CurrentCareSourcePolicy N/A

Cinqair (reslizumab) utilization and coverage criteria

Defines prior authorization, medical necessity criteria, dosing-duration approvals, and situations not recommended for coverage for Cinqair (reslizumab) for treatment of eosinophilic asthma in adults; applies to CareSource medical benefit programs in North Carolina.

Policy Summary

PayerCareSource

PolicyCinqair (reslizumab) utilization and coverage criteria

Policy CodePolicy N/A

Change TypeCriteria clarifiedthreshold revisedexamples added

Effective DateN/A

Next Review DateApr 9, 2025

Key ActionObtain prior authorization; initial approvals granted for 6 months and continuation approvals for 1 year when criteria and response are met.

SourceLink

POLICY UPDATE CHANGES

Criteria clarified that concurrent use prohibition of Cinqair with other monoclonal antibody therapies is specific to named agents (Fasenra, Nucala, Dupixent, Tezspire, Xolair, and Adbry).

Eosinophil level requirement was clarified to require ≥400 cells/µL within the previous 6 weeks OR prior to treatment with a monoclonal antibody that may alter eosinophil levels.

Ebglyss (lebrikizumab) and Nemluvio (nemolizumab) were added as examples of monoclonal antibody therapies in policy notes.

≥400eosinophil threshold for initial approval

6 moinitial approval duration

1 yrcontinuation approval

≥18

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Coverage Criteria for Cinqair (reslizumab)

Initial Therapy (6 months)

Covered when ALL of the following are met:

Initial Therapy criteria: (i) Patient is ≥ 18 years of age; AND (ii) Patient has a blood eosinophil level ≥ 400 cells per microliter within the previous 4 weeks OR had a blood eosinophil level ≥ 400 cells per microliter prior to treatment with Cinqair or another monoclonal antibody therapy that may alter blood eosinophil levels; AND (iii) Patient is receiving an inhaled corticosteroid; AND (iv) Patient has received at least 3 consecutive months of combination therapy with BOTH: (a) an inhaled corticosteroid and (b) at least one additional asthma controller or asthma maintenance medication (examples: inhaled long-acting beta-agonists, inhaled long-acting muscarinic antagonists, or a monoclonal antibody therapy); AND (v) Patient has uncontrolled asthma as defined by ONE of the following: (a) two or more asthma exacerbations requiring systemic corticosteroid bursts in the previous year; OR (b) one or more asthma exacerbation(s) requiring hospitalization, emergency department, or urgent care visit in the previous year; OR (c) FEV1 < 80% predicted; OR (d) FEV1/FVC < 0.80; OR (e) asthma that worsens upon tapering of systemic (oral) corticosteroid therapy.

Continuation Therapy (1 year)

Covered when ALL of the following are met:

Continuation Therapy criteria: (i) Patient has already received at least 6 months of Cinqair therapy; AND (ii) Patient continues to receive therapy with one inhaled corticosteroid or one inhaled corticosteroid-containing combination; AND (iii) Patient has responded to therapy as determined by the prescriber (examples of response include decreased asthma exacerbations, decreased asthma symptoms, and decreased hospitalizations/ED/urgent care visits).

Concurrent use of Cinqair (reslizumab) with another monoclonal antibody therapy is not recommended. The efficacy and safety of Cinqair in combination with other monoclonal antibody agents have not been established; the policy names examples including Dupixent, Fasenra, Nucala, Tezspire, Xolair, Ebglyss, Nemluvio. Requests for coverage involving concurrent monoclonal antibody therapy are a common denial trigger and should be avoided unless supportive evidence is provided and discussed with medical affairs/clinical review.

Coverage is limited to the authorized asthma indications described in the criteria. Use of Cinqair for eosinophilic conditions other than asthma is not recommended (examples: eosinophilic esophagitis, hypereosinophilic syndrome, nasal polyps). These conditions lack sufficient, consistent evidence of efficacy and therefore are excluded from routine approval.

Operational notes: prior authorization is required for Cinqair and denials are likely when the request documents concurrent biologic therapy or an indication outside of asthma. If a provider believes treatment outside these parameters is clinically necessary, submit supporting clinical trial data, rationale, and specialty consultation notes for peer clinical review; otherwise process requests according to the stated exclusions.

