CurrentKaiser PermanentePolicy N/A

Yttrium-90 (90Y) microsphere radioembolization (TheraSphere and SIR-Spheres) — Clinical Review Criteria

Clinical review criteria governing medical necessity and authorization for Yttrium-90 microsphere radioembolization (TheraSphere and SIR-Spheres) for unresectable primary and metastatic liver tumors for Kaiser Foundation Health Plan of Washington members and providers.

Policy Summary

PayerKaiser Permanente

PolicyYttrium-90 (90Y) microsphere radioembolization (TheraSphere and SIR-Spheres) — Clinical Review Criteria

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateN/A

Key ActionAuthorization is required and listed procedure and diagnosis codes are considered medically necessary only when the policy criteria are met; provide last 6 months of clinical notes from the requesting provider or specialist.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Unresectable HCC, CRC mets, select NETPrimary indications

C2616, Q3001, S2095, 37243, 75894Key codes

Insufficient RCT evidence for TheraSphereEvidence note

11/13/2023Last review

Coverage Criteria for Yttrium-90 Radioembolization

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Medically Necessary Indications - Yttrium-90 (90Y) microsphere radioembolization (SIR-Spheres or TheraSphere)

Covered when ALL of the following are met:

Indications considered medically necessary

A. Unresectable metastatic colorectal cancer (CRC): Unresectable metastatic liver tumors from primary colorectal cancer (CRC).
B. Unresectable neuroendocrine (islet cell) tumors: Islet cell (pancreatic endocrine) tumor with diffuse disease that is symptomatic; AND the patient has failed systemic therapy with octreotide to control carcinoid syndrome (e.g., debilitating flushing, wheezing, and diarrhea).
C. Unresectable primary hepatocellular carcinoma (HCC): Unresectable primary hepatocellular carcinoma (HCC).

Yttrium-90 (90Y) microsphere radioembolization (including SIR-Spheres and TheraSphere) is not covered for any indication other than those specifically listed in this policy because its clinical utility for other uses has not been established. Providers must refer to the defined medically necessary indications when requesting authorization; requests for indications outside those listed will be denied. Documentation including the last 6 months of clinical notes from the requesting provider and/or specialist must be provided with requests for covered indications.

Published evidence for TheraSphere and SIR-Spheres in unresectable hepatocellular carcinoma and metastatic liver disease is limited. Specifically, TheraSphere evidence was judged insufficient due to predominance of animal studies and small case series without randomized controlled trials, and SIR-Spheres data are similarly restricted to small or biased trials; available meta-analyses and a single larger randomized trial were considered but did not establish robust efficacy across indications. Overall, the literature does not meet Kaiser Permanente Medical Technology Assessment criteria to support broader use beyond the specified indications in this policy.

Applicable Billing and Procedure Codes

Considered Medically Necessary / Applicable CodesmixedCovered

C2616	Brachytherapy source, nonstranded, yttrium-90, per source
Q3001	Radioelements for brachytherapy, any type, each
S2095	Transcatheter occlusion or embolization for tumor destruction, percutaneous, any method, using yttrium-90 microspheres
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
C22.0	Liver cell carcinoma
C22.1	Intrahepatic bile duct carcinoma
C22.3	Angiosarcoma of liver
C22.4	Other sarcomas of liver
C22.7	Other specified carcinomas of liver

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Authorization, Documentation, and Limits

Prior Authorization

Prior Authorization Required and Coverage Limits

Prior authorization is required. Coverage is limited to the specific indications listed in this policy (e.g., unresectable metastatic liver tumors from primary colorectal cancer, unresectable primary hepatocellular carcinoma, and symptomatic diffuse islet cell/neuroendocrine tumors that have failed prior systemic therapy). Yttrium-90 (90Y) microsphere radioembolization is not covered for indications other than those explicitly listed because clinical utility for other uses has not been established.

Coverage limited to listed indications (examples): unresectable metastatic liver tumors from primary colorectal cancer; unresectable primary hepatocellular carcinoma (HCC); islet cell/pancreatic endocrine tumors that are diffuse and symptomatic and have failed prior systemic therapy with octreotide.
Yttrium-90 (90Y) microsphere radioembolization is not covered for other indications.
Last 6 months of clinical notes from the requesting provider and/or specialist must be submitted with the request.

Documentation Required

Clinical Documentation Requirement

Requests must include the last 6 months of clinical notes from the requesting provider and/or specialist documenting the diagnosis, prior treatments (including trial and failure of systemic therapy where required), symptoms (for example, carcinoid syndrome manifestations), and objective evidence supporting that the case meets the policy indications.

Include documentation of diffuse disease when required (defined as tumor tissue spread throughout the affected organ, e.g., diffuse liver disease).
For islet cell/neuroendocrine tumors, document failure of systemic therapy with octreotide to control carcinoid syndrome (e.g., persistent debilitating flushing, wheezing, diarrhea).

Background and Context

Hepatocellular carcinoma (HCC) and hepatic metastases frequently present in patients who are not candidates for curative surgical resection or transplantation. Yttrium-90 (90Y) intra-arterial radioembolization is a catheter-delivered, minimally invasive approach that exploits the preferential arterial blood supply of liver tumors to deliver localized beta radiation via microspheres, aiming to maximize tumor dose while sparing normal liver parenchyma. This technique may be used to treat unresectable primary HCC, unresectable metastatic colorectal liver tumors, and select symptomatic, diffuse neuroendocrine (islet cell) tumors after failure of systemic octreotide therapy. The procedure carries potential risks, including post-radioembolization syndrome, radiation-induced liver toxicity, radiation pneumonitis from hepatopulmonary shunting, gastrointestinal ulceration, and vascular injury, and therefore should be used only for indications meeting the policy’s criteria.