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.

SIRT, using radioactive Yttrium-90 (90Y) microspheres, may be considered medically necessary in an individual with:  

• Unresectable and/or medically inoperable primary or metastatic liver malignancies
  • Unresectable liver only or liver dominant metastases from neuroendocrine tumors (e.g., carcinoids, pancreatic islet cell tumors, endocrine tumor); or
  • Unresectable primary hepatocellular carcinoma (HCC); or
  • Unresectable metastatic liver tumors from primary colorectal cancer; or
  • Requests for the treatment of liver metastases from other primary malignancies, including breast carcinoma, ocular melanoma, cutaneous melanoma, and intrahepatic cholangiocarcinoma, will be considered on a case-by-case basis.
    • These requests should be based on the lack of any known systemic or liver-directed treatment options for this individual in an effort to relieve symptoms and/or possibly extend life expectancy; and
• The tumor burden should be liver dominant, not necessarily exclusive to the liver ; and
• Eastern Cooperative Oncology Group (ECOG) performance status should be zero (0) or one (1) or Karnofsky Performance Status (KPS) of 70 or more; and
• Life expectancy should be at least 3 months.

SIRT, as a debulking agent, is considered experimental/investigational, and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Note: All requests for repeat radioembolization are subject to medical review and will be judged on a case-by-case basis

Repeat radioembolization may be considered medically necessary for new or progressive primary or metastatic liver cancers when ALL of the following are met:  

• The individual has had a previous satisfactory response to an initial radioembolization treatment as evidenced on results of a computed tomography (CT) scan or positron emission tomography (PET)-CT scan performed 3 months following the previous procedure. Response should be graded according to the revised RECIST guideline (Version 1.1); and
• The disease still must be liver dominant; and
• Life expectancy of at least 3 months; and
• ECOG performance status no greater than two (2) or KPS of 70 or more; and
• There are no other effective systemic or liver-directed treatment options; and
• The individual has compensated liver function tests (LFTs); and
• Estimated lung dose and combined lung dose from previous embolizations are within acceptable dose volume constraints.
  • Exclude an individual with lung shunting in which the lung radiation dose is greater than 35 to 30 Gy per treatment or greater that 50 Gy cumulatively for all treatments; and
• Treatment should be given to a targeted tumor volume.

Repeat whole liver irradiation is considered experimental/ investigational, and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

A third radioembolization is considered experimental/ investigational, and therefore, non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.

Absolute contraindications:

• Inability to catheterize the hepatic artery
• Fulminant liver failure (Childs-Pugh status late B or C)
• 99mTechnetium-Albumin Macroaggregates (99mTc-MAA) hepatic arterial perfusion scintigraphy demonstrating significant reflux or non-target deposition to the gastrointestinal organs that cannot be cannot be corrected by angiographic techniques.
  • It is important that liver injection of 99mTc-MAA is delivered with flow rates and catheter position that mimic the anticipated 90Y infusion rate catheter position
• 99mTc-MAA hepatic arterial perfusion scintigraphy demonstrating the potential greater than 30 Gy radiation exposure to the lung

Relative contraindications

• Excessive tumor burden in the liver with greater than 70% of the parenchyma replaced by tumor
• Prior extensive liver resection
• Total bilirubin greater than 2 mg/dL in the absence of reversible cause (e.g. obstruction), which indicates severe liver function impairment
  • Nonobstructive bilirubin elevations generally indicate that liver metastases have caused liver impairment to a degree at which risks outweigh benefits for this therapy
  • In contrast, patients with hepatocellular carcinoma (HCC) and elevated bilirubin may be treated with radioembolization if a segmental or subsegmental infusion can be performed
• Prior radiation therapy to the liver or upper abdomen that included a significant volume of the liver
  • Based on a study by Lam et al. (2013) the fraction of liver exposed to greater than 30 Gy (V30) is the strongest predictor of hepatotoxicity. All patients with V30 greater than 13% experienced hepatotoxicity
• Concurrent or prior capecitabine chemotherapy (within the previous two months)
• If the patient is known to be pregnant, the potential radiation risks to the fetus and clinical benefits of the procedure required before, during, and after RMBD, and any scatter radiation from the hepatic implant should be considered before proceeding with treatment
• Portal vein thrombosis (PVT):
  • Tsi et al. suggests 90Y microspheres are tolerated in patients with HCC and major PVT
  • Kulik et al. (2008) reported more grade 3/4 adverse events in patients with main portal vein thrombosis
  • Schwartz et al. (2010) states 90Y is a safe microembolization treatment that can be used as an alternative to TACE in patients in case of PVT

Experimental/Investigational (E/I) services are not covered regardless of place of service.

SIRT is typically an outpatient procedure which is only eligible for coverage as an inpatient procedure in special circumstances, including, but not limited to, the presence of a co-morbid condition that would require monitoring in a more controlled environment such as the inpatient setting.

Services that do not meet the criteria of this policy will be considered experimental/investigational (E/I). A network provider can bill the member for the experimental/investigational service. The provider must give advance written notice informing the member that the service has been deemed E/I. The member must be provided with an estimate of the cost and the member must agree in writing to assume financial responsibility in advance of receiving the service. The signed agreement must be maintained in the provider’s records.

• Link to Provider Resource Center for the Medical Policy Update

05/2018, REMINDER: Radiation Therapy
01/2018, REMINDER: Radiation Therapy

• Link to References