ModifiedColorado Rocky Mountain Health PlansPolicy CS2026D0055Y
Respiratory Interleukins (Cinqair, Fasenra, & Nucala) — Medical Benefit Drug Policy
Medical benefit drug policy governing coverage and medical necessity criteria for provider-administered Cinqair (reslizumab), Fasenra (benralizumab), and Nucala (mepolizumab) for Colorado Rocky Mountain Health Plans members (national unless state-specific exceptions noted).
Change TypeTemplate and supporting information updates
Effective DateApr 1, 2026
Next Review DateN/A
Key ActionSubmit prior authorization with documentation of diagnosis, baseline eosinophil count, specialty prescriber, and evidence of treatment failure or inadequate control on optimized controller therapy.
Removed content/language pertaining to the state of Louisiana.
Template Update.
Supporting Information.
3drugs covered by the policy
≥150eosinophil threshold used across indications
requires specialistrequires specialist
≤12 motypical initial authorization length
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Coverage and Medical Necessity Criteria
FDA‑indication coverage groups
Covered when ALL of the following are met (per FDA‑studied populations and indications):
Reslizumab (Cinqair) for severe eosinophilic asthma: Patient is ≥ 18 years old AND has severe asthma with an eosinophilic phenotype AND has an exacerbation history consistent with trials (e.g., ≥1 exacerbation requiring systemic corticosteroid in prior 12 months) AND remains on background asthma therapy; dosing aligns with studied regimen (reslizumab 3 mg/kg IV every 4 weeks).age >= 18; blood eosinophil threshold per trial (often >= 400 cells/µL)
Risk of anaphylaxis; observe during administration.
Mepolizumab (Nucala) for HES: Patient is ≥ 12 years old with HES for ≥ 6 months without an identifiable non‑hematologic secondary cause AND had ≥2 HES flares in the prior 12 months (per trial entry) AND baseline blood eosinophil ≥ 1,000 cells/µL at screening AND is on stable background HES therapy; dosing studied was 300 mg SC every 4 weeks.age >= 12; HES duration >= 6 months; eosinophil >= 1000 cells/µL
Trial excluded non‑hematologic secondary causes and FIP1L1‑PDGFRα positive HES.
Mepolizumab (Nucala) for CRSwNP: Patient is an adult (≥ 18 years) with chronic rhinosinusitis with nasal polyps inadequately controlled on intranasal corticosteroids, with prior bilateral nasal polyposis or prior bilateral polyp surgery, and meeting objective endoscopy/CT findings and symptom severity similar to trial entry; dosing studied was 100 mg SC every 4 weeks.age >= 18; prior nasal polyp surgery within 10 years or bilateral polyposis
Patient receives Nucala as add‑on maintenance with intranasal corticosteroids.
Mepolizumab (Nucala) for COPD with eosinophilic phenotype: Adult patients with COPD who have eosinophilic phenotype and moderate to very severe airflow limitation (post‑bronchodilator FEV1/FVC < 0.7 and FEV1 20%–80% predicted), and who experienced ≥2 moderate or ≥1 severe COPD exacerbation(s) in the prior year despite maintenance inhaled therapy; dosing per trial was every 4 weeks.spirometry: FEV1/FVC < 0.7; FEV1 20%–80% predicted; exacerbations >=2 moderate or >=1 severe in prior year
Efficacy described in MATINEE and METREX trials.
FDA-indicated uses
Covered when consistent with FDA-approved indications and applicable benefit terms
Benralizumab (Fasenra) indication: Add‑on maintenance treatment for patients with severe asthma aged 6 years and older with an eosinophilic phenotype; also indicated for treatment of adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).FDA labeling
Not indicated for other eosinophilic conditions or for acute bronchospasm/status asthmaticus.
Mepolizumab (Nucala) indication: Add‑on maintenance treatment for patients with severe asthma aged 6 years and older with an eosinophilic phenotype; also indicated for EGPA in adults, HES in patients ≥ 12 years (≥ 6 months duration without identifiable non‑hematologic secondary cause), add‑on maintenance for adult COPD with eosinophilic phenotype, and add‑on maintenance for adult CRSwNP.FDA labeling
Not indicated for acute bronchospasm or status asthmaticus.
