Respiratory Interleukins — Coverage Criteria
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Defines prior authorization, quantity/duration limits, step therapy, and medical benefit vs pharmacy benefit handling for specified respiratory interleukin biologic agents for Aloha Care members.
No material clinical or coverage changes in this revision.
Coverage Criteria and Clinical Logic
inv-01: Initial Therapy
Covered when ALL of the following are met:
Agent-specific eosinophil thresholds and prior biologic trial requirements included
inv-02: Continuation/Renewal Therapy
Covered when ALL of the following are met:
Renewal approvals typically 1 year
inv-03: Initial Therapy - Severe Asthma
Covered when ALL of the following are met for initial severe asthma therapy
See chunks 20–22 for required controller therapies and diagnostic criteria
inv-04: Renewal Therapy - Severe Asthma
Covered for renewal when ALL of the following are met
Combination biologic exclusion applies
inv-05: Initial Therapy - EGPA
Covered when ALL of the following are met for initial EGPA therapy
See chunk 23 for EGPA feature list
inv-06: Renewal Therapy - EGPA
Covered when ALL of the following are met for EGPA renewal
Remission defined per BVAS v3 and low steroid dose
inv-07: Initial Therapy - HES
Covered when ALL of the following are met for initial HES therapy
Nucala limitations for secondary HES noted in chunk 28
inv-08: Renewal Therapy - HES
Covered when ALL of the following are met for HES renewal
See chunk 27 for renewal stabilization criteria
inv-09: Initial Therapy - CRSwNP
Covered when ALL of the following are met for CRSwNP initial therapy
Diagnostic confirmations and prior therapy requirements in chunk 29
inv-10: Renewal Therapy - CRSwNP
Covered when ALL of the following are met for CRSwNP renewal
See chunk 30 for renewal confirmation
inv-11: Initial Therapy - IgE-mediated Food Allergy
Covered when ALL of the following are met for initial IgE-mediated food allergy therapy
See chunk 32 for testing and epinephrine requirement
inv-12: Renewal Therapy - IgE-mediated Food Allergy
Covered when ALL of the following are met for IgE-mediated food allergy renewal
See chunk 33 for renewal elements
inv-13: Initial Therapy - CSU
Covered when ALL of the following are met for initial CSU therapy
See chunks 34 and 38 for CSU clinical and combination therapy requirements
inv-14: Renewal Therapy - CSU
Covered when ALL of the following are met for CSU renewal
Chunk 35 begins renewal; supporting renewal details appear in initial criteria
inv-15: Xolair (omalizumab) initial and dosing criteria (partial)
Covered when ALL of the following are met (excerpt):
From policy excerpt
From policy excerpt
inv-16: Initial Therapy
Covered when ALL of the following are met
chunks 54–56
chunks 55–56
chunk 54
chunks 54,56,63
inv-17: Initial Therapy
Covered when ALL of the following are met
Not for acute bronchospasm or status asthmaticus; dosing determined by pretreatment IgE and body weight
inv-18: Dosage Adjustments and Interruptions
Continuation/dose determination rules
Examples provided for split‑vial dosing to reduce injections; weight‑based dosing bands provided
inv-19: Initial therapy
Covered when ALL of the following are met
Total IgE elevated during treatment and up to 1 year after discontinuation; re‑test only if interrupted ≥1 year
inv-20: Initial Therapy
Covered when ALL of the following are met
Dose selection per weight and pretreatment IgE; see dosing bands.
inv-21: Dose adjustments and monitoring
Continuation / dose-adjustment guidance
Dosing bands: 20‑40 kg = 75 mg Q4wk; >40‑90 kg = 150 mg Q4wk; >90‑150 kg = 300 mg Q4wk (examples in document).
inv-22: Initial therapy (pediatric)
Covered when ALL of the following are met
chunk 126,145
chunk 126,145
chunk 126,145
chunk 126,140,145
inv-23: Initial therapy / Covered indication
Covered when ALL of the following are met
Dose selection uses combined pretreatment IgE and body weight bands as shown in dosing tables; adjust for significant weight changes.
