CurrentCignaPolicy N/A

Immunologicals - Cinqair

Defines Cigna's coverage and prior authorization criteria for intravenous reslizumab (Cinqair) as add-on maintenance therapy for adults (≥18) with severe eosinophilic asthma, and lists non-covered indications and coding. Applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyImmunologicals - Cinqair

Policy CodePolicy N/A

Change TypeRevised — material updates

Effective DateSep 1, 2024

Next Review DateJul 3, 2024

Key ActionObtain prior authorization and document age ≥18, lung function/history, blood eosinophil ≥400 cells/µL, prior controller therapy trials, and response for continuation requests.

SourceLink

POLICY UPDATE CHANGES

Eosinophil level requirements were clarified to require a level ≥ 400 cells/microliter either within the previous 6 weeks OR prior to treatment with a monoclonal antibody that may alter eosinophil levels.

Preferred product criteria were updated to require trial of two formulary alternatives; previously coverage required trial of one formulary alternative.

Coverage policy title updated from Reslizumab to Immunologicals - Cinqair.

≥400required blood eosinophil count for approval

≥18minimum patient age for indication

3 mg/kg q4wdosing schedule approved

6 months

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Coverage Criteria for Cinqair (reslizumab)

Initial Therapy Criteria

Approve Cinqair for 6 months if ALL of the following are met:

Initial Therapy (Asthma): Patient is ≥ 18 years of age; AND patient meets qualifying lung function/history criteria; AND blood eosinophil count ≥ 400 cells/µL within the previous 4 weeks or prior to treatment with Cinqair or another monoclonal antibody that may lower eosinophil levels; AND patient has received at least 3 consecutive months of combination therapy with BOTH: (a) an inhaled medium- or high-dose corticosteroid; AND (b) at least one additional asthma controller or maintenance medication; AND asthma is uncontrolled or was uncontrolled at baseline as defined by ONE of the following: two or more exacerbations requiring systemic corticosteroids in the previous year, one or more exacerbations requiring hospitalization/ED/urgent care in the previous year, or asthma that worsens on tapering systemic corticosteroids; AND medication is prescribed by or in consultation with an allergist, immunologist, or pulmonologist; AND preferred product criteria are met.n/a

Lung function/history criteria include either: (1) FEV1 <80% predicted AND FEV1/FVC <0.80 (reduced FEV1 should not be due to smoking-related obstructive pulmonary disease); OR (2) bronchodilator reversibility with increase >12% and >200 mL in FEV1; OR (3) positive exercise challenge testing; OR (4) positive bronchial challenge testing. These lung function criteria may be met at any time prior to or during asthma treatment.

Continuation Therapy Criteria

Approve Cinqair for 1 year if ALL of the following are met:

Continuation Therapy (Asthma): Patient has already received at least 6 months of therapy with Cinqair; AND continues therapy with one inhaled corticosteroid or an inhaled corticosteroid-containing combination; AND patient has responded to therapy as determined by the prescriber (examples include decreased exacerbations, symptoms, healthcare utilization, or oral corticosteroid requirement).n/a

Patients who have received <6 months of Cinqair or who are restarting should be considered under Initial Therapy criteria.

Cinqair (reslizumab) is not covered for indications outside the FDA‑approved add‑on maintenance treatment of severe eosinophilic asthma in adults. Specific non‑covered indications include: concurrent use of Cinqair with another monoclonal antibody therapy (the efficacy and safety of combination monoclonal antibody therapy have not been established) and treatment of other eosinophilic disorders such as eosinophilic esophagitis, eosinophilic gastroenteritis, hypereosinophilic syndrome, and nasal polyps.

Cinqair is considered not medically necessary for any use not described in the Coverage Criteria. This includes concurrent administration with other monoclonal antibody therapies (examples noted in the policy include agents such as Dupixent, Nucala, Fasenra, Xolair, Tezspire, and Adbry) and treatment of eosinophilic conditions other than asthma (for example, eosinophilic esophagitis, eosinophilic gastroenteritis, hypereosinophilic syndrome, and nasal polyps). Clinical trial data and guideline guidance do not support routine use of Cinqair for these non‑asthma eosinophilic indications.

