Resources
Downloadable materials, patient support information, and reimbursement resources for ZELVARA (celdatuzumab-mkrz).
Downloadable Materials
CLDN18.2 Testing
Companion Diagnostic
CLDN18.2 status must be determined using an FDA-approved immunohistochemistry (IHC) test prior to initiating treatment with ZELVARA. CLDN18.2 positivity is defined as ≥75% of tumor cells showing moderate-to-strong membranous staining (IHC 2+/3+).
Testing should be performed at a CLIA-certified laboratory using formalin-fixed, paraffin-embedded (FFPE) tumor tissue from a biopsy or surgical specimen.
Ordering Testing
- 1 Submit FFPE tissue to a CLIA-certified lab offering the approved CLDN18.2 IHC assay
- 2 Results typically available within 5-7 business days
- 3 Ensure report includes percentage of positive cells and staining intensity
Patient Support Program
ZELVARA Access
The ZELVARA Access program provides benefit verification, prior authorization support, and financial assistance for eligible patients.
1-800-555-ZELV (9358)
Mon-Fri, 8 AM - 8 PM ET
Co-Pay Assistance
Commercially insured patients may be eligible for co-pay support, reducing out-of-pocket costs to as low as $0 per infusion. Subject to eligibility criteria and annual cap.
Patient Assistance
Uninsured or underinsured patients who meet income eligibility criteria may receive ZELVARA at no cost through the Meridian Patient Assistance Program.
Coding & Reimbursement
| Code Type | Code | Description |
|---|---|---|
| HCPCS J-Code | J9XXX | Injection, celdatuzumab-mkrz, 10 mg |
| ICD-10-CM | C16.9 | Malignant neoplasm of stomach, unspecified |
| ICD-10-CM | C16.0 | Malignant neoplasm of cardia (GEJ) |
| CPT | 96413 | Chemotherapy administration, IV infusion, first hour |
| CPT | 96415 | Chemotherapy administration, IV infusion, each additional hour |
J-code is pending CMS assignment. Contact ZELVARA Access for interim billing guidance. Verify coverage with the patient's specific payer plan.
Medical Information
For medical inquiries regarding ZELVARA, including clinical data requests, adverse event reporting, and product complaints, please contact Meridian Oncology Medical Information.
Phone
1-800-555-MERI (6374)
medinfo@meridianonc.com
Adverse Event Reporting
1-800-FDA-1088 (MedWatch)