Additional coverage notes: Evidence for Cinqair in non‑asthma eosinophilic disorders is limited and inconsistent. For eosinophilic esophagitis, small trials and a randomized study showed reductions in esophageal eosinophil counts but no clear, consistent clinical benefit versus placebo; guideline statements do not recommend Cinqair for this indication.

For hypereosinophilic syndrome the available data are very limited (small case series and single‑dose reports); international guidance considers Cinqair investigational for this condition and further well‑controlled trials are needed. For nasal polyps, small pharmacokinetic/safety studies and subgroup analyses suggest possible biologic effects, but guidelines recommend other anti‑IL‑5 agents and do not provide recommendations supporting routine Cinqair use for nasal polyps.

Practical guidance: when evaluating requests for these off‑label eosinophilic indications, reviewers should confirm whether submitted evidence demonstrates clinically meaningful outcomes and should route atypical or investigational use to peer clinician review. Absent strong, controlled evidence, these uses remain not recommended for coverage.

Drug Codes and Clinical Thresholds

Drug (description)mixed

reslizumab (Cinqair) intravenous infusion

Cinqair (reslizumab) intravenous infusion Teva Respiratory

inv-06: Blood eosinophil level

ThresholdBlood eosinophil level ≥ 400 cells/µL

TimingMeasured within the previous 4 weeks (or documented ≥400 cells/µL prior to treatment with a monoclonal antibody that may alter eosinophil levels)

ContextThreshold used for initial therapy approval (approve for 6 months)

inv-07: FEV1

ThresholdFEV1 < 80% predicted

RoleOne qualifying criterion indicating uncontrolled asthma for initial therapy consideration

Provider Requirements, Prior Authorization, and Denial Risk

Prior Authorization

Prior Authorization Required

Prior authorization is required. Initial approvals are for 6 months; continuation (maintenance) approvals are for 1 year. Requests for dosing outside the established dosing in this policy will be reviewed case-by-case by a clinician. Initial approvals require the medication to be prescribed by or in consultation with a specialist (allergist, immunologist, or pulmonologist).

Initial approval duration: 6 months (month = 30 days)
Continuation/renewal approval duration: 1 year
Dosing requests outside policy: case-by-case review by clinician (Medical Director or Pharmacist)
Initial prescribing requirement: specialist (allergist, immunologist, or pulmonologist) or documented consultation

Step Therapy

Controller Medication Requirement

Controller medication requirement before initiation. Prior to initiating therapy, the patient must have received at least 3 consecutive months of combination therapy that includes an inhaled corticosteroid and at least one additional asthma controller or maintenance medication.

Background on Cinqair (reslizumab)

Cinqair (reslizumab) is an anti‑interleukin‑5 (anti‑IL‑5) monoclonal antibody indicated as add‑on maintenance treatment for adults aged ≥18 years with severe eosinophilic asthma. It is used as an add‑on therapy for patients whose eosinophilic asthma remains uncontrolled despite appropriate controller therapy.

Clinical trials demonstrated benefit primarily in patients with elevated blood eosinophils; reductions in eosinophil counts and improvements in asthma outcomes were observed in the pivotal studies. Because the role of Cinqair in non‑asthma eosinophilic conditions is not established, the policy limits routine coverage to the labeled adult severe eosinophilic asthma population.

Key Definitions

inv-13: Severe asthma definition

DefinitionSevere asthma: asthma uncontrolled despite optimized high‑dose inhaled corticosteroid plus a second controller (or systemic corticosteroids), or that worsens when high‑dose treatment is decreased.

Frequent severe exacerbationsTwo or more systemic corticosteroid bursts in the previous year can define uncontrolled/severe asthma.

Serious exacerbationsOne or more hospitalizations, ICU stay, or mechanical ventilation in the previous year qualifies as severe/ uncontrolled disease.

Airflow limitationObjective airflow limitation markers include FEV1 < 80% predicted or FEV1/FVC < 0.80 after bronchodilator withholding.