CurrentModa HealthPolicy IC-273

Cinqair (reslizumab) IV — coverage criteria for severe eosinophilic asthma

Policy governing coverage, dosing limits, and authorization criteria for intravenous reslizumab (Cinqair) as add-on maintenance therapy for adults with severe eosinophilic asthma under Moda Health.

Policy Summary

PayerModa Health

PolicyCinqair (reslizumab) IV — coverage criteria for severe eosinophilic asthma

Policy CodePolicy IC-273

Change TypeNo material change

Effective DateSep 1, 2023

Next Review DateOct 3, 2023

Key ActionSubmit prior authorization showing patient is ≥18, has eosinophils ≥400 cells/μL, meets severe asthma criteria, is on medium/high‑dose ICS plus another controller, and had ≥2 oral steroid–requiring exacerbations in the past year.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsauthorization length

3 mg/kg q4wdosing

≥400eosinophil threshold

2+required exacerbations/yr

J2786HCPCS

59310-0610-xx

Policy Summary

PayerModa Health

PolicyCinqair (reslizumab) IV — coverage criteria for severe eosinophilic asthma

Policy CodePolicy IC-273

Change TypeNo material change

Effective DateSep 1, 2023

Next Review DateOct 3, 2023

SourceLink

On This Page

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Coverage Criteria for Reslizumab (Cinqair)

Initial Therapy — Covered when ALL of the following are met

Covered when ALL of the following are met:

Age: Patient is at least 18 years of age>=18 years

No concomitant biologic therapy: Will not be used in combination with other anti-IgE, anti-IL4, anti-IL5, or IgG2 lambda monoclonal antibody agents

Examples: omalizumab, mepolizumab, benralizumab, dupilumab, tezepelumab

Exclusions: Must NOT be used for treatment of other eosinophilic conditions or for relief of acute bronchospasm/status asthmaticus

Examples: allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome

Indication-specific: Severe eosinophilic asthma: Patient must have severe disease and asthma with an eosinophilic phenotype indicated by blood eosinophils >= 400 cells/µL within 4 weeks of dosing>=400 cells/µL

Concurrent maintenance therapy: Used as add-on maintenance in patients regularly receiving BOTH medium to high-dose inhaled corticosteroids AND an additional controller medication

Additional controller examples: long acting beta agonist, leukotriene modifiers

Prior exacerbations: Patient had two or more exacerbations in the previous year requiring daily oral corticosteroids for at least 3 days (in addition to maintenance therapy)>=2 exacerbations requiring >=3 days oral steroids in prior year

Baseline measurements: Baseline measurement of at least one of: use of systemic corticosteroids, use of inhaled corticosteroids, number of hospitalizations/ER/unscheduled visits due to condition, or FEV1

Used for assessment of clinical status

Continuation/Renewal Therapy — Renewal covered when ALL of the following are met

Renewal covered when ALL of the following are met:

Ongoing criteria: Patient continues to meet the universal and indication-specific relevant criteria identified in initial approval (section III)

Tolerability: Absence of unacceptable toxicity from the drug

Examples of unacceptable toxicity include: malignancy, parasitic (helminth) infection, anaphylaxis (e.g., dyspnea, decreased oxygen saturation, wheezing, vomiting, skin and mucosal involvement, urticaria)

Clinical improvement: Either improvement in asthma symptoms/exacerbations (decrease in systemic corticosteroid use, two-fold or greater decrease in inhaled corticosteroid use for at least 3 days, fewer hospitalizations/ER/unscheduled visits) OR improvement from baseline in FEV1

One of these must be documented

Reslizumab must not be used for the treatment of other eosinophilic conditions. Examples explicitly excluded by this policy include allergic bronchopulmonary aspergillosis/mycosis, Churg‑Strauss syndrome, and hypereosinophilic syndrome.

The policy also specifies that reslizumab is not indicated for relief of acute bronchospasm or status asthmaticus. These uses are outside the approved add‑on maintenance indication and are listed as exclusions.

Use of reslizumab in combination with other biologic therapies is restricted. The drug will not be used in combination with other anti‑IgE, anti‑IL‑4, anti‑IL‑5, or IgG2‑lambda monoclonal antibody agents — examples include omalizumab, mepolizumab, benralizumab, dupilumab, and tezepelumab.

Per the policy, requests to use reslizumab concurrently with these listed biologics (or for the excluded eosinophilic conditions or for acute bronchospasm/status asthmaticus) would be considered not medically necessary.

Billing and Coding

Covered HCPCS CodesHCPCSCovered

J2786

Injection, reslizumab, 1 mg

NDCNDCCovered

59310-0610-xx

Cinqair 100 mg/10 mL single-use vial

Covered Diagnosis Codes (ICD-10)ICD-10Covered

J45.50	Severe persistent asthma, uncomplicated
J82.81	Eosinophilic pneumonia, NOS
J82.82	Acute eosinophilic pneumonia
J82.83	Eosinophilic asthma
J82.89	Other pulmonary eosinophilia, not elsewhere classified

inv-08: Blood eosinophils

Blood eosinophil threshold≥ 400 cells/μL (measured within 4 weeks of dosing)

PurposeDefines eosinophilic phenotype required for coverage of reslizumab

Use in criteriaRequired for initial approval alongside severe asthma and other maintenance therapy requirements

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Required

Prior authorization required. Patient must be ≥18 years of age and meet the severe eosinophilic asthma criteria below to qualify for coverage.

Member age ≥ 18 years
Must meet severe eosinophilic asthma criteria (see documentation requirements)

Prior Authorization

Concomitant Biologic Therapy Restriction

Do not prescribe in combination with other biologic therapies that target IgE, IL‑4, IL‑5, or use IgG2 lambda monoclonal antibodies. Concomitant use with agents such as omalizumab, mepolizumab, benralizumab, dupilumab, tezepelumab, and similar products is prohibited.

Examples: omalizumab, mepolizumab, benralizumab, dupilumab, tezepelumab

Background

Reslizumab (Cinqair) is an intravenous monoclonal antibody that targets interleukin‑5 (anti‑IL‑5) and is indicated as an add‑on maintenance treatment for adults with severe eosinophilic asthma. The agent is dosed by body weight and administered via intravenous infusion as part of ongoing controller therapy to reduce eosinophilic inflammation in this specific population.

Definitions

inv-14: Severe asthma

Core definitionSevere asthma: disease with persistent symptoms, frequent exacerbations, impaired lung function and need for high-intensity controller therapy (components may include symptoms throughout the day, nightly awakenings, frequent SABA use, extremely limited activities, or percent predicted FEV1 <60%).

Policy applicationRequired as part of indication-specific criteria for reslizumab coverage — patient must have severe disease plus eosinophilic phenotype

Assessment elementsBaseline measurements such as systemic corticosteroid use, inhaled corticosteroid use, hospital/ER visits, or FEV1 are used to document severity

inv-15: Eosinophilic phenotype

DefinitionEosinophilic phenotype: blood eosinophils ≥ 400 cells/μL measured within 4 weeks prior to dosing.

Role in coverage