RXMP-05 Respiratory Interleukins Form

Effective Date

Last Reviewed

Original Document

Respiratory Interleukins

Updated on: 12/22/2025

Policy Number RXMP-05 Line of Business Medicaid & Medicare Effective Date 10/1/2023 (Medicaid), 1/1/2024 (Medicare) Revision Date 12/22/2025

Products: Cinqair (reslizumab), Fasenra (benralizumab), Nucala (mepolizumab), Tezspire (tezepelumab), Xolair (omalizumab)

Override(s)
Approval Duration
Prior Authorization Quantity Limit Initial:
• Cinqair, Nucala, Xolair, Tezpire: 6 months • Fasenra: 3 months Continuation: 1 year

Medications Quantity/Dosing Limit
Medical Benefit: Authorization Required; Pharmacy Benefits: Non-Formulary, PA required J2786 Injection, reslizumab, 1 mg (Cinqair 100mg vial)ϯ 3 mg/kg every 28 days J0517 Injection, benralizumab, 1 mg (Fasenra 30mg/mL prefilled syringe/autoinjector) (preferred) 30mg/mL syringe (or 1 syr) every 28 days for 3 fills, then 1/56 days for maintenance (at week 4) Nucala (mepolizumab) 40 mg/0.4ml prefilled syringe 40 mg (1 syringe) every 28 days Nucala (mepolizumab) 100 mg/ml prefilled syringe/autoinjector 100 mg (1 syringe) every 28 days; may approve up to 300 mg (3 syringe) every 28 days for eosinophilic granulomatosis with polyangiitis (EGPA) or hypereosinophilic syndrome (HES). J2182 Injection, mepolizumab, 1 mg (Nucala 100mg vial)ϯ 100 mg (1 vial) every 28 days; may approve up to 300 mg (3 vial) every 28 days for eosinophilic granulomatosis with polyangiitis (EGPA) or hypereosinophilic syndrome (HES). J2356 Injection, tezepelumab-ekko, 1mg [Tezspire 210mg/1.91mL prefilled pen, syringe, or vial ϯ] 1 prefilled syringe/pen or vial every 28 days J2357 Injection, omalizumab, 5mg (Xolair 5mg vial)ϯ (Preferred) • Asthma: 375 mg as frequently as every 14 days • Nasal Polyps: 600 mg as frequently as every 14 days • Chronic Idiopathic Urticaria: 300 mg every 28 days • Immunoglobulin E (IgE) -mediated food allergy: 600 mg as frequently as every 14 days Xolair (omalizumab) 75 mg/0.5 mL, 150mg/1mL, 300mg/2mL prefilled syringe/autoinjector Medicare (new starts)/Medicaid preferred agents: Cinqair or Xolair ϯ Indicates covered through the Medical benefit

Medicare CMS Criteria: Medicare Part B Coverage Criteria
• Review using the most current Local Coverage Determination (LCD), National Coverage Determination (NCD), or Local Coverage Article (LCA) that applies to the Hawaii region. The LCD, NCD, or LCA can be found at: https://www.cms.gov/medicare-coverage-database/search.aspx. • No LCD or NCD available as of 11/7/2025. • For new starts, step therapy criteria must be met in addition to clinical criteria before a request may be approved. Medicare Part B 90-Day Transition Period For new Medicare members, a 90-day transition period applies. During this time, if a member is currently on an active course of the requested treatment, including when furnished by an out-of-network provider, Coverage and Step

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Therapy do not apply. After the first 90 days of enrollment, Coverage and Step Therapy Criteria must be met for continued coverage. Medicare Part B Step Therapy Criteria From 7/1/2023 to 12/31/2025: J2786, Injection, reslizumab, 1 mg [Cinqair] (new start): The member has an inadequate response to, intolerable adverse event to, or has a contraindication to J0517, Injection, benralizumab, 1 mg [Fasenra] or J2182 Injection, mepolizumab, 1 mg [Nucala].

