MedicaidPrior AuthMedium impact
Vyloy (zolbetuximab-clzb) (New)
Humana·LA · Oncology, Hematology·Medicaid
Effective date
Oct 1, 2025
We identified it
Jun 25, 2026
Summary
Humana Medicaid Louisiana is implementing a new prior authorization policy for Vyloy (zolbetuximab-clzb), a chimeric claudin 18.2-directed immunoglobulin antibody for treating locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma. Coverage requires CLDN18.2-positive tumors (confirmed by FDA-approved test) and first-line combination use with fluoropyrimidine and platinum-containing chemotherapy. Prior authorization is mandatory with initial and renewal approvals valid for 6 months.
Action Required
By October 1, 2025: Billing team must implement prior authorization requirements for Vyloy (zolbetuximab-clzb) claims in the Humana Medicaid Louisiana system. Before submitting any Vyloy claims, verify that: (1) Patient has diagnosis of locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma; (2) Tumor is CLDN18.2-positive as confirmed by FDA-approved test; (3) Drug will be used as first-line therapy in combination with fluoropyrimidine (5-FU or capecitabine) and platinum-containing chemotherapy. Create prior authorization request workflow requiring oncology provider to submit clinical documentation confirming all three criteria. Do not process claims for patients with prior disease progression on Vyloy. Update claim submission procedures to require prior auth approval before claim entry. Train billing and clinical staff on the CLDN18.2 testing requirement and three mandatory criteria. Track approval durations (6 months initial and renewal) in system for timely reauthorization. Failure to obtain prior authorization will result in claim denials for Humana Medicaid Louisiana members.