Medicare AdvantagePrior AuthMedium impact
Ziihera (zanidatamab-hrii) (Revised)
Humana·KY, SC · Oncology·Medicaid
Effective date
Jan 22, 2025
We identified it
Jun 25, 2026
Summary
Humana has issued a revised prior authorization policy for Ziihera (zanidatamab-hrii), a HER2-directed bispecific antibody for treating previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer. The policy applies to Medicare, Medicaid-Kentucky, and Medicaid-South Carolina plans and requires prior authorization confirming unresectable/metastatic BTC diagnosis, HER2-positive status (IHC 3+), at least one prior line of therapy (gemcitabine-based regimen), and monotherapy use. Claims will be denied if the member has experienced disease progression on Ziihera.
Action Required
By January 22, 2025: Billing and prior authorization teams must implement new workflows for Ziihera (zanidatamab-hrii) requests. (1) Update prior authorization submission templates to require documentation of: unresectable or metastatic BTC diagnosis, HER2-positive status via FDA-approved test (IHC 3+ only), confirmation of at least one prior line of therapy (gemcitabine-based regimen), and confirmation of monotherapy use. (2) Configure billing system to flag any Ziihera claims for manual review if prior authorization has not been obtained. (3) Train front-desk and authorization staff to screen for exclusion criteria before routing requests—specifically, do not approve if member has documented disease progression on Ziihera. (4) Providers should be notified via communication that Ziihera now requires prior authorization; include the four approval criteria in provider bulletins. (5) For Kentucky and South Carolina Medicaid members only, ensure separate tracking if your practice serves multiple states. Failure to obtain prior authorization will result in claim denials. Reference the full policy at www.humana.com/PAL for specific coding information and contact information for authorization requests.