ModifiedWashington State Health Care AuthorityPolicy 44.60.00-1

Asthma and COPD Agents: Monoclonal Antibodies

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Washington Apple Health fee-for-service coverage and prior authorization for monoclonal antibody drugs used for asthma, eosinophilic COPD, EGPA, hypereosinophilic syndrome, chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, and IgE-mediated food allergy.

Policy Summary

PayerWashington State Health Care Authority

PolicyAsthma and COPD Agents: Monoclonal Antibodies

Policy CodePolicy 44.60.00-1

Change TypeModified

Effective DateOct 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization documentation showing the applicable diagnosis, eligibility criteria, prior treatment history, and required clinical evidence.

SourceLink

POLICY UPDATE CHANGES

The policy replaced requirements for prescribing by or consultation with specified specialists with prescribing by or consultation with a provider who specializes in treating the applicable indication.

Drug names were removed from the clinical criteria.

Additional criteria were added for nonpreferred drugs requiring progression through all less costly alternatives.

The dose and quantity information was consolidated into a single table.

Package inserts for all covered drugs were added to the references.

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

ModifiedWashington State Health Care AuthorityPolicy 44.60.00-1

Asthma and COPD Agents: Monoclonal Antibodies

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Sign up for Washington State Health Care Authority Policy 44.60.00-1 alerts

Get alerted when Policy 44.60.00-1 changes without checking for updates manually.

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Policy Summary

PayerWashington State Health Care Authority

PolicyAsthma and COPD Agents: Monoclonal Antibodies

Policy CodePolicy 44.60.00-1

Change TypeModified

Effective DateOct 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization documentation showing the applicable diagnosis, eligibility criteria, prior treatment history, and required clinical evidence.

SourceLink

POLICY UPDATE CHANGES

Drug names were removed from the clinical criteria.

Additional criteria were added for nonpreferred drugs requiring progression through all less costly alternatives.

The dose and quantity information was consolidated into a single table.

Package inserts for all covered drugs were added to the references.

12 monthsStandard authorization period

7 agentsMonoclonal antibody drugs listed

≥300 cells/µLCOPD eosinophil threshold

2Preferred agents required for nonpreferred drugs

Medical Necessity and Coverage Criteria

Moderate to severe asthma: omalizumab and omalizumab-igec

Covered when all applicable criteria are met.

Omalizumab and omalizumab-igec: Patient is at least 6 years old; prescribed by or in consultation with a provider who specializes in asthma treatment; is not using another monoclonal antibody for asthma; has qualifying pretreatment serum total IgE and confirmed perennial aeroallergen reactivity; has moderate or severe asthma; is receiving medium- to high-dose or maximally tolerated inhaled corticosteroid therapy plus an asthma controller; and will continue controller medications unless contraindicated.Age ≥6; pretreatment IgE ≥30 and ≤700 IU/mL for age ≥12, or ≥30 and ≤1300 IU/mL for age 6 to <12

Moderate asthma may be established by functional impairment or exacerbations, daily SABA use, or FEV1 >60% and <80% predicted. Severe asthma may be established by severe functional impairment or exacerbations, SABA use several times daily, or FEV1 <60% predicted.

Moderate to severe asthma: tezepelumab-ekko

Tezepelumab is covered when all applicable criteria are met.

Tezepelumab-ekko: Patient is at least 12 years old and meets the asthma-specialist, no-combination monoclonal antibody, severe-asthma, current-treatment, and continued-controller requirements.Age ≥12

Severe asthma may be established by severe functional impairment or exacerbations, SABA use several times daily, or FEV1 <60% predicted. Authorization is for 12 months when all criteria are met.

Chronic rhinosinusitis with nasal polyps

Covered when all applicable criteria are met.

