Currentsierra health and lifePolicy 2026T0445BB

Transarterial Radioembolization (TARE)/ Selective Internal Radiation Therapy (SIRT) for the Treatment of Malignant Cancers of the Liver

This policy governs medical necessity and coverage criteria for Yttrium-90 TARE/SIRT in individuals ≥19 years old under UnitedHealthcare Commercial and Individual Exchange plans; it also notes coverage without further review for individuals <19 years. It applies to evaluation and authorization of TARE/SIRT for primary and metastatic liver cancers.

Policy Summary

Payersierra health and life

PolicyTransarterial Radioembolization (TARE)/ SIRT for Malignant Liver Cancers

Policy CodePolicy 2026T0445BB

Change TypeTemplate update — no material clinical changes

Effective DateJan 1, 2026

Next Review Date

Key ActionObtain prior authorization and document guideline-based patient selection (ECOG 0–2, life expectancy ≥3 months, labs and mapping studies) per plan rules.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

19+applies to individuals aged

ECOG 0-2required performance status

6proven indications

4 codesprocedure codes referenced

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NCCN category for selected AR therapies

Coverage and Medical Necessity Criteria

Covered indications

TARE/SIRT using yttrium-90 microspheres is proven and medically necessary for the following when the individual has ECOG Performance Status 0, 1, or 2:

Covered indications list: Any of the following indications qualifies when ECOG 0-2: - Liver-dominant primary hepatocellular carcinoma (HCC) in individuals who are not surgical candidates - Primary hepatocellular carcinoma as a bridge to liver transplantation - Liver metastases from neuroendocrine tumors in individuals who are not surgical candidates when systemic therapy has failed to control symptoms - Liver metastases from colorectal carcinoma in individuals with chemotherapy-resistant or refractory disease and with predominant hepatic metastases - Liver metastases from intrahepatic cholangiocarcinoma in individuals who are not surgical candidates - Metastasis from uveal/ocular melanoma when confined to the liverECOG 0-2

Applies to individuals >=19 years unless under-19 exceptional coverage noted separately.

Not medically necessary / Unproven indications

TARE/SIRT using yttrium-90 microspheres is unproven and not medically necessary for indications other than those listed above.

Not covered indications: Any indication not explicitly listed as proven and medically necessary in this policy

Use outside the specified indications is considered not medically necessary due to insufficient evidence of efficacy.

General medical necessity criteria for TARE/SIRT

Covered when ALL of the following are met

General selection: Patient has liver-dominant or predominant hepatic metastases or unresectable primary HCC and is being evaluated by a multidisciplinary team with expertise in SIRT

NCCN and ASCO recommend SIRT only in highly selected or chemotherapy-refractory/intolerant patients

Prior therapy and intent: For metastatic colorectal cancer, SIRT is considered for patients refractory or intolerant to chemotherapy or when used selectively for downstaging or radiation lobectomy approaches

SIRFLOX showed improved hepatic PFS but not PFS at any site

Pre-treatment evaluation: Required labs (CBC, coagulation, liver and renal profile), assessment of prognostic markers (e.g., CEA for CRC), and documentation of prior surgeries/local liver treatments

ASCO guidance specifies these evaluations

Neuroendocrine liver metastases — medical necessity

Covered for neuroendocrine liver metastases when ALL of the following are met

Disease distribution: Lobar or segmental (less than lobar) disease or liver-dominant metastatic neuroendocrine tumor

NCCN notes TARE may be considered particularly for lobar or segmental distributions

Prior systemic therapy: Patient may be pretreated with somatostatin analogs or have progression despite prior therapies; TARE considered as second-line or salvage per clinical judgment

Retrospective studies and meta-analyses show ORR/DCR consistent with clinical benefit though randomized data are limited

Center and operator expertise: Procedure performed in specialized centers by clinicians experienced in SIRT with multidisciplinary patient selection

Guidance and HTA sources emphasize specialized centers and multidisciplinary selection

Primary hepatocellular carcinoma — medical necessity

Covered for primary HCC in select scenarios when ALL of the following are met

HCC stage and resectability: Patient has unresectable primary HCC and is a candidate for liver-directed therapy (intermediate stage or select early-stage not eligible for ablation/surgery)

