HCPCS
J0517
1 mg = 1 unit
Phase 1
Identify what you're billing
Confirm dose, schedule, and which anti-IL-5 you actually have.
Mechanism differentiator — IL-5R-alpha + ADCC FDA verified May 2026
Why Fasenra acts differently than Nucala and Cinqair, even though all three target the IL-5 axis.
Fasenra (benralizumab) is the only anti-IL-5 receptor alpha (IL-5R-alpha) monoclonal antibody on the market. It binds the alpha subunit of the IL-5 receptor expressed on the surface of eosinophils and basophils, and is afucosylated — meaning it has high affinity for the FcgammaRIIIa receptor on natural killer (NK) cells. The result is antibody-dependent cellular cytotoxicity (ADCC): NK cells recognize Fasenra-bound eosinophils and induce eosinophil apoptosis directly.
Clinically, this produces near-complete eosinophil depletion within ~24 hours of the first dose. By contrast, Nucala (mepolizumab) and Cinqair (reslizumab) bind the soluble IL-5 ligand itself — they prevent IL-5 from signaling through the receptor (which slows new eosinophil production and survival) but do not directly kill circulating eosinophils.
Billing implication of mechanism difference: Because Fasenra produces near-complete
eosinophil depletion regardless of baseline count, the FDA label does not impose a specific eosinophil
count threshold. Nucala (>=150 cells/uL) and Cinqair (>=400 cells/uL) do. This is the single most
common source of confusion when comparing PA criteria across the three drugs — payer LCDs may
still impose an eos threshold for Fasenra even though the FDA does not.
Do not paraphrase mechanism on PA forms. When responding to PA questions about
mechanism, cite the FDA label directly. Misstating "binds IL-5" (incorrect) versus "binds IL-5R-alpha
on eosinophils, mediates ADCC" (correct) can trigger clinical-review escalation and approval delay.
Dosing & unit math FDA label verified May 2026
From FDA prescribing information, post-Sep 2024 EGPA expansion.
Severe eosinophilic asthma (adult + adolescents >=12 years)
- Loading: 30 mg SC at weeks 0, 4, and 8 (three doses, every 4 weeks)
- Maintenance: 30 mg SC every 8 weeks thereafter
- Fixed dose — not weight-based
- 1 mg = 1 unit, so each dose = 30 units of J0517
- One prefilled syringe OR one Fasenra Pen autoinjector per dose
EGPA (adult >=18 years; FDA-approved Sep 2024)
- Same dosing as asthma: 30 mg SC at weeks 0, 4, 8, then 30 mg SC every 8 weeks
- Used in addition to oral corticosteroid taper per clinical management plan
Worked example — first-year billing for a severe eosinophilic asthma patient
# Loading phase (weeks 0, 4, 8) -- 3 clinic doses
Drug units billed per dose: 30 (J0517)
HCPCS: J0517 · Modifier: JZ · Device: 1 prefilled syringe
Admin: 96372 (therapeutic SC, non-chemo)
# Maintenance phase (week 16, 24, 32, 40, 48 -- ~6 doses year 1)
Q8wk schedule: ~6.5 doses/year ongoing
Year 1 total doses: ~9 (3 loading + ~6 maintenance)
Year 2+ total doses: ~6.5/year (q8wk maintenance only)
# Year-1 drug cost (Q2 2026 ASP+6% = ~$163.357/mg)
9 doses x 30 mg x $163.357: ~$44,106 before sequestration
Year 2+ ongoing: ~$31,855/year (6.5 doses)
Drug units billed per dose: 30 (J0517)
HCPCS: J0517 · Modifier: JZ · Device: 1 prefilled syringe
Admin: 96372 (therapeutic SC, non-chemo)
# Maintenance phase (week 16, 24, 32, 40, 48 -- ~6 doses year 1)
Q8wk schedule: ~6.5 doses/year ongoing
Year 1 total doses: ~9 (3 loading + ~6 maintenance)
Year 2+ total doses: ~6.5/year (q8wk maintenance only)
# Year-1 drug cost (Q2 2026 ASP+6% = ~$163.357/mg)
9 doses x 30 mg x $163.357: ~$44,106 before sequestration
Year 2+ ongoing: ~$31,855/year (6.5 doses)
No premedication routinely required
Unlike anti-CD20 mAbs (Ocrevus, Briumvi, Tyruko) or chemo/IO infusions, Fasenra does not require premedication. Subcutaneous administration takes 1–2 minutes. Observe for hypersensitivity reactions per FDA label, especially after the first few doses.
