Cinqair (reslizumab) IV — coverage and prior authorization criteria
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Clinical coverage and prior authorization criteria for intravenous reslizumab (Cinqair) for members of Viva Health, including initial and renewal requirements, dosing limits, contraindicated concomitant therapies, and billing information.
No material clinical or coverage changes in this revision.
Coverage and Medical Necessity Criteria
inv-01: Initial Approval
Target agent(s) will be approved when ALL of the following are met:
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Entry path
- Continuation of therapy: Member has been treated with the requested agent (starting on samples is not approvable) within the past 90 days; OR prescriber states treated with the requested agent within the past 90 days AND member is at risk if therapy is changed.
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New initiation for severe eosinophilic asthma
- Phenotype confirmation: Baseline (prior to therapy) blood eosinophil count ≥150 cells/µL 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 OR systemic corticosteroid dependence.
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- Evidence of uncontrolled asthma or prior biologic use: Two or more systemic corticosteroid bursts in the past 12 months OR one or more serious exacerbation (hospitalization, mechanical ventilation, or ER/urgent care) in the past 12 months OR asthma that worsens when corticosteroids are tapered OR baseline FEV1 <80% predicted OR medication history showing use of an FDA‑labeled or compendia‑supported biologic for asthma within the past 12 months OR the member has another FDA‑labeled indication for the requested agent and route of administration.
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inv-02: Renewal Criteria
Target Agent(s) will be approved when ALL of the following are met:
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The policy lists a broad set of immunomodulatory agents that are contraindicated as concomitant therapy with reslizumab (Cinqair). Providers must not prescribe Cinqair in combination with any agent on this list unless the plan’s continuation/combination criteria are specifically met (see renewal criteria). Examples from the policy include TNF inhibitors, IL‑4/IL‑13 and other biologics (e.g., Adalimumab, Nucala (mepolizumab), Fasenra (benralizumab), Dupixent (dupilumab), Omalizumab, and many others) and a long roster of branded immunomodulators and small‑molecule JAK inhibitors.
If combination use is proposed, the renewal criteria require BOTH that the prescribing information for the requested agent does not limit use with another immunomodulator and that clinical evidence supporting combination therapy (clinical trials, phase III studies, or guideline references) is submitted. Absent that documentation, requests proposing concomitant therapy with listed agents are not supported.
Medicare rules may supersede or add requirements for Part B members. The policy instructs providers to follow the Medicare Benefit Policy Manual (Pub. 100‑2, Chapter 15 §50) and to check for applicable National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), or Local Coverage Articles (LCAs). Use the CMS coverage database to verify any Medicare requirements before billing or approving therapy for Medicare members.
Where an LCD/NCD/LCA exists, those determinations must be followed in addition to the policy’s clinical criteria; the plan may apply additional indications at its discretion.
Requests that do not meet the policy’s initial or renewal criteria will be considered not medically necessary. Common denial rationales include failure to meet phenotype or uncontrolled disease criteria (e.g., missing biomarker confirmation such as baseline blood eosinophils ≥150 cells/µL or required exacerbation history), lack of documented clinical benefit on renewal, or use that conflicts with the listed contraindicated concomitant immunomodulators.
Additional denial triggers include absence of required documentation (prior biologic trials, adherence to controller therapy, specialist involvement), failure to obtain required prior authorization, and any FDA‑labeled contraindication to the requested agent.
Billing, Codes, and Quantity Limits
| J2786 | Injection, reslizumab, 1 mg; 1 billable unit = 1 mg |
| 59310-0610-xx | Cinqair 100 mg/10 mL single-use vial NDC |
| 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 |
| No codes listed |
Prior Authorization, Documentation, and Provider Requirements
Prior authorization validity: 12 months
Initial and renewal prior authorizations for Cinqair (reslizumab) are issued for 12 months (365 days).
Prior authorization recommended — use plan PA process
Prior authorization is considered appropriate for this drug based on the indication and cost; providers must use the plan's prior authorization process to request coverage.
Required trial of other anti‑IL‑5 agents (benralizumab or mepolizumab)
For new initiation in severe eosinophilic asthma, the member must have had a prior trial with documented failure, intolerance, or contraindication to benralizumab (Fasenra) or mepolizumab (Nucala).
Step therapy — no explicit rules listed
This policy does not list any additional explicit step therapy rules in the step therapy section.
Required clinical documentation to support PA
Submit documentation that supports prior biologic use and the eosinophilic phenotype and disease severity: baseline blood eosinophil count, FeNO or sputum eosinophils (as specified), evidence of systemic corticosteroid dependence, and history of exacerbations or FEV1 results.
- Baseline blood eosinophil count ≥150 cells/microliter, or FeNO ≥20 ppb on high‑dose ICS or daily oral corticosteroids, or sputum eosinophils ≥2% on high‑dose ICS or daily oral corticosteroids, or systemic corticosteroid dependence (cite: baseline phenotype).
- Evidence of uncontrolled asthma: two or more systemic steroid bursts in past 12 months, one or more serious exacerbation (hospitalization, mechanical ventilation, ER/urgent care) in past 12 months, worsening when corticosteroids tapered, or baseline FEV1 <80% predicted.
- Medication history showing prior use of an FDA‑labeled or compendia‑supported biologic for asthma within the past 12 months, if applicable.
- Documentation of adherence to maximally tolerated inhaled/controller therapies for required durations (e.g., ≥3 months ICS with 90 days adherence within past 120 days) and specialist involvement.
Diagnosis code documentation — use listed ICD‑10 codes
Include one of the listed ICD‑10 diagnosis codes with the request to support medical necessity for coverage.
- Acceptable diagnosis codes include J45.50, J82.81, J82.82, J82.83, J82.89.
Denial triggers — unmet criteria or missing documentation
Requests that do not meet the initial or renewal criteria — including lack of required biomarker or clinical documentation, absence of documented clinical benefit on renewal, or noncompliance with required therapies — may be denied.
Prior authorization risk — PA may be required; lack of PA can lead to denial
Because the indication and drug cost were identified in the NQTL checklist, prior authorization may be applied; failure to obtain required prior authorization can result in denial of the request.
Drug Background and Indications
Cinqair (reslizumab) is an intravenous monoclonal antibody targeting interleukin‑5 (anti‑IL‑5) used to treat severe eosinophilic asthma. The policy frames Cinqair as a specialist‑managed biologic requiring documentation of phenotype (blood eosinophils, FeNO, or sputum eosinophils), evidence of uncontrolled disease on controller therapy or prior biologic use, and prescriber specialty involvement.
Dosing and administration expectations (e.g., weight‑based IV dosing at 3 mg/kg every 4 weeks per product labeling) and billing details are included elsewhere in the policy; prior authorization and ongoing documentation of clinical benefit are required to continue therapy.
Key Definitions and Diagnostic Thresholds
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