HCPCS
J2356
1 mg = 1 unit
Phase 1
Identify what you're billing
Confirm SKU (vial / syringe / pen) and verify severe persistent asthma documentation before billing.
Three SKUs — vial, prefilled syringe, prefilled pen AZ / Amgen 2026
Same HCPCS (J2356), same 210 mg flat dose — but the SKU dictates whether the practice bills under medical benefit or whether specialty pharmacy fills.
| SKU | NDC | Who administers | Billing pathway |
|---|---|---|---|
| 210 mg/1.91 mL single-dose vial | 55513-100-01 |
HCP only (manually drawn into syringe) | Medical benefit — J2356 + 96372 on practice claim |
| 210 mg/1.91 mL prefilled syringe | 55513-112-01 |
HCP only (fixed 27G ½" needle) | Medical benefit — J2356 + 96372 on practice claim |
| 210 mg prefilled pen (autoinjector) | Verify carton NDC at billing | HCP first dose; patient self-admin thereafter | Pharmacy benefit after first dose — specialty pharmacy fills; no practice claim |
Why the SKU matters for site-of-care UM: Commercial payers steer Tezspire toward the prefilled
pen + home self-admin pathway after the first in-clinic dose to shift the cost from medical (Part B / commercial
medical) to pharmacy (Part D / specialty pharmacy carve-out). Practices that continue HCP administration of
the vial/syringe long-term face site-of-care denials and downcoding pressure from UHC, Aetna, and Cigna.
The vial is NOT a patient-supplied SKU. The 210 mg/1.91 mL vial requires HCP withdrawal and
SC injection — do not dispense to patients. Only the prefilled pen is approved for self-administration.
Confirm SKU before billing: pen-supplied drug shipped to the patient from specialty pharmacy CANNOT be billed
as J2356 on the practice claim (recoupment risk).
Severe asthma biologic class comparison FDA verified May 2026
Tezspire is a "class of one" anti-TSLP — the only severe asthma biologic with no biomarker restriction in its FDA label.
Severe asthma biologics are organized by their molecular target. Anti-IgE (Xolair) was the first class, approved 2003 for allergic asthma with elevated IgE. Anti-IL-5 / anti-IL-5Rα (Nucala, Cinqair, Fasenra) target eosinophilic inflammation downstream and require documented eos counts. Anti-IL-4Rα (Dupixent — pharmacy benefit, out of scope for this page) blocks both IL-4 and IL-13 signaling. Tezspire's anti-TSLP mechanism is upstream of all of these — TSLP is an epithelial alarmin released in response to allergens, viruses, and pollutants, and drives both T2 and non-T2 inflammatory cascades. Result: efficacy across phenotypes, including eosinophil-low and IgE-low patients who fail other biologics.
| Tezspire | Nucala | Fasenra | Cinqair | Xolair | |
|---|---|---|---|---|---|
| HCPCS | J2356 | J2182 | J0517 | J2786 | J2357 |
| Generic | tezepelumab-ekko | mepolizumab | benralizumab | reslizumab | omalizumab |
| Target | TSLP (upstream) | IL-5 (ligand) | IL-5Rα (receptor) | IL-5 (ligand) | IgE (Fc-ε) |
| Manufacturer | AstraZeneca / Amgen | GlaxoSmithKline | AstraZeneca | Teva | Genentech / Novartis |
| Route | SC | SC | SC | IV | SC |
| Dose | 210 mg q4wk flat | 100 mg q4wk (asthma) | 30 mg q4wk → q8wk | 3 mg/kg q4wk (weight-based) | 75–375 mg q2–4wk (IgE/weight-based) |
| Biomarker gate (FDA label) | None | Eosinophilic phenotype | Eosinophilic phenotype | Eos ≥400 cells/µL | IgE 30–1500 IU/mL + perennial allergen |
| Admin CPT | 96372 | 96372 | 96372 | 96365 (IV, ~50 min) | 96372 |
| Self-admin available? | Yes (prefilled pen) | Yes (autoinjector + syringe) | Yes (autoinjector) | No (IV only) | Yes (prefilled syringe + autoinjector) |
| Indications | Severe asthma + CRSwNP (both ≥12 yr) | Asthma, EGPA, HES, CRSwNP, COPD (May 2025) | Asthma, EGPA | Asthma only | Asthma, CRSwNP, CSU, food allergy |
Where Tezspire wins on positioning: Severe asthma patients who fail anti–IL-5 (eos-low
responders) or anti–IgE (non-allergic phenotype) often have nowhere to go within the existing classes.
