CommercialPrior AuthHigh impact
Zolbetuximab-clzb (Vyloy) (CPB 1071, reviewed 2025-12-19)
Aetna·Oncology, Gastroenterology·Medical Policy
Effective date
Dec 19, 2025
We identified it
Aug 19, 2026
Summary
Aetna has established a new medical policy (CPB 1071, effective 2025-12-19) covering zolbetuximab-clzb (Vyloy) for CLDN18.2-positive, HER2-negative esophageal, gastric, and gastroesophageal junction adenocarcinoma as first-line treatment in combination with fluoropyrimidine- and platinum-containing chemotherapy. The policy requires mandatory precertification for all uses and establishes specific dosing protocols (800 mg/m² initial dose, then 600 mg/m² every 3 weeks or 400 mg/m² every 2 weeks).
Action Required
IMMEDIATE ACTION REQUIRED - By 2025-12-19: (1) Billing team must update all billing systems to require MANDATORY precertification for CPT codes 96413, 96414, 96415 (chemotherapy administration) when billed with HCPCS code J1326 (zolbetuximab-clzb). (2) Establish precertification routing: calls to (866) 752-7021 or fax to (888) 267-3277 for all Vyloy requests. (3) Obtain Statement of Medical Necessity (SMN) precertification forms from Specialty Pharmacy Precertification resources and integrate into prior auth submission process. (4) Update encounter templates and billing software to capture and verify: CLDN18.2-positive status (confirmed by FDA-approved test), HER2-negative status, disease classification (unresectable, recurrent, metastatic, or not surgical candidate), and first-line treatment status. (5) Train billing, coding, and prior auth staff on policy criteria: coverage ONLY applies to gastric, GEJ, or esophageal adenocarcinoma; all other indications are experimental/investigational and NOT covered. (6) Configure billing system to deny claims for J1326 without prior approval or if clinical criteria are not met. (7) Providers must document baseline disease status and confirmation of biomarker testing in medical record before billing. Failure to obtain precertification will result in claim denials.