UnitedHealthcare Y-90 TARE/SIRT Coverage Update

Coverage and Medical Necessity Criteria

Covered indications

Covered when ALL of the following are met:

Coverage prerequisites

Eligible diagnoses: One of the following primary or metastatic liver conditions: (1) Liver-dominant primary hepatocellular carcinoma (HCC) in individuals who are not surgical candidates; (2) Primary HCC as a bridge to liver transplantation; (3) Liver metastases from neuroendocrine tumors in individuals who are not surgical candidates when systemic therapy has failed to control symptoms; (4) Liver metastases from colorectal carcinoma in individuals with chemotherapy-resistant or refractory disease and with predominant hepatic metastases; (5) Liver metastases from intrahepatic cholangiocarcinoma in individuals who are not surgical candidates; (6) Metastasis from uveal/ocular melanoma when confined to the liver.diagnostic
These are the listed proven and medically necessary indications in the policy.

Not covered / Unproven indications

Other indications: Any indication for TARE/SIRT not explicitly listed as proven above.

TARE/SIRT using yttrium-90 microspheres is unproven and not medically necessary for all other indications due to insufficient evidence of efficacy.

Covered Indications by Tumor Type

Covered when supported by guideline-concordant patient selection and performed in specialized centers:

Colorectal liver metastases: TARE may be appropriate for solitary or multifocal/lobar colorectal liver metastases in highly selected individuals, particularly for chemotherapy-resistant or -refractory disease and for downsizing/remnant hypertrophy (radiation lobectomy) as an alternative to portal vein embolization.

NCCN supports use in highly selected, chemotherapy-refractory patients; radiation lobectomy described as option to induce remnant hypertrophy.

Neuroendocrine liver metastases (NELM): TARE is an option for unresectable, liver-dominant neuroendocrine metastases, especially for lobar/segmental disease or after progression on prior systemic therapy; selection should be by a multidisciplinary team and performed in specialized centers.

NCCN and NICE recommend MDT selection and specialist centers; lobar/segmental distribution favored per NCCN.

Primary hepatocellular carcinoma (HCC): TARE is an acceptable option for solitary unresectable HCC, an alternative intra-arterial therapy for intermediate-stage HCC, and may be used as bridge to transplant or for radiation segmentectomy to provide durable local control.

General coverage criteria

Covered when ALL of the following are met (per professional society guidance and guideline indications where cited):

Patient selection general: Unresectable or inoperable primary or secondary liver malignancy with liver-dominant disease; documented multidisciplinary team evaluation; life expectancy and performance status sufficient to benefit (professional societies cite at least 3 months); and documentation that TARE is chosen after considering alternatives.life expectancy >= 3 months

Safety and procedural prerequisites: Pre-procedure mapping angiography and technetium-99m MAA perfusion scintigraphy demonstrate acceptable target delivery and lung shunt fraction; hepatic arterial catheterization is feasible; laboratory data (including bilirubin, albumin, coagulation) support safe treatment; no acute hepatic infection or uncorrectable coagulopathy.acceptable lung shunt fraction per product

Indications by tumor type (summary): Indications include solitary unresectable HCC (including tumors in locations challenging for ablation), intermediate-stage HCC as alternative to TACE, select peripheral hepatic lobar cholangiocarcinoma (<3 cm) without ductal dilation/vascular invasion/lymphadenopathy, unresectable intrahepatic cholangiocarcinoma for disease control or downstaging in selected cases, and select hepatic metastases (eg, colorectal, neuroendocrine, uveal melanoma) following guideline-based selection.

Relative contraindications / conditional coverage

Consideration/not-covered conditions

Relative contraindications: Excessive hepatic tumor burden (>50–70% parenchyma involvement), total bilirubin above thresholds (eg, >2 mg/dL generally; NCCN notes >3 mg/dL relative unless segmental treatment possible), prior significant hepatic radiation, or systemic therapies that increase procedural risk — these require case-by-case assessment with documentation of preserved hepatic synthetic function or feasibility of segmental therapy.tumor burden >50-70%; bilirubin >2 mg/dL (or >3 mg/dL per NCCN unless segmental)

NICE stance for ICC: For unresectable primary intrahepatic cholangiocarcinoma (ICC), NICE concludes evidence is inadequate for routine use and recommends SIRT only in the context of research; routine coverage outside research contexts may therefore be conditional or not supported.

