Codes & NDC
| HCPCS | J9276 — "Injection, zanidatamab-hrii, 2 mg" (permanent, eff 7/1/2025) |
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| Prior C-code | C9302 — transitional pass-through (OPPS only); eff 4/1/2025, deactivated 6/30/2025 |
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| Generic | zanidatamab-hrii (HER2-targeted bispecific antibody) |
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| NDC | 68727-950-01 single-dose carton (verify 11-digit on current DailyMed); N4 qualifier in 24A shaded |
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| Vial | 300 mg lyophilized powder; reconstitute with 6 mL SWFI → 50 mg/mL (~6 mL withdrawable); 5 vials per typical 70 kg dose |
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| Diluent | 0.9% NaCl ONLY (NOT 5% Dextrose); 250 mL bag; gentle inversion; do not shake; 0.2/0.22 µm in-line filter |
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| Benefit | Medical (provider buy-and-bill); not specialty pharmacy |
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| Pre-4/1/25 | J3490 / J9999 unclassified + NDC documentation |
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Indications & dosing matrix
| Indication | Dose | Schedule | Setting |
|---|
| HER2+ (IHC 3+) intrahepatic cholangiocarcinoma (C22.1) | 20 mg/kg | q14d | Mono |
| HER2+ (IHC 3+) gallbladder carcinoma (C23) | 20 mg/kg | q14d | Mono |
| HER2+ (IHC 3+) extrahepatic cholangiocarcinoma (C24.x) | 20 mg/kg | q14d | Mono |
Weight-based — 20 mg/kg q14d. All BTC subtypes share same dose. First infusion 60 min; subsequent 30 min if tolerated. Previously treated unresectable/metastatic only.
Unit math (worked example, 70 kg)
- 70 kg × 20 mg/kg = 1400 mg
- Vials drawn: ceil(1400/300) = 5 × 300 = 1500 mg drawn
- Admin: 1400 mg = 700 units (JZ) [÷ 2 because 1 unit = 2 mg]
- Waste: 100 mg = 50 units (JW)
- NDC qty on claim = mL drawn (~28 mL of reconstituted 50 mg/mL)
UNIT MATH WARNING: J9276 is 2 mg = 1 unit (NOT 1 mg = 1 unit like Bizengri). 1400 mg = 700 units, NOT 1400. Doubling units triggers payment-limit denials.
Ziihera vs Bizengri — DO NOT CONFUSE
| Ziihera J9276 | Bizengri J9382 |
|---|
| Generic | zanidatamab-hrii | zenocutuzumab-zbco |
| Manufacturer | Jazz Pharmaceuticals | Merus N.V. |
| Target | HER2 bispecific | HER2/HER3 bispecific |
| Biomarker | HER2 IHC 3+ | NRG1 fusion+ |
| Indication | HER2+ biliary tract cancer (BTC) | NRG1+ NSCLC / pancreatic |
| FDA approval | Nov 20, 2024 | Dec 4, 2024 |
| Dose | 20 mg/kg q14d (weight) | 750 mg q14d (flat) |
| Unit | 2 mg = 1 unit | 1 mg = 1 unit |
Two different drugs — not the same. Wrong HCPCS = denial. Verify product dispensed matches J-code AND unit math.
Administration & modifiers
| Code | When |
|---|
96413 × 1 | Chemo IV, single substance, first 60 min (every Ziihera dose — first and subsequent) |
96415 | Only if infusion extends past 60 min (rare — reactions only) |
96365 | NOT appropriate — Ziihera is an antineoplastic mAb (chemo admin codes) |
JZ + JW both lines. 300 mg vial vs weight-based 20 mg/kg dose = vial waste on most patients. Standard 70 kg = 700 JZ + 50 JW. Zero waste only at exact-multiple weights (e.g., 90 kg = 900 JZ, no JW).
