HCPCS
J2357
1 billing unit = 5 mg
Xolair and the other respiratory biologics
Nucala, Fasenra, Tezspire and Cinqair treat overlapping asthma and allergic conditions, but each is its own molecule, with a separate HCPCS code and ASP rate. None is a biosimilar of Xolair, and switching between them is a formulary decision, not a substitution. Pricing comparison lives in Current Xolair pricing.
| Brand | HCPCS | Manufacturer | Generic |
|---|---|---|---|
| Xolair (reference) | J2357 | Genentech / Novartis | omalizumab |
| Nucala | J2182 | GSK | mepolizumab |
| Fasenra | J0517 | AstraZeneca | benralizumab |
| Tezspire | J2356 | Amgen / AstraZeneca | tezepelumab-ekko |
| Cinqair | J2786 | Teva | reslizumab |
These are alternatives, not biosimilars: each of the four other codes above prices a distinct molecule with its own ASP rate, not an FDA-licensed biosimilar of omalizumab. No biosimilar of Xolair carries a CMS payment limit, so none appears in this table.
Dupixent (dupilumab) is also stepped through for some of these same indications, but it has no HCPCS code: it is a pharmacy-benefit drug and never appears on a medical claim. Payers name it directly in policy text; see Xolair coverage.
Buy-and-bill vs. self-administration on the pharmacy benefit
Xolair can be billed two different ways depending on who gives the injection. Buy-and-bill is the office visit: the practice stocks the drug, administers it, and bills J2357 plus 96372 on the medical benefit.
Since 2021 the label also allows self-administration: once a patient has received at least three doses in a healthcare setting with no hypersensitivity reaction, a clinician may prescribe the prefilled syringe or autoinjector for the patient or a caregiver to use at home. A self-administered dose moves to the pharmacy benefit and drops off the medical claim entirely: no J2357 line, no 96372 line. The 14 site-of-care rules in the commercial policy corpus exist to gate that transition, not to restrict where an in-office injection can happen.
Nucala (J2182)
GSK · mepolizumab · billed per 1 mg · $32.1810/mg (Q4 2026), $32,181.00 per 1,000 mg.
Fasenra (J0517)
AstraZeneca · benralizumab · billed per 1 mg · $165.0800/mg (Q4 2026), $165,080.00 per 1,000 mg, the most expensive per milligram of the five.
Tezspire (J2356)
Amgen / AstraZeneca · tezepelumab-ekko · billed per 1 mg · $17.8390/mg (Q4 2026), $17,839.00 per 1,000 mg.
Cinqair (J2786)
Teva · reslizumab · billed per 1 mg · $11.9070/mg (Q4 2026), $11,907.00 per 1,000 mg, the least expensive per milligram of the five.
Xolair dosing, workup and co-therapy
Not one fixed dose but one fixed pattern for every labeled indication: the variation that matters to a biller isn't the dose, it's what has to be documented before it and around it.
| Indication | Regimen | Notes |
|---|---|---|
| Allergic asthma (IgE x weight table) | 75 to 375 mg SC every 2 or 4 weeks, dose and interval from the serum IgE and body-weight table; 300 mg every 4 weeks is a mid-table example | Pre-treatment total IgE (30 to 700 IU/mL for patients 6 years and older, up to 1,300 IU/mL for 6 to 11 years) and weight (20 to 150 kg) fix the dose for the whole course: the label says not to re-dose on IgE levels drawn during treatment. Doses above 300 mg are split across two syringes and every 2 weeks. |
| Chronic spontaneous urticaria | 150 mg or 300 mg SC every 4 weeks, not dependent on IgE or weight | The only fixed-dose indication: 30 or 60 units of J2357 every 4 weeks. Most commercial policies (BCBS HCSC, BCBS KS, Aetna) require failure of an up-dosed second-generation H1 antihistamine first, and several add a second-line agent. |
| Chronic rhinosinusitis with nasal polyps (IgE x weight table) | 75 to 600 mg SC every 2 or 4 weeks from the IgE and body-weight table, as add-on to intranasal corticosteroids; 300 mg every 4 weeks is a mid-table example | Adults only. The polyps table extends to 600 mg every 2 weeks (two 300 mg syringes, 120 units); payers require an intranasal corticosteroid trial first and most keep the steroid on during treatment. |
| IgE-mediated food allergy (IgE x weight table) | 75 to 600 mg SC every 2 or 4 weeks from the IgE and body-weight table, to reduce allergic reactions from accidental exposure; 300 mg every 4 weeks is a mid-table example | Labeled from age 1 year (2024). It is not a treatment for anaphylaxis, and the label requires patients to keep avoiding the allergen; that is what payers quote when they deny it as a stand-alone therapy. |
Co-therapy
Xolair is add-on therapy, not a replacement. Asthma patients continue their inhaled corticosteroid controller; nasal polyps patients continue a daily intranasal corticosteroid; food-allergy patients continue avoiding the allergen and carrying epinephrine. Document that the co-therapy continues alongside Xolair, since several payers' clinical-prerequisite rules require it to stay on the chart through treatment, beyond the trial that preceded approval.
