ModifiedUnitedHealthcarePolicy CSO6OLAL

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

Policy governs use of yttrium-90 microsphere TARE/SIRT for malignant liver tumors for UnitedHealthcare Community Plan members in the State of Louisiana, specifying indications judged medically necessary and those considered unproven/not medically necessary.

Policy Summary

PayerUnitedHealthcare

PolicyTransarterial Radioembolization (TARE)/ SIRT for Malignant Cancers of the Liver (Louisiana only)

Policy CodePolicy CSO6OLAL

Change TypeMaterial revisions: title/scope and ECOG eligibility added

Effective DateNov 1, 2024

Next Review Date

Key ActionObtain prior authorization and document the covered indication and ECOG performance status (0–2) when requesting TARE/SIRT.

SourceLink

POLICY UPDATE CHANGES

Title changed from 'Implantable Beta-Emitting Microspheres for Treatment of Malignant Tumors (for Louisiana Only)' to reflect SIRT yttrium-90 microspheres.

Coverage rationale added: SIRT using yttrium-90 microspheres is proven and medically necessary for listed indications in individuals with ECOG performance status 0, 1, or 2; unproven and not medically necessary for other indications.

Definition of 'Transarterial Radioembolization (TARE)' added.

CPT code 75894 added to applicable codes.

Supporting Information sections (Description of Services, Clinical Evidence; FDA, and References) updated to reflect current information.

5 listedProven indications

0-2ECOG requirement

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CSOGOLA.KPrevious version

88%Pooled DCR (NELM)

Coverage Criteria for TARE / SIRT (Yttrium-90 Microspheres)

General eligibility (ECOG) for proven indications

Covered when ALL of the following are met for listed indications:

ALL of the following

Individual has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
Indication is one of the following proven, guideline-supported uses: - Primary hepatocellular carcinoma (HCC) as a bridge to liver transplantation; - Primary HCC that is unresectable and limited to the liver; - Unresectable intrahepatic cholangiocarcinoma (ICC); - Unresectable liver metastases from colorectal carcinoma in individuals with limited extra-hepatic disease who are refractory to or have relapsed following systemic chemotherapy; - Unresectable liver metastases from neuroendocrine tumors when systemic therapy has failed to control symptoms.
Treatment is planned and delivered by a multidisciplinary team experienced in SIRT/TARE including interventional radiology and relevant specialties (e.g., hepatology, medical oncology, radiation oncology, nuclear medicine, medical physics).
Pre-treatment evaluation including mapping angiography and technetium-99m macroaggregated albumin (99mTc-MAA) perfusion study demonstrates acceptable hepatopulmonary shunt fraction and absence of uncorrectable nontarget deposition to gastrointestinal organs.
No absolute contraindication is present (for example: inability to catheterize the hepatic artery, fulminant liver failure, active hepatic infection, pregnancy unless extraordinary circumstances and multidisciplinary consultation).
No relative contraindication that would preclude benefit-risk balance, such as excessive tumor burden replacing >50%–70% of hepatic parenchyma or severe hepatic impairment (e.g., nonobstructive total bilirubin >2 mg/dL), unless selective segmental/subsegmental infusion can be performed and synthetic hepatic function is preserved as documented.
Patient has life expectancy of at least 3 months and goals of care and alternatives (including other locoregional therapies and systemic therapy) have been documented.
For bridge to transplant or downstaging, documentation supports intent (bridging vs downstaging) and transplant center criteria are addressed; multidisciplinary documentation of expected benefit relative to other locoregional options is provided.

Operational notes

Segmental or selective delivery is preferred whenever feasible to limit hepatic toxicity.
Caution advised when combining TARE with systemic therapies that may potentiate hepatotoxicity; documentation should include timing and rationale.
Prior authorization and documentation must include ECOG status, imaging demonstrating liver-limited disease (or limited extrahepatic disease when applicable), mapping study results, and multidisciplinary plan of care.

Applicable Procedure and Clinical Codes

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.

Applicable CPT CodesCPT

75894

Transcatheter therapy, embolization, any method, radiological supervision and interpretation.

inv-23: ECOG Performance Status — 0-2

ECOG range0–2

Definition sourceStandard ECOG performance status scale (0 = fully active; 5 = dead)

Policy applicationRequired for covered indications of TARE/SIRT per coverage rationale

inv-24: Total bilirubin — > 2 mg/dL

Threshold> 2 mg/dL (total bilirubin, nonobstructive)

Clinical implicationIndicates severe liver function impairment; may be a relative contraindication to TARE unless segmental/subsegmental infusion feasible

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for transarterial radioembolization (TARE) / selective internal radiation therapy (SIRT) procedures (including Y-90 microsphere treatments). Prior authorization requests must document that the proposed procedure is for one of the covered indications listed in the policy, and must include the clinical information described below.