AASLD and NICE list TARE among locoregional options; evidence shows improved TTP and facilitates transplant bridging though OS benefit is inconsistent

Comparative considerations: Consider TARE versus TACE/DEB-TACE or sorafenib based on tumor characteristics, portal vein thrombosis status, and performance status; evidence shows comparable survival but possible better TTP in some trials

TRACE RCT and Hayes reviews report improved tumor control or TTP in select comparisons but overall survival benefit is variable

Patient counseling and follow-up: Document discussion of uncertain overall survival benefit, potential for fewer grade ≤3 adverse events, and risk of late radioembolization-induced chronic hepatotoxicity especially with bilobar treatments

ECRI and systematic reviews note fewer lower-grade AEs but no consistent OS improvement

Guideline-based coverage criteria

Covered when ALL of the following guide-based conditions are satisfied (as supported by cited guidelines and evidence):

Patient selection: Patient has unresectable or inoperable primary or secondary liver malignancy with liver-dominant disease, performance status allowing benefit, and expected life expectancy ≥3 monthslife expectancy ≥3 months

Joint society guidance and AASLD recommend multidisciplinary selection and life expectancy consideration

Anatomic/technical feasibility: Arterial blood supply to tumor can be isolated without excessive non-target treatment and hepatic artery can be catheterized

NCCN and ACR note technical feasibility and avoidance of unacceptable non-target perfusion

Mapping and dosimetry: Pre-treatment mapping angiography and technetium-99m MAA perfusion study demonstrate acceptable non-target deposition and lung shunt fraction within product-specific limitsproduct-specific lung shunt limits

Case-by-case favorable scenarios

Covered with consideration when ANY of the following favorable conditions exist:

Downstaging intent: Disease considered for downstaging to resectability or transplant (e.g., as bridge to transplant or for inducing contralateral hypertrophy)

Hayes and clinical series report use for downstaging/bridging in HCC and iCCA

Segmental/radiation segmentectomy: Segmental or subsegmental infusion may be used in patients with elevated bilirubin or lesions unsuitable for ablation

AASLD and guidelines describe radiation segmentectomy for durable local control and as a transplant bridge

Coverage and appropriateness overview

Coverage considerations and clinical appropriateness summarized from guidelines and evidence:

Appropriate patient selection (general): Patient has limited liver involvement, good performance status, and no or controlled extrahepatic disease; selection by multidisciplinary team is recommended.

Supported by ESO/ESMO, ACR, NCCN and other guidance

Indications supported by evidence/guidelines: Indications include: unresectable HCC as palliative therapy or bridge to transplant/downstaging; peripheral hepatic lobar cholangiocarcinoma in select small tumors per ACR; liver-dominant metastases from uveal melanoma and select colorectal and neuroendocrine tumors.

NCCN, ACR, and other guideline statements support these selective indications

Research-only / limited-evidence indications: For unresectable primary intrahepatic cholangiocarcinoma (ICC), NICE recommends SIRT only in the context of research due to inadequate evidence on efficacy; prospective RCTs are needed.

NICE interventional guidance recommends use in research settings

Clinical coverage considerations

Contextual/clinical coverage considerations drawn from evidence and guideline statements in this section

Selected patients for local therapy: Local therapy (including TARE/SIRT) should be proposed only in very selected patients with good performance status, limited liver involvement, no extrahepatic lesions, and after adequate systemic therapy has demonstrated disease control.

Derived from ESO/ESMO guidance and systematic reviews

Evidence by tumor type: For breast cancer liver metastases, pooled small studies report DCR 78%-96% and median survival 10.8-20.9 months with risks including gastric ulceration and rare treatment-related mortality; for pancreatic liver-dominant metastases, small retrospective series report limited benefit and short median OS after TARE; randomized trials are lacking for many nonconventional primaries.

Summarizes Smits et al. and Kayaleh et al.