Cinqair for severe eosinophilic asthma (IV)
Proven and medically necessary when ALL of the following are met:
Diagnosis of severe asthma.
Uncontrolled asthma: Asthma is uncontrolled or inadequately controlled as defined by at least one: poor symptom control (ACQ > 1.5 or ACT < 20), ≥2 systemic corticosteroid bursts in prior 12 months, asthma‑related emergency treatment, airflow limitation (post‑bronchodilator FEV1 < 80% predicted with reduced FEV1/FVC), or dependence on maintenance oral corticosteroids.
Background controller therapy: Used in combination with maximally‑dosed ICS/LABA or with maximally‑dosed ICS plus an additional controller medication.
Fasenra for severe eosinophilic asthma (provider-administered)
Proven and medically necessary when ALL of the following are met:
Diagnosis of severe asthma.
Uncontrolled asthma: Asthma is uncontrolled or inadequately controlled as defined by at least one: poor symptom control (ACQ > 1.5 or ACT < 20), ≥2 systemic corticosteroid bursts in prior 12 months, asthma‑related emergency treatment, airflow limitation (post‑bronchodilator FEV1 < 80% predicted with reduced FEV1/FVC), or dependence on maintenance oral corticosteroids.
Background controller therapy: Used in combination with maximally‑dosed ICS/LABA or with maximally‑dosed ICS plus an additional controller medication.
Initial therapy — severe eosinophilic asthma
Covered when ALL of the following are met
Asthma diagnosis: Diagnosis of severe asthma.
Uncontrolled asthma: Asthma classified as uncontrolled or inadequately controlled by at least one criterion: ACQ > 1.5 or ACT < 20; ≥2 systemic corticosteroid bursts in prior 12 months; asthma‑related emergency treatment; airflow limitation (post‑bronchodilator FEV1 < 80% predicted with reduced FEV1/FVC); or maintenance oral corticosteroid dependence.
Concomitant controller therapy: Used in combination with either a maximally‑dosed ICS/LABA or maximally‑dosed ICS plus an additional controller medication.
Fasenra for EGPA (provider-administered)
Proven and medically necessary when ALL of the following are met:
Diagnosis of relapsing or refractory EGPA: Diagnosis of EGPA with past medical history or presence of asthma and presence of at least two EGPA‑characteristic features (e.g., eosinophilic vasculitis, perivascular eosinophilic infiltration, eosinophil‑rich granulomatous inflammation, neuropathy, pulmonary infiltrates, sino‑nasal abnormality, cardiomyopathy, glomerulonephritis, alveolar hemorrhage, palpable purpura, or ANCA positive).
List of characteristic findings provided in policy.
Relapsing or refractory disease history: History of relapsing disease (≥1 relapse within past 2 years requiring increased corticosteroids/immunosuppressant or hospitalization) OR refractory disease (failure to attain remission within prior 6 months after induction therapy).
Concomitant standard therapy: Patient is currently taking standard therapy (systemic glucocorticoids with or without immunosuppressive therapy).
Nucala for EGPA (provider-administered)
Proven and medically necessary when ALL of the following are met:
Diagnosis of relapsing or refractory EGPA: Diagnosis of EGPA with past medical history or presence of asthma and presence of at least two EGPA‑characteristic features (see policy list).
Relapsing or refractory disease history: History of relapsing disease (≥1 relapse within past 2 years requiring increased corticosteroids/immunosuppressant or hospitalization) OR refractory disease (failure to attain remission within prior 6 months after induction therapy).
Concomitant standard therapy: Patient is currently taking standard therapy (systemic glucocorticoids with or without immunosuppressive therapy).
Administration or monitoring necessity: One of: physician attestation that patient/caregiver cannot self‑administer; documented severe hypersensitivity to Nucala within past 6 months requiring monitored administration; or new to therapy requiring initial monitored dose (authorization for 1 dose).