Prior authorization applies to procedures billed with applicable codes (see Applicable Codes section; CPT 75894 and others may be used).
Requests for indications not listed as proven and medically necessary in this policy are considered unproven and not medically necessary and are likely to be denied.

Prior Authorization

Prior Authorization — Confirm Contraindications, Life Expectancy, and Multidisciplinary Care

Prior authorization review must confirm absence of absolute contraindications, estimate life expectancy (generally ≥ 3 months expected survival), and document multidisciplinary evaluation. Multidisciplinary expertise should include interventional radiology plus appropriate specialists (e.g., radiation oncology, nuclear medicine/medical physics, hepatology/gastroenterology, medical oncology, surgical oncology, radiation safety).

Regimens, Devices, and Comparative Considerations

Regimen	Evidence summary	Guideline / policy position	Status
TARE + systemic chemotherapy (e.g., FOLFOX)
Randomized trials show improved liver-specific PFS and higher hepatic ORR when SIRT/TARE is added to chemotherapy (FOXFIRE/SIRFLOX/FOXFIRE-global and SIRFLOX analyses: improved liver PFS but no OS benefit; Mulcahy phase 3 adding TARE to second-line chemotherapy showed longer PFS and hepatic PFS but similar OS).
Guideline recommendations vary: NCCN notes TARE as an option in selected, chemotherapy-resistant/refractory colorectal liver metastases; ASCO does not recommend routine addition to first-line chemotherapy. Policy expects prior systemic therapy (refractory or relapsed) for mCRC before TARE in many cases.
mixed

Device comparison	Observed safety differences	Implications for device selection	Status
Glass microspheres (TheraSphere) vs resin microspheres (SIR-Spheres)
Systematic review of observational studies (Kallini et al. 2017) reported that resin microspheres were associated with higher rates of gastrointestinal and hepatobiliary adverse events (eg, gastric ulcers, hepatic encephalopathy, cholecystitis, hepatic failure, pleural effusion) and more grade ≥3 hepatobiliary AEs; glass microspheres had fewer GI and pulmonary AEs though some grade ≥3 ascites and nausea were more frequent with glass in selected reports.
Device-specific AE profiles should inform clinical selection (center experience, patient anatomy, and risks of GI/hepatobiliary/pulmonary toxicity may favor glass in some patients), consistent with literature noting safety differences between TheraSphere (glass) and SIR-Spheres (resin).
neutral

Regimen	Study details / outcomes	Interpretation / limitations	Status
SIRT with resin Y-90 followed by gemcitabine and cisplatin (Chan et al. 2022 phase 2)
Phase 2 single-arm trial administered resin Y-90 at ~120 Gy followed by gemcitabine and cisplatin (31 participants enrolled). Median OS was 13.6 months overall; in 16 participants who received chemotherapy after SIRT median OS was 21.6 months and median PFS was 9.0 months; response rate 25% and DCR 75%. Grade ≥3 treatment-related AEs occurred in <10%.
Findings indicate feasibility and signal of activity for unresectable intrahepatic cholangiocarcinoma in sequence with chemotherapy, but limited by single-arm design, small sample size, and need for randomized comparisons to define benefit and optimal sequencing.
covered

Approach	Scope / indications	Guidance	Status
TARE with Y-90 microspheres (resin or glass) per institutional protocols
May be applied for select hepatocellular carcinoma presentations and metastatic liver disease scenarios where ACR appropriateness criteria consider TARE appropriate (eg, solitary small cirrhotic tumors, selected ICC subsets, solitary colorectal liver metastasis, multifocal NETLM).
ACR 2022 appropriateness criteria list multiple scenarios where TARE may be appropriate; policy supports use per institutional protocols and multidisciplinary assessment for these select indications.
covered

Device	FDA-labelled indication (summary)	Clinical selection notes	Status
TheraSphere (glass Y-90 microspheres)
Approved under Humanitarian Device Exemption / PMA for treatment of unresectable hepatocellular carcinoma for solitary tumors 1–8 cm, Child-Pugh A, no macrovascular invasion, good performance status; PMA updated March 17, 2021 for local tumor control in solitary tumors meeting criteria.
Selection per FDA label emphasizes solitary HCC 1–8 cm, well-compensated liver function, and good performance status; center experience and patient-specific anatomy guide use.
neutral

Definitions and Key Terms

inv-47: ECOG Performance Status — Standard ECOG performance status scale ranging from 0 (fully active) to 5 (dead).

