pinna, A., & Golfieri, R. (2017). Improving patient selection for selective internal radiation therapy of intra-hepatic cholangiocarcinoma: a meta-regression study. Liver International, 2017 Feb 8. Doi: 10.1111/liv.13382 [Epub ahead of print]. Abstract retrieved May 3, 2017 from PubMed database.

National Comprehensive Cancer Network. (2019, March). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Colon cancer. V.1.2019. Retrieved April 22, 2019 from the National Comprehensive Cancer Network.

National Comprehensive Cancer Network. (2019, March). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Hepatobiliary cancers. V.2.2019. Retrieved April 18, 2019 from the National Comprehensive Cancer Network.

National Comprehensive Cancer Network. (2019, March). NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®). Neuroendocrine and adrenal tumors. V.1.2019. Retrieved April 22, 2019 from the National Comprehensive Cancer Network.

National Institute for Health and Care Excellence. (2011, July). Selective internal radiation therapy for nonresectable colorectal metastases in the liver. Retrieved June 7, 2016 from www.nice.org.uk.

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.

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)

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.

Winifred S. Hayes, Inc. Medical Technology Directory. (2014, October; last update search October 2018). Radioactive Yttrium-90 microspheres for treatment of primary unresectable liver cancer. Retrieved April 22, 2019 from www.Hayesinc.com/subscribers. (77 articles and/or guidelines reviewed)

Winifred S. Hayes, Inc. Medical Technology Directory. (2014, October; last update search November 2018). Radioactive Yttrium-90 microspheres for treatment of primary unresectable liver cancer as a bridge to transplantation or surgery. Retrieved April 22, 2019 from www.Hayesinc.com/subscribers.  (73 articles and/or guidelines reviewed)

Winifred S. Hayes, Inc. Medical Technology Directory. (2015, March; last update search March 2018). Radioactive Yttrium-90 microspheres for treatment of secondary liver cancer. Retrieved April 18, 2018 from www.Hayesinc.com/subscribers.  (115 articles and/or guidelines reviewed)

ORIGINAL EFFECTIVE DATE:  1/1/2005

MOST RECENT REVIEW DATE:  5/9/2019

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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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