EGPA indication — added September 2024 FDA verified May 2026
Fasenra is the second anti-IL-5 with FDA EGPA approval (Nucala was first; Cinqair is NOT approved for EGPA).
In September 2024, the FDA approved Fasenra for adult patients (>=18 years) with eosinophilic granulomatosis with polyangiitis — formerly known as Churg-Strauss syndrome. EGPA is a rare ANCA-associated vasculitis characterized by asthma, eosinophilia, and granulomatous inflammation affecting small-to-medium vessels.
ICD-10 for EGPA:
M30.1 — "Polyarteritis with lung involvement
[Churg-Strauss]." Use this on the claim AND in the PA submission. Do not use asthma codes (J45.x)
for the EGPA indication even if the patient also has asthma history.
Adult-only for EGPA. The >=12 years adolescent expansion applies only to severe
eosinophilic asthma. EGPA dosing and indication is restricted to adults >=18 years.
NDC reference FDA NDC Directory verified May 2026
| NDC (10/11-digit) | Device / package | Use |
|---|---|---|
0310-1730-30 / 00310-1730-30 |
30 mg / 1 mL prefilled syringe — 1 syringe per carton | Healthcare-provider administration in clinic / infusion suite |
0310-1830-30 / 00310-1830-30 |
30 mg / 1 mL Fasenra Pen autoinjector — 1 pen per carton | Patient self-administration at home (after first 3 clinic doses); also clinic-administered |
Use carton-level NDC, not vial-level. Payers expect the carton NDC on the claim
form. Specify the device type (prefilled syringe vs Fasenra Pen) clearly in the dispense record —
many payers prefer the autoinjector for home self-admin and the prefilled syringe for clinic admin.
Anti-IL-5 class comparison Verified May 2026
All three target the IL-5 axis for severe eosinophilic asthma but differ in target, dose, route, schedule, and biomarker rules.
| Fasenra (benralizumab) | Nucala (mepolizumab) | Cinqair (reslizumab) | |
|---|---|---|---|
| HCPCS | J0517 | J2182 | J2786 |
| Manufacturer | AstraZeneca | GSK | Teva |
| Target | IL-5 receptor alpha (depletes eos via ADCC) | Soluble IL-5 (ligand) | Soluble IL-5 (ligand) |
| Route | Subcutaneous | Subcutaneous | Intravenous (60-min infusion) |
| Dose | 30 mg fixed | 100 mg fixed (asthma); 300 mg (HES, EGPA) | 3 mg/kg weight-based |
| Loading | q4wk x 3 (weeks 0, 4, 8) | None (q4wk from start) | None (q4wk from start) |
| Maintenance interval | q8wk (the differentiator) | q4wk | q4wk |
| Doses per year (steady state) | ~6.5 | ~13 | ~13 |
| Self-admin at home | Yes (Fasenra Pen, after first 3 doses) | Yes (Nucala autoinjector, prefilled syringe) | No (IV only) |
| FDA eos threshold | None | >=150 cells/uL | >=400 cells/uL |
| Indications | Severe eosinophilic asthma (>=12y); EGPA (adults, Sep 2024) | Asthma, EGPA, HES, CRSwNP | Severe eosinophilic asthma only (adults) |
| Admin CPT | 96372 (SC) | 96372 (SC) | 96365 (IV) |
| 1 mg = 1 unit | Yes | Yes | Yes |
Cross-references:
Nucala (J2182) ·
Cinqair (J2786) ·
Xolair (J2357)
— Xolair (omalizumab) is anti-IgE, not anti-IL-5, and is the most commonly required prior step
therapy for the anti-IL-5 class on commercial PA forms.