Tezspire's lack of biomarker gate makes it the most-flexible add-on — and the only option for the
"biologic naive but low eos and low IgE" patient. PATHWAY (Phase 2) and NAVIGATOR (Phase 3) pivotal trials
showed exacerbation reductions across phenotypes, including the eos-low subgroup.
Step therapy still applies for most payers, despite the label flexibility. UHC, Aetna, and
Cigna commonly require failure of one phenotype-specific biologic (typically Xolair if IgE-elevated, or
Nucala/Fasenra if eos-elevated) before approving Tezspire — even though the FDA label does not require
either biomarker. The step requirement is payer policy, not FDA. Document the prior biologic, duration, and
reason for discontinuation.
Dosing — flat 210 mg SC every 4 weeks FDA label May 2026
From the FDA prescribing information (BLA 761224, label rev Oct 17, 2025). Two indications, one dose, no adjustments.
| Indication | Age | Dose | Schedule | Units billed (J2356) | Doses/year |
|---|---|---|---|---|---|
| Severe asthma (add-on maintenance, any phenotype) | ≥12 yr (adolescent + adult) | 210 mg SC | q4wk | 210 | ~13 |
| CRSwNP NEW (chronic rhinosinusitis with nasal polyps, add-on maintenance) | ≥12 yr (adolescent + adult) | 210 mg SC | q4wk | 210 | ~13 |
Flat dose — no weight, no biomarker, no titration. Every patient billed under J2356
gets 210 units per dose, every visit, every time. There is no loading dose, no q8wk extension (unlike
Fasenra), and no weight-based scaling. This makes Tezspire the simplest biologic to bill in the severe asthma
class — the unit count never changes.
Worked example — severe asthma adult, 210 mg q4wk (in-clinic)
# Per dose
Drug units billed per dose: 210 (J2356)
HCPCS: J2356 · Modifier: JZ · Container: 1 × 210 mg single-dose syringe OR vial
Admin (if in clinic): 96372 (SC injection)
# Year-1 totals (in-clinic, before any home self-admin shift)
Total doses: 13 (q4wk × 52 weeks)
Total drug units billed: 2,730 (13 × 210)
Total drug cost (Q2 2026 ASP+6%): ~$48,001 before sequestration
Drug units billed per dose: 210 (J2356)
HCPCS: J2356 · Modifier: JZ · Container: 1 × 210 mg single-dose syringe OR vial
Admin (if in clinic): 96372 (SC injection)
# Year-1 totals (in-clinic, before any home self-admin shift)
Total doses: 13 (q4wk × 52 weeks)
Total drug units billed: 2,730 (13 × 210)
Total drug cost (Q2 2026 ASP+6%): ~$48,001 before sequestration
Worked example — severe asthma adult, 210 mg q4wk (home self-admin after first dose)
# First dose (in clinic, prefilled pen under HCP observation)
Drug units billed per dose: 210 (J2356)
HCPCS: J2356 · Modifier: JZ · Container: 1 × 210 mg prefilled pen
Admin: 96372
# Subsequent doses (home self-admin, specialty pharmacy fills)
Practice bills: nothing — specialty pharmacy fills + ships pen to patient
Patient self-injects per training; SP handles copay + refill
# Year-1 practice revenue under home-shift model
J2356 billed: 210 units (1 dose only)
96372 billed: 1 line
Drug cost on practice claim: ~$3,692 (Q2 2026 ASP+6%, first dose only)
Drug units billed per dose: 210 (J2356)
HCPCS: J2356 · Modifier: JZ · Container: 1 × 210 mg prefilled pen
Admin: 96372
# Subsequent doses (home self-admin, specialty pharmacy fills)
Practice bills: nothing — specialty pharmacy fills + ships pen to patient
Patient self-injects per training; SP handles copay + refill
# Year-1 practice revenue under home-shift model
J2356 billed: 210 units (1 dose only)
96372 billed: 1 line
Drug cost on practice claim: ~$3,692 (Q2 2026 ASP+6%, first dose only)
No premedication required
Unlike anti-CD20 mAbs (Ocrevus, Briumvi), Tezspire does NOT require pre-injection methylprednisolone or antihistamine. Anaphylaxis is rare but reported — have epinephrine and observation capability available for the first in-clinic dose. Pre-existing helminth infections should be treated before initiation. Do NOT use Tezspire for acute bronchospasm or status asthmaticus — it is a maintenance biologic, not a rescue therapy.