From 1/1/2026:
J2786, Injection, reslizumab, 1 mg [Cinqair] (new start): For the diagnosis of Eosinophilic Asthma: The member has an inadequate response to, intolerable adverse event to, or has a contraindication to omalizumab (Xolair) J0517, Injection, benralizumab, 1 mg [Fasenra] or J2182 Injection, mepolizumab, 1 mg the diagnosis of Eosinophilic Asthma: The member has an inadequate response to, intolerable adverse event to, or has a contraindication to reslizumab (Cinqair)

Criteria Shortcuts Diagnosis Cinqair Fasenra Nucala Tezspire Xolair Asthma [initial | renewal] X X X X X Chronic Rhinosinusitis with Nasal Polyps [initial | renewal]

X Eosinophilic Granulomatosis with Polyangiitis [initial | renewal]

Severe Asthma [initial | renewal]

X X Hypereosinophilic Syndrome [initial | renewal]

IgE-Mediated Food Allergy [initial | renewal]

X Urticaria [initial | renewal]

Approval Criteria Cinqair (reslizumab), Fasenra (benralizumab), Nucala (mepolizumab), Xolair (omalizumab) Duration • Initial: Cinqair, Nucala, Xolair, Tezpire: 6 months • Fasenra: 3 months • Renewal: 1 year
Override PA, QL Pharmacy staff: For QUEST non-ABD members with cancer, send ADRC (Aid to Disability Referral Committee) referral with chart notes through G8 CM module. Initial Request for Eosinophilic Asthma

The request is for a diagnosis of severe eosinophilic asthma (ICD-10 code J82.83); AND
The medication prescribed or recommended by an Allergist, Immunologist, or Pulmonologist; AND
Chart notes provided showed that the member has asthma as demonstrated by both the following: a. A pretreatment forced expiratory volume in 1 second (FEV1) less than 80% predicted; AND b. FEV1 reversibility of at least 12% and 200 mL after albuterol administration. AND
The member ha a 3-month trial and inadequate response or intolerance to ALL of the following: a. High dose inhaled corticosteroids (ICS) + long acting beta2-agonist (LABA) [e.g. fluticasone/salmeterol inhaler, Dulera (mometasone/formoterol) inhaler, fluticasone/vilanterol (Breo Ellipta) inhaler, budesonide/fomoterol (Symbicort) inhaler); AND b. Leukotriene modulators [e.g. montelukast (Singulair) tablet, zafirlukast (Accolate) tablet, zileuton ER (Zyflo) tablet]; AND c. Long-acting muscarinic antagonists (LAMA) [e.g. Incruse (umeclindium), tiotropium (Spiriva), Tudorza

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Updated on: 12/22/2025

Cinqair (reslizumab), Fasenra (benralizumab), Nucala (mepolizumab), Xolair (omalizumab) (aclidinium), Seebri (glycopyrrolate), Yupelri (revendacin)] OR oral corticosteroids (prednisone, methylprednisolone) Note: This is a combination of an ICS, LABA, leukotriene modulators AND either a LAMA OR an oral corticosteroid. AND

The member has experienced 2 or more asthma exacerbations in the prior 12 months requiring use of a systemic corticosteroid or temporary increase in the member’s usual maintenance dosage of oral corticosteroids; AND
For Xolair, okay to approve
For Cinqair, documentation been provided showing blood eosinophil count of greater than or equal to 400 cells/microliter (400 cells/mm3) at initiation of therapy. [Note: blood eosinophil count is in the absence of other potential causes of eosinophilia, including hypereosinophilic syndromes, neoplastic disease, and known or suspected parasitic infection;
OR
For Nucala or Fasenra, both of the following: a. Documentation been provided showing blood eosinophil count is greater than or equal to 150 cells/microliter (150 cells/mm3) at initiation of therapy. [Note: blood eosinophil count is in the absence of other potential causes of eosinophilia, including hypereosinophilic syndromes, neoplastic disease, and known or suspected parasitic infection.]; AND
b. The member had a 3-month trial and inadequate response or intolerance to Xolair and Cinqair. • Combination use of Cinqair, Dupixent, Fasenra, Nucala, Tezspire or Xolair is not allowed. • Cinqair has a black box warning for anaphylaxis. Anaphylaxis occurred with Cinqair infusion in 0.3% of participants in placebo-controlled studies. Individuals should be observed after Cinqair administration for an appropriate period of time by a healthcare professional prepared to manage anaphylaxis that can be life-threatening. Discontinue Cinqair immediately if the patient experiences signs or symptoms of anaphylaxis. Renewal Request for Eosinophilic Asthma
The request is for a diagnosis of severe eosinophilic asthma (ICD-10 code J82.83); AND
The medication prescribed or recommended by an Allergist, Immunologist, or Pulmonologist; AND
The member currently using the requested drug in combination with inhaled corticosteroid-based controller therapy; AND
Documentation or chart notes been provided showing clinical improvement in one or more of the following: a. Decreased utilization of reliever medication;
b. Decreased frequency of exacerbations (defined as worsening of asthma that requires an increase in inhaled corticosteroid dose or treatment with systemic corticosteroids);
c. Increase in percent predicted FEV1 from pretreatment baseline; or d. Reduction in reported asthma-related symptoms, such as, asthmatic symptoms upon awakening, coughing, fatigue, shortness of breath, sleep disturbance, or wheezing. • Combination use of Cinqair, Dupixent, Fasenra, Nucala, Tezspire or Xolair is not allowed. • Cinqair has a black box warning for anaphylaxis. Anaphylaxis occurred with Cinqair infusion in 0.3% of participants in placebo-controlled studies. Individuals should be observed after Cinqair administration for an appropriate period of time by a healthcare professional prepared to manage anaphylaxis that can be life-threatening. Discontinue Cinqair immediately if the patient experiences signs or symptoms of anaphylaxis.
Tezspire (tezepelumab-ekko), Xolair (omalizumab) Severe Asthma Duration Initial: 6 months, Renewal: 1 year Override PA, QL