ICD-10 by indication
| Code | For |
|---|
C22.1 | Intrahepatic bile duct carcinoma (intrahepatic cholangiocarcinoma) |
C23 | Malignant neoplasm of gallbladder |
C24.0 | Extrahepatic bile duct (perihilar/distal CBD) |
C24.1 | Ampulla of Vater |
C24.8 / C24.9 | Overlapping / biliary tract unspecified |
C78.0x | Secondary lung mets (common BTC met) |
C78.6 | Secondary peritoneum/retroperitoneum (common BTC met) |
C78.7 | Secondary liver mets (for extrahepatic primary) |
C79.51 / C77.x | Bone mets / lymph node mets (paired) |
Payer requirements (May 2026)
| Payer | PA | HER2 IHC 3+ focus |
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| UnitedHealthcare | Yes | FDA-approved companion diagnostic; previously treated (gem+cis ± durva); baseline LVEF |
| Aetna (CPB 1075) | Yes | VENTANA PATHWAY 4B5 or equivalent; NCCN-aligned; ECOG documentation |
| BCBS plans | Yes | NCCN-aligned; HER2 IHC 3+ report; some plans require baseline LVEF |
| Carelon (Anthem) | Yes | Ziihera-specific policy; HER2 IHC 3+ confirmed; appropriate prior systemic therapy |
| Medicare | No | MAC LCDs; HER2 IHC 3+ documentation + appropriate ICD-10 (C22.1/C23/C24.x) |
#1 DENIAL: HER2 IHC 3+ documentation missing or IHC 2+ submitted. IHC 2+ NOT eligible (even with ISH amplification). Submit full pathology report: antibody clone (4B5), intensity, % positive cells, CAP/CLIA lab.
Medicare reimbursement (Q2 2026)
| Field | Value |
|---|
| ASP + 6% | $24.996 / unit (2 mg) ≈ $12.498/mg (eff. 4/1 – 6/30/2026) |
| 70 kg dose (1400 mg / 700 units) | $17,497.20 admin + ~$1,250 JW (50 units) = ~$18,747 total |
| 90 kg dose (1800 mg / 900 units) | $22,496.40 (exact 6-vial; zero waste) |
| Annualized (70 kg, 26 doses) | ~$487,400/yr admin (+JW ~$32K) pre-sequestration |
| After ~2% sequestration | ~$509,500/yr actual paid (70 kg) |
Site of care (J9276 = all sites)
| Setting | POS | Notes |
|---|
| Physician oncology office | 11 | Preferred Cycle 2+ (30-min infusion) |
| Ambulatory infusion suite | 49 | Preferred |
| Oncology ASC | 24 | Acceptable |
| Hospital outpatient | 19/22 | OK Cycle 1 (60-min first dose); disfavored Cycle 2+ by UM |
J9276 (perm code) bills universally. During C9302 transitional (4/1–6/30/2025), HOPD-only billing. Audit straddle claims by DOS.
Patient assistance — JazzCares
- Phone: 1-833-533-JAZZ (1-833-533-5299)
- Web: jazzcares.com
- Ziihera Copay Program: commercial pts reduced OOP per infusion (excl Medicare/Medicaid/federal)
- Jazz PAP: free product for uninsured/underinsured meeting income criteria
- HER2 IHC testing assistance: JazzCares can coordinate HER2 IHC 3+ testing for not-yet-tested BTC patients
- Foundations (Medicare): PAN, HealthWell, CancerCare, Good Days, Cholangiocarcinoma Foundation — verify open funds quarterly
TOP 3 DENIAL DRIVERS: (1) HER2 IHC 3+ documentation missing — submit pathology report with antibody clone (4B5), intensity, % positive cells, CAP/CLIA lab; IHC 2+ NOT eligible regardless of ISH; (2) Cross-product confusion with Bizengri (zenocutuzumab, J9382, NRG1+ NSCLC/pancreatic) — verify product matches J-code AND unit (Ziihera = 2 mg/unit, Bizengri = 1 mg/unit); (3) Missing JW line on weight-based dose with vial waste (most claims need both JZ + JW).
FIRST-IN-CLASS HER2-directed therapy for biliary tract cancer. No competitor product. NCCN compendium support Category 2A. Accelerated approval Nov 20, 2024 — continued approval contingent on confirmatory trial (HERIZON-BTC-302).