Cinqair (reslizumab) (Intravenous) — Coverage Criteria
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Criteria, dosing, coding, and prior authorization rules governing coverage of intravenous reslizumab (Cinqair) for members of the plan, including initial and renewal authorization requirements and concomitant therapy prohibitions.
No material clinical or coverage changes in this revision.
Coverage Criteria for Cinqair (reslizumab)
Initial Approval Criteria
Target agents will be approved when ALL of the following are met (commercial and Medicaid have different step requirements):
See policy: For Commercial Members Only (chunk 6) and For Medicaid Members Only (chunk 7).
Agents Eligible for Continuation of Therapy (chunk 8).
Diagnostic thresholds and exacerbation criteria (chunk 8).
FDA labeling/compendia requirements (chunk 9).
Controller therapy, duration, and adherence criteria (chunks 9-10).
Biologic treatment options and ICS adherence (chunk 9).
Prescriber specialty/consultation requirement (chunk 10).
Concomitant therapy restrictions and evidence requirements (chunk 10).
Contraindications requirement (chunk 10).
Renewal Criteria
Target agents will be approved on renewal when ALL of the following are met:
Renewal criteria (chunk 11).
Agents listed in the policy are designated as NOT to be used concomitantly with the requested agent unless the prescribing information allows combination use and supporting evidence is submitted. The policy provides an extensive list of specific biologics and immunomodulators that are considered contraindicated or not recommended for concomitant use, including but not limited to: Abrilada (adalimumab-afzb), Actemra (tocilizumab), Adalimumab and its biosimilars (Amjevita, Hadlima, Hulio, Humira, etc.), Anzupgo (delgocitinib), Arcalyst (rilonacept), Avsola (infliximab-axxq), Benlysta (belimumab), Bimzelx (bimekizumab-bkzx), Cibinqo (abrocitinib), Cimzia (certolizumab), Cosentyx (secukinumab), Dupixent (dupilumab), Ebglyss (lebrikizumab-lbkz), Enbrel (etanercept), Entyvio (vedolizumab), Fasenra (benralizumab), Nucala (mepolizumab), Omlyclo (omalizumab), Skyrizi (risankizumab-rzaa), Tezspire (tezepelumab-ekko), Xolair (omalizumab), and many others as listed in the policy.
For requests to use the requested agent in combination with another immunomodulatory therapy, the policy requires BOTH that: (1) the prescribing information for the requested agent does NOT limit such combined use, and (2) the provider submits supportive evidence for combination therapy (for example, clinical trial data, phase III studies, or guideline citations). If these conditions are not met, concomitant use with agents on the list will render the request noncompliant with the policy and may result in denial.
Medicare coverage determinations, including National Coverage Determinations (NCDs), Local Coverage Determinations (LCDs), and Local Coverage Articles (LCAs), may apply to outpatient Part B drugs and must be followed where applicable. The policy’s guidance is intended for non-Medicare coverage determinations; when a member or claim is subject to Medicare rules, compliance with CMS manuals and any applicable NCD/LCD/LCA is required.
Providers may search the CMS coverage database for applicable NCDs, LCDs, or LCAs at https://www.cms.gov/medicare-coverage-database/search.aspx and should apply any additional Medicare-specific instructions (including Part B billing or coverage clarifications) when Medicare is the applicable payer.
Use of the requested agent without meeting required diagnostic and clinical criteria is considered not medically necessary. The policy requires documented confirmation of severe eosinophilic asthma by ONE of the following baseline biomarkers while on high-dose inhaled corticosteroid or daily oral corticosteroid: blood eosinophils ≥150 cells/µL, FeNO ≥20 parts per billion, or sputum eosinophils ≥2%. In addition, evidence of uncontrolled disease must be shown (for example, ≥2 steroid-treated severe exacerbations in the past 12 months, ≥1 serious exacerbation requiring hospitalization/ventilation/ER, worsening with steroid taper, or baseline FEV1 <80% predicted).
The policy also requires that members be on and continue appropriate asthma controller therapy (e.g., inhaled corticosteroid or ICS/LABA combinations, LTRA, LAMA, theophylline) and meet prior therapy/step requirements where applicable (commercial members must document inadequate response, intolerance, or contraindication to at least two specified biologics per the plan’s step criteria; Medicaid has similar requirements). Failure to document the required controller therapy, prior biologic trials, prescriber specialty/consultation, or the diagnostic biomarker and severity criteria may lead to denial as not medically necessary.
Billing Codes and Diagnosis Codes
| J2786 | Injection, reslizumab, 1 mg; 1 billable unit = 1 mg |
| 59310-0610-xx | Cinqair 100 mg/10 mL single-use vial |
| 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 Requirements, Prior Authorization, and Documentation
Prior authorization length and renewal
Prior authorization is required for Cinqair. Initial approvals are valid for 12 months (365 days) and may be renewed for successive 12-month (365 day) periods when renewal criteria are met.
