Anti-IL-5 class comparison FDA labels verified 2026
Three anti-IL-5 biologics for severe eosinophilic asthma. Cinqair stands apart on route, dosing, and eosinophil threshold.
| Cinqair (reslizumab) | Nucala (mepolizumab) | Fasenra (benralizumab) | |
|---|---|---|---|
| HCPCS | J2786 | J2182 | J0517 |
| Manufacturer | Teva | GSK | AstraZeneca |
| Route | IV (20–50 min) | SC | SC |
| Dosing | 3 mg/kg q4wk (weight-based) | 100 mg q4wk fixed (asthma); 300 mg q4wk fixed (HES/EGPA) | 30 mg q4wk × 3, then q8wk fixed |
| Eosinophil threshold | ≥400 cells/µL | ≥150 cells/µL (current) or ≥300 (12-mo history) | No specific FDA-mandated threshold |
| Boxed warning | YES — Anaphylaxis | No | No |
| Self-administration? | NO — clinic only | Yes (autoinjector) | Yes (autoinjector) |
| Pediatric indication? | No (adults ≥18 only) | Yes (down to age 6 for SEA) | Yes (age ≥6 for SEA) |
| FDA approval | March 2016 | November 2015 | November 2017 |
| Single approved indication | Severe eosinophilic asthma | SEA, EGPA, HES, CRSwNP | SEA, CRSwNP, EGPA |
Dosing & unit math (weight-based) FDA label verified 2026
From FDA prescribing information (BLA 761033). Weight-based dosing is the major biller distinction from fixed-dose Nucala and Fasenra.
Adult dosing (only adults ≥18 are FDA-approved)
- 3 mg/kg IV every 4 weeks (no loading dose, no maintenance interval change)
- Infusion over 20–50 minutes (depends on dilution volume)
- 13 doses/year (q4wk × 52 weeks)
- Bill the actual mg administered as units of J2786 (1 mg = 1 unit)
- Round dose per institutional rounding policy (typically nearest whole mg)
Worked examples by patient weight
| Weight | Dose (3 mg/kg) | Vials needed (100 mg) | Waste | Modifier | Units billed |
|---|---|---|---|---|---|
| 50 kg | 150 mg | 2 (200 mg) | 50 mg | JW (50 units) | 150 + 50 (waste) |
| 60 kg | 180 mg | 2 (200 mg) | 20 mg | JW (20 units) | 180 + 20 (waste) |
| 70 kg | 210 mg | 3 (300 mg) | 90 mg | JW (90 units) | 210 + 90 (waste) |
| 75 kg (typical) | 225 mg | 3 (300 mg) | 75 mg | JW (75 units) | 225 + 75 (waste) |
| 80 kg | 240 mg | 3 (300 mg) | 60 mg | JW (60 units) | 240 + 60 (waste) |
| 100 kg | 300 mg | 3 (300 mg) | 0 mg | JZ | 300 |
| 120 kg | 360 mg | 4 (400 mg) | 40 mg | JW (40 units) | 360 + 40 (waste) |
Worked example — first-year billing for a 75 kg adult
Dose: 75 × 3 = 225 mg
Vials used: 3 × 100 mg = 300 mg
Drug administered: 225 mg → bill 225 units J2786
Drug discarded: 75 mg → bill 75 units J2786 with JW modifier
Admin: 96365 (therapeutic IV, 20–50 min)
# Year-1 totals (13 doses, q4wk)
Total doses: 13
Total drug units billed (admin + waste): 13 × 300 = 3,900 units
Total drug cost (Q2 2026 ASP+6%): ~$44,975 before sequestration
Eosinophil count biomarker (≥400 cells/µL required) FDA verified 2026
Cinqair has the highest eosinophil threshold of any anti-IL-5. Document baseline eos count BEFORE the PA submission.
Cinqair's FDA label specifies that patients must have a blood eosinophil count of at least 400 cells per microliter for the drug to be considered indicated. This is significantly higher than Nucala's ≥150 cells/µL threshold and stricter than Fasenra (which has no specific FDA-mandated threshold). Most major payers enforce this requirement strictly in their prior authorization criteria.