inv-24: Initial therapy
Covered when ALL of the following are met
supporting chunks: 163,165
inv-25: Dose determination and adjustments
Dosing and monitoring rules
IgE levels elevated during treatment and up to 1 year after discontinuation; re‑testing only after ≥1 year interruption
inv-26: Initial therapy / dosing eligibility
Covered when ALL of the following are met
supported in multiple chunks
explicit indication statement
Dose table present in text fragments
inv-27: Initial Therapy (pediatric dosing by IgE and weight)
Covered when ALL of the following are met for pediatric patients age 6 to less than 12 years:
Not indicated for acute bronchospasm or status asthmaticus
Re‑testing of IgE during treatment cannot be used to guide dose unless treatment interrupted ≥1 year; dose determination after interruptions <1 year should use initial pretreatment IgE
Doses should be adjusted for significant changes in body weight
inv-28: Indication and dosing groupings
Coverage and dosing references present for Xolair and other biologics include the following grouped conditions and parameters
Document pretreatment IgE and prior controller therapy
Confirm antihistamine‑refractory status
See full policy for complete criteria
Combination therapy with more than one of the listed biologic agents is prohibited. Combination use of Cinqair, Dupixent, Fasenra, Nucala, Tezspire, or Xolair is not allowed and requests that document concurrent use of these agents will be denied.
Concurrent prescribing of the named biologics is an exclusion. Combination use of Cinqair, Dupixent, Fasenra, Nucala, Tezspire, and Xolair is not allowed and such combination-use requests are not covered.
Nucala (mepolizumab) is not appropriate for certain subtypes of hypereosinophilic syndrome. Nucala may not be approved for non‑hematologic secondary HES (for example, drug hypersensitivity, parasitic helminth infection, HIV infection, or non‑hematologic malignancy) or for FIP1L1‑PDGFRα–positive HES.
The policy disallows overlapping therapy with multiple interleukin/IgE biologics. Combination use of Cinqair, Dupixent, Fasenra, Nucala, Tezspire, or Xolair is not allowed and will be a basis for denial.
These biologic agents are not intended for acute relief of bronchospasm. Not indicated for relief of acute bronchospasm or status asthmaticus; requests for use as rescue therapy will be considered inappropriate.
For Xolair specifically, acute rescue use is excluded. Use of Xolair for relief of acute bronchospasm or status asthmaticus is explicitly excluded and such requests will not meet coverage criteria.
The policy reiterates that interleukin/IgE biologics are not for emergency asthma treatment. Not indicated for relief of acute bronchospasm or status asthmaticus; approvals require use for chronic management per the listed indications.
Requests for these agents to treat acute bronchospasm or status asthmaticus are excluded. Use for relief of acute bronchospasm or status asthmaticus is not indicated and will not satisfy coverage requirements.
The indications explicitly exclude emergency bronchodilator use. Not indicated for the relief of acute bronchospasm or status asthmaticus; these situations are excluded from the indication and such uses are non‑covered.
The policy confirms that these agents are for chronic management, not rescue therapy. Not indicated for the relief of acute bronchospasm or status asthmaticus; acute‑rescue requests are inappropriate.
Multiple sections restate exclusion of acute rescue use. Not indicated for the relief of acute bronchospasm or status asthmaticus; coverage requires use consistent with the chronic indications and documented prerequisites.
Xolair is not a rescue medication. Xolair is not indicated for the relief of acute bronchospasm or status asthmaticus and requests for such use will not meet the coverage criteria.
Package‑label limitations are noted for other uses of omalizumab. XOLAIR is not indicated for treatment of other allergic conditions beyond the approved indications referenced in the dosing/indication tables.
Approvals for Xolair dosing require baseline objective data. Requests submitted without documented pretreatment total serum IgE and current body weight for dose determination, or without required pretreatment FEV1/reversibility or prior trials of specified controller therapies where applicable, will not meet coverage criteria and may be denied.
The policy identifies specific HES subtypes where Nucala is unlikely to be approved. Use of Nucala for non‑hematologic secondary HES or for FIP1L1‑PDGFRα–positive HES is not appropriate and may be denied.
Total serum IgE values measured while a patient is receiving Xolair are not reliable for dosing decisions. Re‑testing of total IgE during treatment should not be used to guide dosing because total IgE levels are elevated during treatment and may remain elevated for up to one year after discontinuation.
Because Xolair raises total IgE, on‑treatment IgE measurements do not reflect baseline levels. Re‑testing total IgE during active Xolair treatment cannot be used to guide dose determination because total IgE levels remain elevated during treatment and for up to one year after stopping therapy.
The policy consistently advises against using on‑treatment IgE to set dose. Re‑testing IgE during Xolair treatment to determine dosing is not medically useful because total IgE remains elevated during treatment and up to one year after discontinuation.
