MedicaidPrior AuthMedium impact
Ziihera (zanidatamab-hrii) (New)
Humana·OH · Oncology, Hematology·Medicaid
Effective date
Nov 1, 2025
We identified it
Jun 25, 2026
Summary
Humana Medicaid (Ohio) has established a new prior authorization policy for Ziihera (zanidatamab-hrii), a HER2-directed bispecific antibody for treating previously treated, unresectable or metastatic HER2-positive biliary tract cancer. Billing teams must implement prior authorization requirements before November 1, 2025, and verify four clinical criteria plus one exclusion before claims can be approved. This is an accelerated approval drug with special monitoring requirements.
Action Required
By November 1, 2025: (1) Billing team must configure system to require prior authorization for all Ziihera (zanidatamab-hrii) claims for Humana Medicaid Ohio members. (2) Create authorization checklist requiring documentation of: unresectable/metastatic BTC diagnosis, HER2-positive status (IHC 3+) by FDA-approved test, at least one prior line of therapy (gemcitabine-based regimen), and monotherapy use. (3) Flag and DENY any authorization requests if member has disease progression on Ziihera or if indication is experimental/not supported by CMS compendia. (4) Providers must submit claims with complete clinical documentation attached. (5) Update patient eligibility verification and pre-service notification processes. (6) Reference www.humana.com/PAL for applicable provider claim codes. Failure to obtain prior authorization will result in claim denials.