CRSwNP: Patient is at least 18 years old; is prescribed by or in consultation with a provider who specializes in CRSwNP; has CRSwNP with bilateral sinonasal polyposis shown by endoscopy or CT; has ongoing moderate-to-severe nasal congestion, blockage, or obstruction and at least one of nasal discharge, facial pain or pressure, or reduced or lost smell; has failed, is intolerant of, or has a contraindication to required corticosteroid therapy; and will continue intranasal corticosteroid therapy unless contraindicated.Age ≥18; intranasal corticosteroid trial for at least 2 months or oral systemic corticosteroid therapy for 10–14 days within the last 24 months

Tezepelumab additionally requires age ≥12. Mepolizumab additionally requires ineffective, contraindicated, or not-tolerated treatment with dupilumab, omalizumab, and tezepelumab for a minimum of 1 year.

Chronic spontaneous urticaria

Covered when all applicable criteria are met.

CSU: Patient is at least 12 years old; is prescribed by or in consultation with a provider who specializes in CSU; has CSU for at least 8 consecutive weeks; is not using another monoclonal antibody for CSU; has a UAS7 of at least 16; and has tried and failed two second-generation H1 antihistamines at maximally tolerated doses or after titration to two to four times the FDA-approved dose for at least 2 weeks each, unless all are contraindicated.Age ≥12; urticaria ≥8 consecutive weeks; UAS7 ≥16; at least 2 weeks per antihistamine

Authorization is for 12 months when all criteria are met.

COPD with eosinophilic phenotype

Covered when all applicable criteria are met.

COPD with eosinophilic phenotype: Patient is at least 18 years old; is managed by or in consultation with a provider who specializes in COPD with eosinophilic phenotype; has the required eosinophil count, lung function, and exacerbation history; is not using another monoclonal antibody for this indication; receives maximal inhaled therapy or LABA plus LAMA when ICS is contraindicated; and has had ineffective, contraindicated, or not-tolerated dupilumab after a minimum trial of 12 weeks.Blood eosinophils ≥300 cells/µL within 12 months; FEV1 20%–80% predicted within 12 months; 2 moderate or 1 severe exacerbation within 12 months

Applies to mepolizumab. Authorization is for 12 months when all criteria are met.

Eosinophilic granulomatosis with polyangiitis

Covered when all applicable criteria are met.

EGPA: Patient is at least 18 years old; is managed by or in consultation with a provider who specializes in EGPA; has EGPA; is not using another monoclonal antibody for EGPA; has a history of asthma and eosinophilia; has relapsing or refractory disease treated with background prednisolone or prednisone with or without immunosuppressive therapy; and has at least two characteristic EGPA features.Eosinophils ≥150 cells/µL or >10% of leukocytes; at least 2 characteristic features

Characteristic features include extravascular eosinophils on biopsy, pulmonary infiltrates, paranasal sinus abnormality, cardiomyopathy, mono- or polyneuropathy, glomerulonephritis, alveolar hemorrhage, palpable purpura, or ANCA positivity. Mepolizumab additionally requires benralizumab failure after at least 1 year unless contraindicated or not tolerated.

Hypereosinophilic syndrome

Covered when all applicable criteria are met.

HES: Patient is at least 12 years old; is managed by or in consultation with a provider who specializes in HES; has HES for at least 6 months; is not using another monoclonal antibody; has at least 2 flares in the past 12 months; has FIP1L1-PDGFRα-negative disease; has no identifiable non-hematologic secondary cause; and has the required blood eosinophil count.HES ≥6 months; at least 2 flares in the past 12 months; blood eosinophils ≥1,000 cells/µL within 12 months

Secondary causes include drug hypersensitivity, parasitic helminth infection, HIV, and non-hematologic malignancy. Mepolizumab additionally requires benralizumab failure after at least 1 year unless contraindicated or not tolerated.

IgE-mediated food allergy

Covered when all applicable criteria are met.

IgE-mediated food allergy: Patient is at least 1 year old; is prescribed by or in consultation with a provider who specializes in IgE-mediated food allergy; has IgE-mediated food allergy confirmed by food-specific skin-prick testing, IgE antibody testing, or oral food challenge; is not using another monoclonal antibody; and has been prescribed or has access to epinephrine for emergencies.Age ≥1

Severe asthma with eosinophilic phenotype

Covered when all applicable criteria are met.