Initial therapy — HES
Initial therapy — covered when ALL of the following are met
HES diagnosis duration: Diagnosis of hypereosinophilic syndrome (HES) of ≥ 6 months duration.>=6 months
Exclude secondary causes and FIP1L1‑PDGFRα: No identifiable non‑hematologic secondary cause of HES and HES is not FIP1L1‑PDGFRα kinase‑positive.
Examples of secondary causes provided in policy.
Provider administration necessity: One of: physician attestation that patient/caregiver cannot self‑administer; history of severe hypersensitivity to Nucala within past 6 months requiring monitored administration; or new to therapy requiring initial monitored dose (authorization for 1 dose).
Baseline eosinophils and background therapy:
Initial therapy — CRSwNP
Initial therapy — covered when ALL of the following are met
CRSwNP diagnosis: Diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) defined by ≥2 symptoms for >12 weeks and objective endoscopy or CT findings, plus bilateral nasal polyposis or prior bilateral polyp surgery.
Symptom list and objective findings provided in policy.
Prior treatments: Patient has required prior sinus surgery OR systemic corticosteroids for CRSwNP in previous 2 years OR has failed a trial of two classes (e.g., saline irrigation, intranasal corticosteroids, antileukotrienes).
Add‑on intranasal corticosteroid: Nucala will be used as add‑on maintenance therapy in combination with intranasal corticosteroids.
Provider administration necessity: One of: physician attestation that patient/caregiver cannot self‑administer; documented severe hypersensitivity within past 6 months requiring monitored administration; new‑to‑therapy requiring initial monitored dose (authorization for 1 dose); or patient ≤ 11 years of age.
Initial therapy — COPD
Initial therapy — covered when ALL of the following are met
COPD diagnosis: Diagnosis of chronic obstructive pulmonary disease (COPD) defined by post‑bronchodilator FEV1/FVC < 0.7 and post‑bronchodilator FEV1 % predicted between 20% and 80%.FEV1/FVC < 0.7; FEV1% predicted 20–80
Uncontrolled disease: Uncontrolled COPD demonstrated by either ≥2 exacerbations in prior year requiring systemic corticosteroids/antibiotics or ≥1 exacerbation resulting in hospitalization/observation >24 hours in past year.
Reauthorization / Continuation
Authorization for continued use will be approved when ALL of the following are met:
Clinical response: Documentation of positive clinical response demonstrated by at least one: reduction in frequency/severity of relapses; reduction or discontinuation of corticosteroids and/or immunosuppressant; disease remission; or reduction in severity/frequency of EGPA‑related symptoms.
Provider administration necessity: One of: physician attestation that patient/caregiver cannot self‑administer; documented severe hypersensitivity within past 6 months requiring monitored administration; or other specified conditions per product.
No concomitant biologic therapy: Patient is not receiving the product in combination with specified biologics for the same indication (cross‑product prohibitions apply per agent).
Dosing and duration: Dosing in accordance with FDA labeling; reauthorization will be for no more than 12 months.
Reauthorization — asthma
Reauthorization/Continuation of Care — covered when ALL of the following are met
Clinical response: Documentation of positive clinical response demonstrated by at least one: reduction in exacerbation frequency; decreased rescue medication use; increase in percent predicted FEV1 from pretreatment baseline; or reduction in severity/frequency of symptoms.
Concomitant therapy: Used in combination with an ICS‑containing maintenance medication.
Examples of ICS‑containing medications provided.
No concomitant biologic therapy: Patient is not receiving the product in combination with listed biologics for the same indication (specific cross‑product restrictions per agent).
Dosing and special conditions: Dosing per FDA labeling; reauthorization conditions vary by product (e.g., physician attestation or hypersensitivity history or pediatric age allowances); Cinqair reauth may require prior failure of Fasenra or Nucala or contraindication/intolerance.
Reauthorization — HES
Reauthorization/Continuation of Care — covered when ALL of the following are met
Clinical response: Documentation of positive clinical response demonstrated by at least one: reduction in frequency of HES flares; or maintenance/reduction in background HES therapy requirements.
