Xolair (omalizumab) — HCPCS J2357
CareCost Estimate · Billing Cheat Sheet
Genentech / Novartis
75 mg + 150 mg prefilled syringe / autoinjector
Subcutaneous q2-4wk (varies by indication)
Reviewed: May 3, 2026
ASP: Q2 2026
HCPCS
J2357
1 unit = 5 mg (TRAP)
CSU Dose
60 units
300 mg SC q4wk · fixed
Modifier
JZ
Single-dose syringe/pen
Admin CPT
96372
SC therapeutic, non-chemo
Medicare ASP+6%
$41.823
/5-mg unit · $8.36/mg
UNIT BASIS TRAP: J2357 = 5 mg per unit (NOT 1 mg). Multiply mg dose ÷ 5 to get billable units. 300 mg = 60 units. 150 mg = 30 units. 75 mg = 15 units.
Codes & NDC
| HCPCS | J2357 — "Omalizumab injection" (1 unit = 5 mg) |
|---|
| NDC 75 mg syr | 50242-040-01 75 mg/0.5 mL prefilled syringe |
|---|
| NDC 150 mg syr | 50242-041-01 150 mg/mL prefilled syringe |
|---|
| NDC 75 mg pen | 50242-080-01 75 mg/0.5 mL autoinjector |
|---|
| NDC 150 mg pen | 50242-081-01 150 mg/mL autoinjector |
|---|
Indication-specific dosing
| Indication | Dose | Frequency | Units |
|---|
| Allergic asthma (≥6 yr) | 75-600 mg | q2 or q4wk per IgE+wt table | 15-120 |
| CSU (≥12 yr) | 150 or 300 mg fixed | q4wk | 30 or 60 |
| CRSwNP (≥18 yr) | 75-600 mg | per IgE+wt table | 15-120 |
| Food allergy (≥1 yr, NEW 2024) | 75-600 mg | per IgE+wt table | 15-120 |
IgE biomarker (asthma/CRSwNP/food allergy)
- Total serum IgE: 30-1500 IU/mL (asthma)
- CPT testing:
82785 (total IgE), 86003 (specific IgE per allergen)
- Document baseline IgE + body weight in chart for dose calculator
- CSU does NOT require IgE testing — fixed-dose indication
Admin & modifiers
| Code | When |
|---|
96372 | Therapeutic SC, non-chemo (primary) |
| NOT 96365/96366 (IV) or 96413/96415 (chemo) |
BOXED WARNING — Anaphylaxis (~0.2%). HCP admin first 3 doses with observation; subsequent doses may be self-administered with patient training. Wallet card recommended.
ICD-10
| Code | For |
|---|
J45.40-52 | Asthma (mod-severe persistent) |
L50.1 | Idiopathic urticaria (CSU) |
L50.8 | Other chronic urticaria |
J33.0-9 | Nasal polyps (CRSwNP) |
Z91.01x | Food allergy status |
T78.0x-T78.4x | Anaphylaxis / allergic reaction |
Food allergy (NEW Feb 2024)
- FDA approved Feb 2024 — first biologic for IgE-mediated food allergy
- Indicated for reduction of allergic reactions following accidental exposure
- NOT a substitute for food avoidance
- Age ≥1 yr; dosing per IgE/weight calculator
- Payer policies still evolving — allergist documentation + severe reaction history typically required
Payer requirements (May 2026)
| Payer | PA | Indication-specific |
|---|
| UnitedHealthcare | Yes | IgE level (asthma) + step from ICS/LABA |
| Aetna | Yes | Allergist for food allergy; severe rxn hx |
| Cigna | Yes | Spec pharmacy after first 3 doses |
| Medicare LCD | Yes | FDA-approved indication + dx |
Medicare reimbursement (Q2 2026)
| Field | Value |
|---|
| ASP + 6% | $41.823 / 5-mg unit = $8.36/mg |
| 75 mg (15 units) | $627.35 |
| 150 mg (30 units) | $1,254.69 |
| 300 mg (60 units) | $2,509.38 |
| 375 mg (75 units) | $3,136.73 |
Site of care
| Setting | POS | Notes |
|---|
| Physician office | 11 | First 3 doses |
| Allergy/pulm clinic | 11 | Common |
| Patient home | 12 | After training |
Patient assistance — Genentech
- Phone: 1-866-422-2377 (Genentech Access Solutions)
- Xolair Co-pay Card: $0 first dose, ongoing copay support (commercial)
- Genentech Patient Foundation: free for uninsured
Pending SME review. Verify against current Genentech label, payer policies, and CMS ASP file at billing time.