Device-specific indication consideration: Coverage decisions should consider device-specific FDA indications and labeling (e.g., SIR-Spheres and TheraSphere) and applicable regulatory or licensing requirements.

FDA approvals and device labeling are informational and do not alone determine coverage

Absolute contraindications precluding TARE/SIRT must be confirmed before authorization. Per guideline summaries, these include pregnancy or lactation, life expectancy < 3 months, and evidence of clinical hepatic impairment or disseminated extrahepatic disease. Documentation that none of these conditions are present is required because their presence excludes the patient from safe treatment.

Additional absolute technical and safety contraindications include inability to catheterize the hepatic artery, fulminant liver failure, mapping studies that demonstrate unacceptable non‑target deposition that cannot be corrected, an unacceptable lung shunt fraction above product‑specific limits, acute hepatic infection, or uncorrectable coagulopathy. Any of these findings on pre‑treatment angiography, contrast cone‑beam CT, or technetium‑99m MAA perfusion testing should preclude proceeding with TARE/SIRT.

Mapping angiography and pre‑treatment perfusion (eg, technetium‑99m MAA) are required to assess anatomic feasibility and to detect non‑target perfusion. If mapping demonstrates unacceptable non‑target deposition or a lung shunt fraction that exceeds the product‑specific safe limits, treatment is contraindicated. Successful selective catheterization demonstrating isolatable arterial supply to the tumor and the ability to embolize collateral vessels as needed are prerequisites for safe dosimetry and delivery.

Certain clinical features are relative exclusions and require cautious individualized assessment. Notably, extensive intrahepatic tumor replacement (>50%–70% of liver parenchyma) increases risk and is generally a relative contraindication unless synthetic hepatic function is preserved and a selective approach is possible. Elevated bilirubin is another key consideration: a total bilirubin > 2 mg/dL is generally considered a relative contraindication (NCCN notes that >3 mg/dL is relatively contraindicated unless segmental treatment is feasible). Other relative precautions include elevated Child‑Pugh score (>7), creatinine clearance <30 mL/min, and prior extensive hepatic radiation.

Health Technology Assessment guidance for intrahepatic cholangiocarcinoma (ICC) advises caution: NICE recommends SIRT for unresectable primary ICC only in the context of research because current evidence on efficacy is inadequate in quantity and quality. Use of SIRT for ICC outside prospective study settings therefore should be limited and documented as part of research when considered.

Guideline panels and HTA bodies consistently emphasize that local intrahepatic therapies (including TARE/SIRT) should not be routinely offered except in highly selected patients. Selection should be limited to individuals with good performance status, limited liver involvement, and controlled or absent extrahepatic disease, and occur after multidisciplinary review and when systemic therapy has been appropriately applied.

TARE/SIRT using yttrium‑90 microspheres is not medically necessary for indications not explicitly listed as proven and medically necessary in this policy. Requests for uses outside the covered indications are considered unproven due to insufficient evidence and may be denied.

Professional society guidance notes that SIRT is generally reserved for highly selected patients with metastatic colorectal cancer who are chemotherapy‑refractory or intolerant, and that SIRT is not routinely recommended for individuals with unilobar or bilobar mCRC in routine practice because harms may outweigh benefits. Careful justification and prior authorization documenting refractory status and hepatic‑dominant disease are expected.

When alternative, less risky, or equally effective arterially directed therapies (for example, bland embolization or TACE/DEB‑TACE in appropriate patients) are preferred or clearly indicated, those options should be considered before TARE. Comparative reviews report mixed survival differences across modalities; selection should favor the option with more favorable risk‑benefit for the individual patient and be documented in multidisciplinary deliberations.

Evidence for TARE/SIRT in many other primary tumor types is limited and heterogeneous. Small retrospective series and pooled case series exist for indications such as breast and pancreatic liver metastases, but randomized data are lacking; therefore routine use for these other primary tumors is not established and should generally be limited to clinical trials or carefully documented case‑by‑case consideration.

Caution is warranted when considering TARE in patients with poor performance status or with extensive liver involvement. Guideline statements recommend restricting local therapy to patients with good performance status, limited hepatic disease, and no uncontrolled extrahepatic disease; outcomes and safety are poorer when these selection criteria are not met.