Provider administration necessity: Physician attestation inability to self‑administer; or documented history of severe hypersensitivity to Nucala within past 6 months requiring monitored administration.
No concomitant biologic therapy: Patient is not receiving other listed biologics for the same indication.
Dosing per FDA labeling; reauthorization ≤ 12 months.<=12 months
Reauthorization — CRSwNP
Reauthorization/Continuation of Care — covered when ALL of the following are met
Clinical response: Documentation of positive clinical response to Nucala therapy.
Continued intranasal corticosteroid: Patient will continue Nucala as add‑on maintenance therapy in combination with intranasal corticosteroids.
Provider administration necessity: One of: physician attestation inability to self‑administer; documented severe hypersensitivity within past 6 months requiring monitored administration; or patient ≤ 11 years of age.
No concomitant biologic therapy: Patient is not receiving listed biologics for the same indication.
Reauthorization — COPD
Reauthorization/Continuation of Care — covered when ALL of the following are met
Clinical response: Documentation of positive clinical response to Nucala therapy.
Combination therapy: Nucala is being used in combination with maintenance therapy (examples provided: Advair/AirDuo, Bevespi Aerosphere, Breo Ellipta, Symbicort, Trelegy Ellipta).
Provider administration necessity: One of: physician attestation inability to self‑administer; or documented history of severe hypersensitivity within past 6 months requiring monitored administration.
No concomitant biologic therapy: Patient is not receiving listed biologics for the same indication.
Self-administered subcutaneous formulations of Fasenra and Nucala are billed and obtained under the pharmacy benefit, not the medical benefit. Provider‑administered formulations of these agents remain subject to the medical benefit criteria in this policy.
Concurrent use of another biologic directed at the same indication is prohibited. Specifically, members must not receive anti‑IL‑4 (e.g., dupilumab), anti‑IL‑5 (e.g., reslizumab, benralizumab, mepolizumab), anti‑IgE (e.g., omalizumab), or TSLP inhibitor (e.g., tezepelumab) therapy together for the same diagnosis.
Use of Cinqair, Fasenra, or Nucala for indications outside those supported by evidence and the FDA label is considered unproven and not medically necessary. Examples listed in the policy include other eosinophilic conditions, acute bronchospasm, status asthmaticus, granulomatosis with polyangiitis, microscopic polyangiitis, and organ or life‑threatening EGPA; the policy states that robust randomized controlled trial evidence is lacking to support these uses.
Cinqair (reslizumab) and Nucala (mepolizumab) are not indicated for the relief of acute bronchospasm or for status asthmaticus. Additionally, Cinqair is not indicated for other eosinophilic conditions outside its label. For Cinqair, the policy also highlights the need for patient observation during administration because of the risk of anaphylaxis.
Requests will be denied when key entry criteria are not met. Denial triggers include absence of the required eosinophilic phenotype (e.g., baseline peripheral blood eosinophils < 150 cells/µL where specified), failure to document severity or uncontrolled asthma per the policy definitions, lack of required background controller therapy (maximally‑dosed ICS/LABA or equivalent), or missing documentation of prior therapy or failure (for example, required step‑therapy or prior biologic trials).
Use of Cinqair or Fasenra for chronic obstructive pulmonary disease (COPD) is explicitly listed as not medically necessary in this policy. While Nucala has a separate FDA indication for COPD in certain settings, the policy specifies that Cinqair and Fasenra lack support for COPD and are considered unproven for that condition.
Nucala and Cinqair are not supported for treatment of other eosinophilic conditions beyond FDA‑approved indications. The policy states these uses are unproven and lack adequate randomized controlled trial evidence to establish safety and efficacy for those conditions.
Treatment solely for acute bronchospasm or status asthmaticus is not an FDA‑approved indication for Cinqair, Fasenra, or Nucala and is considered not medically necessary per this policy. Requests for these acute uses will not meet the indicated uses and are subject to denial.
Provider Requirements, Prior Authorization, and Documentation
Prior Authorization
Prior Authorization Required and Initial Authorization Duration
Prior authorization is required for Nucala, Fasenra, and Cinqair. Initial authorizations are limited to the durations below and dosing must follow U.S. FDA–approved labeling.