Boxed warning, anaphylaxis: the label reports anaphylaxis as early as the first dose and also more than a year into regularly administered treatment. Every dose begins under observation in a healthcare setting, and self-administration is only appropriate after at least three doses with no hypersensitivity reaction.
Pre-treatment workup checklist
- Serum total IgE and body weight, drawn before the first dose: they fix the dose and interval for the whole course for asthma, nasal polyps and food allergy. The label says not to re-dose on IgE levels drawn during treatment.
- Anaphylaxis counseling, plus an observation period after each in-office injection.
- Document the indication's prerequisite: the controller-therapy, antihistamine or intranasal-steroid trial the payer's policy names.
Discontinuation and self-administration
Treatment is open-ended: the label does not define a course length for any of the four indications, and the same pre-treatment IgE and weight give the same dose and interval for as long as the patient stays on therapy. Reauthorization in the commercial corpus (4 rules) turns on documented clinical response (asthma control, urticaria activity score, polyp score), not on a re-drawn IgE.
Since 2021 the label allows self-injection after in-office initiation, so a patient may move from buy-and-bill to the pharmacy benefit mid-course. That shift changes who bills what, not the dose: flag it in the chart so a claim that suddenly stops showing J2357 reads as a benefit change, not a lapsed course of therapy.
Need the billing units for a patient? Convert dose to J2357 billing units →
Xolair billing reference
HCPCS
J2357: 5 mg per billing unit. A 300 mg dose is 60 units. The other respiratory biologics in this family (Nucala, Fasenra, Tezspire, Cinqair) are billed per 1 mg; check the code before converting a dose to units.
NDC
The primary billing number is 50242-227-01 (Xolair 300 mg prefilled syringe, Genentech labeler 50242). Pad to 11 digits with a leading zero in the appropriate segment for CMS-1500 Box 24A.
| NDC (10-digit) | NDC (11-digit, claim form) | Package |
|---|---|---|
50242-214-03 | 50242-0214-03 | 75 mg/0.5 mL single-use prefilled syringe |
50242-215-03 | 50242-0215-03 | 150 mg/mL single-use prefilled syringe |
50242-227-01 | 50242-0227-01 | 300 mg/2 mL single-use prefilled syringe |
50242-040-62 | 50242-0040-62 | 150 mg single-dose lyophilized vial |
Administration
Xolair is a subcutaneous injection, not an infusion. Administration bills 96372 once per injection: a dose built from two syringes (225, 375 or 600 mg) is two 96372 lines on the same date, the second appended with modifier 59 or XS on most payers' edits. There is no time-based add-on code, because there is no infusion to extend.
| CPT | Description | Use for |
|---|---|---|
96372 | Therapeutic, prophylactic or diagnostic injection; subcutaneous or intramuscular | The only administration code Xolair uses ($15.36, Medicare PFS national non-facility, 2026). |
96413 / 96415 | Chemotherapy/complex-biologic IV infusion administration | Not appropriate. These are the IV infusion codes used by infused drugs elsewhere in this reference (Remicade, Keytruda); Xolair is not infused and does not use them. |
96401 | Chemotherapy administration, SC/IM; non-hormonal anti-neoplastic | Not appropriate. Xolair is an anti-IgE antibody for allergic and inflammatory disease, not an anti-neoplastic drug. |
Modifiers
JZ: required when no drug is discarded; the norm on essentially every Xolair claim. JW: required for documented waste; not applicable to how this drug is dosed.
Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. Because a Xolair dose is always built from whole syringes (225 mg as 150 mg plus 75 mg, 375 mg as 300 mg plus 75 mg, 600 mg as two 300 mg syringes), there is normally nothing left to discard, so append JZ to the J2357 line on essentially every claim. JW would only apply if a syringe were opened and not fully used, which the label's whole-syringe fill pattern does not call for.
Modifier 25: same-day E/M. Append modifier 25 to the same-day E/M code only if a significant, separately identifiable evaluation occurred beyond the routine pre-injection check-in, which is bundled into the administration code.
TB: 340B drug pricing. Hospitals that acquire omalizumab through 340B and bill Medicare report the TB modifier, the sole 340B identifier since CMS discontinued JG on January 1, 2025.