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Tezspire (tezepelumab-ekko), Xolair (omalizumab) Severe Asthma Pharmacy staff: For QUEST non-ABD members with cancer, send ADRC (Aid to Disability Referral Committee) referral with chart notes through G8 CM module. Initial Request for Severe Asthma

The request is for a diagnosis of severe asthma [ICD-10: J45.50-J45.52 (Severe persistent asthma)]; AND
The medication prescribed or recommended by an Allergist, Immunologist, or Pulmonologist; AND
The request for a diagnosis of severe asthma [ICD-10: J45.50-J45.52 (Severe persistent asthma)]; AND
The medication prescribed or recommended by an Allergist, Immunologist, or Pulmonologist; AND
The request is for initial therapy; AND
Chart notes show that the member has asthma as demonstrated by both of the following: a. A pretreatment forced expiratory volume in 1 second (FEV1) less than 80% predicted; AND b. FEV1 reversibility of at least 12% and 200 ml after albuterol administration. AND
The member had a 3-month trial and inadequate response or intolerance to the combination controller therapy such as: a. High dose inhaled corticosteroids (ICS) + long acting beta2 –agonists (LABA): [eg. fluticasone/salmeterol inhaler, Dulera (mometasone/ formoterol, fluticasone/vilanterol (Breo Ellipta) inhaler, budesonide/formoterol (Symbicort) inhaler] **See high dosing table; AND b. Leukotriene modulators [eg. montelukast (Singulair) tablet, zafirlukast tablet (Accolate), or zileuton ER (Zyflo) tablet]; AND c. Long-acting muscarinic antagonists (LAMA) [eg. Incruse (umeclindium), tiotropium (Spiriva), Tudorza (aclidinium), Seebri (glycopyrrolate), Yupelri (revendacin)] OR oral corticosteroids (prednisone, methylprednisolone) Note: This is a combination of ICS, LABA, leukotriene modulators AND either a LAMA or an oral corticosteroid AND
The member experienced 2 or more asthma exacerbations in the prior 12 months requiring use of a systemic corticosteroid or temporary increase in the individual’s usual maintenance dosage of oral corticosteroids; AND
For Xolair- okay to approve; OR
For Tezpsire, the member had a 3-month trial and inadequate response or intolerance, or contraindication to Xolair (omalizumab). Renewal Request for Severe Asthma
Chart notes provided show that treatment with Tezspire (tezepelumab-ekko) resulted in one or more of the following clinical signs of improvement such as:
a. Decrease utilization of rescue medications; b. Decrease frequency of exacerbations (defined as worsening of asthma that requires an increased in inhaled corticosteroid dose or treatment with systemic corticosteroids); c. Increase in percent predicted FEV1 from pretreatment baseline; or
d. Reduction in reported asthma-related symptoms, including asthmatic symptoms upon awakening, coughing, fatigue, shortness of breath, sleep disturbance or wheezing. Combination use of Cinqair, Dupixent, Fasenra, Nucala, Tezspire or Xolair are not allowed.
Nucala (mepolizumab), Xolair (omalizumab)
Duration Initial: 6 months, Renewal: 1 year Override PA, QL Initial Request for Eosinophilic Granulomatosis with Polyangiitis

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Nucala (mepolizumab), Xolair (omalizumab)
Pharmacy staff: For QUEST non-ABD members with cancer, send ADRC (Aid to Disability Referral Committee) referral with chart notes through G8 CM module.