Nucala initial authorization: up to 12 months (many indications, including severe asthma, CRSwNP, HES, EGPA); dosing per FDA labeling.
Fasenra initial authorization: up to 12 months for most indications; dosing per FDA labeling.
Cinqair initial authorization: up to 12 months; dosing per FDA labeling.
Documentation Required
Reauthorization Requirements for Nucala
Reauthorization (continuation) for Nucala requires documentation of ongoing benefit and appropriate concomitant therapy. Reauthorization approvals are limited to no more than 12 months.
Billing Codes and Key Clinical Thresholds
Drug HCPCS CodesHCPCS
J0517
Injection, benralizumab, 1 mg.
J2182
Injection, mepolizumab, 1 mg.
J2786
Injection, reslizumab, 1 mg.
Relevant ICD-10 CodesICD-10
D72.11
Hypereosinophilic Syndrome.
J31.0
Chronic rhinitis.
J32.0
Chronic maxillary sinusitis.
J32.1
Chronic frontal sinusitis.
J32.2
Chronic ethmoidal sinusitis.
J32.3
Chronic sphenoidal sinusitis.
J32.4
Chronic pansinusitis.
J32.8
Other chronic sinusitis.
J32.9
Chronic sinusitis, unspecified.
J33.0
Polyp of nasal cavity.
1–10 of 24
1/3
Peripheral blood eosinophil count — common threshold
UseDefines eosinophilic phenotype for Nucala severe asthma coverage criteria
Clinical Background and Rationale
These agents target the interleukin‑5 pathway and related eosinophilic inflammation. Cinqair (reslizumab) is an IV anti‑IL‑5 antibody indicated as add‑on maintenance therapy for adults with severe eosinophilic asthma. Fasenra (benralizumab) and Nucala (mepolizumab) are anti‑IL‑5 pathway biologics for add‑on maintenance treatment of severe eosinophilic asthma (Fasenra and Nucala approved for ages ≥6 years) and have additional labeled indications (eg, EGPA, HES, CRSwNP, or COPD for Nucala) as described in their FDA labeling.
Clinical contextUsed to identify patients likely to benefit from anti‑IL‑5 or anti‑IL‑5 receptor therapies
Supporting guidanceERS/ATS and trial inclusion criteria support use of ≥150 cells/µL as an adult cut-point
Provider‑administered vs self‑administered
Administration benefit distinctionCertain provider‑administered formulations of Fasenra and Nucala are covered under the medical benefit; self‑administered SC formulations are obtained under the pharmacy benefit
Provider documentationRequests for provider administration should include justification (e.g., inability to self‑administer or hypersensitivity requiring monitored dose)
Policy Revision Notes
2026-04-01Template updateLatest
Policy template updated and administrative content revised (removed state‑specific language for Louisiana); supporting references updated.
References supporting this policy were added or updated and the administrative policy template was revised. The prior policy version CS2026D0055X was archived as part of this update.
Change TypeTemplate and supporting information updates
Effective DateApr 1, 2026
Next Review DateN/A
Key ActionSubmit prior authorization with documentation of diagnosis, baseline eosinophil count, specialty prescriber, and evidence of treatment failure or inadequate control on optimized controller therapy.
Step therapy or contraindication: One of: history of failure to a 4‑month trial of Fasenra or Nucala; or contraindication/intolerance to Fasenra or Nucala.
Step therapy requirement for Cinqair.
No concomitant biologic therapy: Patient is not receiving Cinqair in combination with anti‑IL‑4, anti‑IL‑5, anti‑IgE, or TSLP inhibitors for the same indication.
Examples listed.
Dosing and prescriber: Dosing in accordance with FDA labeling; prescribed by a pulmonologist or allergist/immunologist; initial authorization ≤ 12 months.<=12 months
Examples provided in policy.
Provider administration necessity: One of: physician attestation that patient/caregiver cannot self‑administer; documented severe hypersensitivity to Fasenra within past 6 months requiring monitored administration; or new‑to‑therapy requiring initial monitored dose (authorization for 1 dose).
