Does not apply to Medicare members, please refer to the Medicare policy addressing this topic.
DESCRIPTION
Hepatic (liver) tumors can arise either as primary liver cancer or by metastasis to the liver from other tissues or organs. Surgical resection is presently the treatment of choice for hepatic tumors. Unfortunately, most hepatic tumors are unresectable at diagnosis. This is due either to the tumors anatomic location, size, and number of lesions, concurrent nonmalignant liver disease or insufficient hepatic reserve.
Radioembolization, referred to as selective internal radiation therapy (SIRT) in older literature, is being offered as a non-surgical technique that seeks to cure or palliate primary and metastatic tumors of the liver. Radioactive microspheres are injected into the hepatic artery via a transfemoral catheter or a permanently implanted hepatic artery port with catheter. Once injected, the microspheres travel through the blood stream and target the tumor within the liver, delivering high doses of ionizing radiation (beta radionuclide yttrium-90). Treatment takes about 20-30 minutes and may be delivered under mild sedation.
At the present time two forms of yttrium-90 impregnated microspheres are commercially available. Theraspheres® are FDA approved under a Humanitarian Device Exemption. SIR-Spheres® are approved by FDA for use in combination with hepatic artery infusion chemotherapy to treat unresectable hepatic metastatic colorectal cancer. The two products differ in the size and composition of the microspheres and radiation dosimetry calculations. The physical characteristics of the active and inactive ingredients affect the flow of microspheres during injection, their retention at the tumor site, spread outside the therapeutic target region, and dosimetry calculations.
POLICY
Radioembolization for the treatment of primary hepatocellular carcinoma that is unresectable and limited to the liver is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Radioembolization in primary hepatocellular carcinoma as a bridge to transplant is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Radioembolization in the treatment of diffuse symptomatic hepatic metastases from neuroendocrine tumors (carcinoid and non carcinoid) when systemic therapy has failed is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Radioembolization to treat unresectable hepatic metastases from colorectal carcinoma is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Radioembolization to treat all other hepatic metastases including, but not limited to, breast cancer is considered investigational.
See also:
MEDICAL APPROPRIATENESS
Radioembolization is considered medically appropriate if ALL of the following criteria are met:
ANY ONE of the following:
Primary hepatocellular carcinoma if ANY ONE of the following criteria are met:
Unresectable tumor that is limited to the liver
A bridge to transplant (See Milliman Care Guidelines for Liver Transplant)
ECOG score 0-2
Hepatic metastases and ALL of the following criteria are met:
Metastasized with ANY ONE of the following:
Diffuse symptomatic metastases from a neuroendocrine tumor (carcinoid or non carcinoid)
Unresectable metastases from colorectal tumor
Liver dominant metastases
Systemic therapy has failed
ECOG score 0-1
Child-Pugh score A or B
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.
Does not apply to Medicare members, please refer to the Medicare policy addressing this topic.
ADDITIONAL INFORMATION
Unresectable hepatocellular carcinoma is generally defined as tumors greater than 3 cm.
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.
The use of radioembolization in metastatic breast cancer to the liver have shown promising initial results; however, the data are limited and the studies have been small and composed of heterogeneous patients. The use of radioembolization in other tumors metastatic to the liver are too limited to draw meaningful conclusions.
SOURCES
American College of Radiology. (2008 October). Practice guideline for radioembolization with microsphere brachytherapy device (RMBD) for treatment of liver malignancies. Retrieved November 18, 2009 from http://www.acr.org/SecondaryMainMenuCategories/quality_safety/guidelines/ro/RMBD.aspx.
BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2011). Radioembolization for primary and metastatic tumors of the liver (8.01.43). Retrieved May 23, 2011 from BlueWeb. (30 articles and/or guidelines reviewed)
Cianni, R., Urigo, C., Notarianni, E., Saltarelli, A., Salvatori, R., Pasqualini, V. et al. (2009). Selective internal radiation therapy with SIR-spheres for the treatment of unresectable colorectal hepatic metastases. Cardiovascular and Interventional Radiology, 32 (6), 1179-1186. (Level 2 Evidence - Independent)
ECRI Institute. Health Technology Information Service. Emerging Technology (TARGET) Evidence Report. (2010, October). Intrahepatic yttrium- 90 microsphere therapy for primary unresectable liver cancer. Retrieved January 21. 2011 from ECRI Institute. (36 articles and/or guidelines reviewed)
Hendlisz, A., Van den Eynde, M., Peeters, M., Maleux, G., Lambert, B., Vannoote, J., et al. (2010) Phase III trial comparing protracted intravenous fluorouracil infusion alone or with yttrium-90 resin microspheres radioembolization for liver-limited metastatic colorectal cancer refractory to standard chemotherapy. Journal of Clinical Oncology, 28 (23), 3687 - 3694. (Level 2 Evidence - Independent)
Kennedy, A., Nag, S., Salem, R., Murthy, R., McEwan, A., Nutting, C. et al. (2006). Recommendations for radioembolization of hepatic malignancies using yttrium 90 microsphere brachytherapy: A consensus panel report from the radioembolization brachytherapy oncology consortium. International Journal of Radiation Oncology, 68 (1), 13-23.