Prior authorization requirement
Prior authorization is applied to Cinqair based on consideration of indication, safety and efficacy, and drug cost; utilization management non-quantitative treatment limitations (NQTLs) are used in the prior authorization design.
Biologic step therapy requirement (Commercial)
For commercial members, the member must have an inadequate response, intolerance, or contraindication to at least a three-month trial of two specified biologic agents prior to approval.
- Required trials: two of mepolizumab (Nucala), dupilumab (Dupixent), tezepelumab (Tezspire), or omalizumab (Xolair).
- Each trial must be at least three (3) months.
Step therapy not specified in NQTL checklist
The NQTL checklist documents that prior authorization was considered for this agent but does not specify step therapy sequences within the checklist section of the policy.
Clinical documentation to support medical necessity
Include clinical documentation to support medical necessity: baseline biomarker results, exacerbation history, spirometry (FEV1), medication adherence, and documentation of prior biologic and controller therapy trials.
- Baseline biomarker: blood eosinophil count, FeNO, or sputum eosinophils (see thresholds).
- History of uncontrolled asthma/exacerbations (e.g., ≥2 steroid-treated exacerbations in past 12 months or ≥1 serious exacerbation).
- Baseline (prior to therapy) FEV1 value.
- Medication history showing use/adherence to controller therapy and prior biologic use (excluding samples).
Required coding and diagnosis documentation
Bill using HCPCS J2786 (reslizumab, 1 mg). When relevant, document the product NDC 59310-0610-xx for the Cinqair 100 mg/10 mL vial and include an applicable ICD-10 diagnosis from the covered list.
- HCPCS: J2786 - Injection, reslizumab, 1 mg; 1 billable unit = 1 mg.
- NDC: Cinqair 100 mg/10 mL single-use vial — 59310-0610-xx.
- Include an applicable diagnosis code from Appendix 1 (e.g., J45.50, J82.81–J82.89).
Prior biologic therapy required — denial risk
Failure to document required prior biologic therapy trials as specified (commercial: two agents including mepolizumab, dupilumab, tezepelumab, or omalizumab for ≥3 months each) may result in denial of coverage.
- Commercial requirement: two biologic agents tried for at least three months each (see policy for allowed agents).
- Medicaid lists a similar two-agent requirement (mepolizumab, dupilumab, or omalizumab).
Diagnostic and severity confirmation required — denial risk
Lack of documented diagnostic confirmation of severe eosinophilic asthma (baseline eosinophils ≥150 cells/µL, FeNO ≥20 ppb, or sputum eosinophils ≥2%) or failure to document severity/exacerbation history or FEV1 may lead to denial.
- Diagnostic thresholds: blood eosinophils ≥150 cells/µL; FeNO ≥20 ppb; or sputum eosinophils ≥2% (measured while on high-dose ICS or daily oral corticosteroid).
- Severity evidence: ≥2 steroid-treated exacerbations in past 12 months, ≥1 serious exacerbation requiring hospitalization/ventilation/ER, worsening with steroid taper, or baseline FEV1 <80% predicted.
Prior authorization drivers (NQTL factors)
Prior authorization may be applied due to indication considerations, safety and efficacy concerns, and the cost of the drug as noted in the NQTL factor checklist.
- NQTL checklist conclusions marked 'Consider for PA' for indication, safety and efficacy, and cost.
Background and Scope
This policy addresses use of intravenous reslizumab (Cinqair) for severe eosinophilic asthma. The diagnosis is confirmed when the member meets biomarker thresholds while on high-dose inhaled corticosteroid or daily oral corticosteroid: baseline blood eosinophil count ≥150 cells/µL, FeNO ≥20 parts per billion, or sputum eosinophils ≥2%, together with evidence of uncontrolled asthma such as frequent steroid-treated exacerbations, serious exacerbations requiring hospitalization or ER care, worsening control with steroid taper, or baseline FEV1 <80% predicted.
Scope of the policy includes criteria for initial authorization and renewal, concomitant therapy prohibitions, required continuation rules (members treated with the agent within the past 90 days may be eligible for continuation), prior authorization requirements (initial approvals valid for 12 months and renewable for 12-month intervals), and billing/coding expectations (billing with HCPCS J2786 and NDC 59310-0610-xx for the 100 mg vial as applicable). Providers must document the diagnostic biomarkers, exacerbation history, controller therapy adherence, prior biologic use, and prescriber specialty or consultation to support medical necessity.
Definitions and Key Identifiers
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