Mountain State Medical Policy Bulletin
Section: Radiation Therapy & Nuclear Medicine
Number: R-15
Topic: Selective Internal Radiation Therapy (SIRT)
Effective Date: August 1, 2005
Issued Date: September 10, 2007
Date Last Reviewed: 02/2006

General Policy Guidelines

Indications and Limitations of Coverage

Selective Internal Radiation Therapy (SIRT) using intra-arterial injections of radiolabeled microspheres, such as SIR-Spheres® or TheraSphere®, to treat primary or metastatic liver tumors is considered experimental/investigational.

Articles published in peer-reviewed medical journals report on the technical aspects of SIRT and recent experiences with SIRT in clinical trials. These reviews provide favorable preliminary evidence of the effects of SIRT on hepatic tumors. However, these clinical trials have been limited, yielding insufficient data on long-term follow-up. Additional research is necessary to document the duration of responses to, and patient survival after SIRT.

Selective internal radiation therapy (SIRT)(procedure code S2095) is therefore considered investigational and not eligible for payment. Claims reporting these services will be denied. A participating, preferred, or network provider can bill the member for a service denied as investigational.

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.

Procedure Codes

S2095     

Traditional Guidelines

Refer to General Policy Guidelines

FEP Guidelines

Under the Federal Employee Program, all services that utilize FDA-approved drugs, devices, or biological products are eligible when intended for the treatment of a serious or life-threatening condition and when medically necessary and appropriate for the patient’s condition. Selective internal radiation therapy (SIRT) is considered eligible when determined medically necessary based on the patient’s condition.

Also refer to General Policy Guidelines

PPO Guidelines

Refer to General Policy Guidelines

Managed Care POS Guidelines

Refer to General Policy Guidelines

Publications

References

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

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Table Attachment

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Glossary




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.

Medical policies are designed to supplement the terms of a member's contract. The member's contract defines the benefits available; therefore, medical policies should not be construed as overriding specific contract language. In the event of conflict, the contract shall govern.

Medical policies do not constitute medical advice, nor the practice of medicine. Rather, such policies are intended only to establish general guidelines for coverage and reimbursement under Mountain State Blue Cross Blue Shield plans. Application of a medical policy to determine coverage in an individual instance is not intended and shall not be construed to supercede the professional judgment of a treating provider. In all situations, the treating provider must use his/her professional judgment to provide care he/she believes to be in the best interest of the patient, and the provider and patient remain responsible for all treatment decisions.

Mountain State Blue Cross Blue Shield (MSBCBS) retains the right to review and update its medical policy guidelines at its sole discretion. These guidelines are the proprietary information of MSBCBS. Any sale, copying or dissemination of the medical policies is prohibited; however, limited copying of medical policies is permitted for individual use.