Claim form
CMS-1500 / 837P (physician office; POS 11) field map for a J2357 claim.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | Format: N4 qualifier + 11-digit NDC + UN + quantity drawn (1 syringe) |
| HCPCS J2357 + JZ (JW only if waste) | 24D (drug line) | 60 units for Xolair, per MAC rounding |
| CPT 96372 | 24D (admin line) | One line per injection; two for a split-syringe dose (225, 375 or 600 mg) |
| ICD-10 | 21 | Indication-specific; see Coverage |
| NPI | 17b / 24J / 33a | Rendering and billing provider NPI |
| PA number (when required) | 23 | Required by 25 of 28 commercial payer policies |
| TB modifier (340B sites only) | 24D | Hospital outpatient 340B claims only |
Xolair coverage
- 25 of 28 commercial payer policy sets require prior authorization
- 14 of 28 carry a site-of-care rule
- 656 individual coverage rules exist across those 28 payers: clinical prerequisites (411), covered indications (109), dosing (45), prior authorization (27), contraindication exclusions (25), quantity limits (17), site of care (14), reauthorization (4), billing/coding (2) and combination rules (2)
- Because Xolair's four indications sit under one J-code, a payer's policy sets different clinical-prerequisite rules by indication rather than by product; verify the diagnosis on file matches the indication the prior authorization was written for
ICD-10 codes by indication
Use the most specific code supported by chart documentation. Each indication has a distinct code and a distinct set of payer prerequisites.
| Indication | ICD-10 | Notes |
|---|---|---|
| Moderate to severe persistent allergic asthma | J45.50 | Ages 6 and older, IgE-positive, inadequately controlled on inhaled corticosteroids; 28 of 28 payers in the corpus carry a rule for this indication |
| Chronic spontaneous urticaria | L50.1 | Ages 12 and older; dosing is fixed and does not depend on IgE or weight; 28 of 28 payers |
| Chronic rhinosinusitis with nasal polyps | J33.9 | Adults only, add-on to intranasal corticosteroids; 25 of 28 payers |
| IgE-mediated food allergy | Z91.010 | Labeled from age 1 (2024); not a treatment for anaphylaxis, and the label requires continued allergen avoidance; 24 of 28 payers |
The label's only contraindication is severe hypersensitivity to Xolair or any of its ingredients; no diagnosis code substitutes for documenting it.
See Medicare covered diagnoses for omalizumab for the MAC-level ICD-10 ranges.
Check the patient's actual policy: See Xolair coverage by payer →
Current Xolair pricing
Medicare ASP+6%: $45.687 / 5 mg · $2,741.22 / 300 mg. Add the $15.36 administration allowance for 96372 and the claim totals $2,756.58 before the sequester.
Sequestration reduces Medicare's 80% share by 2%. Commercial plans pay a contracted rate that differs by payer and state.
13 doses a year (300 mg SC every 4 weeks, the chronic spontaneous urticaria schedule; asthma is 75 to 375 mg every 2 or 4 weeks by IgE and weight) at $2,756.58 per dose — drug plus 96372 administration — total $35,835.54 before the sequester. That is the full annual drug-plus-administration cost for a patient staying on schedule, before benefits or assistance.
| Product | HCPCS | Rate / mg | Rate / 1,000 mg |
|---|---|---|---|
| Xolair | J2357 | $9.1374 | $9,137.40 |
| Nucala | J2182 | $32.1810 | $32,181.00 |
| Fasenra | J0517 | $165.0800 | $165,080.00 |
| Tezspire | J2356 | $17.8390 | $17,839.00 |
| Cinqair | J2786 | $11.9070 | $11,907.00 |
Look up commercial reimbursement →
Patient cost
The patient's actual responsibility depends on: payer allowed rate · remaining Part B deductible ($283 in 2026) · benefits · − assistance · = patient responsibility. At 20% coinsurance with the deductible already met, a Medicare patient's share of a 300 mg dose is roughly $551.31 ($548.24 drug plus $3.07 injection).
Calculate a Xolair patient estimate →
Copay & financial assistance
Xolair has two manufacturer programs: a $5 copay card capped at $15,000 a year, and Genentech's free-drug program for uninsured patients at or below 400% of the federal poverty level. Three foundation funds that once covered omalizumab are now closed: HealthWell's Asthma and Urticaria funds and PAN's Asthma fund. Check current open/closed status before assuming availability; status changes without notice.