NDC reference FDA NDC Directory verified May 2026
| NDC (10/11-digit) | Strength | Package Size | Units/Container |
|---|---|---|---|
55513-112-01 |
210 mg / 1.91 mL (110 mg/mL) | Single-dose prefilled syringe with fixed 27G ½" needle — 1 syringe per carton | 210 units (1 mg = 1 unit J2356) |
55513-100-01 |
210 mg / 1.91 mL (110 mg/mL) | Single-dose vial — 1 vial per carton (HCP-administered only; do not dispense to patients) | 210 units |
| Prefilled pen (autoinjector) — verify current carton NDC on packaging | 210 mg / 1.91 mL | Single-dose prefilled pen — 1 per carton. FDA-approved for at-home self-administration after first in-clinic dose. | 210 units |
Use carton-level NDC, not vial-level. Payers expect the 11-digit carton NDC on the claim
form. Verify the current NDC on the actual carton at billing time — AstraZeneca / Amgen maintain
three SKUs (vial, syringe, pen), and NDCs can rotate when packaging is refreshed. Use the carton-level NDC
printed on the SKU you administered.
Storage: Refrigerate at 2°C to 8°C (36°F to 46°F) in original carton to
protect from light. Per AZ label, prefilled syringe and pen may be kept at room temperature (68°F to
77°F) for a maximum of 30 days — once removed from refrigeration, do not return to refrigerator.
Manufacturer note: Tezspire is co-developed and co-marketed by AstraZeneca and Amgen. AZ
leads commercialization in most regions; Amgen handles manufacturing. Patient support is jointly delivered
via AstraZeneca Access 360 and Amgen Assist 360 — see patient assistance
section.
Phase 2
Code the claim
SC injection codes apply — not IV, not chemo. Self-admin shifts billing entirely to pharmacy benefit.
SC administration codes CPT verified May 2026
Tezspire is subcutaneous — do NOT use IV or chemo admin codes.
| Code | Description | When to use |
|---|---|---|
96372 |
Therapeutic, prophylactic, or diagnostic injection (specify substance or drug); subcutaneous or intramuscular | Primary code for in-clinic Tezspire SC administration. Most-accepted across payers. |
96401 |
Chemotherapy administration, SC/IM; non-hormonal anti-neoplastic | Some payers historically accepted 96401 for biologic SC admin, but Tezspire is not anti-neoplastic. 96372 is the safer choice. |
96365 / 96366 |
Therapeutic IV infusion (non-chemo) | NOT appropriate. Tezspire is subcutaneous, not IV. |
96413 / 96415 |
Chemotherapy IV infusion | NOT appropriate. Wrong route AND wrong category. |
| No admin CPT | Patient home self-administration with prefilled pen | Practice bills nothing after the patient transitions to pen self-admin. Specialty pharmacy fills the prescription; no medical claim from the practice for the drug or admin. |
First in-clinic dose vs subsequent home doses: Tezspire's typical billing pathway is one
in-clinic dose under HCP observation (J2356 + 96372 + JZ) followed by transition to home self-admin with
the prefilled pen (specialty pharmacy fills, no medical claim). Some patients remain in-clinic long-term
(no caregiver, pen aversion, etc.) — those continue J2356 + 96372 per visit.
Don't bill J2356 for a drug your specialty pharmacy already shipped to the patient. Once
the SP transition has occurred for the prefilled pen, the practice is administering patient-supplied drug
if any in-office dose occurs. Bill ONLY the admin code (96372) — not the drug. Billing J2356 for
SP-supplied drug is a recoupment risk.
Modifiers CMS verified May 2026
JZ — required on virtually every claim (default for Tezspire)
Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. The Tezspire 210 mg prefilled syringe and 210 mg prefilled pen deliver fixed doses with no partial-volume waste possible. The 210 mg single-dose vial is also a single-dose container, used in whole units (one vial per 210 mg dose). JZ is the default modifier on every J2356 claim.
JW — essentially never needed
JW reports the discarded portion of a single-dose vial. With prefilled syringes and pens, partial waste is essentially impossible. With the 210 mg vial, the entire vial is withdrawn for the 210 mg dose — zero waste is the norm. JW is essentially never billed for Tezspire. One of JZ or JW must be on every J2356 claim per CMS's July 2023 single-dose container policy — for Tezspire, that's JZ in virtually all cases.
Modifier 25 — same-day E/M
Use modifier 25 on the E/M code when a significant, separately identifiable evaluation and management service is performed on the same day as the injection. Routine pre-injection clinical assessment is bundled.