Procedure, Regulatory Codes, and Key Clinical Parameters

Applicable procedure codesmixed

37243	Vascular embolization or occlusion, inclusive of all radiological supervision and interpretation, intraprocedural roadmapping, and imaging guidance necessary to complete the intervention; for tumors, organ ischemia, or infarction.
75894	Transcatheter therapy, embolization, any method, radiological supervision and interpretation.
79445	Radiopharmaceutical therapy, by intra-arterial particulate administration
S2095	Transcatheter occlusion or embolization for tumor destruction, percutaneous, any method, using yttrium-90 microspheres

Covered CPT Codesmixed

No codes listed

No explicit codes in this document segmentmixed

No codes listed

FDA PMA/HDE identifiers mentionedmixed

P990065	FDA premarket approval code referenced for SIR-Spheres
H980006	Humanitarian Device Exemption approval code referenced for TheraSphere
P200029	PMA ID referenced for TheraSphere SIRT approval (2021)

inv-25: bilirubin — clinical threshold values for candidacy

Total bilirubin threshold (general)Patients' bilirubin should be < 2 mg/dL for Y-90 radioembolization

Ideal bilirubin for lobar/bilobar treatmentIdeally bilirubin < 1.3 mg/dL when lobar or bilobar treatment is planned

Selective/segmental exceptionHigher bilirubin levels may be acceptable when selective radiation segmentectomy is performed

inv-26: albumin — prognostic / selection value

Albumin prognostic threshold> 3 g/dL associated with improved survival after TARE/SIRT

Role in selection

Authorization, Documentation, and Operational Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for highly selected indications of transarterial radioembolization (TARE)/selective internal radiation therapy (SIRT) for commercial and individual exchange members. Requests must demonstrate guideline-based selection (e.g., NCCN, ASCO) and that disease is liver‑dominant or hepatic‑only as appropriate to the indication. Verify member-specific benefits prior to authorization and obtain prior authorization when the member's plan requires it.

Prior authorization required for highly selected indications (e.g., mCRC with chemotherapy‑resistant/refractory disease and predominant hepatic metastases; bridge-to‑transplant for HCC)
Confirm member-specific benefit and plan authorization requirements before scheduling
Authorization must reference guideline-based indication and line-of-therapy context

Documentation Required

Documentation Requirements and Medical Records

Documentation submitted with prior authorization requests must include complete medical records and clinical data to support medical necessity. This includes prior therapies and response, performance status, relevant labs, imaging, and multidisciplinary review notes.

Background and Context

Background: Surgical resection remains the preferred curative treatment for hepatic malignancies when feasible, but many tumors are unresectable. TARE/SIRT with yttrium‑90 microspheres delivers targeted intra‑arterial radiation to hepatic tumors, enabling high tumor dose while sparing uninvolved liver and providing a locoregional option for unresectable primary and metastatic liver cancers in selected patients.

Definitions and Key Terms

inv-56: ECOG Performance Status — definitions 0–5

ECOG 0Fully active, able to carry on all pre-disease activities without restriction

ECOG 1Restricted in physically strenuous activity but ambulatory and able to carry out light work

ECOG 2Ambulatory and capable of self-care but unable to work; up and about >50% of waking hours

ECOG 3Capable of limited self-care; confined to bed or chair >50% of waking hours

ECOG 4Completely disabled; cannot carry on any self-care; totally confined to bed or chair

ECOG 5Dead

Policy Summary

Payersierra health and life

PolicyTransarterial Radioembolization (TARE)/ SIRT for Malignant Liver Cancers

Policy CodePolicy 2026T0445BB

Change TypeTemplate update — no material clinical changes

Effective DateJan 1, 2026

Next Review Date

Key ActionObtain prior authorization and document guideline-based patient selection (ECOG 0–2, life expectancy ≥3 months, labs and mapping studies) per plan rules.