Multiple passages state that on‑treatment IgE is unreliable for dosing. Re‑testing total serum IgE during Xolair treatment cannot be used to guide dose determination because total IgE levels are elevated during treatment and may remain elevated for up to one year after discontinuation.
Dose selection for omalizumab must be based on baseline data. Treatment requests submitted without documented pretreatment total serum IgE and body weight for dose determination, or requests for acute bronchospasm/status asthmaticus, will not meet coverage criteria.
The guidance clarifies that IgE remains elevated after stopping Xolair. Re‑testing IgE during ongoing Xolair treatment cannot be used for dose determination because total IgE levels remain elevated for up to one year after discontinuation; re‑testing is only informative if therapy was interrupted for ≥1 year.
The policy reiterates that on‑treatment IgE is not a valid dosing input. Re‑testing of IgE levels during Xolair treatment cannot be used as a guide for dose determination because total IgE levels are elevated during treatment and may remain elevated for up to one year after discontinuation.
Dose determination must be based on pretreatment measures. Use of these products without documented pretreatment total serum IgE and body weight for Xolair dose determination, or for treatment of acute bronchospasm/status asthmaticus, does not meet the coverage criteria and may be denied.
Within the excerpted fragments there are no additional explicit 'not medically necessary' rulings beyond the indicated limitations for Xolair; comprehensive NMN determinations are provided elsewhere in the full policy. No additional NMN statements are present in this fragment beyond the indication‑limitation language for Xolair.
Prior Authorization, Documentation, and Step Therapy
Prior authorization required; approval durations and QL apply
Prior authorization is required for respiratory interleukin biologics; initial approvals are typically for 6 months (Fasenra exception noted at 3 months) and renewals are typically for 1 year. Quantity limits (QL) and PA apply per the formulary coding (e.g., J2786, J0517, J2182, J2356, J2357).
- Initial durations: generally 6 months (Cinqair, Nucala, Xolair, Tezspire).
- Fasenra (benralizumab) initial override duration: 3 months.
- Renewal duration: typically 1 year.
PA and quantity limits required; typical durations
Prior authorization (PA) and quantity limits (QL) must be obtained before use; initial authorizations are commonly for 6 months with renewals commonly approved for 1 year.
Follow FDA IgE/weight dosing table; allow monthly total dosing to avoid vial waste
For omalizumab (Xolair), prior authorization follows the FDA IgE-and-body-weight dosing table; the policy allows approval of total monthly dosing to avoid vial waste (i.e., approving equivalent monthly totals instead of strict q2wk splits).
- Dosing follows FDA weight/IgE chart for Xolair.
- Total monthly doses may be approved to prevent wasting medication due to split vial dosing.
Vial-sparing dosing allowed—approve equivalent monthly totals
Providers may request approval of total monthly doses to permit vial-sparing administration (examples given in policy: 375 mg q2 weeks may be administered as 450 mg then 300 mg two weeks later; 225 mg q2 weeks may be administered as 300 mg then 150 mg).
- Approval of equivalent total monthly dosing is allowed to reduce injections and vial waste.
- Examples: 375 mg q2wk → approved as 450 mg then 300 mg; 225 mg q2wk → approved as 300 mg then 150 mg.
PA must include indication plus pretreatment IgE and body weight
Prior authorization must document the indication and baseline labs: moderate-to-severe persistent asthma with positive skin test or in vitro reactivity to a perennial aeroallergen, inadequate control on inhaled corticosteroids, pretreatment total serum IgE, and body weight for dose determination.
- Document positive skin or in vitro reactivity to a perennial aeroallergen.
- Provide pretreatment total serum IgE (IU/mL) and current body weight (kg) to determine Xolair dosing.
PA must include age, allergen testing, control status, IgE and weight
Prior authorization requires documentation of patient age, positive allergy testing to a perennial aeroallergen, inadequate control on inhaled corticosteroids, body weight, and pretreatment total serum IgE for dose determination.
- Provide evidence of positive skin test or in vitro reactivity.
- Document inadequate control on inhaled corticosteroids.
- Include pretreatment total serum IgE and current body weight for dose selection.
PA must show diagnosis, allergen test, pretreatment IgE and weight
PA submissions should include the clinical diagnosis of moderate-to-severe persistent asthma, positive skin test or in vitro reactivity to a perennial aeroallergen, inadequate control on inhaled corticosteroids, pretreatment serum IgE, and current body weight to determine the appropriate Xolair dose.
