Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Zanidatamab-hrii (Ziihera) may be considered medically necessary in individuals 18 years and older when ALL of the following criteria are met:
-
Individual has unresectable or metastatic biliary tract cancer (BTC);
and
-
The individual has been previously treated;
and
- The individual's BTC is HER2-positive (IHC 3+), as detected by an FDA-approved test.
Compendia Sources
Zanidatamab-hrii (Ziihera) may be considered medically necessary for treatment of any of the current category 1, 2A, or 2B NCCN recommendations.
The use of zanidatamab-hrii (Ziihera) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Procedure codes
