MedicaidPrior AuthMedium impact
Vyloy (zolbetuximab-clzb) (New)
Humana·IN · Oncology·Medicaid
Effective date
Oct 1, 2025
We identified it
Jun 25, 2026
Summary
Humana Medicaid Indiana has established a NEW prior authorization policy for Vyloy (zolbetuximab-clzb), effective October 1, 2025. This is a pharmacy coverage policy requiring prior auth for this monoclonal antibody used to treat HER2-negative, CLDN18.2-positive gastric/GEJ adenocarcinoma as first-line combination chemotherapy. Billing teams must implement prior authorization workflows immediately for this new drug.
Action Required
By September 30, 2025: Billing team must implement prior authorization requirement for Vyloy (zolbetuximab-clzb) in the billing system for all Indiana Medicaid claims. Action items: (1) Configure billing software to require prior authorization submission before claim submission; (2) Create/update encounter form templates to alert providers that Vyloy requires PA; (3) Establish protocol requiring verification of three eligibility criteria before PA submission: locally advanced unresectable/metastatic HER2-negative gastric/GEJ adenocarcinoma diagnosis, CLDN18.2 positive status (determined by FDA-approved test), and first-line combination use with fluoropyrimidine and platinum chemotherapy; (4) Document exclusion criteria (disease progression on Vyloy) in PA denial workflow; (5) Set approval duration tracking for initial 6-month and renewal 6-month periods. Responsible parties: Billing team (system configuration), providers/clinical staff (submission of clinical documentation), oncology practice managers. Consequence: Claims submitted without prior authorization will be denied by Humana Indiana Medicaid.