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.

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.

PRN References

06/2004, Selective internal radiation therapy (SIRT) considered investigational

National Blue Cross Blue Shield Medical Policy Reference Manual, Policy #8.01.43, October 2003

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