The request is for a diagnosis of relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA); AND
The medication is prescribed or recommended in consultation with Allergist, Dermatologist, Pulmonologist, or Immunologist; AND
All of the following are met: a. A history or presence of asthma; AND b. Lab report showing blood eosinophil level of ≥10% of leucocytes or an absolute eosinophil count of >1000 cells per mm3 (in the absence of other potential causes of eosinophilia, including hypereosinophilic syndromes, neoplastic disease, and known or suspected parasitic infection); AND c. The presence of ≥2 features of eosinophilic granulomatosis with polyangiitis such as:
1) Biopsy showing histopathological evidence of eosinophilic vasculitis, perivascular eosinophilic infiltration, or eosinophil-rich granulomatosis inflammation 2) Neuropathy, mono or poly evidenced by motor deficit or nerve conduction abnormality 3) Non-fixed pulmonary infiltrates 4) Sinonasal abnormality 5) Cardiomyopathy 6) Glomerulonephritis 7) Alveolar hemorrhage 8) Palpable purpura 9) Antineutrophil cytoplasmic antibody [ANCA] positive status AND
For Xolair, okay to approve; OR
For Nucala, the member had a 3-month trial and inadequate response or intolerance, or contraindication to Xolair (omalizumab); AND
The member is using Nucala in combination with oral corticosteroid therapy. Renewal Request for Eosinophilic Granulomatosis with Polyangiitis (EGPA)
The request is for a diagnosis of relapsing or refractory eosinophilic granulomatosis with polyangiitis (EGPA)
(ICD-10 code M30.1); AND
The medication prescribed or recommended in consultation with Allergist, Dermatologist, Pulmonologist, or Immunologist; AND
The member achieve a remission while on Nucala as defined by both of the following: a. Birmingham Vasculitis Activity Score (BVAS), version 3, of 0 (on a scale from 0 to 63), and documentation is provided; AND b. Receipt of prednisolone or prednisone at a dose of 4.0 mg or less per day. Combination use of Cinqair, Dupixent, Fasenra, Nucala, Tezspire or Xolair are not allowed.
Nucala (mepolizumab) Initial Request for Hypereosinophilic Syndrome (HES)
LOB Medicaid Duration Initial: 6 months, Renewal: 1 year Override PA, QL Pharmacy staff: For QUEST non-ABD members with cancer, send ADRC (Aid to Disability Referral Committee) referral with chart notes through G8 CM module.
The request is for a diagnosis of hypereosinophilic syndrome (HES) for at least six months (ICD-10 D72.119); AND
The medication prescribed or recommended in consultation with Allergist or Immunologist; AND

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The member had a trial and inadequate response to oral corticosteroids; AND
Documentation provided showing that the member has experienced two or more HES flares within the past 12 months requiring escalation in therapy (increase in oral corticosteroid dose or increase/addition of immunosuppressive or cytotoxic therapy); AND
Documentation provided showing the member has a blood eosinophil count ≥ 1,000 cells/microliter. Renewal Request for Hypereosinophilic Syndrome (HES)
The request is for a diagnosis of hypereosinophilic syndrome (HES) for at least six months ICD-10 D72.119); AND
The medication prescribed or recommended in consultation with Allergist or Immunologist; AND
Documentation provided showing that the member experienced stabilization in clinical signs and symptoms of disease (including but not limited to decrease or absence of HES flares, improvement in fatigue). Nucala (mepolizumab) for hypereosinophilic syndrome (HES) may not be approved for the following: • Individuals with non-hematologic secondary HES (including but not limited to drug hypersensitivity, parasitic helminth infection, HIV infection, non-hematologic malignancy); OR • Individuals with FIP1L1-PDGFRα kinase-positive HES.
Nucala (mepolizumab) LOB Medicaid Duration Initial: 6 months, renewal: 1 year Override PA, QL Initial Request for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) Pharmacy staff: For QUEST non-ABD members with cancer, send ADRC (Aid to Disability Referral Committee) referral with chart notes through G8 CM module.
The request is for a diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) (ICD 10: J32.9: Chronic sinusitis, unspecified & J33.9: Nasal polyp, unspecified); AND
The medication prescribed or recommended in consultation with Allergist, ENT (Ear, Nose, and Throat) specialist, or Immunologist
Chart notes provided confirm presence of bilateral nasal polyps by one of the following: a. Anterior rhinoscopy;
b. Nasal endoscopy; or c. Computed tomography (CT)
The member had a trial and inadequate response to maintenance intranasal corticosteroids such as budesonide nasal susp 32 mcg/act, fluticasone propionate nasal susp 50 mcg/act, or triamcinolone acetonide nasal aerosol suspension 55 mcg/act; AND
Documentation provided showing that the member is refractory to or is ineligible or intolerant to the following systemic corticosteroids or sinonasal surgery; AND
For Nucala: the member had a trial and inadequate response to Xolair (omalizumab). Renewal Request for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
The request is for a diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) (ICD 10: J32.9: Chronic sinusitis, unspecified & J33.9: Nasal polyp, unspecified); AND
The medication prescribed or recommended in consultation with an Allergist, ENT (Ear, Nose, and Throat) specialist, or Immunologist; AND
Chart notes show that treatment with the requested drug resulted in improvement in clinical signs and symptoms of disease (including but not limited to improved nasal polyp score or nasal congestion score); AND
The member continue to use Nucala in combination with maintenance intranasal corticosteroids such as budesonide nasal susp 32 mcg/act, fluticasone propionate nasal susp 50 mcg/act, or triamcinolone acetonide nasal aerosol suspension 55 mcg/act.