| Anti-IL-5 biologic | FDA eos threshold | Time window | Payer enforcement |
|---|---|---|---|
| Cinqair | ≥400 cells/µL | Baseline (pre-treatment) | Strict by all major payers |
| Nucala | ≥150 cells/µL (current) OR ≥300 cells/µL (within 12 mo) | Current OR 12-month history | Strict by all major payers |
| Fasenra | No FDA-mandated threshold (label notes greater efficacy at ≥300) | N/A (label silent) | Most payers require ≥150–300 anyway |
Documentation checklist for Cinqair PA
- Baseline blood eosinophil count ≥400 cells/µL (CBC with differential, dated within 12 months)
- Date of eosinophil measurement
- Lab report (preferred over EHR transcription)
- Confirmation that the eos count was obtained while NOT on systemic corticosteroids (where possible)
- If eos count drops <400 on therapy: document the pre-treatment baseline; do NOT submit on-therapy values
Eosinophil testing CPT codes (separate billing)
| Test | CPT | Notes |
|---|---|---|
| CBC with automated differential | 85025 | Includes absolute eosinophil count; standard pre-PA test |
| CBC without differential | 85027 | Not sufficient — differential needed for eos count |
| WBC differential, manual | 85007 | If automated differential is unavailable |
Anaphylaxis (boxed warning) FDA boxed verified 2026
Cinqair is the only anti-IL-5 with a boxed warning. Plan administration accordingly.
Operational requirements driven by the boxed warning
- Healthcare professional administration only — nurse or physician must administer; no patient self-admin
- Healthcare setting required — office, clinic, infusion suite, or ASC; no home administration without HCP
- 30+ minute observation period post-infusion — document time of completion + observation end time
- Anaphylaxis kit on-site — epinephrine, IV access, oxygen, resuscitation equipment
- No autoinjector formulation exists — this is a deliberate FDA decision driven by the boxed warning
Adult-only indication (no pediatric) FDA verified 2026
Major distinction from Nucala (down to age 6) and Fasenra (down to age 6).
Cinqair is FDA-approved only for patients aged 18 years and older. There is no pediatric indication. Pediatric patients with severe eosinophilic asthma who need an anti-IL-5 biologic must use Nucala (mepolizumab, J2182), which is approved down to age 6 for severe eosinophilic asthma, or Fasenra (benralizumab, J0517), also approved down to age 6 (under 12 by SC route only).
Age-eligibility table (anti-IL-5 class)
| Drug | Minimum age (severe eosinophilic asthma) | Notes |
|---|---|---|
| Cinqair | 18 years (adults only) | No pediatric indication of any kind |
| Nucala | 6 years | 40 mg SC q4wk for ages 6–11; 100 mg SC q4wk for ages 12+ |
| Fasenra | 6 years | 10 mg SC q4wk × 3, then q8wk for ages 6–11; 30 mg SC for ages 12+ |
NDC reference FDA NDC Directory verified May 2026
| NDC (10/11-digit) | Package | Use |
|---|---|---|
59676-810-01 / 59676-0810-01 |
100 mg / 10 mL (10 mg/mL) single-dose vial — 1 vial per carton | All adult dosing — combine vials per weight-based 3 mg/kg calculation |
Administration codes CPT verified May 2026
Cinqair is a non-chemotherapy therapeutic IV biologic. Use 96365, NOT 96413.
| Code | Description | When to use |
|---|---|---|
96365 |
Intravenous infusion, for therapy, prophylaxis, or diagnosis; initial, up to 1 hour | Primary code for Cinqair. 20–50 minute infusion fits within 1-hour window. |
96366 |
IV infusion, therapy, each additional hour | Rarely needed — Cinqair infusion is typically ≤50 min. |
96413 |
Chemotherapy administration, IV infusion, up to 1 hour | NOT appropriate. Cinqair is a biologic for asthma, not anti-neoplastic. |
99211–99215 |
E/M, established patient | If significant separately identifiable E/M is performed same day, append modifier 25. |
Modifiers (JW + JZ) CMS verified May 2026
JW — required on most Cinqair claims (weight-based waste)
Effective January 1, 2017, CMS requires the JW modifier to report the discarded portion of a single-dose vial. Cinqair's weight-based dosing means partial-vial waste is the norm: a 75 kg patient receives 225 mg from three 100 mg vials, discarding 75 mg. Bill the wasted 75 mg as a separate claim line with JW modifier and 75 units. Wasted drug is reimbursable but must be reported.
JZ — only when weight produces exact multiple of 100 mg
Effective July 1, 2023, CMS requires the JZ modifier on single-dose container claims when no drug is discarded. For Cinqair, JZ applies only when patient weight produces an exact multiple of 100 mg (33.3 kg, 66.7 kg, 100 kg, 133.3 kg, etc.). Most adult patients will produce some waste — JZ is the exception, not the rule. One of JZ or JW must be on every J2786 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 infusion. Routine pre-infusion clinical assessment is bundled into 96365.