Per-mg ASP is misleading on its own. Fasenra has the highest per-mg ASP among the
three (30 mg dose vs Nucala 100 mg vs Cinqair weight-based) but the q8wk maintenance and lower mg per
dose mean total annual drug cost is competitive. Always model annual cost when comparing.
Phase 2
Code the claim
Subcutaneous, non-chemo. CPT 96372 in clinic; pharmacy benefit at home.
Administration codes CPT verified May 2026
Fasenra is a SC injection. Use 96372 in clinic. Do not use IV or chemo admin codes.
| Code | Description | When to use |
|---|---|---|
96372 |
Therapeutic, prophylactic, or diagnostic injection (specify substance/drug); subcutaneous or intramuscular | Primary code for clinic-administered Fasenra. SC injection takes 1–2 minutes. |
96365 / 96366 |
Therapeutic IV infusion (non-chemo) | NOT appropriate. Fasenra is SC, not IV. For Cinqair (IV anti-IL-5), use 96365 instead. |
96401 |
Chemotherapy admin, SC/IM; non-hormonal anti-neoplastic | NOT appropriate. Benralizumab is non-chemo. Reserve 96401 for chemo SC drugs. |
96413 / 96415 |
Chemotherapy IV infusion | NOT appropriate. Wrong route AND wrong drug class. |
Why 96372 (not 96401): CPT 96401 is reserved for non-hormonal anti-neoplastic SC
chemotherapy. Benralizumab is an immunomodulator, not chemo. The AMA classification places
non-chemo therapeutic mAbs under 96372 when administered SC in clinic.
Clinic admin vs home self-admin billing Verified May 2026
Fasenra Pen is approved for home use AFTER the first 3 doses. Major billing transition between loading and maintenance.
Fasenra has a structural billing transition that is unique among injectable biologics: the first three doses (weeks 0, 4, 8) must be administered in a healthcare setting, and then the patient becomes eligible for home self-administration with the Fasenra Pen autoinjector. This shifts the drug from the medical benefit (buy-and-bill, J0517 + 96372) to the pharmacy benefit (specialty pharmacy dispense, no admin code).
| Phase | Setting | Benefit | How billed | Practice revenue |
|---|---|---|---|---|
| Loading (weeks 0, 4, 8) | Clinic / office / infusion suite | Medical (Part B for Medicare) | J0517 (30 units) + JZ + 96372 + ICD-10 | Drug margin + admin fee |
| Maintenance (q8wk) | Patient home (Fasenra Pen) | Pharmacy (Part D for Medicare; specialty pharmacy for commercial) | Specialty pharmacy dispense | None (drug shifts off practice's books) |
| Maintenance (alternative) | Clinic / office | Medical (Part B) | J0517 (30 units) + JZ + 96372 + ICD-10 | Drug margin + admin fee |
Patient preference + payer steering both push toward home self-admin. Most
commercial plans and Medicare Part D plans will steer maintenance dosing to pharmacy benefit once
the patient is trained on the Fasenra Pen. Practices that want to retain the dose under medical
benefit must document a clinical reason (e.g., dexterity issues, adherence concerns).
Medicare specifics: When Fasenra moves to home self-admin, the drug is typically
covered under Medicare Part D rather than Part B. Confirm the patient's Part D formulary placement
and any required PA before the loading phase ends to avoid a coverage gap at maintenance.
Modifiers CMS verified May 2026
JZ — required on virtually every clinic claim
Effective July 1, 2023, CMS requires the JZ modifier on all single-dose container claims when no drug is discarded. The Fasenra prefilled syringe and Fasenra Pen are single-dose devices with a fixed 30 mg dose — entire device is administered with zero waste. JZ applies to virtually every clinic-administered Fasenra claim.
JW — rare for Fasenra
JW reports the discarded portion of a single-dose vial/device. With prefilled syringes and pens delivering the entire 30 mg dose, partial-vial waste is rare. JW would apply only in unusual scenarios (e.g., device malfunction with documented discard). Document carefully if JW is used. One of JZ or JW must be on every J0517 clinic claim.
