CurrentEmblemHealthPolicy N/A

Vyloy (zolbetuximab-clzb) — coverage criteria for CLDN18.2-positive gastric/GEJ adenocarcinoma

Defines indications, coverage criteria, coding, exclusions, and prior authorization expectations for Vyloy (zolbetuximab-clzb) in adults with CLDN18.2-positive, HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma for Evolent/EmblemHealth lines of business.

Policy Summary

PayerEmblemHealth

PolicyVyloy (zolbetuximab-clzb) — coverage criteria for CLDN18.2-positive gastric/GEJ adenocarcinoma

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrior authorization is required and must document CLDN18.2 positivity by an FDA-approved test, HER2-negative status, and intended first-line chemotherapy regimen.

SourceLink

J1326HCPCS code listed

First-lineLine of therapy

CLDN18.2+Biomarker required

HER2-HER2 status

≤800 mg/m2Dose limit

Coverage Criteria for Vyloy (zolbetuximab-clzb)

Initial therapy — Vyloy in combination with chemotherapy

Covered when ALL of the following are met:

First-line combination indication: Member is an adult with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma and treatment is first-line in combination with fluoropyrimidine- and platinum-containing chemotherapy.

HER2 status: Tumor is HER2-negative.

CLDN18.2 biomarker: Tumor is CLDN18.2 positive as determined by an FDA-approved test.

Coverage is excluded when any of the following apply: disease progression while taking Vyloy (zolbetuximab-clzb); the member’s tumor is CLDN18.2‑negative; a requested dosing schedule would exceed a single dose of 800 mg/m2; or the requested use is investigational or an off‑label indication that lacks sufficient supporting evidence as defined by CMS‑recognized compendia or acceptable peer‑reviewed literature.

Policy Summary

PayerEmblemHealth

PolicyVyloy (zolbetuximab-clzb) — coverage criteria for CLDN18.2-positive gastric/GEJ adenocarcinoma

Policy CodePolicy N/A

Change TypeNo material change

Effective Date

Next Review Date

Key ActionPrior authorization is required and must document CLDN18.2 positivity by an FDA-approved test, HER2-negative status, and intended first-line chemotherapy regimen.

SourceLink

On This Page

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Requests for Vyloy for indications that are investigational or off‑label will be denied when the clinical evidence is insufficient by the policy’s criteria. The policy specifically directs that uses for members with CLDN18.2‑negative tumors are not approvable and may be considered not medically necessary. The policy defines insufficient evidence as lacking adequate representation of the patient or regimen in published studies, not demonstrating clinically meaningful outcomes (for example, an OS or PFS benefit of at least 3 months or hazard ratio < 0.80), or relying solely on uncontrolled case reports or abstracts without full peer‑reviewed articles.

Regimens Covered with Vyloy

Regimen	Indication	Coverage status
Vyloy (zolbetuximab-clzb) + fluoropyrimidine + platinum	First-line treatment of adults with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma that is HER2-negative and CLDN18.2-positive as determined by an FDA-approved test.	Covered with criteria

Coding and Dosing Limits

Covered HCPCS CodesHCPCSCovered

J1326

Injection, zolbetuximab-clzb, 2 mg

Single dose maximum — dosing limit <= 800 mg/m2

Single dose maximumDosing exceeds single dose limit of 800 mg/m2 (requests exceeding this limit are excluded).

ApplicationApplies to administration of Vyloy (zolbetuximab-clzb) as described in exclusions — doses >800 mg/m2 are not approvable.

Policy consequenceRequests where a single dose exceeds 800 mg/m2 are subject to denial per exclusion criteria.

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for Vyloy (zolbetuximab-clzb). Requests must document the indication, CLDN18.2 positivity confirmed by an FDA‑approved test, HER2‑negative tumor status, and the full proposed regimen including combination with fluoropyrimidine- and platinum-containing chemotherapy when for first-line gastric/GEJ adenocarcinoma.

