Medicare AdvantagePrior AuthMedium impact
Vyloy (zolbetuximab-clzb) (Revised)
Humana·KY, SC · Oncology·Medicaid
Effective date
Nov 27, 2024
We identified it
Jun 25, 2026
Summary
Humana has updated its prior authorization policy for Vyloy (zolbetuximab-clzb), a newly approved cancer immunotherapy for HER2-negative gastric and gastroesophageal junction adenocarcinoma. The policy applies to Medicare, Kentucky Medicaid, and South Carolina Medicaid and requires prior authorization before dispensing. Key approval criteria include CLDN18.2-positive disease confirmation via FDA-approved test and use as first-line combination chemotherapy. The policy was revised on August 27, 2025 with a review date of August 20, 2025.
Action Required
By November 27, 2024: Billing and clinical teams must implement prior authorization requirements for Vyloy (zolbetuximab-clzb) intravenous infusions across Medicare, Kentucky Medicaid, and South Carolina Medicaid plans. Establish pre-authorization workflow to verify: (1) diagnosis of locally advanced unresectable or metastatic HER2-negative gastric or GEJ adenocarcinoma, (2) CLDN18.2-positive status confirmed by FDA-approved test, and (3) intended use as first-line therapy in combination with fluoropyrimidine and platinum chemotherapy. Update billing system to flag claims for prior authorization review. Ensure oncology providers submit documentation of CLDN18.2 testing results with authorization requests. Set renewal reminders for 6-month intervals. Do not process claims for members with disease progression on Vyloy without additional clinical review. Denials may result from missing prior authorization or failure to meet clinical criteria.