SourceLink

On This Page

Contraindications absent: No absolute contraindications present (pregnancy/lactation, life expectancy <3 months, clinical hepatic impairment, disseminated extrahepatic disease)

Presence of these contraindications excludes coverage

Unacceptable mapping results are absolute contraindications

Liver function and labs: Laboratory data support safety (e.g., bilirubin within acceptable limits and preserved synthetic function) and prior radiation to liver is considered in planningbilirubin generally ≤2 mg/dL; NCCN notes relative contraindication if >3 mg/dL unless segmental treatment possible

Guidelines reference bilirubin and other lab thresholds as selection criteria

Multidisciplinary evaluation: Treatment plan documented by a multidisciplinary team including interventional radiology and relevant specialties

Joint society guidance recommends multidisciplinary expertise for selection and planning

Evidence notes on outcomes: Outcomes vary by primary tumor: uveal melanoma and breast cancer series report median OS in the range of months to low years; evidence is largely retrospective or single-arm and RCT data are limited.

See referenced systematic reviews and meta-analyses

Safety and monitoring: SIRT/TARE can cause fatigue, abdominal pain, nausea, gastric ulceration, and rare radioembolization-induced liver disease; post-procedure monitoring with labs and imaging is described in protocols.

Guideline and trial protocols outline monitoring and follow-up

Decreasing albumin levels forecast impending liver dysfunction and should prompt caution in patient selection

Interaction with other factorsAlbumin should be interpreted alongside bilirubin and synthetic function to assess risk of hepatic decompensation

inv-27: liver involvement by tumor — percent hepatic replacement relative contraindication

Upper limit for considerationAvoid treatment if >70%–75% liver involvement by tumor (relative contraindication)

Infiltrative disease concernInfiltrative disease with tumor burden >50% is an indicator of poor outcomes and requires caution

Synthetic function caveatExtensive tumor burden may be considered only if synthetic hepatic function is preserved and selective treatments are possible

inv-28: Life expectancy — threshold relevant to contraindication

Life expectancy exclusionLife expectancy < 3 months is an absolute contraindication to TARE/SIRT

Documentation expectationExpected life expectancy should be ≥3 months to support consideration per guideline-based coverage criteria

Implication for authorizationPresence of life expectancy <3 months may trigger denial of the procedure

inv-29: Renal function — relative contraindication parameter

Renal function cutoffAcute or severe chronic renal failure with creatinine clearance < 30 ml/min is a relative contraindication

Pre-treatment evaluationRenal profile should be included in laboratory evaluation prior to Y-90 per ASCO guidance

Clinical significanceSevere renal impairment increases likelihood of hepatic decompensation and procedural risk

inv-30: Child-Pugh score — relative contraindication threshold

Child-Pugh score thresholdElevated Child-Pugh score (>7) is a relative contraindication due to increased likelihood of hepatic decompensation

Device-specific labelTheraSphere PMA specifies Child-Pugh Score A (well-compensated) for its approved HCC indication

Clinical cautionChild-Pugh status should be considered with other hepatic function markers when selecting candidates

inv-31: Intrahepatic tumor replacement — relative contraindication

Intrahepatic replacement limit> 50%–70% replacement of liver parenchyma by tumor is a relative contraindication

Outcome indicatorInfiltrative disease with tumor burden >50% is associated with poorer outcomes and higher risk of liver dysfunction

Selective treatment considerationTreatment can be considered with preserved synthetic function and selective (segmental) delivery

inv-32: Total bilirubin — guideline/threshold variations (NCCN vs others)

General bilirubin guidanceTotal bilirubin > 2 mg/dL is a relative contraindication in general practice

NCCN variationNCCN states arterially directed therapies are relatively contraindicated if bilirubin > 3 mg/dL unless segmental treatment is possible

Segmental exceptionPatients with HCC and elevated bilirubin may still be treated if a segmental or subsegmental infusion can be performed

inv-33: Tumor hepatic replacement — restated relative contraindication detail

Tumor hepatic replacement restatement>50%–70% hepatic parenchymal replacement by tumor constitutes a relative contraindication to TARE/SIRT

Consider preserved functionExtensive replacement may still be considered if synthetic hepatic function is preserved and selective therapy feasible

