CurrentCignaPolicy N/A

Vyloy (zolbetuximab) prior authorization form

This form governs prior authorization requests for Vyloy (zolbetuximab) injection for Cigna members and guides providers on required information and submission method; it affects prescribing clinicians, infusion sites, and pharmacies supplying the drug.

Policy Summary

PayerCigna

PolicyVyloy (zolbetuximab) prior authorization form

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form with patient and provider identifiers, J-code and ICD-10, disease and biomarker status, planned therapy, and supporting clinical information.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysstandard response time

855-840-1678fax to submit

800-882-4462phone (urgent)

Accredopreferred specialty pharmacy

Coverage Determination and Criteria

Information needed for coverage determination

Authorization will be assessed based on submitted clinical information.

Required submitted items: Submit completed patient and provider identifiers, medication requested (including J-code and ICD-10), indication (gastric or gastroesophageal junction [GEJ] adenocarcinoma or other), disease extent (locally advanced unresectable or metastatic), HER2 status, CLDN18.2 status, line of therapy, planned concurrent chemotherapy, prior therapies and performance status.

Form fields specify these data points.

No explicit exclusion conditions are listed on the Vyloy (zolbetuximab) prior authorization form. The form is structured to collect clinical and administrative information to support an eligibility or medical necessity determination rather than to enumerate specific exclusion criteria.

The form does not define explicit Not Medically Necessary conditions. Instead, determinations about medical necessity are made after review of the submitted clinical information and supporting documentation provided on the form.

Billing Codes and Response Time

Requested medication billing codemixed

J-code

J-Code (to be specified by provider on form)

Policy Summary

PayerCigna

PolicyVyloy (zolbetuximab) prior authorization form

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit a completed prior authorization form with patient and provider identifiers, J-code and ICD-10, disease and biomarker status, planned therapy, and supporting clinical information.

SourceLink

On This Page

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Response time — standard response time for prescription drug coverage requests

Standard response time5 business days

Urgent requestsIf request is urgent, provider should call to expedite

Online submission optionSubmit online at covermymeds.com or via SureScripts in EHR

Provider Requirements and Submission Instructions

Prior Authorization

Prior Authorization Required

Prior authorization required — Prior authorization is required. Complete the form with the medication name (e.g., Vyloy 100 mg), J‑code, ICD‑10 diagnosis, and all clinical details. Urgent requests should be called in to expedite review.

Include medication requested, dosing, frequency, duration, and J‑code/ICD‑10.

Note

Therapy Context

Therapy context — Indicate whether the requested medication is for a chronic or long‑term condition and whether it will be given as first‑line therapy. Specify if the drug will be given in combination with fluoropyrimidine- and platinum-containing chemotherapy when applicable (for example, in gastric/GEJ adenocarcinoma).

Check the box if medication is for chronic/long‑term use and provide related diagnosis.
For gastric/GEJ adenocarcinoma, state if therapy is first‑line and whether it will be combined with fluoropyrimidine‑ and platinum‑containing chemotherapy.

Documentation Required

Required Documentation

Required documentation — Provide patient identifiers (Cigna ID, name, DOB, address), physician identifiers (name, specialty, DEA/NPI/TIN, office contact, phone, fax), and facility/dispensing details (facility name, tax ID, address). Include the medication requested with dosing and schedule, J‑code, ICD‑10, frequency and duration of therapy, and supporting clinical information (disease stage, prior therapies, performance status, concurrent agents with names/doses/schedules).

Complete all asterisked items; missing required fields will prevent fax response.
Include the clinical attestation and prescriber signature/date on the form.

Denial Risk

Incomplete Form Risk

Incomplete form risk — Failure to complete all required patient and physician information (asterisked items) may prevent response via fax and can delay or impede processing of the prior authorization request.

All asterisked fields (patient name, Cigna ID, DOB, physician DEA/NPI/TIN, etc.) must be completed to avoid processing delays.

Policy Background and Indication

This prior authorization form is for administration of Vyloy (zolbetuximab) for patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma. It requests key tumor biomarkers (including HER2 and CLDN18.2 status), disease extent (such as locally advanced unresectable or metastatic), line of therapy, planned concurrent chemotherapy (for example fluoropyrimidine- and platinum-containing regimens), prior therapies, performance status, and standard patient and provider identifiers needed to process the request.

Key Definitions

CLDN18.2 positivity — CLDN 18.2 positive

DefinitionCLDN 18.2 positive

Form fieldForm asks: 'Are the patient’s tumors claudin (CLDN) 18.2 positive?' with Yes/No checkboxes

Use contextRequested for gastric or GEJ adenocarcinoma clinical information section

Site of Care and Dispensing

Note

Site‑of‑care and acquisition: Accredo, retail, home infusion, office or hospital outpatient

Specify the intended site of acquisition and administration: medication may be obtained from Accredo (Cigna's nationally preferred specialty pharmacy), retail, hospital outpatient, home infusion vendor, or physician office stock; administration site options include patient home, physician office, or hospital outpatient as indicated on the form.

Order/obtain drug via Accredo (preferred specialty pharmacy; NCPDP 4436920) or select alternative site (Chunk 4)
Administration site: Patient's home, Physician's office, or Hospital outpatient (Chunk 6)