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 into 96372.
340B modifiers (JG, TB)
For 340B-acquired Fasenra, follow your MAC's current 340B modifier policy. AstraZeneca's billing guide does not provide 340B-specific instructions.
ICD-10-CM by indication FY2026 verified May 2026
Use the most specific code supported by encounter documentation.
| Indication | ICD-10 family | Notes |
|---|---|---|
| Severe eosinophilic asthma — severe persistent | J45.50 / J45.51 (uncomplicated / acute exacerbation) / J45.52 (status asthmaticus) | Most common Fasenra indication; document severity |
| Severe eosinophilic asthma — moderate persistent | J45.40 / J45.41 / J45.42 | Use when documentation supports moderate persistent severity |
| Mild persistent asthma | J45.30 / J45.31 / J45.32 | Generally insufficient for Fasenra PA approval |
| Other &/unspecified asthma | J45.9x | Avoid for PA — use specificity instead |
| EGPA (Churg-Strauss) | M30.1 | Polyarteritis with lung involvement; adult only (>=18); Sep 2024 FDA approval |
| Chronic eosinophilic pneumonia (clinical context) | J82.81 | Not a labeled Fasenra indication; reference only |
| Eosinophilia (lab finding, not stand-alone Dx) | D72.10 / D72.18 | Often supporting code, not primary; use disease ICD-10 as primary |
Specificity matters for asthma PA approval. Most payers require severe persistent
(J45.50–52) or, with strong supporting documentation, severe persistent eosinophilic phenotype
documented in the chart. Unspecified asthma codes (J45.9x) almost always trigger a PA denial.
Site of care & place of service Verified May 2026
UnitedHealthcare and Aetna run site-of-care UM for biologics. For Fasenra specifically, the q8wk maintenance and home self-admin pathway means most plans expect maintenance doses out of the clinic entirely (pharmacy benefit). Loading doses and patients who cannot self-administer are the main remaining medical-benefit scenarios.
| Setting | POS | Claim form | Payer steering |
|---|---|---|---|
| Pulmonologist / allergist office | 11 | CMS-1500 / 837P | Preferred for loading + medical-benefit maintenance |
| Ambulatory infusion suite (AIC) | 49 | CMS-1500 / 837P | Acceptable; common during loading |
| Hospital outpatient (on-campus) | 22 | UB-04 / 837I | Disfavored by commercial UM (SC drug) |
| Hospital outpatient (off-campus PBD) | 19 | UB-04 / 837I | Disfavored by commercial UM (SC drug) |
| Patient home (self-admin via Fasenra Pen) | N/A (pharmacy benefit) | Specialty pharmacy claim | Preferred for maintenance after loading |
Site-of-care opportunity: Once the patient self-administers at home with the
Fasenra Pen, the practice no longer captures the drug margin OR the admin fee. Plan accordingly
when projecting biologic revenue from a Fasenra panel.
Claim form field mapping AstraZeneca 2025
From AstraZeneca Access 360 / Fasenra Connect billing & coding guide.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b | Rendering provider |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | N4 + carton NDC + ML + 1 (one device per dose) |
| HCPCS J0517 + JZ | 24D (drug line) | Mark JZ on virtually every clinic claim |
| Drug units | 24G | 30 (always 30 for the standard dose) |
| CPT 96372 (admin line) | 24D (admin line) | SC injection; 1–2 minute administration |
| ICD-10 | 21 | Asthma severe persistent (J45.50–52) or EGPA (M30.1) |
| PA number | 23 | Required by all major commercial payers |
Phase 3
Get paid
Eos count, prior step therapy, and pulmonology documentation are the PA gates.
Eosinophil count biomarker — no FDA threshold, but payer LCDs may apply Verified May 2026
The single most important nuance distinguishing Fasenra from Nucala (>=150) and Cinqair (>=400).
The FDA label for Fasenra does not impose a specific eosinophil count threshold. This contrasts with Nucala (mepolizumab; FDA threshold of >=150 cells/uL within 6 weeks for severe eosinophilic asthma) and Cinqair (reslizumab; FDA threshold of >=400 cells/uL within 4 weeks). Mechanistically, the explanation is that Fasenra produces near-complete eosinophil depletion via ADCC regardless of baseline count.
