Cinqair (reslizumab) (Intravenous)
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Policy M-P0273 defines prior authorization, dosing limits, initial and renewal medical necessity criteria, contraindicated concomitant therapies, and administration dosing for Cinqair (reslizumab) for Moda Health members.
No material clinical or coverage changes in this revision.
Coverage Criteria for Cinqair (reslizumab)
Initial Therapy (Commercial)
Covered when ALL of the following are met for commercial members:
Commercial initial criteria
- Continuation eligibility: Member treated with the requested agent within the past 90 days (starting on samples is not approvable) OR prescriber states member treated within past 90 days and is at risk if therapy changed.
Agents eligible for continuation
- Severe eosinophilic asthma confirmation: Diagnosis confirmed by ONE of: baseline blood eosinophils >=150 cells/microliter while on high-dose inhaled corticosteroids or daily oral corticosteroids; OR FeNO >=20 ppb while on high-dose inhaled corticosteroids or daily oral corticosteroids; OR sputum eosinophils >=2% while on high-dose inhaled corticosteroids or daily oral corticosteroids; AND ONE of: history of uncontrolled asthma (>=2 systemic corticosteroid bursts in past 12 months OR hospitalization/mechanical ventilation/ER/urgent care visit in past 12 months OR controlled asthma that worsens when corticosteroids are tapered) OR baseline FEV1 <80% predicted.
Nested diagnostic and exacerbation criteria
- Controller therapy and adherence: If not currently on a biologic, member treated with a maximally tolerated inhaled corticosteroid for >=3 months and adherent for 90 days within the past 120 days; OR if currently treated with a biologic, member is on adequate inhaled corticosteroid therapy and adherent as specified; OR has intolerance/hypersensitivity/contraindication to inhaled corticosteroid options; AND member treated >=3 months and adherent for 90 days within past 120 days with at least one of LABA, LAMA, LTRA, or theophylline (or documented intolerance/contraindication as specified).
Medication history and adherence requirements
Initial Therapy (Medicaid)
Covered when ALL of the following are met for Medicaid members:
Refer to continuation and diagnostic nodes for full requirements.
Initial Therapy / Indication
Covered when ALL of the following are met
Based on policy dosing and covered diagnoses from Appendix 1
Continuation/Renewal Therapy
Covered upon renewal when ALL of the following are met:
Clinical benefit documentation required
Continuation Eligibility
Continuation eligibility rules and compendia support:
Compendia allowed: AHFS, DrugDex 1 or 2a, or NCCN 1 or 2a
Contraindicated Concomitant Therapy
Not covered/contraindicated when used concomitantly with any of the following therapies
See full list in policy chunk 18
The policy lists an extensive set of immunomodulatory and biologic agents that should not be used concomitantly with Cinqair (reslizumab) without justification. Providers requesting coverage must document any clinical rationale for concurrent use and demonstrate that concomitant therapy is necessary, supported by prescribing information or compendia, and does not increase undue risk. Absent a clear, documented justification showing medical necessity and safety, concurrent administration with agents on the policy's "Agents NOT to be used Concomitantly" list may lead to denial or require further review.
Certain biologic and immunomodulatory agents are explicitly labeled in the policy as contraindicated as concomitant therapy with reslizumab; use of Cinqair together with these listed agents (for example, tezepelumab, omalizumab, mepolizumab, and multiple other IL/biologic or immunomodulatory products) is not allowed and will exclude coverage. Prescribers should verify the patient's medication list against the policy's contraindicated agents before submitting an authorization request.
If the clinical submission does not meet the policy's required elements — for example, failure to document the requisite prior biologic trials, diagnostic confirmation of severe eosinophilic asthma, adherence to controller therapy, or specialist involvement — the request will be considered not medically necessary under the policy. Providers should include complete documentation of prior trials, baseline eosinophil or FeNO measurements, controller therapy history, and specialist consultation to avoid a determination of non‑medical necessity.
For Medicare members, this policy does not replace or modify any applicable National Coverage Determinations (NCDs) or Local Coverage Determinations (LCDs). Providers must comply with relevant Medicare NCDs/LCDs where applicable; the policy notes that Medicare Part B covered diagnosis coding and contractor jurisdictional rules remain applicable and should be followed when submitting claims.