Scale descriptionECOG performance status ranges 0 (fully active) to 5 (dead)

Examples0 = fully active; 2 = ambulatory and capable of self-care but unable to work; 5 = dead

Use in policyReferenced as the standard performance status measure for eligibility and documentation

inv-48: Limited Extra-Hepatic Disease — Metastases limited to lung with <5 nodules with < ? cm diameter or a single nodule <1.7 cm and/or single lymph node involvement <2 cm (per policy definitions).

DefinitionMetastases limited to lung with <5 nodules or a single nodule <1.7 cm and/or single lymph node involvement <2 cm (per Wasan et al., 2017)

Context

Positioning by Line of Therapy

first-line | second-line | salvage

Line-of-therapy considerations:

mCRC line of therapy notes: For metastatic colorectal cancer with liver-dominant disease, TARE has been used in first-, second-, and later-line settings; coverage is focused on individuals who are refractory to or relapsed following systemic chemotherapy and have limited extra-hepatic disease

Prospective registries and randomized trials report use across lines with mixed survival benefits.

first-line | second-line

Line-of-therapy positioning for HCC and NETLM:

HCC/NETLM positioning: TARE may be used as an alternative intra-arterial therapy for intermediate-stage HCC and as a hepatic regional option for symptomatic or liver-dominant NET metastases after multidisciplinary consideration

Guideline sources (AASLD, NCCN, ACR) list TARE among regional therapies.

Background and Evidence Context

TARE, also called selective internal radiation therapy (SIRT), delivers yttrium-90 microspheres by hepatic arterial administration to provide high‑dose, localized radiation to liver tumors while sparing normal liver. Surgical resection remains the preferred curative option for liver tumors; TARE is an option for unresectable disease or as a bridge to transplantation in appropriately selected patients with multidisciplinary evaluation.

COVERAGE CRITERIA (informational notes overlapping background)

Additional coverage-context notes (informational):

Documentation and authorization: Prior authorization is expected for listed procedure codes; documentation should confirm the covered indication, ECOG 0–2, prior systemic therapy status where relevant, mapping angiography/99mTc-MAA results (including lung shunt fraction), hepatic function and tumor burden assessments, and multidisciplinary evaluation

See policy coding and prior authorization sections for required codes and documentation.

Policy Revision History

2024-11-01Title and scope updateLatest

Title changed from 'Implantable Beta-Emitting Microspheres for Treatment of Malignant Tumors (for Louisiana Only)' to reflect SIRT yttrium-90 microspheres and broadened scope; previous policy version CSOGOLA.K archived.

2024-11-01Clinical criteria added

Coverage rationale updated to specify SIRT (yttrium-90 microspheres) is proven and medically necessary for listed indications in individuals with ECOG performance status 0, 1, or 2.

2024-11-01Coding update

Policy Summary

PayerUnitedHealthcare

PolicyTransarterial Radioembolization (TARE)/ SIRT for Malignant Cancers of the Liver (Louisiana only)

Policy CodePolicy CSO6OLAL

Change TypeMaterial revisions: title/scope and ECOG eligibility added

Effective DateNov 1, 2024

Next Review Date

Key ActionObtain prior authorization and document the covered indication and ECOG performance status (0–2) when requesting TARE/SIRT.

SourceLink

On This Page

Policy contextListed under relative contraindications that may lead to withholding treatment

inv-25: Hepatic tumor burden — > 50-70% parenchymal replacement

Threshold> 50–70% liver parenchymal replacement by tumor

Clinical implicationExcessive hepatic tumor burden is a relative contraindication; treatment may be considered if synthetic hepatic function preserved or segmental approach feasible

Policy noteExcessive tumor burden may lead to treatment being withheld due to unfavorable risk–benefit

Confirm life expectancy ≥ 3 months unless extraordinary circumstances with multidisciplinary justification.
Document that multidisciplinary team review occurred and names/specialties of participants.
If mapping angiography/99mTc-MAA demonstrates uncorrectable nontarget deposition or unacceptable lung shunt fraction per device-specific limits, treatment is contraindicated.

