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Zanidatamab-hrii (Ziihera) (CPB 1075, reviewed 2025-12-19)

Aetna·Oncology, Gastroenterology, General Surgery·Medical Policy
Effective date
Mar 14, 2025
We identified it
Aug 19, 2026
Days to comply

Summary

Aetna has established coverage for zanidatamab-hrii (Ziihera) for HER2-positive biliary tract cancer with specific criteria: unresectable or resected gross residual (R2) disease or metastatic disease. All uses require precertification before treatment. Billing teams must ensure precertification is obtained and use the correct HCPCS code J9276 for the drug, along with appropriate premedication and infusion administration codes.

Action Required

Action needed
By March 14, 2025: Billing team must implement the following: (1) Establish precertification requirement for all Aetna patients receiving zanidatamab-hrii—contact Aetna at (866) 752-7021 or fax (888) 267-3277 BEFORE treatment begins; (2) Update billing system to recognize HCPCS code J9276 (zanidatamab-hrii, 2 mg) as a covered code ONLY when linked to ICD-10 codes C22.1, C23, C24.0, C24.8, or C24.9 AND disease status is unresectable/R2/metastatic HER2-positive (IHC 3+); (3) Ensure providers document HER2 status (IHC 3+) and disease classification in medical records—claims without this documentation will be denied; (4) Add premedication codes (J0131-J0138, J1200-J1201, J2550, J3410, J0702, J1020, J1030, J1040, J1094, J1100, J1700, J1710, J1720, J7509, J7510, J7512, J8540) to encounter forms for infusions; (5) Pair drug administration with CPT 96413 (first hour) and CPT 96415 (each additional hour) on claims. Flag any claims for zanidatamab-hrii WITHOUT prior authorization for denial. This policy applies to Aetna commercial plans only—Medicare beneficiaries follow separate Medicare Part B criteria.

Affected Billing Codes

96413
96415
J9276
J0131
J0134
J0136
J0137
J0138
J1201
J1200
J2550
J3410
J0702
J1020
J1030
J1040
J1094
J1100
J1700
J1710
J1720
J2357
J2650
J2786
J2920
J2930
J7509
J7510
J7512
J8540
C22.1
C23
C24.0
C24.8
C24.9