CurrentCignaPolicy v031526

Ziihera (zanidatamab-hrii) prior authorization form and instructions

This document is Cigna's prior authorization request form and instructions for coverage consideration of Ziihera (zanidatamab-hrii), used by prescribers and facilities to request authorization for patients (including those with unresectable or metastatic HER2-positive biliary tract cancer). It affects providers submitting drug coverage requests to Cigna and designated specialty pharmacies.

Policy Summary

PayerCigna

PolicyZiihera (zanidatamab-hrii) prior authorization form and instructions

Policy CodePolicy v031526

Change TypeNo material change

Effective Date

Next Review Date

Key ActionSubmit the completed prior authorization form with all required patient, prescriber, medication (including J-code and ICD-10) and clinical information by fax or online for coverage review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

5 business daysstandard response time

855-840-1678fax

800-882-4462urgent phone

Accredopreferred specialty pharmacy

Coverage criteria and determination

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Authorization review criteria

Coverage is considered when the provider submits required clinical and administrative information and indicates relevant prior treatment history for the indicated condition.

Submission requirements: Provider has completed all required patient and prescriber fields (asterisked items), provided medication details (dose, quantity, duration, J-code), ICD-10 diagnosis, number of injections per month, expected duration, and facility/dispensing information if applicable.

See form fields in chunks 3 and 5

Clinical indication: Patient has unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC) as indicated on the form.

Form specifically asks about prior treatment for this condition (chunk 6)

Prior treatment history: Provider indicates whether the patient has previously been treated for unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC).

Selection of Yes/No on the clinical information section (chunk 6) may affect authorization decision

Chronicity attestation: Provider indicates if the medication is for a chronic or long-term condition (Yes/No) where therapy may be necessary for the life of the patient.

Chronic/long-term question is on the facility/dispensing section (chunk 5)

The form asks the provider to indicate whether the requested medication is for a chronic or long-term condition by a direct yes/no question. The document does not list any explicit exclusions tied to that response on the form itself; it functions only as an attestation field to inform the authorization review.

The form does not enumerate specific conditions that are automatically not medically necessary. Instead it requires an attestation that the information is true and accurate; incomplete, inaccurate, or missing attestations and required asterisked patient or prescriber fields can affect processing and may lead to denial or audit.

What providers must do to request authorization

Prior Authorization

Prior Authorization Required

Prior authorization is required for Ziihera (zanidatamab-hrii). Submit requests online at www.covermymeds.com/main/prior-authorization-forms/cigna/ or via SureScripts in your EHR, or fax per the form instructions. Our standard response time for prescription drug coverage requests is 5 business days. If the request is urgent, call to expedite.

Ziihera (zanidatamab-hrii) requires prior authorization
Submit online at CoverMyMeds or via SureScripts in your EHR; fax is also accepted

Note

Prior Treatment Inquiry

The prior authorization form asks whether the patient has been previously treated for unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC). Complete all clinical prior-treatment questions to support the review.

Question: Has the patient previously been treated for unresectable or metastatic HER2-positive (IHC 3+) BTC? (Yes/No)

Documentation Required

Required Documentation on Form

Complete all required patient and provider demographics and medication details on the form. Items marked with an asterisk (*) are required — missing these may delay or prevent approval.

Required patient info: Patient name, Cigna ID, Date of birth, Patient street address, Patient phone
Required provider info: Physician name, Specialty, DEA/NPI/TIN, Office contact person, Office phone, Office fax, Office street address
Medication details: Medication requested (Ziihera), Directions for use, Dose and quantity, Duration of therapy, J-Code, ICD-10, Number of injections per month, Expected duration, Patient weight

Denial Risk

Incomplete or Missing Information May Delay or Prevent Approval

If any asterisked items or the clinical prior-treatment information are incomplete or missing, the review may be delayed or the request may be denied. Ensure ALL required fields and the HER2-positive BTC prior-treatment response are completed before submission.

Missing asterisked items or clinical prior-treatment info may delay or prevent approval
Provide all required demographics, medication dosing, and prior-treatment answers to avoid denials

Initial therapy submission requirements

Initial therapy authorization requires medication-specific details.

Required drug details: Provider must provide medication name (Ziihera), directions for use, dose, quantity, duration of therapy, J-code, ICD-10 diagnosis, number of injections per month, expected duration, and patient weight.

Fields located in the medication requested section (chunk 3)

Step	Question on form	Form response options	Implication for authorization review
1	Has the patient previously been treated for unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer (BTC)?	Yes; No	Prior treatment history is collected and considered as part of the authorization review; the form does not specify required prior therapies or mandatory step sequencing.

Where medication will be obtained and administered

Note

Specify infusion/dispensing site — Accredo preferred

Indicate where the medication will be obtained and/or administered by selecting the appropriate option on the form; Accredo is identified as Cigna's nationally preferred specialty pharmacy.

Options on form: Accredo Specialty Pharmacy; Hospital Outpatient; Retail pharmacy; Home Health/Home Infusion vendor; Physician's office stock; Other.
Accredo noted as Cigna's nationally preferred specialty pharmacy (ordering options and contact info provided).
Provide facility/doctor dispensing information when applicable (facility name, state, Tax ID, address).

Key definitions used in this form

HER2-positive (IHC 3+) biliary tract cancer (BTC) — definition

TermHER2-positive (IHC 3+) biliary tract cancer (BTC)

DefinitionBiliary tract cancer that tests positive for HER2 by immunohistochemistry at a 3+ level and is identified on the form as unresectable or metastatic.

Clinical context on formThe form specifically asks whether the patient has previously been treated for unresectable or metastatic HER2-positive (IHC 3+) BTC (Yes/No).

Relevance to authorizationPresence of this diagnosis as indicated on the form is a clinical indication considered during prior authorization for Ziihera (zanidatamab-hrii).