No concomitant biologic therapy: Patient is not receiving Fasenra in combination with anti‑IL‑4, anti‑IL‑5, anti‑IgE, or TSLP inhibitors for the same indication.
Examples listed.
Dosing and prescriber: Dosing per FDA labeling; prescribed by a pulmonologist or allergist/immunologist; initial authorization ≤ 12 months.<=12 months
Examples provided.
Provider administration necessity: One of: physician attestation that patient/caregiver cannot self‑administer; history of severe hypersensitivity to product within past 6 months requiring monitored administration; new‑to‑therapy requiring initial monitored dose (authorization for 1 dose); or patient ≤ 11 years of age.
No concomitant biologic therapy: Patient is not receiving Nucala in combination with anti‑IL‑4, anti‑IL‑5, anti‑IgE, or TSLP inhibitors for the same indication.
Examples listed.
Dosing and prescriber: Dosing per FDA labeling; prescribed by pulmonologist or allergist/immunologist; initial authorization ≤ 12 months.<=12 months
Administration or monitoring necessity:
One of: physician attestation that patient/caregiver cannot self‑administer; documented severe hypersensitivity to Fasenra within past 6 months requiring monitored administration; or new to therapy requiring initial monitored dose (authorization for 1 dose).
No concomitant biologic therapy: Patient is not receiving Fasenra in combination with anti‑IL‑5, anti‑IgE, anti‑IL‑4, or TSLP inhibitors for the same indication.
Dosing and prescriber: Dosing per FDA labeling; prescribed by a pulmonologist, rheumatologist, or allergist/immunologist; initial authorization ≤ 12 months.<=12 months
No concomitant biologic therapy: Patient is not receiving Nucala in combination with anti‑IL‑5, anti‑IgE, anti‑IL‑4, or TSLP inhibitors for the same indication.
Dosing and prescriber: Dosing per FDA labeling; prescribed by a pulmonologist, rheumatologist, or allergist/immunologist; initial authorization ≤ 6 months.<=6 months
Baseline (pre‑mepolizumab) blood eosinophil level ≥ 1,000 cells/µL within the past 4 weeks AND patient is currently receiving a stable dose of background HES therapy (e.g., oral corticosteroid, immunosuppressant, or cytotoxic therapy).
>=1000 cells/µL
Submission of medical records required.
No concomitant biologic therapy: Patient is not receiving other anti‑IL‑5, anti‑IgE, anti‑IL‑4, or TSLP inhibitors for the same indication.
Dosing and prescriber: Dosing per FDA labeling; prescribed by an allergist, immunologist, hematologist, cardiologist, or pulmonologist; initial authorization ≤ 12 months.<=12 months
No concomitant biologic therapy: Patient is not receiving Nucala in combination with anti‑IL‑5, anti‑IgE, anti‑IL‑4, or TSLP inhibitors for the same indication.
Dosing and prescriber: Dosing per FDA labeling; prescribed by an allergist/immunologist, otolaryngologist, or pulmonologist; initial authorization ≤ 12 months.<=12 months
Background therapy failure/combination: Exacerbations occurred while on maintenance therapy (triple LAMA+LABA+ICS or dual LAMA+LABA with failure/contraindication/intolerance to ICS); Nucala to be used as add‑on maintenance with these therapies.
Examples of maintenance therapies provided.
Provider administration necessity: One of: physician attestation that patient/caregiver cannot self‑administer; documented severe hypersensitivity within past 6 months requiring monitored administration; or new‑to‑therapy requiring initial monitored dose (authorization for 1 dose).
No concomitant biologic therapy: Patient is not receiving Nucala in combination with anti‑IL‑5, anti‑IgE, anti‑IL‑4, or TSLP inhibitors for the same indication.
Dosing and prescriber: Dosing per FDA labeling; prescribed by an allergist/immunologist or pulmonologist; initial authorization ≤ 12 months.<=12 months
<=12 months
Reauthorization ≤ 12 months.
