Codes & NDC
| HCPCS | J9382 — "Injection, zenocutuzumab-zbco, 1 mg" (permanent, eff 7/1/2025) |
|---|
| Generic | zenocutuzumab-zbco (HER2/HER3 bispecific antibody) |
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| NDC | 83077-0100-01 single-dose carton (verify 11-digit on current DailyMed); N4 qualifier in 24A shaded |
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| Vial | 375 mg / 18.75 mL @ 20 mg/mL ready-to-dilute (NO reconstitution); 2 vials per std dose |
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| Diluent | 0.9% NaCl OR 5% Dextrose per label; 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-7/1/25 | J3490 / J9999 / C9399 transitional pass-through |
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Indications & dosing matrix
| Indication | Dose | Schedule | Setting |
|---|
| NRG1+ NSCLC (advanced/metastatic, previously treated) | 750 mg flat | q14d | Mono |
| NRG1+ pancreatic adenocarcinoma (advanced/metastatic, previously treated) | 750 mg flat | q14d | Mono |
| Toxicity-reduced dose (Grade 3+ recovery) | 600 mg flat | q14d | Mono |
Flat dose — not weight-based. Same 750 mg q14d for every patient, every indication. First infusion 4 hr; subsequent 2 hr.
Unit math (standard 750 mg)
- Std 750 mg → 2 vials drawn = 750 mg → 750 admin (JZ) + 0 JW
- Reduced 600 mg → 2 vials drawn = 750 mg → 600 admin (JZ) + 150 JW
- NDC qty on claim = mL drawn (37.5 mL for 2 full vials)
JZ is the default for Bizengri (zero waste on standard dose). JW only when toxicity dose reduction creates real partial-vial waste.
Bizengri vs Ziihera — DO NOT CONFUSE
| Bizengri J9382 | Ziihera C9302 |
|---|
| Generic | zenocutuzumab-zbco | zanidatamab-hrii |
| Manufacturer | Merus N.V. | Jazz Pharmaceuticals |
| Target | HER2/HER3 bispecific | HER2 bispecific |
| Indication | NRG1 fusion+ NSCLC / pancreatic | HER2+ biliary tract cancer (BTC) |
| FDA approval | Dec 4, 2024 | Nov 20, 2024 |
| Dose | 750 mg q14d flat | Weight-based |
Two different drugs — not the same. Wrong HCPCS = denial. Verify product dispensed matches J-code.
Administration & modifiers
| Code | When |
|---|
96413 | Chemo IV, first hr (every dose) |
96415 × 3 | First dose only — 4-hr infusion = 3 additional hrs |
96415 × 1 | Subsequent doses — 2-hr infusion = 1 additional hr |
96365 | NOT appropriate — Bizengri is an antineoplastic mAb (chemo admin codes) |
JZ default. 750 mg flat / 2 vials × 375 mg = zero waste on standard dose. JW only when toxicity-reduced. One of JZ/JW required since 7/1/2023.
ICD-10 by indication
| Code | For |
|---|
C34.11/12, C34.31/32 | NSCLC upper/lower lobe (R/L); pair with NRG1 fusion report |
C34.91/92 | NSCLC unspecified part (R/L) |
C25.0 | Pancreatic head (most common) |
C25.1 / C25.2 | Pancreatic body / tail |
C25.7 / C25.8 / C25.9 | Pancreatic other / overlap / NOS |
C78.0x | Secondary lung mets |
C78.6 | Secondary peritoneum/retroperitoneum |
C78.7 | Secondary liver mets |
C79.31 / C79.51 | Brain / bone mets |
C77.x | Lymph node mets (paired) |
Payer requirements (May 2026)
| Payer | PA | NRG1 fusion focus |
|---|
| UnitedHealthcare | Yes | RNA-based NGS preferred; specific fusion partner; previously treated; baseline LVEF |
| Aetna (CPB 1076) | Yes | Validated NGS with methodology; NCCN-aligned; ECOG documentation |
| BCBS plans | Yes | NCCN-aligned; NRG1 fusion report; some plans require baseline LVEF + pulmonary |
| Medicare | No | MAC LCDs; NRG1 fusion documentation + appropriate ICD-10 |
#1 DENIAL: NRG1 fusion documentation missing or DNA-only. Submit RNA-based NGS report with specific 5' fusion partner (CD74-NRG1, ATP1B1-NRG1, SLC3A2-NRG1, etc.).
Medicare reimbursement (Q2 2026)
| Field | Value |
|---|
| ASP + 6% | $33.567 / mg (eff. 4/1 – 6/30/2026) |
| 750 mg flat dose | $25,175.25 |
| 600 mg reduced dose | $20,140.20 (admin) + JW pays 150 mg additional |
| Annualized (26 doses/yr) | ~$654,557/yr pre-sequestration |
| After ~2% sequestration | ~$641,466/yr actual paid |
Site of care
| Setting | POS | Notes |
|---|
| Physician oncology office | 11 | Preferred Cycle 2+ (2-hr infusion) |
| Ambulatory infusion suite | 49 | Preferred |
| Oncology ASC | 24 | Acceptable |
| Hospital outpatient | 19/22 | OK Cycle 1 (4-hr first dose); disfavored Cycle 2+ by UM |
Cycle 1 in HOPD/AIC due to 4-hr infusion + reaction monitoring. Transition to office Cycle 2+ to avoid commercial UM denials.
Patient assistance — Bizengri Access (Merus)
- Phone: 1-833-MERUS-4U (1-833-637-8748)
- Web: bizengri.com/access
- Bizengri Copay Program: commercial pts reduced OOP per infusion (excl Medicare/Medicaid/federal)
- Merus PAP: free product for uninsured/underinsured meeting income criteria
- Foundations (Medicare): PAN, HealthWell, CancerCare, Good Days, National Pancreas Foundation — verify open funds quarterly
TOP 3 DENIAL DRIVERS: (1) NRG1 fusion documentation missing — attach RNA-based NGS report with specific 5' partner; (2) Cross-product confusion with Ziihera (zanidatamab, C9302, HER2+ BTC) — verify product matches J-code; (3) Spurious JW line on standard 750 mg dose (zero waste on 2-vial draw — JZ only).
FIRST-IN-CLASS for NRG1 fusion-positive cancers. No competitor product. NCCN compendium support Category 2A for both indications. Accelerated approval Dec 4, 2024 — continued approval contingent on confirmatory trial.