340B modifiers (JG, TB)
For 340B-acquired Cinqair, follow your MAC's current 340B modifier policy. JG for hospital outpatient settings; TB on rural sole community hospitals and certain critical access hospitals. Check Teva's pricing & coverage page for current 340B-specific guidance.
ICD-10-CM by indication FY2026 verified May 2026
Single approved indication: severe eosinophilic asthma in adults ≥18.
| Indication | ICD-10 family | Notes |
|---|---|---|
| Severe persistent asthma, eosinophilic phenotype | J45.50 — uncomplicated | Most common primary code |
| Severe persistent asthma with (acute) exacerbation | J45.51 | Use during acute exacerbation visit |
| Severe persistent asthma with status asthmaticus | J45.52 | Critical/hospital scenario |
| Moderate persistent asthma, uncomplicated | J45.40 | Some payers accept moderate persistent if eos ≥400 + step therapy met |
| Moderate persistent asthma with exacerbation | J45.41 | As above |
| Moderate persistent asthma with status asthmaticus | J45.42 | As above |
| Other and unspecified asthma | J45.9x | Generally not accepted for Cinqair PA — specificity required |
| Cough variant asthma, exercise-induced asthma | J45.991, J45.990 | Not appropriate for Cinqair |
Site of care & place of service Verified May 2026
Because Cinqair has a boxed warning for anaphylaxis and requires healthcare professional administration plus a 30+ minute observation period, payer site-of-care UM is generally lighter than for chemo or oncology biologics. The infusion is short (20–50 min) and fits comfortably in office-based or AIC settings.
| Setting | POS | Claim form | Payer steering |
|---|---|---|---|
| Pulmonologist / allergist office | 11 | CMS-1500 / 837P | Preferred by commercial UM |
| Ambulatory infusion suite (AIC) | 49 | CMS-1500 / 837P | Preferred by commercial UM |
| Asthma/allergy specialty center | 11 or 49 | CMS-1500 / 837P | Preferred |
| Hospital outpatient (on-campus) | 22 | UB-04 / 837I | Disfavored after first dose |
| Hospital outpatient (off-campus PBD) | 19 | UB-04 / 837I | Disfavored |
| Patient home | 12 | N/A | NOT ALLOWED — boxed warning prohibits home admin |
Claim form field mapping Teva 2026
From Teva Cinqair Coding & Coverage HCP page.
| Information | CMS-1500 box | Notes |
|---|---|---|
| NPI | 17b | Rendering provider (typically pulmonologist or allergist) |
| NDC qualifier + 11-digit NDC + UoM + qty | 24A shaded area | N4 + 59676-0810-01 + ML + total volume (e.g., 30 mL for 3-vial 75 kg dose) |
| HCPCS J2786 + JZ or JW | 24D (drug line) | JW for waste (most claims); JZ if no waste |
| Drug units (administered) | 24G | Actual mg administered (e.g., 225 for 75 kg patient at 3 mg/kg) |
| Drug units (waste, JW line) | 24G | Discarded mg on separate claim line |
| CPT 96365 (admin line) | 24D (admin line) | 20–50 min infusion fits within 1-hour window |
| ICD-10 | 21 | J45.50–J45.52 (severe persistent asthma) |
| Patient weight | Documentation | Document in chart for weight-based dose audit defense |
| Eosinophil count | Documentation / PA | ≥400 cells/µL baseline required |
| PA number | 23 | Required by all major payers |
Payer policy snapshot + step therapy Reviewed May 2026
All major payers require eos count ≥400 documentation. Step therapy from ICS + LABA is universal; step from SC anti-IL-5 (Nucala/Fasenra) is payer-specific.
| Payer | PA? | Eos ≥400 enforced? | Step therapy |
|---|---|---|---|
| UnitedHealthcare Asthma Biologics Medical Drug Policy |
Yes | Strict | Step from high-dose ICS + LABA + (often) SC anti-IL-5 trial; pulmonologist or allergist documentation |
| Aetna CPB Asthma biologics |
Yes | Strict | Step from ICS + LABA; SC anti-IL-5 step requirement varies by plan |
| BCBS plans Vary by plan |
Yes | Strict | Generally aligned with NHLBI / GINA guidance + payer formulary preference |
| Medicare Part B Local MAC policies |
Generally no PA for Part B | Yes (medical necessity) | FDA label criteria + on-label severe persistent asthma diagnosis |
Step therapy — standard sequence
- High-dose inhaled corticosteroid (ICS) + long-acting beta-agonist (LABA) for ≥3 months
- Add LAMA (tiotropium) or LTRA (montelukast) trial in many policies
- Trial of SC anti-IL-5 (Nucala or Fasenra) — payer-specific; some require, some allow direct Cinqair
- If failed and eos ≥400 documented: Cinqair approved
Medicare reimbursement CMS Q2 2026 (live)
Quarterly ASP from CMS Part B Drug Pricing File. Refreshes automatically each quarter.