Dosing per FDA labeling; reauthorization ≤ 12 months.<=12 months
Dosing per FDA labeling; reauthorization will be for no more than 12 months.<=12 months
Confirmation that Nucala is being used with maintenance/background therapy (examples: ICS/LABA products, other maintenance COPD/asthma regimens as applicable).
Attestation or documentation when patient/caregiver cannot self-administer or has recent severe hypersensitivity (see administration competency/hypersensitivity callout).
Note
Verify Benefit Plan Terms
Verify the member’s benefit plan, federal/state, and contractual terms before using this policy — those terms govern coverage if they differ from the standard policy.
Check member-specific benefit documents and any applicable federal or state mandates prior to processing authorization requests.
In event of conflict, federal/state/contractual requirements supersede this policy.
Denial Risk
Indication-Based Denial Risk
Requests outside FDA‑approved indications or that do not meet the clinical criteria in this policy are at high risk for denial.
Uses explicitly identified as unproven/not medically necessary (e.g., other eosinophilic conditions, acute bronchospasm, status asthmaticus, certain vasculitides) will not meet criteria.
Requests for COPD indications for Cinqair or Fasenra are considered unproven/not medically necessary per policy and may be denied.
Indication-based denial risk also applies when dosing, prescriber specialty, or required documentation are not met.
Documentation Required
Administration Competency or Hypersensitivity Documentation
When administration competency is an issue or severe hypersensitivity exists, provide documentation to support in‑office administration and monitoring.
Physician attestation that patient or caregiver are not competent or physically unable to self‑administer FDA‑labeled product (Fasenra or Nucala) to justify provider administration.
Documented history of severe hypersensitivity (e.g., anaphylaxis, angioedema, bronchospasm, hypotension) within the past 6 months requiring healthcare professional administration and direct monitoring — authorization for 1 monitored dose may be granted for initial supervised administration.
For patients new to therapy who require initial observed administration prior to self‑administration, request should note that authorization for the single observed dose will be granted when applicable.
Note
Reference Plan Terms
Providers must reference plan terms and local contract rules; this policy is informational and may be superseded by federal, state, or contractual requirements.
Before relying on this policy, check the member’s specific plan language and any applicable mandates.
UnitedHealthcare may use external tools (e.g., InterQual) to assist in administration; plan or contractual requirements control coverage decisions.
Step Therapy
Step Therapy for Cinqair
Step therapy applies for Cinqair: prior failure of other anti‑IL‑5 options is required unless contraindicated or not tolerated.
Cinqair requires prior failure of a 4‑month trial of Fasenra or Nucala, OR documented contraindication or intolerance to Fasenra or Nucala.
Ensure documentation of prior biologic trials, duration, and reason for discontinuation (lack of effect, intolerance, or contraindication).
Note
Optimize Inhaled Therapy Before Biologics
Optimize inhaled and background therapy before initiating biologics; document adherence and inhaler technique where applicable.
Confirm and document trial of optimized high‑dose ICS‑LABA and other appropriate controller medications (or maximally‑dosed ICS plus an additional controller) prior to biologic initiation.
Address and document adherence, inhaler technique, and management of contributory factors (per GINA/ERS‑ATS guidance) before classifying asthma as severe and initiating add‑on biologic therapy.