340B modifiers (JG, TB)
For 340B-acquired Tezspire, follow your MAC's current 340B modifier policy (JG and/or TB depending on Medicare vs Medicaid). AstraZeneca / Amgen's joint billing guide does not provide 340B-specific instructions — defer to your MAC.
ICD-10-CM by indication FY2026 verified May 2026
Tezspire has two FDA-approved indications: severe asthma and CRSwNP, both as add-on maintenance in patients ≥12 yr.
| ICD-10 code | Description | Use for Tezspire? | Notes |
|---|---|---|---|
J45.50 |
Severe persistent asthma, uncomplicated | Yes — primary | Most common Tezspire diagnosis code. Document severe persistent asthma per GINA / NHLBI criteria. |
J45.51 |
Severe persistent asthma with (acute) exacerbation | Yes — primary | Use when patient has documented recent exacerbation; strengthens PA case for biologic add-on. |
J45.52 |
Severe persistent asthma with status asthmaticus | Yes — primary | Use when patient had recent status episode requiring ED/hospitalization. Note: Do not initiate Tezspire DURING an acute status episode — biologic is maintenance only. |
J45.40–J45.42 |
Moderate persistent asthma (with/without exacerbation/status) | Sometimes accepted | Some payers accept when severity is documented as borderline severe; verify per plan. Severe codes (J45.5x) are the safer billing choice. |
J45.30–J45.32 |
Mild persistent asthma | No | Tezspire FDA label is for severe asthma. Mild persistent codes will trigger denial. |
J45.20–J45.22 |
Mild intermittent asthma | No | Outside FDA label. Denial. |
J33.0 / J33.1 / J33.8 / J33.9 |
Chronic rhinosinusitis with nasal polyps (CRSwNP) | Yes — NEW indication | FDA-approved for CRSwNP add-on maintenance in patients ≥12 yr (label rev Oct 2025, WAYPOINT trial). J33.0 antrochoanal polyp, J33.1 polypoid sinus degeneration, J33.8 other polyp, J33.9 unspecified. Pair with chronic rhinosinusitis code J32.x if appropriate. Compete with Nucala (J2182), Xolair (J2357), and Dupixent in this space. |
Concurrent ICS+LABA controller therapy documentation is required. Tezspire is an
add-on maintenance biologic — it does not replace inhaled controller therapy. Most payers
require the chart to document active concurrent high-dose ICS+LABA at the time of Tezspire initiation
(and continuing during therapy). Missing controller documentation is a top denial trigger.
Wrong ICD-10 = automatic denial. Tezspire billed against mild asthma codes (J45.2x / J45.3x)
or non-asthma / non-CRSwNP respiratory codes will not be approved. The FDA label is severe persistent asthma OR
CRSwNP, age ≥12, add-on maintenance. Match the ICD-10 to the documented indication BEFORE submitting the claim.
Site of care & place of service Verified May 2026
UnitedHealthcare, Aetna, and most major BCBS plans run aggressive site-of-care UM for SC biologics like Tezspire — pushing administration into the office (POS 11) for the first dose, then transitioning to home self-admin with the prefilled pen via specialty pharmacy. Hospital outpatient (HOPD / POS 22 / 19) is actively disfavored and frequently denied for SC biologics.
| Setting | POS | Claim form | Payer steering |
|---|---|---|---|
| Pulmonologist / allergist office | 11 | CMS-1500 / 837P | Preferred for first dose |
| Patient home (pen self-admin) | n/a (pharmacy benefit) | Specialty pharmacy fill | Strongly preferred after first dose |
| Patient home (HHA-administered syringe) | 12 | CMS-1500 | Variable; verify HHA scope |
| Hospital outpatient (on-campus) | 22 | UB-04 / 837I | Rare and disfavored; UM steers out quickly |
| Hospital outpatient (off-campus PBD) | 19 | UB-04 / 837I | Rare and disfavored |
| Ambulatory infusion suite | 49 | CMS-1500 | Acceptable but uncommon for SC |
Specialty pharmacy is the long-term home for Tezspire. Practices typically administer the
first 1–3 doses in clinic (PA processing + patient education on the prefilled pen + injection training),
then the patient transitions to SP-shipped pen for home self-admin. Plan staffing and revenue accordingly
— Tezspire is not a long-term in-clinic patient.
HOPD administration of Tezspire is almost never approved for commercial plans. If the
patient was started in the hospital outpatient department, plan to transition to office or home within
1–2 doses or face site-of-care denials. Document medical necessity for HOPD setting (e.g., comorbid
anaphylaxis risk, prior severe reaction to other biologic) if HOPD is unavoidable.