Q2 2026 payment snapshot — J2786
Effective April 1 – June 30, 2026 · Based on 4Q25 ASP submissions
Coverage
No NCD specific to reslizumab. Coverage falls under MAC LCDs for biologics + the generic drug-coverage framework. All MACs cover J2786 for FDA-approved on-label severe eosinophilic asthma with appropriate ICD-10 (J45.50–J45.52) and eosinophil count documentation (≥400 cells/µL).
Code history
- J2786 — permanent code, "Injection, reslizumab, 1 mg" (effective post-FDA approval; pre-permanent code period used unclassified J3490)
- FDA approval: March 23, 2016 (BLA 761033)
Patient assistance — Teva Shared Solutions / Cinqair Patient Support Teva verified May 2026
- Cinqair Patient Support / Teva Shared Solutions: 1-888-825-1356 — benefits investigation, prior authorization assistance, appeal support
- Cinqair Co-Pay Assistance Program: commercial copay support for eligible commercially-insured patients (excludes Medicare, Medicaid, federal program patients)
- Teva Patient Assistance Program: free product for uninsured / underinsured patients meeting income requirements
- Foundations: for Medicare patients, refer to PAN, HealthWell, Asthma & Allergy Foundation of America (AAFA) — verify open severe asthma funds quarterly
- Web: cinqair.com
Common denials & how to fix them
| Denial reason | Common cause | Fix |
|---|---|---|
| Eosinophil count not documented or <400 | PA submitted without baseline CBC w/ diff or with on-treatment eos value | Submit pre-treatment CBC w/ differential showing eos ≥400 cells/µL. Use most recent baseline within 12 months. |
| Wrong admin code (96413) | Chemo IV billed instead of therapeutic IV | Resubmit with 96365. Cinqair is non-chemo biologic; chemo admin codes inappropriate. |
| JW missing on weight-based dose | Wasted drug not reported on dose < exact 100 mg multiple | Add JW line for discarded units. JZ on the administered units; JW on the wasted units. |
| JZ missing on no-waste claim | Single-dose vial claim without JZ when weight = 100 kg multiple | Resubmit with JZ. Required since 7/1/2023 on every claim with no waste. |
| Pediatric patient (under 18) claim | Cinqair prescribed for patient <18 years | Cinqair is adult-only. Switch to Nucala (ages 6+) or Fasenra (ages 6+). |
| Step therapy not met (ICS + LABA) | PA submitted without documented high-dose ICS + LABA trial | Submit complete medication history with dates, doses, and reasons for failure / inadequate response. |
| Step therapy not met (SC anti-IL-5) | Payer requires Nucala or Fasenra trial first | Verify payer's specific class step-therapy criteria. If required, document SC anti-IL-5 trial + failure or contraindication. |
| Wrong ICD-10 (J45.909) | Generic asthma code instead of severe persistent | Resubmit with J45.50/J45.51/J45.52 + chart documentation of eosinophilic phenotype. |
| Site-of-care (HOPD) denial | HOPD admin after first dose on commercial plan with site-of-care UM | Move to office (POS 11) or AIC (POS 49). Submit medical necessity letter if HOPD required. |
| Home administration denial | Cinqair billed under home infusion (POS 12) without HCP present | Cinqair cannot be self-administered. Boxed warning prohibits. Must be in clinical setting with HCP + anaphylaxis kit. |
Frequently asked questions
What is the HCPCS code for Cinqair?
Cinqair (reslizumab) is billed under HCPCS J2786 — "Injection, reslizumab, 1 mg." Each
milligram equals one billable unit. For a typical 75 kg adult at the FDA-labeled 3 mg/kg q4wk dose, that's
225 mg = 225 units per infusion. J2786 is a permanent code.
How many units do I bill for a Cinqair dose?
Cinqair dosing is weight-based — 3 mg/kg IV every 4 weeks. Bill the actual mg
administered as units of J2786. A 75 kg patient: 225 mg = 225 units (3 vials, 75 mg waste billed
as JW). Weight-based dosing means partial-vial waste is the rule, not the exception — JW is required
on virtually every claim where the dose is not an exact multiple of 100 mg.
What administration CPT do I use for Cinqair?