Hepatocellular Carcinoma (HCC) – Bridge/Downstaging/Locoregional

Covered indications and clinical contexts described in the evidence/guidelines

Bridge to transplant or downstaging: Use of Y-90 TARE/SIRT as locoregional therapy to bridge individuals to liver transplantation or to downstage tumors to meet transplant/resection criteria is an accepted indication when multidisciplinary evaluation documents intent and expected benefit; evidence suggests comparable or favorable efficacy and safety versus other locoregional therapies in limited studies.

Hayes assessment and retrospective cohort data support bridging/downstaging roles.

Radiation segmentectomy/local control: Radiation segmentectomy or selective lobar/segmental TARE may be used to provide durable local tumor control, prolong time to progression, and treat lesions in locations not amenable to ablation, as described by AASLD guidance.

Metastatic Liver Disease – Indications and Evidence

Metastatic disease contexts where SIRT/TARE is considered

Uveal (ocular) melanoma liver metastases: Regional therapies including radioembolization may be considered when disease is confined to the liver; systematic reviews and prospective series report median OS in select series around ~12–19 months and disease control rates, but evidence is limited by retrospective designs and small trials; multidisciplinary selection recommended.

Breast cancer liver metastases: SIRT/TARE may be used for unresectable breast cancer liver metastases with reported disease control rates and median OS from mainly retrospective series; comparative benefit versus other modalities remains uncertain and selection should be individualized.

Other non-conventional liver metastases (pancreatic, ICC, renal cell, lung): Limited, heterogeneous evidence suggests potential palliative or disease-control benefits for some nonconventional primaries, but randomized comparative data are lacking; intrahepatic cholangiocarcinoma evidence is insufficient for routine use outside research per NICE.

Per the American Society of Clinical Oncology (ASCO) guideline review, absolute contraindications to Y‑90 TARE/SIRT include pregnancy or lactation, life expectancy less than 3 months, clinical hepatic impairment, and disseminated extrahepatic disease. These conditions should preclude consideration of radioembolization and be documented in the medical record when present.

This policy requires that procedures be performed in specialist centers by clinicians with specific training and experience in SIRT; treatments performed by clinicians without SIRT-specific training or at non‑specialized facilities may be considered inappropriate and are subject to denial. Prior authorization and multidisciplinary review should confirm provider credentialing, center expertise, and that patient selection aligns with guideline-supported indications.

Additional absolute exclusions include inability to catheterize the hepatic artery, fulminant liver failure, mapping angiography or technetium‑99m MAA perfusion scintigraphy showing clinically unacceptable non‑target deposition or an unacceptable lung shunt fraction for the selected Y‑90 product, acute hepatic infection, and uncorrectable coagulopathy. ASCO also lists life expectancy under 3 months and clinically significant hepatic impairment as absolute contraindications; these findings must be documented and will preclude SIRT.

The National Institute for Health and Care Excellence (NICE) recommends that SIRT for unresectable primary intrahepatic cholangiocarcinoma (ICC) should only be used in the context of research because current evidence on efficacy is inadequate in quantity and quality. NICE further advises that patient selection for such research should be multidisciplinary and procedures performed in specialist centers by clinicians experienced in cholangiocarcinoma management.

When assessing coverage, consider product‑specific labeled indications. The FDA has cleared two commercial Y‑90 microsphere products with differing labeled uses: SIR‑Spheres® (resin) with an approved indication in unresectable metastatic colorectal liver tumors in the setting of intra‑hepatic artery chemotherapy, and TheraSphere® (glass) with Humanitarian Device Exemption approval for certain unresectable HCC presentations. Product labeling and applicable regulatory approvals should inform clinical appropriateness and coverage discussions.

TARE/SIRT using yttrium‑90 microspheres for indications other than those explicitly listed as proven in this policy is considered unproven and not medically necessary due to insufficient evidence of efficacy. Requests for off‑label or unlisted uses should include robust supporting data and will be evaluated case‑by‑case, but standard coverage is not supported.

Multiple systematic reviews and comparative assessments report that while TARE may improve time to progression or tumor response in some non‑surgical HCC populations, evidence does not consistently demonstrate an overall survival (OS) benefit versus standard therapies. In the absence of OS improvement, use of TARE for non‑surgical HCC should be justified by documented clinical rationale (for example, bridge to transplant, downstaging, or tumor control) and multidisciplinary consensus.