Prior Authorization

Prior Authorization for Y-90 by Indication

Prior authorization must identify the specific Y-90 indication being requested and show that patient selection meets the covered-indication criteria (e.g., bridge to transplant for HCC, unresectable HCC limited to the liver, unresectable intrahepatic cholangiocarcinoma, unresectable neuroendocrine liver metastases after failed systemic therapy, or colorectal liver metastases refractory to or relapsed following systemic chemotherapy with limited extrahepatic disease).

Specify which covered indication is being treated and reference prior systemic therapy where required (for mCRC, document refractory/relapsed status to systemic chemotherapy).
If used for downstaging or bridge to transplant, include transplant program intent and waitlist context.

Note

Device Approvals (Informational)

Device approvals for commercial Y-90 microspheres are informational and do not by themselves determine coverage. The FDA has approved SIR-Spheres (resin) and TheraSphere (glass) with labeled indications as summarized in the policy.

SIR-Spheres (Sirtex Medical) — PMA approval for treatment of unresectable metastatic colorectal liver tumors in conjunction with intra-hepatic artery chemotherapy (FUDR) (historical PMA P990065).
TheraSphere (Boston Scientific / BTG) — Humanitarian Device Exemption and PMA approvals for specific HCC indications (solitary tumors 1–8 cm, Child-Pugh A, no macrovascular invasion) — informational only.

Denial Risk

Denial Triggers — Non‑listed Indications or ECOG > 2

Denials may be issued when the request does not meet the policy’s covered indications or patient eligibility thresholds. Patients with ECOG performance status greater than 2 are generally considered not candidates for TARE/SIRT under this policy and may be denied.

Procedures for indications not listed as proven and medically necessary in this policy are considered unproven and not medically necessary and are likely to be denied.
ECOG > 2 is a denial trigger unless exceptional multidisciplinary justification is provided.

Prior Authorization

Selection Limits for Local Liver‑Directed Therapy

Local liver‑directed therapy (including TARE) should be proposed only in carefully selected patients. Selection limits emphasize good performance status, limited liver involvement, and absence of extrahepatic disease that determines prognosis; adequate systemic therapy should have been given and shown disease control when applicable.

Local therapy is appropriate only in selected cases: good PS (ECOG 0–2), limited hepatic tumor burden, and no extrahepatic disease adversely affecting prognosis.
Guidelines position TARE as one of several hepatic regional therapies (embolization, chemoembolization, RE); no single modality is universally preferred.
Require documentation of prior systemic therapy when applicable (e.g., metastatic colorectal cancer, neuroendocrine tumors where systemic therapy failed).

Documentation Required

Typical Study Inclusion and Follow‑Up Documentation

Clinical documentation submitted with prior authorization should mirror typical study inclusion and follow-up protocols: confirm histology or imaging‑proven hepatic metastases/primary tumor, ECOG performance status (0–2), pre‑treatment labs, and planned post‑treatment surveillance.

Include baseline imaging (contrast CT or MRI) documenting hepatic disease extent and absence/presence of extrahepatic disease.
Provide baseline labs including bilirubin, liver synthetic function, and other relevant tests; document prior liver radiation if any.
Include mapping angiography/99mTc‑MAA results with lung shunt fraction, documentation of catheterization feasibility, and proposed dosimetry/plan.
Describe planned follow‑up imaging (CT/MRI/PET) and laboratory monitoring schedule (e.g., frequent blood tests in first months, imaging at ~3 months and then per standard surveillance).

Note

Plan‑Specific Authority and Use of Decision‑Support Tools

Before applying this policy, verify federal, state, or contractual plan terms; in the event of conflict those terms govern. UnitedHealthcare may also use third‑party decision‑support tools (e.g., InterQual) to assist in administering benefits.

Check plan-specific benefits, medical necessity definitions, and any state mandates prior to approval.
UnitedHealthcare may require use of decision‑support criteria or additional documentation per plan rules.

Denial Risk

Contraindications and Clinical Cautions (Denial Risk)

Absolute and relative contraindications that would trigger denial or require caution should be confirmed during prior authorization review. Examples include inability to catheterize the hepatic artery, uncorrectable nontarget deposition on mapping angiography/MAA, fulminant liver failure, excessive hepatic tumor burden, elevated nonobstructive bilirubin, active hepatic infection, and significant prior liver radiation.

Absolute contraindications: inability to catheterize the hepatic artery; uncorrectable nontarget gastrointestinal deposition on mapping angiography/MAA; fulminant liver failure; unacceptable lung shunt fraction per device limits; active hepatic infection.
Relative contraindications that may preclude therapy: >50–70% hepatic parenchymal replacement by tumor (unless synthetic function preserved), total bilirubin > 2 mg/dL (nonobstructive), prior significant liver radiation, or concurrent systemic therapies that markedly increase risk.