DocumentationMust be recorded in submitted laboratory values or chart notes
DocumentationSubmit medical records showing pre-treatment eosinophil level within prior 4 weeks
Asthma symptom control scores
Asthma control score thresholdsACQ > 1.5 or ACT < 20 (indicates poor symptom control)
Use in criteriaCounts as evidence of uncontrolled asthma for biologic therapy eligibility
Alternate evidenceAlternatively, frequent exacerbations or OCS dependence may also define uncontrolled disease
Blood eosinophil count — common thresholds across trials
Common trial thresholdsBlood eosinophil thresholds commonly referenced: ≥150, ≥300, and ≥400 cells/µL
ApplicationThreshold used varies by agent, indication, and trial enrollment criteria
DocumentationUse the trial- or indication-specific eosinophil cut-point when aligning with coverage rationale
Blood eosinophil count — trial‑specific values
Reslizumab (Cinqair) trial valuesPivotal reslizumab trials required blood eosinophil ≥ 400 cells/µL for most Studies I–III (some cohorts unselected in Study IV)
HES trial valueNucala HES trial required screening eosinophils ≥ 1,000 cells/µL and used 300 mg SC q4w dosing
ERS/ATS guidanceERS/ATS suggests a blood eosinophil cut-point ≥ 150 cells/µL to guide anti‑IL‑5 initiation in adults
Initial dose monitoringNew‑to‑therapy patients may receive a single monitored administration authorization before self‑administration
Uncontrolled asthma (examples)
Examples of uncontrolled asthma/COPDPoor symptom control (ACQ>1.5 or ACT<20), ≥2 systemic corticosteroid bursts in prior 12 months, asthma/COPD‑related emergency treatment, or dependence on maintenance oral corticosteroids
Objective measuresAirflow limitation (post‑bronchodilator FEV1 <80% predicted for asthma; COPD defined by FEV1/FVC <0.7 and FEV1 20%–80% predicted)
Exacerbation historyFor COPD, ≥2 moderate or ≥1 severe exacerbation in prior year despite maintenance therapy qualifies as uncontrolled disease
EGPA — definition summary
EGPA descriptionVasculitic syndrome characterized by asthma, sinusitis, pulmonary infiltrates, neuropathy, and eosinophilic vasculitis of one or more end organs
Treatment contextSystemic glucocorticoids are standard treatment; biologics are used in refractory or relapsing disease
EGPA featuresPolicy lists characteristic findings such as eosinophilic vasculitis, neuropathy, cardiomyopathy, and sino‑nasal abnormalities
HES — definition summary
HES descriptionDisorder of sustained eosinophil overproduction with organ damage; often defined by >1,500 eosinophils/µL for ≥6 months
Trial exclusions and therapyHES trial excluded non‑hematologic secondary causes and FIP1L1‑PDGFRα positive disease; mepolizumab reduced flare incidence in trial when baseline eosinophils ≥1,000 cells/µL
Background therapyPatients in HES trial remained on stable background HES therapy during randomized treatment
Uncontrolled / Severe Asthma — definitions
Severe/uncontrolled asthma criteriaUncontrolled asthma: poor symptom control and/or frequent exacerbations (≥2/year) or serious exacerbation (≥1/year). Severe asthma: uncontrolled despite optimized high‑dose ICS‑LABA and management of contributory factors
Reauthorization evidencePositive clinical response may be demonstrated by reduced exacerbations, decreased rescue use, or improved FEV1
Specialist prescribingPrescribed by pulmonologist or allergist/immunologist per policy criteria
Blood eosinophil thresholds — guidance and trials
ERS/ATS guidance and trial thresholdsERS/ATS suggests blood eosinophil cut‑point ≥150 cells/µL to guide anti‑IL‑5 initiation; trials often used higher thresholds (eg, ≥400 cells/µL for reslizumab; ≥1,000 cells/µL screening for HES)
Trial variabilityDifferent trials and indications used varying eosinophil cut‑points depending on population and endpoint
Implication for coveragePolicy aligns coverage thresholds to indication‑ or trial‑specific values where applicable
Add‑on maintenance treatment — definition
Add‑on maintenance treatmentTherapy is intended as add‑on maintenance treatment in combination with maximally‑dosed ICS/LABA or other controller medications for severe asthma
ExamplesPolicy lists examples of combination inhaled therapies (e.g., Advair, Symbicort) and additional controllers
Reauthorization requirementContinued use requires documentation of positive clinical response while on background controller therapy
Eosinophilic phenotype — phenotype responsive to biologics
Eosinophilic phenotype (responsiveness)An asthma phenotype characterized by elevated peripheral blood eosinophil counts (e.g., ≥150 cells/µL) associated with type‑2 inflammation and responsiveness to anti‑eosinophil biologics
Clinical identificationIdentified by baseline blood eosinophil count and clinical features of eosinophilic inflammation
Role in prescribingUsed to determine eligibility for anti‑IL‑5 and anti‑IL‑5 receptor therapies per policy criteria