CPT 96365 — "Intravenous infusion, for therapy, prophylaxis, or diagnosis; initial, up
to 1 hour." Cinqair is a non-chemotherapy therapeutic IV infusion administered over 20–50 minutes,
fitting cleanly within the 1-hour 96365 window. Do NOT bill 96413 (chemo admin) — Cinqair is a
biologic for asthma, not anti-neoplastic.
Do I bill JZ or JW for Cinqair?
Both are common. Use JW for the discarded portion of any partial vial — Cinqair vials are
100 mg single-dose, so any dose that's not a multiple of 100 mg produces waste. Use JZ on the
rare claim where a patient's weight produces an exact multiple of 100 mg (33.3 kg, 66.7 kg, 100 kg). One of
JZ or JW must be on every J2786 claim per CMS's July 2023 single-dose container policy.
What is the Medicare reimbursement for J2786?
For Q2 2026, the Medicare Part B payment limit for J2786 is $11.532 per mg (ASP + 6%). A typical 75 kg patient at 3 mg/kg = 225 mg per dose reimburses at approximately $2,594.70 per infusion. Annualized at 13 doses = approximately $33,731/year. Sequestration (~2%) reduces actual paid to roughly ASP + 4.3%.
What eosinophil count is required for Cinqair coverage?
Cinqair's FDA label requires baseline blood eosinophil count of at least 400 cells/µL — a significantly higher threshold than other anti-IL-5 biologics. Nucala (mepolizumab) requires only ≥150 cells/µL and Fasenra (benralizumab) has no specific FDA-mandated threshold. Document the baseline eos count in the prior authorization submission.
Why is Cinqair the only IV anti-IL-5?
Cinqair is the only FDA-approved anti-IL-5 monoclonal antibody administered by IV infusion. Nucala
(mepolizumab, J2182) is given subcutaneously every 4 weeks and Fasenra (benralizumab,
J0517) is given subcutaneously every 4 weeks for the first 3 doses, then every 8 weeks.
Cinqair requires office or clinic administration with a healthcare professional present — there is no
Cinqair autoinjector or self-administration option, primarily due to the boxed warning for anaphylaxis.
Is Cinqair approved for pediatric patients?
No. Cinqair is FDA-approved only for adults aged 18 years and older. This is a major distinction from Nucala (mepolizumab), which has pediatric indications down to age 6 for severe eosinophilic asthma. Pediatric patients who need anti-IL-5 therapy must use Nucala or Fasenra — Cinqair will be denied for any patient under 18.
Can Cinqair be self-administered at home?
No. Cinqair has a boxed warning for anaphylaxis (incidence ~0.3%, occurring during or within 20 minutes after infusion completion). The FDA label requires administration in a healthcare setting by a healthcare professional prepared to manage anaphylaxis, with a 30+ minute observation period post-infusion. There is no Cinqair autoinjector formulation. Home infusion is permitted only with a nurse/HCP physically present and an anaphylaxis kit on-site.
Source documents
- Cinqair (reslizumab) HCP product page — Teva Pharmaceuticals
- DailyMed — CINQAIR (reslizumab) Prescribing Information
- FDA Cinqair label PDF (initial approval, 2016)
- CMS — Medicare Part B Drug ASP Pricing File
- SEER CanMED — HCPCS J2786 reference
- UnitedHealthcare — Asthma Biologics Medical Drug Policy
- Aetna CPB — Asthma biologics (mepolizumab, reslizumab, benralizumab, dupilumab, tezepelumab, omalizumab)
- GINA — Global Initiative for Asthma 2026 strategy report
- ACAAI — American College of Allergy, Asthma & Immunology severe asthma + biologics guidance
- Teva Shared Solutions — patient support 1-888-825-1356
- 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) | Semi-annual | Manual review against published payer policy documents. |
| HCPCS / CPT / modifier rules + eos test codes | Annual | Reviewed against CMS HCPCS quarterly files and AMA CPT releases. |
| NDC, dosing, FDA label, indication | Event-driven | Tied to manufacturer document version + FDA label revision date. |
Reviewer
Change log
- — Initial publication. ASP data: Q2 2026 ($11.532/mg). Manufacturer source: Teva 2026 (Cinqair Coding & Coverage). FDA label: BLA 761033, initial approval March 23, 2016. Anti-IL-5 class comparison vs Nucala (J2182) and Fasenra (J0517). Boxed warning for anaphylaxis emphasized; adult-only indication emphasized; eos ≥400 threshold emphasized.
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 and dosing are verified against the current FDA label. Anti-IL-5 class comparisons use each drug's current FDA label. We do not paraphrase from billing-software vendor blogs.