However, payer LCDs and PA criteria typically still require an eosinophil count to support medical necessity. Common thresholds across commercial and Medicare Advantage policies:
- Commercial step-therapy policies: documented blood eosinophil count >=150 cells/uL (sometimes >=300) within the past 12 months
- Some payers accept historical peak eosinophilia (e.g., a documented value >=300 within the past 24 months)
- EGPA indication: history of eosinophilia and ANCA serology generally documented; specific threshold less commonly imposed
What to document for PA approval: Most recent absolute eosinophil count (AEC),
date of test, prior anti-IgE / ICS+LABA failure (Xolair often required as prior step), pulmonologist
or allergist confirmation of severe eosinophilic phenotype, and any prior anti-IL-5 trial outcome.
Common error: citing the FDA label as having no threshold and ignoring the payer policy.
Payer policy beats the label for reimbursement. Always check the specific payer's LCD or coverage
policy before submitting PA.
Payer policy snapshot Reviewed May 2026
Commercial PA gates: pulmonologist documentation, prior ICS+LABA, prior Xolair (often), and an eos count.
| Payer | PA? | Step therapy / preferred | Eos requirement |
|---|---|---|---|
| UnitedHealthcare Asthma Biologic Medical Drug Policy |
Yes | Step from ICS+LABA + Xolair (or documented contraindication); some plans step from another anti-IL-5 | Typically >=150 cells/uL in past 12 months |
| Aetna CPB 0790 (Asthma Biologics) |
Yes | Step from high-dose ICS+LABA; Xolair commonly required if IgE-mediated | >=150-300 depending on plan; document peak AEC |
| BCBS plans Vary by plan |
Yes | Generally aligned with NHLBI / GINA severe asthma management; pulmonologist required | Plan-specific; >=150 most common |
| Cigna / Express Scripts Specialty pharmacy |
Yes | ICS+LABA + Xolair step; some plans require trial of preferred anti-IL-5 first | >=150 cells/uL typical |
Step therapy patterns
Most commercial payers require: (1) high-dose ICS+LABA failure or intolerance, (2) Xolair (omalizumab) trial if IgE-mediated phenotype is also present, and (3) for some plans, a trial of the plan's preferred anti-IL-5 (often Nucala if cheaper, or vice versa). Document each step explicitly with dates, doses, and outcomes.
Pulmonology / allergy documentation
Pulmonologist or allergist evaluation is generally required before Fasenra approval. Primary care prescriptions are often denied without specialist co-signature. Document the consult and the severity assessment in the chart.
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J0517
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
ASP + 6%
$163.357
per mg / per unit
30 mg dose
$4,900.71
30 units × ASP+6%
Annual cost (year 2+)
~$31,855
~6.5 doses/year (q8wk)
Annualized cost: Year 1: 9 doses x 30 mg x $163.357 = ~$44,106
(3 loading + ~6 maintenance). Year 2+: 6.5 doses x 30 mg x $163.357 = ~$31,855/year.
After ~2% sequestration: ~$30,800/year actual paid in maintenance.
Highest per-mg ASP in the anti-IL-5 class — but offset by lower mg per dose AND q8wk
maintenance. When comparing total annual drug cost vs Nucala (J2182, 100 mg q4wk = ~13 doses
x 100 mg) and Cinqair (J2786, weight-based 3 mg/kg q4wk), Fasenra's annual cost is competitive
despite the higher per-mg price.
Coverage
No NCD specific to benralizumab. Coverage falls under MAC LCDs for biologics + the asthma biologic-coverage framework. All MACs cover J0517 for FDA-approved on-label indications with appropriate ICD-10 (J45.50–52 or M30.1) and pulmonology / allergy documentation. When the patient transitions to home self-admin, the drug typically moves to Medicare Part D.