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Xolair (omaliizumab) LOB Medicaid Duration Initial: 6 months, renewal: 1 year Override PA, QL Initial Request for IgE Mediated Food Allergy
Pharmacy staff: For QUEST non-ABD members with cancer, send ADRC (Aid to Disability Referral Committee) referral with chart notes through G8 CM module.

The request is for a diagnosis of IgE-mediated food allergy (ICD 10: Z91.018: Allergy to other food); AND
The medication prescribed or recommended in consultation with an Allergist, or Immunologist; AND
Documentation shows that the diagnosis is confirmed with clinical history of IgE-mediated food allergy demonstrated by (1) moderate to severe symptoms (including but not limited to throat tightness, dyspnea/wheezing, (2) clinically signification hypotension, generalized urticaria), or (3) requiring administration of epinephrine or emergency medical care; AND
Documentation shows positive skin prick test or positive serum IgE test or positive food challenge; AND
Chart notes or lab notes show that the member has a serum Immunoglobulin E (IgE) level ≥30 IU/mL; AND
Xolair (omalizumab) be used in combination with food allergen avoidance; AND
The member has a recent (within the last year) prescription or prescription claim for an auto-injectable epinephrine agent. Renewal Request for IgE Mediated Food Allergy
The request is for a diagnosis of IgE-mediated food allergy (ICD 10: Z91.018: Allergy to other food); AND
The medication prescribed or recommended in consultation with an Allergist, or Immunologist; AND
Xolair (omalizumab) be used in combination with food allergen avoidance; AND
The member has a recent (within the last year) prescription or prescription claim for an auto-injectable epinephrine agent.
Xolair (omaliizumab) LOB Medicaid Duration Initial: 6 months, renewal: 1 year Override PA, QL Initial Request for Chronic Spontaneous Urticaria (CSU) Pharmacy staff: For QUEST non-ABD members with cancer, send ADRC (Aid to Disability Referral Committee) referral with chart notes through G8 CM module.
The request is for a diagnosis of chronic spontaneous urticaria (CSU) (ICD 10: L50.8 – Other Urticaria); AND
The medication prescribed or recommended in consultation with an Allergist, or Immunologist; AND
The member had a trial and inadequate response to a two-week trial of a second-generation H1 antihistamine, titrated up to a maximum of four times the approved dose with symptoms present for 3 days or more per week
The member has tried and failed, been intolerant, or had a contraindication to a combination of a non-sedating H1 antihistamine AND one of the following: a. A combination of two non-sedating H1 antihistamine;
b. An H2 antagonist such as famotidine, ranitidine, or cimetidine; or
c. Leukotriene receptor antagonist (LRA) such as montelukast, zafirlukast, or zileuton. AND
The member has tried and failed, been intolerant, or had a contraindication to cyclosporine; AND
Xolair (omalizumab) is used in combination with a second generation H1 antihistamine or cyclosporine; AND
The member is 12 years of age or older Renewal Request for Chronic Spontaneous Urticaria (CSU)
The request is for a diagnosis of chronic spontaneous urticaria (CSU) (ICD 10: L50.8 – Other Urticaria); AND