Nace, G., Steel, J., Amesur, N., Zajko, A., Nastasi, B., Joyce, J., et al. (2011). yttrium-90 radioembolization for colorectal cancer liver metastases: A single institution experience. International Journal of Surgical Oncology, 2011 (2011) (Level 3 Evidence - Independent)
National Comprehensive Cancer Network. (2009). NCCN Clinical Practice Guidelines in Oncology. Hepatobiliary Cancers. V.I.2010. Retrieved January 24, 2011 from http://www.nccn.org/professionals/physician_gls/f_guidelines.asp#site.
National Comprehensive Cancer Network. (2010). NCCN Clinical Practice Guidelines in Oncology. Colon Cancer. V.2.2011. Retrieved January 24, 2011 from http://www.nccn.org/professionals/physician_gls/f_guidelines.asp#site.
National Guideline Clearinghouse. American College of Radiology. (2007 November). ACR appropriateness criteria hepatic malignancy. Retrieved January 24, 2011 from http://www.guideline.gov/summary/summary.aspx?ss=15&doc_id=11558&string=liver+AND+cancer.
National Institute for Health and Clinical Excellence. (2004, September). Selective internal radiation therapy for colorectal metastases in the liver. Retrieved January 24, 2011 from http://www.nice.org.uk/nicemedia/pdf/ip/IPG093guidance.pdf.
Salem, R., Lewandowski, R. J., Atassi, B., Gordon, S. C., Gates, V. L., Barakat, O., et al. (2005). Treatment of unresectable hepatocellular carcinoma with use of 90Y microspheres (TheraSphere): Safety, tumor response, and survival. Journal of Vascular and Interventional Radiology, 16 (12), 1627 - 1639. (Level 4 Evidence - Independent)
Sharma, R. A., Van Hazel, G. A., Morgan, B., Berry, D. P., Blanshard, K., Price, D., et al. (2007). Radioembolization of liver metastases from colorectal cancer using yttrium-90 microspheres with concomitant systemic oxaliplatin, fluorouracil, and leucovorin chemotherapy. Journal of Clinical Oncology, 25 (9), 1099 - 1106. (Level 2 Evidence - Independent)
U. S. Department of Health & Human Services. Centers for Medicare & Medicaid Services. LCDs for Wisconsin Physicians Service. (2010, November). LCD for selective internal radiation therapy (SIRT) for primary and secondary hepatic malignancy (90Y-Microsphere Hepatic Brachytherapy) (L30137). Retrieved November 18, 2009 from http://www.cms.hhs.gov/mcd/viewlcd.asp?lcd_id=30137&lcd_version=3&show=all.
U. S. Food and Drug Administration. (1999, December). Center for Devices and Radiological Health. Product approval information - licensing action. H980006 - TheraSpheres®. Retrieved January 24, 2011 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=H980006.
U. S. Food and Drug Administration. (2002, March). Center for Devices and Radiological Health. Product approval information - licensing action. SIR-Spheres® - P990065. Retrieved November 18, 2009 from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=p990065.
Winifred S. Hayes, Inc. Medical Technology Directory. (2008, July. Last update search June 23, 2010). Radioactive Yttrium-90 Microspheres for treatment of primary liver cancer. Retrieved November 18, 2009 from www.Hayesinc.com/subscribers. (79 articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Medical Technology Directory. (2008, July. Last update search July 8, 2010). Radioactive Yttrium-90 Microspheres for treatment of secondary liver cancer. Retrieved November 18, 2009 from www.Hayesinc.com/subscribers. (96 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 1/1/2005
MOST RECENT REVIEW DATE: 9/11/2011
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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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