Used to define limited extra-hepatic disease in selection for colorectal liver metastases candidates

DocumentationRequired when applying coverage criteria for liver-dominant metastatic disease

inv-49: Refractory — Cancer that does not respond to treatment or becomes resistant during treatment.

DefinitionCancer that does not respond to treatment or becomes resistant during treatment

SynonymAlso called resistant cancer (NCI, 2021)

Policy relevanceReferenced for indications requiring prior systemic therapy failure (eg, refractory colorectal liver metastases)

inv-50: Transarterial Radioembolization (TARE)/SIRT — Intra-arterial therapy using radioactive yttrium-90 microspheres delivered via hepatic arteries (also called radioembolization or SIRT).

DefinitionIntra-arterial therapy delivering yttrium-90 radioactive microspheres via hepatic arteries (also called radioembolization or SIRT)

Alternate nameSelective Internal Radiation Therapy (SIRT)

MechanismDelivers high-dose localized radiation to liver tumors while sparing adjacent normal liver

inv-51: ORR — Objective response rate (ORR) — defined in referenced studies as complete or partial response.

DefinitionObjective response rate (ORR) = complete response or partial response as defined in referenced studies

UseReported in trial and observational outcomes for neuroendocrine and other liver metastases

Policy noteORR used alongside DCR and survival endpoints in evidence summaries

inv-52: DCR — Disease control rate (DCR) — defined as complete response, partial response, or stable disease.

DefinitionDisease control rate (DCR) = complete response, partial response, or stable disease

Evidence examplesPooled DCR for neuroendocrine liver metastases reported as 88% (27-study meta-analysis)

Policy useDCR cited in effectiveness summaries and meta-analyses informing coverage considerations

inv-53: Arterially directed therapies — Includes bland TAE, TACE (including DEB-TACE), and radioembolization (RE/TARE/SIRT) with yttrium-90 microspheres as per NCCN guidance.

Included therapiesBland TAE, TACE (including DEB-TACE), and radioembolization (RE/TARE/SIRT) with yttrium-90 microspheres

Guideline sourceCategorized as 'arterially directed therapies' in NCCN HCC guidance

Policy relevanceTARE is positioned among these options when selecting hepatic regional therapy

inv-54: SIR-Spheres — Resin Y-90 microspheres indicated (per FDA PMA) for unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intent in trials.

DeviceSIR-Spheres (resin Y-90 microspheres)

FDA indicationIndicated for unresectable metastatic liver tumors from primary colorectal cancer with adjuvant intra-hepatic artery chemotherapy (floxuridine) per PMA

Regulatory notePMA P990065 with supplemental approvals; informational only for policy coverage

inv-55: TheraSphere — Glass Y-90 microspheres approved under HDE/PMA for treatment of unresectable hepatocellular carcinoma with specific patient selection criteria noted.

DeviceTheraSphere (glass Y-90 microspheres)

FDA indicationApproved under HDE/PMA for unresectable hepatocellular carcinoma with selection criteria (solitary tumors 1–8 cm, Child-Pugh A, no macrovascular invasion, good performance status)

Regulatory noteApproval and Humanitarian Device Exemption details provided for informational use

inv-56: TARE — Transarterial Radioembolization (TARE)

TermTARE — Transarterial Radioembolization (synonymous with SIRT)

DescriptionDelivery of yttrium-90 microspheres via hepatic arterial administration to target liver tumors

Alternate nameSelective Internal Radiation Therapy (SIRT)

first-line | second-line | salvage

Line-of-therapy in ICC series:

First-, second-, salvage-line: In multicenter retrospective ICC series, RE/TARE has been used as first-, second-, and salvage-line therapy with no consistent overall survival differences across lines in that cohort

Schaarschmidt et al. 2023 reports distribution and outcomes across lines.

first-line | second-line

Line-of-therapy in uveal melanoma and small prospective series:

First or second line in trials: Radioembolization has been used as first- or second-line liver-directed therapy in small prospective trials for uveal melanoma hepatic metastases with acceptable safety

Gonsalves 2019 phase II and supporting systematic reviews.

CPT code 75894 was added to the applicable procedure codes for TARE/SIRT.

2024-11-01Definitions updated

Definition of 'Transarterial Radioembolization (TARE)' was added to the policy definitions.

2024-11-01Supporting information revised

Supporting sections (Description of Services, Clinical Evidence; FDA, and References) were updated to reflect current information.