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Xolair (omaliizumab)

The medication prescribed or recommended in consultation with an Allergist, or Immunologist; AND
Chart notes show that treatment with Xolair (omalizumab) resulted in improvement or stabilization in clinical signs and symptoms of disease (including but not limited to itch severity and hive count); AND
Xolair (omalizumab) is used in combination with a second generation H1 antihistamine or cyclosporine.
Exclusions • Combination use of Cinqair, Dupixent, Fasenra, Nucala, Tezspire, or Xolair is not allowed FDA Indications & Dosing Drug Name Indication Dosing/Administration Cinqair (reslizumab) Severe asthma with an eosinophilic phenotype ▪ (age 18 years or older) 3mg/kg once every 4 weeks by IV infusion over 20-50 minutes ▪ Discontinue the infusion immediately if a severe systemic reaction occurs, including anaphylaxis Fasenra (benralizumab) Severe asthma, Members with an eosinophilic phenotype; Adjunct (12 years or older) 30 mg subQ once every 4 weeks for the first 3 doses, and then once every 8 weeks; inject into the upper arm, thigh, or abdomen Nucala (mepolizumab) Severe asthma, Add-on maintenance in members with eosinophilic phenotype ▪ 12 years or older: 100mg SQ every 4 weeks into the upper arm, thigh, or abdomen. ▪ 6 to 11 years: 40 mg SQ once every 4 weeks injected into the upper arm, thigh or abdomen Eosinophilic granulomatosis with polyangiitis
▪ (adults): 300mg SQ once every 4 weeks (as 3 separate 100mg injections) Hypereosinophilic syndrome ▪ (12 years or older) 300 mg SQ every 4 weeks as 3 separate 100-mg injections into the upper arm, thigh, or abdomen. Administer individual 100-mg injections at least 5 cm (approximately 2 inches) apart ▪ Missed dose: If a dose is missed, administer as soon as possible, and resume dosing on the usual day of administration. If the next dose is already due, then administer as planned Tezspire (tezepelumab- ekko) Add-on maintenance treatment of severe asthma in adult and pediatric patients ≥12 years of age 210 mg subQ once every 4 weeks Xolair (omalizumab) IgE-mediated allergic asthma, not controlled by inhaled corticosteroids ▪ Moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a Adult: Pre- txtmt IgE (IU/ml) Body Weight (Kg)
30-60
60-70 70-90 90-150 30-100 150mg Q4wk 150mg Q4wk 150mg Q4wk 300mg Q4wk 100-200 300mg Q4wk 300mg Q4wk 300mg Q4wk 225mg Q2wk 200-300 300mg Q4wk 225 mg Q2wk 225mg Q2wk 300mg Q2wk 300-400 225mg Q2wk 225mg Q2wk 300mg Q2wk DO NOT DOSE 400-500 300mg Q2wk 300mg Q2wk 375mg Q2wk DO NOT DOSE 500-600 300mg Q2wk 375mg Q2wk DO NOT DOSE

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Drug Name Indication Dosing/Administration perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. ▪ Not indicated for the relief of acute bronchospasm or status asthmatics

600-700 375mg Q2wk DO NOT DOSE
Approved dosing is based on FDA dosing guidelines as summarized in the above chart. However, due to the long half-life of the medication and the fact that the medication can be dosed once a month, total monthly doses will be approved in order to prevent wasting of medication due to split vial dosing (i.e. 375 mg every 2 weeks would be approved to be dosed as 450 mg then in 2 weeks 300 mg, i.e. 225 mg q2weeks would be approved 300 mg then in 2 weeks 150 mg – in both examples total administered drug is the same, and it benefits the member because they receive one less injection of medication). DOSAGE ADJUSTMENTS ▪ Total IgE levels are elevated during treatment and remain elevated for up to one year after the discontinuation of treatment. Therefore, re-testing of IgE levels during Xolair treatment cannot be used as a guide for dose determination. Dose determination after treatment interruptions lasting less than 1 year should be based on serum IgE levels obtained at the initial dose determination. Total serum IgE levels may be re-tested for dose determination if treatment with Xolair has been interrupted for one year or more. Doses should be adjusted for significant changes in body weight. Xolair IgE-mediated allergic asthma, not controlled by inhaled corticosteroids Age 6 to less than 12 years ▪ Moderate to severe persistent asthma who have a positive skin test or in vitro reactivity to a perennial aeroallergen and whose symptoms are inadequately controlled with inhaled corticosteroids. Not indicated for the relief of acute bronchospasm or status asthmatics
pretreatment IgE (IU/mL) Body weight (kg) 30-100 20-40: 75mg Q4wk 40-90: 150mg Q4 wk 90-150: 300mg Q4wk