Claim form field mapping AZ / Amgen 2026
From AstraZeneca Access 360 + Amgen Assist 360 joint billing & coding guidance for Tezspire.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b | Rendering provider (pulmonologist / allergist / primary care) |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | N4 + carton NDC + ML + 1.91 (for the 210 mg / 1.91 mL single-dose syringe or vial) |
| HCPCS J2356 + JZ | 24D (drug line) | JZ on virtually every claim (single-dose container, zero waste) |
| Drug units | 24G | 210 per dose (flat, no exceptions) |
| CPT 96372 (admin line) | 24D (admin line) | SC injection — bill 1 line per encounter |
| ICD-10 | 21 | J45.50 / J45.51 / J45.52 (severe persistent asthma) primary |
| Prior biologic history (when payer requires) | (chart, not claim) | Document prior Xolair / Nucala / Fasenra trial, duration, and reason for discontinuation in chart and PA attachment |
| Concurrent ICS+LABA documentation | (chart, not claim) | Maintain in chart for PA defense; many payers require active concurrent controller therapy |
| PA number | 23 | Required by all major payers |
Phase 3
Get paid
Step therapy from a phenotype-specific biologic is the most common PA prerequisite, despite the no-biomarker FDA label.
Payer policy snapshot + step therapy Reviewed May 2026
All major payers require PA, ICS+LABA documentation, and (usually) step therapy from a phenotype-specific biologic — despite Tezspire's no-biomarker FDA label.
| Payer | PA? | Severe asthma documentation | Step therapy | Site-of-care UM |
|---|---|---|---|---|
| UnitedHealthcare Severe Asthma Biologics policy |
Yes | Severe persistent asthma (J45.5x); ICS+LABA failure; pulm/allergist prescriber | Failure of one prior biologic (Xolair for allergic phenotype OR Nucala/Fasenra for eosinophilic phenotype) commonly required | Aggressive: pen self-admin transition via Optum Specialty within 30–60 days |
| Aetna CPB + Medical Drug policies |
Yes | Severe persistent asthma; high-dose ICS+LABA + LTRA trial documented | Step from another asthma biologic typically required; some plans permit Tezspire first for documented eos-low / IgE-low patients | Yes; SP transition via designated SP partner |
| BCBS plans Vary by plan |
Yes | Generally aligned with GINA + payer asthma biologic policies | Plan-specific; many require ICS+LABA + step from another asthma biologic | Plan-specific; most have SP steering |
| Cigna Coverage Policy IP0186 (severe asthma biologics) |
Yes | Severe persistent asthma documented; ICS+LABA failure | ICS+LABA + LTRA + commonly step from another biologic (Xolair or Nucala/Fasenra) | Yes; Accredo SP transition common |
| Medicare (MAC LCDs) No NCD; coverage via local LCDs |
Generally no PA, but documentation requirements apply | Severe persistent asthma + concurrent ICS+LABA documented in chart | Step from inhaled controllers documented; prior biologic trial often documented but not always required | Less aggressive than commercial; most MACs cover in-clinic admin without strict SP shift |
Step-therapy logic within the severe asthma biologic class
Despite Tezspire's no-biomarker FDA label, most commercial payers apply step therapy. Common ladders:
- Step 1: high-dose ICS (inhaled corticosteroid) + LABA (long-acting beta-agonist) trial documented
- Step 2: add LTRA (montelukast) and/or LAMA (tiotropium); document failure
- Step 3 (phenotype-targeted biologic):
- If allergic phenotype with elevated IgE → Xolair (J2357) first
- If eosinophilic phenotype (eos ≥150) → Nucala (J2182) or Fasenra (J0517) first
- If both phenotypes negative (eos-low, IgE-low) → some plans permit Tezspire directly
- Step 4: Tezspire after failure of one phenotype-specific biologic, OR direct after Step 2 for biomarker-negative patients (plan-dependent)
Some plans permit Tezspire as first-line biologic when the patient has documented severe asthma but no clear T2 phenotype (eos-low AND IgE-low). Others require Xolair or Nucala/Fasenra trial first regardless. Verify per plan before submitting PA.
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J2356
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
ASP + 6%
$17.583
per mg / per unit
210 mg dose (severe asthma)
$3,692.43
210 units × ASP+6%
Annualized (~13 doses)
~$48,001
drug cost only, pre-sequestration
Per-dose calculation: 210 mg × $17.583/mg = $3,692.43 per dose
(ASP + 6%, Q2 2026). After ~2% sequestration: roughly $3,618.58 paid (ASP + 4.3% effective).