Code history
- J0517 — permanent code, "Injection, benralizumab, 1 mg" (replaced earlier unclassified J3490 use)
Patient assistance — AstraZeneca Access 360 / Fasenra Connect AZ verified May 2026
- Fasenra Connect: 1-844-FASENRA (1-844-327-3672) — benefits investigation, prior authorization assistance, appeal support, training on Fasenra Pen self-administration
- AstraZeneca Access 360: central access program covering benefits investigation and reimbursement support across the AZ portfolio
- Fasenra Co-Pay Savings Program: commercial copay support; eligible commercially-insured patients pay as little as $0 for the first dose (excludes Medicare, Medicaid, federal program patients)
- AZ Patient Assistance Program: free product for uninsured / underinsured patients meeting income requirements (administered through AZ&MeRx)
- Foundations: for Medicare patients, refer to PAN, HealthWell, Good Days — verify open severe asthma funds quarterly
- Web: fasenra.com / myaccess360.com
Need to model what a specific patient will actually pay after copay assistance, deductible,
coinsurance, and OOP max? Run a CareCost Estimate — J0517
pre-loaded.
Phase 4
Fix problems
Wrong admin code, missing eos documentation, and benefit-transition errors are the top three.
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Eosinophil count not documented | PA submitted without recent AEC (or only baseline pre-treatment value) | Submit recent AEC (within 12 months for most plans). FDA label has no threshold but payer policies almost always do. |
| Wrong admin code (96365 or 96401) | IV or chemo admin billed for SC non-chemo drug | Resubmit with 96372 (therapeutic SC, non-chemo). Fasenra is SC injection, not IV, and not chemo. |
| Step therapy not met (Xolair) | No documented Xolair trial or contraindication | Document Xolair trial + outcome OR document IgE-mediated contraindication / not-IgE phenotype. |
| Pulmonologist documentation missing | PCP-prescribed without specialist evaluation | Obtain pulmonology / allergy consult note documenting severe eosinophilic asthma severity and Fasenra rationale. |
| Wrong ICD-10 (unspecified asthma) | J45.9 used instead of J45.50–52 | Use specific severity code (severe persistent J45.50–52). For EGPA, use M30.1. |
| JZ missing on clinic claim | Single-dose syringe/pen claim without JZ | Resubmit with JZ. Required since 7/1/2023 on every claim with no waste. |
| Wrong NDC format (vial-level) | Vial NDC submitted instead of carton NDC | Use carton NDC: 00310-1730-30 (prefilled syringe) or 00310-1830-30 (Fasenra Pen). |
| Site of care (HOPD) for SC drug | Hospital outpatient administration of a SC drug | Move to office (POS 11) or AIC (POS 49). HOPD steering is universal for SC biologics. |
| Benefit transition error at maintenance | Practice billed J0517 medical claim after patient began home self-admin (drug in pharmacy benefit) | Coordinate transition with specialty pharmacy at start of maintenance phase. Check patient's actual dispense source. |
| EGPA billed under asthma ICD-10 | J45.x code on EGPA claim | Use M30.1 for EGPA. Document EGPA Dx in chart with ANCA / biopsy / clinical criteria. |
Frequently asked questions
What is the HCPCS code for Fasenra?
Fasenra (benralizumab) is billed under HCPCS J0517 — "Injection, benralizumab,
1 mg." Each milligram equals one billable unit, so the standard 30 mg SC dose is billed as
30 units. J0517 is a permanent code. Billed under the medical benefit when administered in clinic;
shifts to pharmacy benefit when patients self-administer at home with the Fasenra Pen autoinjector
after the loading phase.
How many units do I bill for a Fasenra dose?
Bill 30 units of J0517 per 30 mg dose. The dose is fixed (not
weight-based) for both severe eosinophilic asthma and EGPA. One prefilled syringe or one Fasenra
Pen autoinjector per dose — 1 device = 30 mg = 30 units.
What is the Fasenra dosing schedule?
30 mg SC at weeks 0, 4, and 8 (three loading doses every 4 weeks), then 30 mg SC every 8 weeks thereafter as maintenance. The q8wk maintenance interval is the major patient-adherence differentiator from Nucala (q4wk ongoing) and Cinqair (q4wk ongoing IV). After the first 3 doses are administered in clinic, patients can self-administer at home with the Fasenra Pen autoinjector.
