Selective internal radiation therapy (SIRT) using intra-arterial injections of radiolabeled microspheres, such as SIR-Spheres® or TheraSphere®, is covered for the treatment of unresectable hepatocellular cancer and unresectable metastatic liver tumors from primary colorectal cancer. 

This includes unresectable and/or medically inoperable primary or secondary liver malignancies that are not typically amenable to ablation therapy only (for example, tumors greater the 5 centimeters in size).  The tumor burden should be liver dominant, but not necessarily exclusive to the liver. Patients should demonstrate that the procedure will allow them to benefit from such therapy such as an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, or Karnofsky Performance Status (KPS) of 70 or more. In addition, the patient should have a life expectancy of at least three months. 

All other indications are considered to be investigational. There is no published scientific evidence on the potential impact of this treatment modality on survival or the quality of life for other applications. In addition, randomized controlled trials are needed to determine the clinical utility of this treatment for other indications. A participating, preferred, or network provider can bill the member for the non-covered service.

Description

Tumors within the liver derive their blood supply almost exclusively from the hepatic artery. Selective internal radiation therapy (SIRT) is the targeted delivery of small beads (microspheres) impregnated with a radioactive source, for example, yttrium–90 (⁹⁰Y), into the liver to destroy liver tumors. Initially, the hepatic artery is catheterized. The radioactive microspheres are administered via the catheter, traveling through the bloodstream to the liver tumor where they become embedded in the microvasculature of the liver cancer. This technique provides a mechanism by which a very high radiation dose can be delivered to tumors within the liver. Once trapped within the tumor, these microspheres destroy the tumor, with limited concurrent damage to normal, healthy liver tissue.

NOTE:

This policy is designed to address medical guidelines that are appropriate for the majority of individuals with a particular disease, illness, or condition. Each person's unique clinical circumstances may warrant individual consideration, based on review of applicable medical records.

This medical policy may not apply to FEP. Medical policy is not an authorization, certification, explanation of benefits, or a contract. Benefits are determined by the Federal Employee Program.

⁹⁰ Yttrium Microspheres for Nonresectable Liver Cancer: The University of Connecticut Health Center Experience, Connecticut Medicine, October 2007

Complete Eradication of Hepatic Metastasis from Colorectal Cancer by Yttrium-90 SIRT, World Journal of Gastroenterology, June 2007

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, Biology and Physics, May 2007

Radioembolization with Yttrium-90 Microspheres: A State-of-the-Art Brachytherapy Treatment for Primary and Secondary Liver Malignancies, Part 1: Technical and Methodologic Considerations, Journal of Vascular and Interventional Radiology, August 2006

Radioembolization with Yttrium-90 Microspheres: A State-of-the-Art Brachytherapy Treatment for Primary and Secondary Liver Malignancies, Part 2: Special Topics, Journal of Vascular and Interventional Radiology, September 2006

Radioembolization with Yttrium-90 Microspheres: A State-of-the-Art Brachytherapy Treatment for Primary and Secondary Liver Malignancies, Part 3: Comprehensive Literature Review and Future Direction, Journal of Vascular and Interventional Radiology, October 2006

Selective Internal Radiation Therapy with Yttrium-90 Microspheres for Colorectal Liver Metastases: Single-Centre Experience with 100 Patients, ANZ Journal of Surgery, August 2006

National Blue Cross Blue Shield Medical Policy Reference Manual, Policy #8.01.43

Selective Internal Radiation Therapy with SIR-Spheres in Patients with Nonresectable Liver Tumors, Cancer Biotherapy & Radiopharmaceuticals, April 2005

Treatment of Unresectable Hepatocellular Carcinoma with Intrahepatic Yttrium 90 Microspheres: A Risk-Stratification Analysis, Journal of Vascular and Interventional Radiology, February 2005

Treatment of Unresectable Hepatocellular Carcinoma with Intrahepatic Yttrium 90 Microshperes: Factors Associated with Liver Toxicities, Journal of Vascular and Interventional Radiology, February 2005

Yttrium-90 Microspheres for the Treatment of Hepatocellular Carcinoma, Gastroenterology, November 2004

Use of Yttrium-90 TheraSpheres for the Treatment of Unresectable Hepatocellular Carcinoma, American Surgeon, November 2004

Randomised Phase 2 Trial of Sir-Spheres Plus Fluorouracil/Leucovorin Chemotherapy Versus Fluorouracil/Leucovorin Chemotherapy Alone in Advanced Colorectal Cancer, Journal of Surgical Oncology, November 2004

Use of Yttrium-90 Glass Microspheres (TheraSphere) for the Treatment of Unresectable Hepatocellular Carcinoma in Patients with Portal Vein Thrombosis, Journal of Vascular and Interventional Radiology, April 2004

Hepatic arterial 90Yttrium glass microspheres (TheraSphere) for unresectable hepatocellular carcinoma: interim safety and survival data on 65 patients, Liver Transplantation, February 2004

Current treatment for liver metastases from colorectal cancer, World Journal of Gastroenterology, Vol. 9, February 2003

Emerging Therapies for Hepatocellular Carcinoma: Opportunities for Radiologists, Journal of Vascular and Interventional Radiology, September 2002

Yttrium-90 Microspheres: Radiation Therapy for Unresectable Liver Cancer, Journal of Vascular and Interventional Radiology, September 2002

Selective Internal Radiation Therapy for Hepatic Metastases using Sir-spheres®, an assessment report of the Medical Services Advisory Committee, Commonwealth of Australia, March 2002

Selective internal radiation therapy with 90yttrium microspheres for extensive colorectal liver metastases, Journal of Gastrointestinal Surgery, May 2001

Kennedy A, Nag S, Salem, et al. Recommendations for Radioembolization of Hepatic Malignancies Using Yttrium-90 Microsphere Brachytherapy: A Consensus Panel Report from the Radioembolization Brachytherapy Oncology Consortium (REBOC). Int J Radiat Oncol Biol Phys. 2007;68(1):13-23.

Gulec S, Pennington K, Hall M, Fong Y. Preoperative Y-90 microsphere selective internal radiation treatment for tumor downsizing and future liver remnant recruitment: a novel approach to improving the safety of major hepatic resections. World J Surg Oncol. 2009;7.

Riaz A, Lewandowski RJ, Kulik L, Salem R. Yttrium-90 radioembolization using TheraSphere® in the management of primary and secondary liver tumors. Q J Nucl Med Mol Imaging. 2009;53:311-316.

Woodall CE, Scoggins CR, Ellis SF, et al. Is Selective Internal Radioembolization Safe and Effective for Patients with Inoperable Hepatocellular Carcinoma and Venous Thrombosis? J Am Coll Surg. 2009;208:375-382.

National Comprehensive Cancer Network (NCCN) Clinical Practice Guideline in Oncology™ for Hepatobiliary Cancers (v.1.2010).