Pharmacy Prior Authorization Criteria

Ziihera (zanidatamab-hrii)

Indications for Prior Authorization

Ziihera (zanidatamab-hrii) injection

• For diagnosis of Biliary tract cancer (BTC)
  indicated for the treatment of adults with previously treated, unresectable, or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC), as detected by an FDA-approved test.

  This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

Criteria

Ziihera

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of biliary tract cancer (BTC)
AND
• Disease is one of the following:
• Unresectable
• Metastatic
AND
• Presence of human epidermal growth factor receptor (HER2) - positive (Immunohistochemistry [IHC] 3+) as detected by a U.S. Food and Drug Administration (FDA) - approved test or a test performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA)
AND
• Patient has been previously treated (e.g., chemotherapy)

Ziihera

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient does not show evidence of progressive disease while on therapy

P & T Revisions

2024-12-23

References

1. Ziihera Prescribing Information. Jazz Pharmaceuticals, Inc. Palo Alto, CA. November 2024.
2. Center. List of Cleared or Approved Companion Diagnostic Devices. U.S. Food and Drug Administration. Published 2024. Accessed December 17, 2024. http://www.fda.gov/CompanionDiagnostics

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Revision History

• 2024-12-23: New Program

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