Coding, Billing, and Dose Limits
| J1745 | Injection, reslizumab, 1 mg |
| J2786 | Injection, reslizumab, 1 mg; 1 billable unit = 1 mg |
| 59310-0610-xx | Cinqair 100 mg/10 mL single-use vial |
| J45.50 | Severe persistent asthma, uncomplicated |
| J82.81 | Chronic eosinophilic pneumonia |
| J82.82 | Acute eosinophilic pneumonia |
| J82.83 | Eosinophilic asthma |
| J82.89 | Other pulmonary eosinophilia, not elsewhere classified |
Provider Actions, Prior Authorization, and Documentation
Prior authorization required — 12‑month approvals
Prior authorization is required for Cinqair; initial and renewal approvals are valid for 12 months (365 days). Renewals must be processed through the plan prior authorization process and will be renewed every 12 months thereafter.
Consider PA per NQTL checklist (indication, cost, safety)
Consider prior authorization for Cinqair based on the drug indication and cost as part of the plan's NQTL assessment; utilization management factors cited include indication, safety/efficacy, and drug cost.
Document trials of two prior biologics (commercial)
For commercial members, document inadequate response, contraindication, or intolerance to at least a three‑month trial of TWO of the following agents before approval will be granted: mepolizumab, dupilumab, tezepelumab, or omalizumab.
- Trials must be at least three (3) months in duration
- Two distinct agents from the listed group are required for commercial members
Include indication and supporting clinical data with PA request
Ensure prior authorization submission includes the specific clinical indication and relevant supporting data per policy to allow review against medical necessity criteria.
Required clinical documentation for PA and renewal
Include documentation of prior biologic trials with evidence of inadequate response, contraindication, or intolerance; for severe eosinophilic asthma include baseline eosinophil count, FeNO or sputum eosinophils, history of exacerbations or FEV1 as specified, medication adherence, and specialist involvement.
- Baseline blood eosinophils ≥150 cells/µL while on high‑dose ICS or oral corticosteroids, OR FeNO ≥20 ppb while on high‑dose ICS or oral corticosteroids, OR sputum eosinophils ≥2%
- Evidence of uncontrolled asthma (e.g., ≥2 steroid bursts in past 12 months, hospitalization/ER, or worsening when steroids tapered) or baseline FEV1 <80% predicted
- Medication history showing prior biologic use or controller therapy adherence and specialist prescriber/consultation
Document diagnosis, dosing, and bill with J2786 + NDC
Document the supported ICD-10 covered diagnosis (e.g., J45.50; J82.81–J82.83; J82.89) and provide dose and administration details; bill using HCPCS J2786 with the matching NDC for Cinqair (59310-0610-xx).
- HCPCS: J2786 — Injection, reslizumab, 1 mg; 1 billable unit = 1 mg
- NDC: Cinqair 100 mg/10 mL single‑use vial — 59310-0610-xx
- Covered diagnoses: J45.50, J82.81, J82.82, J82.83, J82.89
Denial risk — missing required prior biologic trials or clinical evidence
Failure to document required trials of prior biologic agents or lack of evidence that clinical criteria are met (diagnostic confirmation, controller therapy trials, adherence, specialist involvement, or contraindication/intolerance) can trigger denial of the request.
Denial triggers — contraindicated concomitant therapy, billing, diagnosis mismatches
Use of contraindicated concomitant biologic or immunomodulatory therapies, mismatched billing units or NDC, or an unsupported diagnosis will trigger denial per policy.
- Concurrent use with listed agents (e.g., tezepelumab, omalizumab, multiple other biologics in the policy) is contraindicated unless supported by prescribing information and evidence
- Billing must use HCPCS J2786 units consistent with dosing and include the matching NDC
- Diagnosis must map to covered ICD‑10 codes (J45.50; J82.81–J82.89)
Definitions and Diagnostic Thresholds
Background
Cinqair (reslizumab) is an intravenous monoclonal antibody that targets interleukin‑5 (anti–IL‑5) and is indicated for treatment of severe eosinophilic asthma. The policy specifies weight‑based dosing of 3 mg/kg IV every 4 weeks and requires objective evidence of eosinophilic inflammation and uncontrolled disease despite appropriate controller therapy; specialist prescriber involvement and prior authorization are required per the policy.
Revision History
Policy M-P0273 last reviewed; prior authorization length and renewal specified as 12 months (365 days).
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