- Document FEV1 and reversibility where applicable per severity criteria.
- Use pretreatment total serum IgE and body weight to select dose band per policy dosing tables.
PA for pediatric Xolair must document age 6–<12, allergen sensitization, IgE and weight
For pediatric omalizumab (age 6 to <12 years), prior authorization must reflect the specific indication: moderate‑to‑severe persistent IgE‑mediated allergic asthma with positive perennial aeroallergen sensitization and inadequate control on inhaled corticosteroids; include pretreatment total serum IgE and body weight for dose determination.
- Age must be documented as 6 to less than 12 years.
- Provide positive skin test or in vitro reactivity to a perennial aeroallergen.
- Include pretreatment total serum IgE and current body weight to determine dosing band.
Pediatric dosing PA requires pretreatment IgE and body weight
Prior authorization must document that the pediatric member (6 to <12 years) has moderate‑to‑severe persistent IgE‑mediated allergic asthma uncontrolled on inhaled corticosteroids, and must include pretreatment total serum IgE and body weight to select the appropriate dose.
- Confirm inadequate control on inhaled corticosteroids before initiating Xolair.
- Document pretreatment IgE (IU/mL) and body weight (kg) to determine dose per weight/IgE bands.
PA must state pretreatment total serum IgE and body weight for dose determination
PA requests must include the pretreatment total serum IgE level and body weight used to determine the Xolair dose; for pediatric patients also include evidence of moderate‑to‑severe persistent asthma inadequately controlled on inhaled corticosteroids and positive perennial aeroallergen testing.
- Pretreatment IgE is required for initial dose determination.
- Body weight (kg) is required to select dose band from dosing table.
PA for pediatric Xolair—confirm age, sensitization, control status, IgE and weight
Prior authorization for pediatric Xolair requires documentation of age 6 to less than 12 years, positive perennial aeroallergen sensitization, inadequate control on inhaled corticosteroids, pretreatment total serum IgE, and current body weight to determine dosing.
- Age 6 to <12 years must be clearly documented.
- Provide pretreatment IgE and body weight to select appropriate dosing band per table.
PA requires pretreatment IgE and body weight; missing data risks denial
Prior authorization must document pretreatment serum total IgE and body weight to determine the appropriate Xolair dose and confirm age and inadequate control on inhaled corticosteroids; requests lacking these data may be denied.
- Pretreatment IgE and body weight are required for dose selection.
- Lack of documented pretreatment IgE and weight may trigger coverage review or denial.
PA required for interleukin/IgE biologics; include indication and dosing
Prior authorization is required for interleukin/IgE biologics and must specify indication and dosing; examples in the policy include Xolair dosing alternatives (150 or 300 mg every 4 weeks for CIU and weight/IgE-based Q2wk/Q4wk regimens for asthma).
- PA should include the dosing schedule and indication.
- CIU dosing example: 150 or 300 mg subQ every 4 weeks for patients ≥12 years.
Step therapy applies to new starts—document prior trials per Part B rules
Step therapy rules apply for new starts per Medicare Part B guidance and internal criteria; for example, reslizumab (J2786) new starts historically require prior inadequate response/intolerance/contraindication to benralizumab (J0517) or mepolizumab (J2182) for specified periods.
Ensure prerequisite controller and biologic trials are documented
For severe asthma and other specified indications, the member must have documented trials with inadequate response or intolerance to specified controller therapies (e.g., high‑dose ICS+LABA, leukotriene modulators, plus LAMA or oral corticosteroids); for certain agents, a prior trial of Xolair may be required before approval of other biologics.
- Document a 3‑month trial with inadequate response or intolerance to combination controller therapy (high‑dose ICS+LABA, leukotriene modulators, plus LAMA or oral corticosteroids).
- For some indications (e.g., Nucala in EGPA/HES/CRSwNP), prior trial and inadequate response/intolerance to Xolair may be required.
Xolair must be prescribed/recommended with allergist/immunologist consultation
For Xolair, the policy expects the medication be prescribed or recommended in consultation with an Allergist or Immunologist and, for CIU, used in combination with a second‑generation H1 antihistamine or cyclosporine.
- Document specialist consultation (Allergist or Immunologist).
- For CIU, confirm use with second‑generation H1 antihistamine or cyclosporine.
Document inadequate control on inhaled corticosteroids before Xolair
Prior controller therapy is required: symptoms must be inadequately controlled with inhaled corticosteroids before initiating Xolair for IgE‑mediated allergic asthma.