Annualized cost (Medicare ASP+6%, 13 doses/year): ~$48,001/year on the
in-clinic Part B pathway. After SP transition, drug cost shifts to Part D / specialty pharmacy and the
practice claim drops to admin-only (or zero, if patient self-administers fully at home). ASP is updated
quarterly by CMS — next update: July 1, 2026 for Q3.
Coverage
No NCD specific to tezepelumab. Coverage falls under MAC LCDs for asthma biologics + the generic drug-coverage framework. All MACs cover J2356 for the FDA-approved on-label indication (severe persistent asthma, ≥12 yr, add-on maintenance) with appropriate ICD-10 and ICS+LABA documentation.
Code history
- J2356 — permanent code, effective January 1, 2023
- Pre-permanent-code period (Dec 2021 – Dec 2022) — claims used unclassified
J3490(drugs not otherwise classified) orC9399(HOPD unclassified) with manual NDC documentation
Patient assistance — AZ Access 360 + Amgen Assist 360 AZ / Amgen verified May 2026
Tezspire is co-marketed by AstraZeneca and Amgen, and patient support is jointly delivered through both manufacturers' hub programs. Tezspire-specific resources sit primarily under AstraZeneca Access 360, with Amgen Assist 360 backstopping certain commercial copay and reimbursement workflows. Use the Tezspire-specific portal (tezspire.com) as the single-entry point for HCP and patient resources.
- AstraZeneca Access 360 (Tezspire hub): 1-844-275-2360 — benefits investigation, prior authorization assistance, appeal support, specialty pharmacy coordination
- Amgen Assist 360: 1-888-427-7478 — backup reimbursement support; coordinates with AZ Access 360 on Tezspire-specific cases
- Tezspire Co-pay Card (commercial): eligible commercially-insured patients may pay as little as $0 per dose (excludes Medicare, Medicaid, TRICARE, VA, and other federal program patients) — annual cap applies, verify current limit at tezspire.com
- AZ&Me Prescription Savings Program (PAP): free product for uninsured patients meeting income requirements (typically ≤300% FPL)
- Foundations (Medicare patients): refer to PAN Foundation, HealthWell Foundation, NORD — verify open severe asthma funds quarterly (funds frequently close and reopen)
- Tezspire HCP/patient portal: tezspire.com
- AZ Access 360 portal: myaccess360.com
- Amgen Assist 360 portal: amgenassist360.com
Start with AZ Access 360 first. For Tezspire-specific benefits investigation, PA support,
and copay card enrollment, AstraZeneca Access 360 is the primary entry point. Amgen Assist 360 backstops
Tezspire and is the right starting point only if the patient is already in Amgen's system for another
Amgen product (e.g., Repatha, Aimovig — though Aimovig is now pharmacy benefit).
Need to model what a specific patient will actually pay after copay assistance, deductible, coinsurance,
and OOP max? Run a CareCost Estimate — J2356 pre-loaded with the 210 mg
flat-dose calculation and both AZ Access 360 + Amgen Assist 360 program logic.
Phase 4
Fix problems
Missing severe asthma documentation, missing concurrent controller, and step-therapy gaps are the top three denials.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Severity not documented (asthma classified as moderate or mild in chart) | ICD-10 J45.2x or J45.3x billed, or J45.4x billed without severity clarification | Re-stage asthma severity per GINA / NHLBI criteria. Document severe persistent classification (J45.50/.51/.52) in chart and on PA. Submit corrected claim with severe code. |
| Concurrent ICS+LABA controller therapy not documented | PA submitted without evidence of active high-dose ICS+LABA at time of Tezspire initiation | Document specific ICS+LABA product, dose, duration, and continuation plan. Tezspire is add-on, not replacement — controller must continue. |
| Step therapy from prior biologic not documented | Plan requires Xolair / Nucala / Fasenra trial first; PA submitted without prior biologic history | Document prior biologic, duration of trial (typically ≥4 months), and specific reason for discontinuation (continued exacerbations, lack of response, intolerance). Submit appeal with full history. |
| Pediatric <12 yr (off-label) | Tezspire prescribed for patient under age 12 | Tezspire FDA label is ≥12 yr only. Use Nucala (40 mg pediatric SKU, 6-11 yr) for severe eosinophilic asthma in younger patients. Tezspire pediatric trials ongoing. |
| Indication off-label (CRSwNP, COPD, atopic dermatitis) | Tezspire billed against non-asthma ICD-10 | Tezspire is FDA-approved for severe asthma only. CRSwNP → use Nucala or Dupixent. COPD and atopic dermatitis are not approved indications — claim will deny. |
| Wrong admin code (96365 IV) | IV therapeutic billed instead of SC | Resubmit with 96372 (SC injection). Tezspire is subcutaneous, not IV. |
| Wrong admin code (96413 chemo) | Chemo IV billed | Resubmit with 96372. Tezspire is not chemotherapy and not IV. |
| JZ missing | Single-dose container claim without JZ | Resubmit with JZ. Required since 7/1/2023 on every claim with no waste — default for Tezspire (single-dose syringe / vial / pen). |
| Site of care (HOPD) denial | HOPD administration with commercial plan + site-of-care UM | Move to office (POS 11). For long-term, transition patient to home self-admin with prefilled pen via SP. |
| Drug billed after specialty pharmacy transition | Practice billed J2356 after patient transitioned to SP-shipped pen supply | Bill ONLY admin (96372) for SP-supplied drug — not the drug. Billing J2356 for SP-supplied drug is recoupment risk. Confirm SP fulfillment status before each visit. |
| Prescriber specialty mismatch | Tezspire prescribed by primary care without pulm/allergy involvement; some plans require specialist | Confirm prescriber specialty matches plan requirements. UHC and several plans require pulmonologist or allergist prescriber for severe asthma biologics. Co-management documentation may satisfy this. |
Frequently asked questions
What is the HCPCS code for Tezspire?
