Medicare AdvantagePrior AuthMedium impact
Vyloy (zolbetuximab-clzb) (Revised)
Humana·KY, SC · Oncology, Pharmacy·Medicaid
Effective date
Nov 27, 2024
We identified it
Jul 23, 2026
Summary
Humana has established a new prior authorization policy for Vyloy (zolbetuximab-clzb), a specialized cancer immunotherapy for HER2-negative gastric and gastroesophageal junction adenocarcinoma. This policy applies to Medicare, Kentucky Medicaid, and South Carolina Medicaid members and requires prior authorization before dispensing, with specific clinical criteria including CLDN18.2-positive tumor confirmation and first-line combination chemotherapy use.
Action Required
By November 27, 2024: Billing and prior authorization teams must implement the following: (1) Establish prior authorization workflow for Vyloy (zolbetuximab-clzb) in pharmacy billing system for Medicare, Kentucky Medicaid, and South Carolina Medicaid plans; (2) Create authorization request checklist requiring verification of all three criteria: diagnosis of locally advanced unresectable or metastatic HER2-negative gastric/GEJ adenocarcinoma, CLDN18.2-positive disease confirmation via FDA-approved test, and intended use as first-line therapy with fluoropyrimidine and platinum chemotherapy; (3) Configure system to deny claims if member has documented disease progression on Vyloy; (4) Set initial and renewal authorization periods to 6 months or as determined by clinical review; (5) Train pharmacy team and providers on requirement to obtain prior authorization before dispensing; (6) Update claim processing to flag any Vyloy claims from these three plan types lacking prior authorization for denial. Failure to obtain prior authorization will result in claim denials and patient care delays.