- Document prior use and inadequate control on inhaled corticosteroids.
- Confirm other controller trials per severe asthma criteria as applicable.
Prior controller therapy (inhaled corticosteroid) required before initiation
Documented requirement: patients should have symptoms inadequately controlled with inhaled corticosteroids prior to Xolair initiation (i.e., prior controller therapy trial expected).
- Policy indicates prior controller therapy must be attempted and found inadequate.
- Provide chart evidence of inadequate control while on inhaled corticosteroids.
Submit specialist chart notes, objective labs, prior trials, and renewal improvement data
For PA and renewal decisions, providers must submit chart notes from an appropriate specialist (Allergist, Immunologist, Pulmonologist, ENT as applicable) documenting diagnosis, pretreatment FEV1 and reversibility where applicable, prior controller trials, blood eosinophil counts when required, and for renewals evidence of clinical improvement (reduced exacerbations, decreased reliever use, increased % predicted FEV1, or symptom reduction).
- Include specialist recommendation/prescription and objective measures (FEV1, reversibility).
- For renewals provide documentation of clinical improvement or stabilization while on therapy.
Document pretreatment IgE and weight; on‑treatment IgE not valid for dose changes
Provider documentation must include pretreatment total serum IgE (IU/mL) and current body weight (kg) for Xolair dose determination; note that total IgE rises during treatment and may remain elevated up to one year after stopping, so on‑treatment IgE should not be used to guide dosing unless treatment was interrupted ≥1 year.
- Provide pretreatment IgE used for initial dose determination.
- If treatment interrupted ≥1 year, re‑test IgE for dose selection; otherwise use original pretreatment IgE.
Incomplete clinical documentation or missing required tests may result in denial
Providers risk denial if requests do not meet initial or renewal clinical criteria—examples include missing specialist recommendation, insufficient documentation of prior controller trials, absent FEV1/reversibility or eosinophil counts where required, or lack of documented clinical improvement for renewals.
- Missing required objective data (FEV1/reversibility, eosinophil counts, pretreatment IgE/weight) can trigger denial.
- Lack of documented specialist involvement or prior controller trials risks non-approval.
Combination biologic therapy is excluded and will be denied
Requests will be denied if combination use of listed biologics is present; the policy explicitly prohibits concurrent use of Cinqair, Dupixent, Fasenra, Nucala, Tezspire, or Xolair.
- Do not request or prescribe combination biologic therapy with the listed agents.
- Combination biologic use is an explicit exclusion and will be denied.
Billing and Diagnostic Codes
| J2786 | Injection, reslizumab, 1 mg (Cinqair) |
| J0517 | Injection, benralizumab, 1 mg (Fasenra) |
| J2182 | Injection, mepolizumab, 1 mg (Nucala) |
| J2356 | Injection, tezepelumab-ekko, 1 mg (Tezspire) |
| J2357 | Injection, omalizumab, 5 mg (Xolair) |
| J82.83 | ICD-10 code referenced for severe eosinophilic asthma |
| J45.50-J45.52 | Severe persistent asthma (ICD-10) |
| M30.1 | Eosinophilic granulomatosis with polyangiitis (EGPA) (ICD-10) |
| D72.119 | Hypereosinophilic syndrome (HES) (ICD-10) |
| J32.9 | Chronic sinusitis, unspecified (ICD-10) |
| J33.9 | Nasal polyp, unspecified (ICD-10) |
| Z91.018 | Allergy to other food (IgE-mediated food allergy) (ICD-10) |
| L50.8 | Other urticaria (Chronic spontaneous urticaria) (ICD-10) |
| N/A | FDA dosing chart referenced for omalizumab (IgE and body weight-based dosing). Exact numeric table present in policy text. |
Background and Context
Background: These targeted biologic agents are used to treat severe eosinophilic asthma and other eosinophil‑ or IgE‑mediated conditions, including chronic rhinosinusitis with nasal polyps, eosinophilic granulomatosis with polyangiitis (EGPA), hypereosinophilic syndrome (HES), and chronic spontaneous/idiopathic urticaria. The policy references agent‑specific thresholds, dosing tables, and safety considerations (for example, Cinqair anaphylaxis warning) to guide appropriate prescribing.
Definitions and Clinical Thresholds
Policy Revision History
Policy updated and revised; document shows 'Last revised 2025-12-22' and the policy content (criteria, dosing tables, durations) reflects the 12/22/2025 revision.
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