100-200 20-40: 150mg Q4wk 40-90: 300mg Q4wk 90-125: 225mg Q2wk 90-125: 25mg Q2wk

200-300 20-30: 150mg Q4wk 30-40: 225mg Q4wk 40-60: 300 mg Q4wk 60-90: 225mg Q2wk 90-125: 300mg Q2wk 125-150: 375mg Q2wk 300-400 20-30: 225mg Q4wk 30-40: 300mg Q 4wk 40-70: 225 mg Q2wk 70-90: 300mg Q2wk

400-500 20-25: 225mg Q4wk 25-30: 300 mg SQ Q 4wk 30-50: 225mg Q2wk 50-70: 300mg Q2wk 70-90: 375mg Q2wk

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Drug Name Indication Dosing/Administration

500-600 20-30: 300mg Q4wk 30-40: 225mg Q2wk 40-60: 300mg Q2wk 60-70: 375mg Q2wk

600-700 20-25: 300mg Q4wk 25-40: 225mg Q2wk 40-50: 300mg Q2wk 50-60: 375mg Q2wk

700-900 20-30: 225mg Q2wk 30-40: 300mg Q2wk 40-50: 375mg Q2wk

900-1100 20-25: 225mg Q2wk 25-30: 300mg
Q2wk 30-40: 375mg Q2wk

1100-1200 20-30: 300mg Q2wk

1200-1300 20-25: 300mg Q2wk

Xolair Idiopathic urticaria, chronic, H1 antihistamine-refractory ▪ (12 years or older) 150 or 300 mg subQ every 4 weeks. Appropriate duration of therapy has not been established Limitations of Use: XOLAIR is not indicated for treatment of other allergic conditions
High Dose ICS/LABA (taken from the GINA 2025) High Dose ICS/LABA High Dose beclometasone dipropionate 40 or 80 mcg/actuation 320-640mcg budesonide 90 or 180 mcg/actuation 720-1440 mcg ciclesonide 80 or 160 mcg/actuation 640 mcg fluticasone furoate 50, 100, or 200 mcg/dose 200 mcg fluticasone propionate DPI 50, 100, 250mg mcg/dose 500-2000 mcg fluticasone propionate MDI 44, 110, or 220mcg/actuation 400-1760 mcg mometasone furoate DPI 110 or 220 mcg/actuation 440-880 mcg mometasone furoate MDI 50, 100, or 200mcg/actuation 400-800 mcg *DPI = dry powder inhaler; HFA = hydrofluoroalkane propellant; ICS = inhaled corticosteroid; LABA = long-acting beta2- agonist; pMDI = pressurize meter dose inhaler
References
Bradding P. Asthma: eosinophil disease, mast cell disease, or both? Allergy Asthma Clin Immunol. 2008; (4)2:84-90.
Chung KF, Wenzel SE, Brozek JL, et al. International European Respiratory Society/American Thoracic Society (ERS/ATS) guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014; 43(2):343-
Chung SA, Langford CA, Maz M, et. al. 2021 American College of Rheumatology/Vasculitis Foundation Guideline for the Management of Antineutrophil Cytoplasmic Antibody-Associated Vasculitis. Arthritis Rheumatol. 2021;73(8):1366-1383.
Cloutier MM, Baptist AP, Blake KV, et. al. 2020 Focused Updates to the Asthma Management Guidelines: A Report from the National Asthma Education and Prevention Program (NAEPP) Coordinating Committee Expert Panel Working Group. J Allergy Clin Immunol. 2020 Dec;146(6):1217-1270.
DailyMed. Package Inserts. U.S. National Library of Medicine, National Institute of Health website. http://dailymed.nlm.nih.gov/dailymed/about.cfm. Accessed: July 9, 2025.

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DrugPoints® System [electronic version]. Truven Health Analytics, Greenwood Village, CO. Updated periodically.
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