What administration CPT do I use for Fasenra?
CPT 96372 — "Therapeutic, prophylactic, or diagnostic injection (specify
substance/drug); subcutaneous or intramuscular." Fasenra is a SC injection. Do NOT bill 96365
(therapeutic IV) or 96401/96413 (chemo admin). When patients self-administer at home with the
Fasenra Pen, no admin code is billed and the drug shifts to the pharmacy benefit.
Does Fasenra require an eosinophil count threshold for FDA approval?
No FDA threshold, distinct from Nucala (>=150 cells/uL) and Cinqair (>=400 cells/uL). However, payer LCDs and PA criteria typically require documentation of an elevated baseline AEC (commonly >=150-300 cells/uL within 12 months) to support medical necessity. Always check the specific payer policy.
What is the Medicare reimbursement for J0517?
For Q2 2026, the Medicare Part B payment limit for J0517 is approximately $163.357 per mg (ASP + 6%). The standard 30 mg dose reimburses at approximately $4,900.71 per dose. After loading (year 1: ~9 doses ~$44,106), ongoing maintenance is ~6.5 doses/year at ~$31,855/year. Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%. ASP is updated quarterly by CMS.
How does Fasenra compare to Nucala and Cinqair?
Fasenra (J0517): 30 mg SC q4wk x 3 then q8wk, IL-5 receptor alpha target (depletes eosinophils via ADCC), no FDA eos threshold, also approved for EGPA. Nucala (J2182): 100 mg SC q4wk fixed, IL-5 ligand target, FDA threshold >=150, also approved for EGPA, HES, CRSwNP. Cinqair (J2786): 3 mg/kg IV q4wk weight-based, IL-5 ligand target, FDA threshold >=400. Fasenra's q8wk maintenance and home autoinjector make it the easiest for patient adherence; Cinqair's IV requirement is the most burdensome.
Is Fasenra approved for EGPA?
Yes. The FDA approved Fasenra for adult EGPA (formerly Churg-Strauss) in September 2024.
Use ICD-10 M30.1. Adult only (>=18 years) for EGPA; the >=12 years adolescent expansion
applies to severe eosinophilic asthma only. Fasenra is the second anti-IL-5 with EGPA approval
(Nucala/mepolizumab was first); Cinqair is NOT approved for EGPA.
Can patients self-administer Fasenra at home?
Yes — the Fasenra Pen autoinjector is approved for home self-administration after the first 3 clinic-administered doses (the loading phase at weeks 0, 4, 8). Once the patient is trained, maintenance doses can be self-administered every 8 weeks at home. This shifts the drug from the medical benefit (J0517 + 96372) to the pharmacy benefit (specialty pharmacy dispense).
Reference
Sources & methodology
Every claim on this page is sourced. Methodology and review history below.
Source documents
- DailyMed — FASENRA (benralizumab) Prescribing Information
- Fasenra HCP site — AstraZeneca
- Fasenra HCP Coding & Coverage
- FDA EGPA expansion announcement (September 2024)
- CMS — Medicare Part B Drug ASP Pricing File
- SEER CanMED — HCPCS J0517 reference
- UnitedHealthcare — Asthma Biologic Medications Medical Drug Policy
- Aetna CPB 0790 — Asthma Biologics (Fasenra, Nucala, Cinqair, Xolair, Tezspire, Dupixent)
- GINA Global Strategy for Asthma Management and Prevention
- ACAAI Severe Asthma & Biologics guidance
- 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 and AMA CPT releases. |
| NDC, dosing, FDA label, indication list | Event-driven | Tied to manufacturer document version + FDA label revision date. EGPA added Sep 2024. |
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. Manufacturer source: AstraZeneca Access 360 / Fasenra Connect. FDA label: post-EGPA expansion (Sep 2024). Coverage of severe eosinophilic asthma (>=12 years) and EGPA (adults).
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 is verified against the current FDA label. We do not paraphrase from billing-software vendor blogs.