Associated risksHigh hepatic tumor burden increases risk of post-procedure hepatic failure and poorer outcomes

inv-34: Hepatic tumor burden — prognostic stratifier for breast cancer metastases

Prognostic stratifier for breast metsHepatic metastatic burden < 25% is associated with better response and improved outcomes in breast cancer liver metastases

Observed outcomesMeta-analyses report higher tumor control and longer median survival when hepatic burden is limited (<25%)

Implication for selectionPatients with limited hepatic tumor burden and no extrahepatic disease are better candidates for TARE/SIRT

Medical records and clinical data: complete chart notes, prior oncologic treatment history, surgical and local therapy history (e.g., TACE, ablation)
Required pre-treatment clinical documentation: ECOG performance status, CBC, coagulation profile, liver and renal function tests, tumor markers (e.g., CEA for mCRC), and imaging demonstrating liver‑dominant disease
Multidisciplinary evaluation: documentation of tumor board or multidisciplinary review including interventional radiology, medical oncology, hepatology, radiation oncology, and nuclear medicine when applicable

Prior Authorization

Prior Authorization — Bridge to Transplant / Downstaging

Prior authorization for bridge‑to‑transplant/downstaging procedures is required. Requests should include evidence that TARE/Therasphere or SIR‑Spheres is being used to slow progression or downstage to meet transplant criteria, and include expected transplant candidacy and transplant center coordination.

Include prior authorization rationale: intended use as bridge or downstage to liver transplant or resection
Provide documentation of transplant candidacy assessment, listing status or intent, and coordination with transplant center
Provide outcomes/expectations from prior local regional therapies if applicable

Step Therapy

Step Therapy and Line-of-Therapy Considerations

Step therapy expectations: guidelines generally consider SIRT/TARE after or when disease is refractory to systemic chemotherapy in mCRC and in highly selected patients after appropriate systemic control. There is no universal mandated sequence; clinical context and guideline recommendations should be documented.

Step therapy comments: clinical rationale should explain prior systemic therapies attempted, response, intolerance, or resistance (e.g., chemotherapy‑resistant/refractory mCRC)
Consideration of alternative locoregional therapies (LRTs) should be documented — e.g., TACE, ablation, or surgical options and reasons they were not appropriate or failed
Systemic therapy prior to local therapy: document prior systemic disease control or why local therapy is being considered despite systemic options

Denial Risk

Contraindications That May Trigger Denial

Contraindications and technical conditions that may trigger denial must be documented and assessed prior to authorization. Absolute and relative contraindications from professional guidelines should be checked and clearly addressed in submitted records.

Absolute contraindications (may trigger denial): pregnancy or lactation; life expectancy < 3 months; clinical/fulminant hepatic failure; disseminated extrahepatic disease precluding benefit; inability to catheterize the hepatic arterial supply; acute hepatic infection; uncorrectable coagulopathy; unacceptable nontarget deposition on mapping angiography/MAA or pulmonary shunt fraction above product‑specific limits
Relative contraindications to address in documentation: Child‑Pugh score >7 or high likelihood of hepatic decompensation; excessive tumor burden (>50–70% liver replacement); total bilirubin >2 mg/dL (nonobstructive); prior significant upper abdominal radiation; severe renal impairment (CrCl <30 mL/min); concurrent systemic therapies that increase risk
Technical contraindications: mapping angiography or MAA showing non‑target flow that cannot be corrected; unfavorable lung shunt fraction exceeding product limits; inability to safely access target vasculature

Note

Regulatory and Licensing Compliance

Regulatory, device, and facility licensing compliance must be confirmed in the authorization process. Ensure use of FDA‑approved or appropriately licensed 90Y microsphere products and facility/nuclear medicine licensing where applicable.

Confirm product regulatory status: TheraSphere (glass) PMA and Humanitarian Device Exemption details; SIR‑Spheres (resin) PMA indications and labeling
Verify facility and operator licensing and compliance with U.S. NRC requirements for handling and administering yttrium‑90 microspheres
Include device/product selection rationale and any product‑specific dosimetry or shunt limits in documentation

Documentation Required