Prior authorization required for Vyloy
Request must cite: indication, CLDN18.2 positivity by FDA‑approved test, HER2‑negative status, and regimen details

Documentation Required

Continuation / Renewal Conditions

Continuation (renewal) requests are permitted only if the member has not experienced disease progression on Vyloy, the therapy was used within the last year without a lapse >30 days from active authorization, and no additional medications are being added to the continuation request.

Exemption: continuation allowed when no disease progression on Vyloy
Exemption: prior authorization active within past year with ≤30 day lapse
Exemption: no new medications added to continuation request

Documentation Required

Required Clinical Documentation

Supporting documentation must demonstrate: CLDN18.2 positivity by an FDA‑approved test, HER2‑negative gastric or gastroesophageal junction adenocarcinoma diagnosis when applicable, and use of Vyloy in combination with fluoropyrimidine- and platinum-containing chemotherapy for first‑line treatment. Include pathology/test reports, treatment regimen details (agents, doses, schedule), and prior therapy history.

Document CLDN18.2 positivity by FDA‑approved test
Document HER2‑negative status and diagnosis (gastric/GEJ adenocarcinoma when applicable)
Document combination chemotherapy regimen (agents, doses, schedule) and prior treatment history

Denial Risk

Triggers for Denial

Denials may be issued when exclusion criteria are met: tumor is CLDN18.2 negative; disease progression occurred while on Vyloy; dosing exceeds a single dose of 800 mg/m2; or use is investigational/off‑label without sufficient supporting evidence (not supported by FDA labeling, CMS‑recognized compendia, NCCN/ASCO guidelines, or adequate peer‑reviewed literature). Insufficient evidence includes inadequate representation of the patient/cancer population, inappropriate or unrepresented concomitant regimens, lack of clinically meaningful outcomes, poor study design, reliance on case reports or abstracts without full peer‑reviewed publication.

Denial trigger: CLDN18.2 negative tumor
Denial trigger: disease progression on Vyloy
Denial trigger: single dose > 800 mg/m2
Denial trigger: investigational or off‑label use without sufficient evidence (not supported by FDA label, CMS compendia, NCCN/ASCO, or adequate peer‑reviewed literature)
Examples of insufficient evidence: inadequate patient/cancer representation, regimen mismatch, lack of clinically meaningful outcomes (e.g., OS/PFS benefit), poor study design, reliance on case reports or abstracts

Line of Therapy Indication

first-line

Line of therapy: First-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy for locally advanced unresectable or metastatic disease.

Biomarker Requirements for Coverage

CLDN18.2 — Positive as determined by an FDA-approved test

Biomarker requirementTumor must be CLDN18.2 positive as determined by an FDA-approved test.

ContextRequired for first-line use of Vyloy in combination with fluoropyrimidine- and platinum-containing chemotherapy for gastric/GEJ adenocarcinoma.

DocumentationPrior authorization requests must document CLDN18.2 positivity by an FDA-approved test.

HER2 — Negative

HER2 status requiredTumor must be HER2-negative for covered use of Vyloy in gastric/GEJ adenocarcinoma.

Line of therapyHER2-negative status is part of the eligibility for first-line combination therapy with Vyloy.

DocumentationPrior authorization should include documentation of HER2-negative tumor status.

Definitions

CLDN18.2 positive as determined by an FDA-approved test — definition/key assertion

DefinitionCLDN18.2 positive means the member's tumor is claudin (CLDN) 18.2 positive as determined by an FDA-approved test.

ScopeRequired for coverage of Vyloy in combination with fluoropyrimidine- and platinum-containing chemotherapy for gastric/GEJ adenocarcinoma.

Evidence basisUse must be supported by FDA labeling, CMS-recognized compendia, NCCN, ASCO guidelines, or acceptable peer-reviewed literature.

Background

Vyloy (zolbetuximab‑clzb) is indicated in combination with fluoropyrimidine‑ and platinum‑containing chemotherapy for adults with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2‑positive and HER2‑negative. This policy frames coverage around that first‑line combination indication and requires biomarker and HER2 status documentation, appropriate regimen selection, and prior authorization per the plan’s requirements.