Tezspire (tezepelumab-ekko) is billed under HCPCS J2356 — "Injection, tezepelumab-ekko,
1 mg." Each milligram equals one billable unit. J2356 became a permanent code on January 1, 2023; before
that, claims used unclassified J3490 / C9399.
How many units do I bill for a Tezspire dose?
210 units per dose, every dose, every visit. Tezspire uses a flat 210 mg SC dose every 4 weeks regardless of weight, age, eosinophil count, or IgE level — no biomarker-based or weight-based adjustment. Annualized: ~13 doses per year = 2,730 units of J2356.
How does Tezspire compare to Nucala, Fasenra, and Xolair?
Tezspire (tezepelumab, J2356) is anti-TSLP — a "class of one" upstream-of-eosinophil biologic with no biomarker gate in its FDA label. Nucala (mepolizumab, J2182) and Fasenra (benralizumab, J0517) are anti–IL-5 SC q4wk biologics that require eosinophil documentation (typically ≥150 cells/µL). Cinqair (reslizumab, J2786) is anti–IL-5 IV q4wk, also eosinophil-gated. Xolair (omalizumab, J2357) is anti-IgE for allergic asthma with elevated IgE + perennial aeroallergen sensitization. Tezspire works in patients who fail biomarker-targeted biologics — but payers often still require step therapy.
Is a biomarker required for Tezspire coverage?
The FDA label has no biomarker threshold — Tezspire is approved for severe asthma add-on maintenance regardless of phenotype. However, most major commercial payers (UnitedHealthcare, Aetna, Cigna, BCBS plans) still impose step therapy: documented severe persistent asthma (J45.50/.51/.52), failure of high-dose ICS+LABA, and many require failure of at least one prior phenotype-specific biologic (typically Xolair for allergic phenotype or Nucala/Fasenra for eosinophilic phenotype) before approving Tezspire.
What are the step therapy considerations?
Standard ladder: (1) high-dose ICS+LABA, (2) add LTRA/LAMA, (3) phenotype-targeted biologic trial — Xolair if IgE-elevated + allergic, Nucala/Fasenra if eosinophil-elevated, (4) Tezspire after failure of step 3, OR Tezspire directly for biomarker-negative (eos-low AND IgE-low) patients on plans that permit it. UHC and Cigna commonly require one biologic step; Aetna and some BCBS plans permit direct-to-Tezspire for documented biomarker-negative cases. Verify per plan.
Can patients self-administer Tezspire at home?
Yes. The 210 mg prefilled pen (autoinjector) is FDA-approved (added in 2023) for at-home self-administration after the first dose is given in clinic under HCP observation. Once a patient transitions to home self-admin, billing shifts entirely from the medical benefit (J2356 + 96372) to the pharmacy benefit (specialty pharmacy fills, no admin code). The prefilled syringe and vial SKUs remain HCP-administered only.
Is Tezspire billed under pharmacy or medical benefit?
Both, depending on the SKU and setting. Vial (NDC 55513-100-01) and prefilled syringe (NDC 55513-112-01) are HCP-administered → medical benefit (J2356 + 96372 on practice claim). Prefilled pen (autoinjector) shifts to pharmacy benefit after the first in-clinic dose → specialty pharmacy fills, no medical claim from the practice. UHC and most major payers steer patients to the pen + pharmacy benefit pathway to shift cost out of the medical line.
