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MedicaidPrior AuthMedium impact

Vyloy (zolbetuximab-clzb) (New)

Humana·IN · Oncology, Pharmacy·Medicaid
Effective date
Oct 1, 2025
We identified it
Jul 23, 2026
Days to comply

Summary

Humana Medicaid (Indiana) has established a new prior authorization policy for Vyloy (zolbetuximab-clzb), a monoclonal antibody for treating HER2-negative, CLDN18.2-positive gastric and gastroesophageal junction adenocarcinoma. Billing teams must now obtain prior authorization before claims are submitted for this IV therapy when used as first-line combination chemotherapy. Approval is granted for initial and renewal periods of 6 months or as determined by clinical review.

Action Required

Action needed
By October 1, 2025: Billing team must implement prior authorization requirement for Vyloy (zolbetuximab-clzb) IV infusion claims for Humana Medicaid Indiana members. Update billing system and EMR to flag all Vyloy requests for prior auth review before claim submission. Providers must document: (1) diagnosis of locally advanced unresectable or metastatic HER2-negative gastric/GEJ adenocarcinoma, (2) CLDN18.2 positivity confirmed by FDA-approved test, and (3) intent to use Vyloy in combination with fluoropyrimidine and platinum-containing chemotherapy as first-line therapy. Route all authorization requests through Humana PAL (https://www.humana.com/PAL). Do not submit claims without prior approval. Obtain renewal authorization every 6 months. Claims submitted without required prior authorization will be denied.