CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Vyloy (zolbetuximab-clzb) — coverage criteria for CLDN18.2‑positive, HER2‑negative gastric/GEJ adenocarcinoma

Clinical guideline governing prior authorization and coverage criteria for Vyloy (zolbetuximab-clzb) in treating adults with CLDN18.2-positive, HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma; applies to providers submitting medication requests to Evolent for Neighborhood Health Plan of Rhode Island members.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyVyloy (zolbetuximab-clzb) — coverage criteria for CLDN18.2‑positive, HER2‑negative gastric/GEJ adenocarcinoma

Policy CodePolicy N/A

Change TypeNo material clinical or coverage changes

Effective DateN/A

Next Review DateN/A

Key ActionObtain prior authorization with documentation of CLDN18.2 positivity by an FDA‑approved test and HER2‑negative status for first‑line combination therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

J1326HCPCS

first-lineLine

800 mg/m2Single dose max

CLDN18.2+Biomarker

HER2‑negative

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Coverage Criteria for Vyloy (zolbetuximab-clzb)

Initial therapy (first-line) coverage

Covered when ALL of the following are met

Eligibility for Vyloy first-line therapy: 1) Adult member with locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma; 2) Tumor is CLDN18.2 positive as determined by an FDA-approved test; 3) Tumor is HER2-negative; 4) Plan to use Vyloy (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy as first-line treatment; 5) Use is supported by FDA-approved product labeling, CMS-recognized compendia, NCCN/ASCO guidelines, or acceptable peer-reviewed literature.

Per policy indication and documentation requirements.

Regimen	Indication	Line of therapy	Coverage status
Vyloy (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy	CLDN18.2-positive, HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma	First-line	Covered when criteria met

Coverage excludes use of Vyloy (zolbetuximab-clzb) in the following situations: disease progression occurred while the member was taking Vyloy; the member’s tumor is CLDN18.2-negative; or dosing for a single administration would exceed 800 mg/m2. Additionally, requests will be excluded when Vyloy is prescribed for an off‑label or investigational indication that lacks sufficient supporting evidence as defined by CMS‑recognized compendia or acceptable peer‑reviewed literature.

Requests for Vyloy for investigational or off‑label indications are considered not approvable unless the use is supported by adequate evidence. Adequate evidence is defined by reference to CMS‑recognized compendia or acceptable peer‑reviewed literature and is evaluated on factors including whether the patient and cancer characteristics are represented in the published evidence, whether the administered regimen is represented, whether reported outcomes are clinically meaningful (for example ASCO‑recommended thresholds such as hazard ratio < 0.80 or at least a 3‑month benefit in OS or PFS), and whether the study design is appropriate. Case reports and meeting abstracts without full peer‑reviewed publication generally do not provide sufficient evidence.

Billing and Coding

Covered HCPCS CodesHCPCSCovered

J1326

Injection, zolbetuximab-clzb, 2 mg

Single dose limit — maximum single dose

Maximum single dose800 mg/m2

Threshold typeSingle dose limit

Policy action on exceedanceRequests exceeding single dose limit are excluded (denied)

Provider Actions and Authorization

Prior Authorization

Prior authorization required: indication, CLDN18.2 and HER2 status, regimen

Prior authorization is required for Vyloy (zolbetuximab-clzb). Requests must document the indication for use, confirm the tumor is CLDN18.2 positive as determined by an FDA‑approved test, document that the tumor is HER2‑negative, and indicate use in combination with fluoropyrimidine‑ and platinum‑containing chemotherapy in the first‑line setting.

Include HCPCS code J1326 for zolbetuximab-clzb where applicable.

Step Therapy

Renewal exemption when no progression and recent use

Continuation (renewal) requests may be exempt from re‑review if the member has not experienced disease progression on Vyloy, the medication was used within the last year without a lapse of more than 30 days of active authorization, and no additional medications are being added to the request.

Biomarker and Tumor Status Requirements

CLDN18.2 — positivity requirement

Biomarker requiredCLDN18.2 positive

Test requirementPositive as determined by an FDA-approved test

Context of requirementRequired for coverage of Vyloy in first-line gastric/GEJ adenocarcinoma

HER2 — requirement

HER2 status requiredHER2-negative

Clinical contextRequired for Vyloy use in first-line gastric/GEJ adenocarcinoma

Definition source

Line of Therapy Specification

first-line

First-line use: Use in combination with fluoropyrimidine- and platinum-containing chemotherapy for untreated locally advanced unresectable or metastatic disease.

Policy specifies first-line setting per indication.

Definitions

CLDN18.2-positive definition

DefinitionTumors that test positive for claudin 18.2 by an FDA-approved assay

Role in coverageCLDN18.2-positive status is required for Vyloy coverage

Determination methodMust be by an FDA-approved test

HER2-negative definition

DefinitionTumors without overexpression or amplification of human epidermal growth factor receptor 2 (HER2)

Role in coverageHER2-negative status is required for Vyloy coverage

Clinical context

Background

Vyloy (zolbetuximab‑clzb) is indicated in this policy as a targeted monoclonal antibody used in combination with fluoropyrimidine‑ and platinum‑containing chemotherapy for first‑line treatment of adults with locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors are CLDN18.2‑positive and HER2‑negative. The policy requires documentation that the tumor is CLDN18.2 positive by an FDA‑approved assay and that the use aligns with FDA labeling and recognized clinical evidence sources.