NICE evaluated SIRT for unresectable primary ICC and concluded the evidence is inadequate for routine use; consequently, NICE recommends SIRT for ICC only within clinical research. Where NICE guidance is followed, routine coverage outside of research studies may be denied for insufficiency of evidence and safety concerns.

Use of TARE/SIRT for primary tumors other than those listed (for example, pancreatic, renal cell, lung primaries or unusual metastases) remains investigational in many contexts because evidence is limited, heterogeneous, and primarily from small cohorts. Larger randomized controlled trials are needed before routine coverage can be recommended.

Regulatory clearance or FDA approval of a Y‑90 device alone does not constitute coverage. The policy explicitly states that FDA approval alone is not a basis for coverage determinations; coverage decisions require assessment of clinical indications, supporting evidence, and plan, federal, or state terms.

Procedure Codes and Device Coding

Applicable procedure codesCPT/HCPCS/mixed

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

FDA-approved Devicesmixed

TheraSphere®	Glass 90Y microspheres (device name) - FDA HDE H980006
SIR-Spheres®	Resin 90Y microspheres (device name) - FDA PMA P990065

inv-20: Tumor burden threshold (relative contraindication)

Tumor burden threshold> 50% to 70% of liver parenchyma replaced by tumor (relative contraindication); treatment may be considered if synthetic hepatic function is preserved or for segmental infusions

Context for considerationIn cases with >50–70% involvement, document preserved synthetic hepatic function and multidisciplinary rationale for proceeding

Implication for coverage reviewExcessive tumor burden is a relative contraindication and may lead to denial unless documentation justifies segmental treatment or adequate liver function

inv-21: Total bilirubin thresholds (relative contraindication)

Primary bilirubin thresholdTotal bilirubin > 2 mg/dL is cited as a relative contraindication (nonobstructive) — indicates severe liver function impairment

Prior Authorization, Documentation, and Operational Requirements

Denial Risk

Documentation Insufficiency and Prior Authorization

Prior authorization is required for procedures described in this policy. Providers must ensure all requested documentation is available at the time of review. Incomplete or missing documentation may result in denial or delay of authorization. Use the member's benefit plan, applicable state or federal mandates, and contractual provisions to determine coverage and eligibility.

Documentation must include relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.
Failure to provide requested medical records may result in denial of the request.

Prior Authorization

Provider Credentialing and Specialized Setting

Clinicians performing SIRT/TARE should have specific training and experience in SIRT. Procedures should be performed in specialized centers with multidisciplinary expertise (interventional radiology, nuclear medicine, medical physics, radiation oncology, hepatology, surgical oncology, and transplant services as appropriate).

Background and Evidence Summary

Transarterial radioembolization/selective internal radiation therapy (TARE/SIRT) delivers yttrium‑90 microspheres via the hepatic arterial circulation to provide high‑dose focal radiation to liver tumors while sparing normal parenchyma. Surgical resection remains the preferred curative option for many liver tumors, but TARE is an option for patients with unresectable primary or metastatic liver malignancies; patient selection must consider performance status (ECOG 0–2), liver function, tumor burden, prior therapies, and multidisciplinary evaluation.

Definitions and Key Terms

inv-45: ECOG Performance Status

ECOG scale overviewECOG Performance Status ranges from 0 (fully active) to 5 (dead)

Defined categories0 = fully active; 1 = restricted in strenuous activity but ambulatory; 2 = ambulatory, capable of self-care but unable to work (>50% of waking hours up and about); 3–5 defined as greater impairment up to death

Coverage requirementECOG 0–2 required for covered indications (patients must have performance status allowing expected benefit)

inv-46: Limited Extra-Hepatic Disease

DefinitionMetastases limited to lung with <5 nodules ≤1 cm or a single nodule ≤1.7 cm and/or a single lymph node area <2 cm

Clinical relevanceRepresents limited extra-hepatic disease acceptable for consideration of liver-directed therapies when liver-dominant disease present

OpenPayer

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

Coverage and Medical Necessity Criteria

Procedure Codes and Device Coding

Prior Authorization, Documentation, and Operational Requirements

Background and Evidence Summary

Definitions and Key Terms