Is Tezspire approved for pediatric patients?
Tezspire is FDA-approved for patients aged 12 years and older with severe asthma. It is NOT approved for children under 12. For severe eosinophilic asthma in patients ages 6–11 yr, use Nucala (40 mg pediatric prefilled syringe SKU). Tezspire pediatric (<12 yr) trials are ongoing.
Can I switch a patient from another asthma biologic to Tezspire?
Yes — Tezspire is commonly used after failure of anti–IL-5 (Nucala, Fasenra, Cinqair) or anti–IgE (Xolair) biologics, particularly in patients with persistent uncontrolled severe asthma despite biomarker-targeted therapy. Document the prior biologic, duration of trial (typically ≥4 months recommended), and reason for discontinuation. Most payers will not approve concurrent biologic therapy — discontinue the prior biologic before initiating Tezspire. Coordinate with specialty pharmacy on transition timing to avoid coverage gaps.
What is the Medicare reimbursement for J2356?
For Q2 2026, the Medicare Part B payment limit for J2356 is $17.583 per mg (ASP + 6%). The 210 mg dose reimburses at approximately $3,692.43 per injection. Annualized (Medicare ASP+6%, 13 doses/year): ~$48,001 for the in-clinic Part B pathway. Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%.
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- Tezspire product website (AstraZeneca / Amgen)
- FDA Prescribing Information — TEZSPIRE (tezepelumab-ekko)
- DailyMed — TEZSPIRE (tezepelumab-ekko) Prescribing Information
- AstraZeneca Access 360 — Tezspire hub
- Amgen Assist 360 — reimbursement support
- CMS — Medicare Part B Drug ASP Pricing File
- SEER CanMED — HCPCS J2356 reference
- UnitedHealthcare — Severe Asthma Biologics Coverage Policy
- Aetna — Asthma & Asthma Biologics Clinical Policy Bulletins
- Cigna — Coverage Policy IP0186 (severe asthma biologics)
- GINA — Global Initiative for Asthma 2026 strategy report
- NHLBI — National Heart, Lung, and Blood Institute severe asthma guidance
- NAVIGATOR Phase 3 trial — Menzies-Gow et al, NEJM 2021
- PATHWAY Phase 2 trial — Corren et al, NEJM 2017
- FDA National Drug Code Directory
About this page
We maintain this page as a living reference. Medicare ASP pricing is bound to our underlying CareCost data layer and refreshes automatically when CMS publishes new quarterly files. Coding and policy content is reviewed at least quarterly and updated whenever a source document changes.
Found an error? Email hello@carecostestimate.com.
Refresh cadence
| Element | Cadence | How it's refreshed |
|---|---|---|
| Medicare ASP pricing | Quarterly | Auto-bound to CareCost ASP layer; updates on CMS file release. |
| Payer policies (UHC, Aetna, BCBS, Cigna) | Semi-annual | Manual review against published payer policy documents. |
| HCPCS / CPT / modifier rules | Annual | Reviewed against CMS HCPCS quarterly files, AMA CPT releases. |
| NDC, dosing, FDA label, indication list | Event-driven | Tied to manufacturer document version + FDA label revision date. WAYPOINT (CRSwNP) results pending; may add CRSwNP indication if approved. |
Reviewer
Pending SME review. This page is staff-authored from primary sources (FDA, CMS,
manufacturer, payer documents — all linked above). Editorial review in progress. Until that review
is complete, treat this as a draft reference and verify each cited source for high-stakes claims.
Change log
- — Initial publication. ASP data: Q2 2026 ($17.583/mg). Manufacturer source: AstraZeneca Access 360 + Amgen Assist 360 joint billing materials. FDA label: most recent revision (BLA 761224, initial approval Dec 17, 2021; self-administration pen added 2023). Single FDA indication: severe persistent asthma add-on maintenance, ≥12 yr, no biomarker restriction. Severe asthma biologic class comparison vs Nucala (J2182), Fasenra (J0517), Cinqair (J2786), and Xolair (J2357).
Methodology
Every claim on this page is sourced inline. Pricing reflects the current CMS Part B Drug ASP Pricing File. Payer policies are read directly from each payer's published medical/pharmacy policy documents. Indication list and dosing are verified against the current FDA label revision. NAVIGATOR (Phase 3) and PATHWAY (Phase 2) trial data cited for phenotype-spanning efficacy. We do not paraphrase from billing-software vendor blogs.