Coding and Clinical Thresholds

Considered Medically Necessary when criteria metHCPCSCovered

J2786

Injection, reslizumab, 1 mg

inv-06: Blood eosinophil count — required threshold and timing (≥ 400 cells/µL within previous 4–6 weeks or prior to monoclonal antibody that may alter levels).

Required thresholdBlood eosinophil count ≥ 400 cells/µL

Timing windowMeasured within the previous 4–6 weeks OR obtained prior to treatment with a monoclonal antibody that may alter eosinophil levels

Examples of monoclonal antibodies that may alter levelsIncludes agents such as Ebglyss (lebrikizumab) and Nemluvio (nemolizumab) — measure baseline prior to these therapies

PurposeBaseline eosinophil requirement supports selection of patients likely to benefit from Cinqair based on pivotal trials

Provider Actions, Prior Authorization, and Step Therapy

Prior Authorization

Prior Authorization Recommended

Prior Authorization is recommended for Cinqair (reslizumab). Initial approvals are for 6 months; continuation approvals are for up to 1 year. Approval requires prescribing by or in consultation with an allergist, immunologist, or pulmonologist. When approval durations are given in months, 1 month = 30 days.

Initial approvals: 6 months (see FDA‑Approved Indication, Initial Therapy).
Continuation approvals: 1 year for patients already receiving ≥ 6 months of Cinqair and meeting continuation criteria.

Step Therapy

Step Therapy / Formulary Alternatives

For Employer and Individual/Family lines of business, a trial of BOTH preferred formulary alternatives is required prior to coverage of Cinqair, unless the patient is already receiving Cinqair. The two preferred alternatives specified are Nucala (mepolizumab) and Fasenra (benralizumab). Employer/plan variations and prior authorization requirements for the alternatives may apply.

Employer Plans: trial of BOTH Nucala and Fasenra required, unless already on Cinqair.

Definitions

inv-12: Definition of severe asthma — criteria including high-dose ICS plus second controller or uncontrolled disease with examples (poor control, frequent exacerbations, FEV1 <80% predicted).

Core definitionSevere asthma requires treatment with a high‑dose inhaled corticosteroid plus a second controller (and/or systemic corticosteroids) to prevent uncontrolled disease, or asthma that remains uncontrolled despite this therapy

Examples of uncontrolled asthmaPoor symptom control (ACQ ≥1.5 or ACT <20), frequent severe exacerbations (≥2 bursts of systemic corticosteroids in prior year), or serious exacerbations (≥1 hospitalization/ICU/mechanical ventilation in prior year)

Airflow limitation criterionFEV1 <80% predicted after appropriate bronchodilator withholding qualifies as uncontrolled disease

Clinical contextSevere asthma patients considered for Cinqair are adults (≥18) with an eosinophilic phenotype and ongoing exacerbations or poor control despite high‑dose ICS/LABA

Background

Cinqair (reslizumab) is an anti–IL‑5 monoclonal antibody indicated as an add‑on maintenance therapy for adults (age ≥18) with severe eosinophilic asthma. Clinical evidence demonstrates benefit primarily in patients with elevated baseline blood eosinophils (studies focused on populations with higher eosinophil counts); Cinqair is not indicated for acute bronchospasm and has limited/insufficient evidence for other eosinophilic disorders.

Revision History

2026-05-01Step therapy updateLatest

Preferred product criteria were updated to require trial of two formulary alternatives (previously required one).

2025-07-15Eosinophil timing clarified

Eosinophil level requirement clarified to require ≥ 400 cells/µL either within the previous 6 weeks or prior to treatment with a monoclonal antibody that may alter eosinophil levels; Ebglyss and Nemluvio added as example monoclonal antibodies in notes.

2025-05-01