Common Xolair denials & fixes
| Denial reason | Common cause | Fix |
|---|---|---|
| Wrong administration code | Biller defaulted to an infusion code (96413/96415) or the chemo injection code (96401) out of habit from other drugs | Resubmit with 96372, the only administration code Xolair bills. |
| Wrong unit count for a split-syringe dose | A 375 mg dose billed as 60 units (only the 300 mg syringe counted) instead of 75 | Recompute at 5 mg per unit across both syringes and confirm both 96372 lines are present. |
| Self-administered dose billed with 96372 | The patient self-injected at home under the pharmacy benefit, but the practice still billed the medical-benefit injection code | Confirm whether the dose was given in-office or self-administered before billing 96372; self-administered doses run through the pharmacy benefit and carry no administration line. |
| JZ missing | Single-dose-syringe claim without JZ when no drug was discarded | Resubmit with JZ on the drug line, the norm on nearly every Xolair claim. |
| Controller-therapy trial not documented | 27 of 28 payers require a controller-therapy, antihistamine or intranasal-steroid trial by indication before Xolair; this is a clinical prerequisite, not a preferred-product step | Submit trial-and-failure documentation for the specific therapy the payer's policy names for that indication. |
| PA missing | Claim submitted without prior authorization | Submit PA before the next scheduled dose; 25 of 28 commercial payer policies require it. |
| Anaphylaxis observation not documented | No record of the in-office observation period after injection, or no risk assessment before approving self-administration | Document the post-injection observation, and before self-administration confirm the patient received at least three in-office doses with no hypersensitivity reaction. |
| Diagnosis mismatch under a shared J-code | The ICD-10 on file doesn't match the indication the PA was approved for: asthma, CSU, polyps and food allergy each carry separate criteria | Confirm the diagnosis code matches the approved indication; a claim coded for one indication against a PA written for another will deny. |
Frequently asked questions
What is the difference between buy-and-bill Xolair and self-administered Xolair on the pharmacy benefit?
Same drug, different benefit and different claim. Buy-and-bill Xolair is given in the office and billed under J2357 plus 96372 on the medical benefit. Since 2021 the label allows self-administration: once a patient has taken at least three doses in a healthcare setting with no hypersensitivity reaction, a clinician may have the patient or a caregiver inject the prefilled syringe or autoinjector at home.
A self-administered dose moves to the pharmacy benefit and drops off the medical claim entirely: no J2357 line, no 96372 line, and no site-of-care rule to satisfy.
What is the dosing for omalizumab by indication?
There is no single fixed dose: asthma, nasal polyps and food allergy doses come off the label's serum IgE times body-weight table, and only chronic urticaria uses a fixed 150 mg or 300 mg dose. The pre-treatment IgE and weight set the dose and interval for the whole course; the label says not to re-dose on IgE levels drawn during treatment. One worked example per indication:
- Allergic asthma = 75 to 375 mg every 2 or 4 weeks from the IgE x weight table
- Chronic spontaneous urticaria = 150 mg or 300 mg every 4 weeks
- Nasal polyps = 75 to 600 mg every 2 or 4 weeks from the IgE x weight table
- Food allergy = 75 to 600 mg every 2 or 4 weeks from the IgE x weight table
What other biologics treat the same indications as Xolair?
Four others sit in the same clinical space, but none is a Xolair biosimilar, since each is a distinct molecule with its own HCPCS code and its own ASP rate: Nucala (mepolizumab, J2182, GSK), Fasenra (benralizumab, J0517, AstraZeneca), Tezspire (tezepelumab-ekko, J2356, Amgen/AstraZeneca) and Cinqair (reslizumab, J2786, Teva). Dupixent (dupilumab) is also stepped through for some of these indications, but it carries no HCPCS code and never appears on a medical claim.
What warnings apply to Xolair?
Xolair carries a boxed warning for anaphylaxis, which the label says can occur as early as the first dose or more than a year into treatment: every dose starts under observation in a healthcare setting. A separate warning covers malignancy: 0.5% of Xolair-treated patients developed a malignant neoplasm in clinical studies against 0.2% of controls, though a later 5-year observational study found similar rates between treated and untreated patients.
Why doesn't a Xolair claim carry a JW line?
The fill rule builds every dose from whole syringes (225 mg as 150 mg plus 75 mg, 375 mg as 300 mg plus 75 mg, 600 mg as two 300 mg syringes), so nothing is opened and left over. That leaves JZ on the J2357 line on essentially every claim; a 150 mg vial exists, but the doses worked here are built from the prefilled syringe, not drawn from the vial.
Sources
- AAPC: HCPCS J2357 (Xolair / omalizumab)
- AAPC: HCPCS J2182 (Nucala)
- AAPC: HCPCS J0517 (Fasenra)
- AAPC: HCPCS J2356 (Tezspire)
- AAPC: HCPCS J2786 (Cinqair)
- DailyMed: Xolair (omalizumab) prescribing information
- CMS: Medicare Part B Drug ASP Pricing File
- CMS: HCPCS quarterly update file
- CMS: JW / JZ modifier guidance
Dataset dates: pricing Q4 2026 · payer policies Aug 2026 · assistance Jul 2026.
Reviewed September 20, 2026 by Erin Rose, CareCost Estimate founder. Methodology →