Severe eosinophilic asthma: Patient is at least 6 years old; is managed by or in consultation with a provider who specializes in severe asthma with eosinophilic phenotype; has severe asthma; is not using another monoclonal antibody for this indication; has qualifying blood eosinophils; is receiving high-dose or maximally tolerated ICS plus an asthma controller; and will continue controller medications unless contraindicated.Age ≥6; eosinophils ≥150 cells/µL in the prior 6 weeks or ≥300 cells/µL in the prior 12 months; FEV1 <60% predicted, or qualifying severe impairment/exacerbation or SABA use several times daily

Reslizumab additionally requires age ≥18. Mepolizumab additionally requires failure of benralizumab, dupilumab, and reslizumab for at least 12 weeks each. Depemokimab-ulaa additionally requires age ≥12 and failure of benralizumab, dupilumab, mepolizumab, and reslizumab for at least 12 weeks each.

Reauthorization across indications

Reauthorization is covered when all applicable criteria are met.

Continuation across indications: The applicable diagnosis and no-combination monoclonal antibody requirements continue to be met; required controller or background therapy continues unless contraindicated; and documentation demonstrates disease stability or a positive clinical response.Authorization period: 12 months

Examples include reduced asthma exacerbations, improved FEV1, fewer hospitalizations or reduced systemic corticosteroid requirements, improved nasal obstruction or polyps, improved UAS7, fewer COPD exacerbations or less dyspnea, fewer EGPA symptoms or relapses, fewer HES flares, or reduced allergic reactions.

General reauthorization criteria

Reauthorization is covered when all documented criteria are met.

Reauthorization: Criteria 2, 4, 6, and 7 from the applicable initial criteria continue to be met, and documentation demonstrates disease stability or a positive clinical response.Authorization period: 12 months

Positive response may include reduced asthma exacerbations, improved or maintained FEV1, reduced systemic corticosteroid requirements, or reduced hospitalizations.

Concurrent use of another monoclonal antibody indicated for the same disease or treatment indication is excluded where the applicable criteria prohibit combination therapy. This restriction applies across the policy’s covered indications, including asthma, CRSwNP, CSU, eosinophilic COPD, EGPA, HES, and IgE-mediated food allergy.

Coverage for hypereosinophilic syndrome requires documentation that there is no identifiable non-hematologic secondary cause. Excluded secondary causes include drug hypersensitivity, parasitic helminth infection, HIV, and non-hematologic malignancy.

New-to-market drugs in this class that are non-preferred are not covered unless the required preferred-agent step therapy is documented. The patient must have an inadequate response or documented intolerance due to a severe adverse reaction or contraindication to at least two preferred agents; when only one preferred agent exists, an inadequate response to that agent is required.

Initial Authorization by Indication

Asthma initial therapy — drug-specific criteria

Omalizumab and omalizumab-igec may be approved when all applicable criteria are met; tezepelumab additionally requires age at least 12 and severe-asthma criteria.

Omalizumab or omalizumab-igec: Meet the applicable asthma age, specialist, no-combination, pretreatment IgE, perennial aeroallergen reactivity, asthma-severity, current controller-treatment, and continued-controller requirements.Age ≥6; IgE ≥30 and ≤700 IU/mL for age ≥12 or ≥30 and ≤1300 IU/mL for age 6 to <12

Moderate asthma requires a qualifying impairment or exacerbation feature, daily SABA use, or FEV1 >60% and <80% predicted. Severe asthma requires a qualifying severe impairment or exacerbation feature, SABA use several times daily, or FEV1 <60% predicted.

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Reauthorization and Continued Eligibility

General continuation therapy criteria across indications

Reauthorization may be approved when all applicable continuation criteria are met.

Continuation therapy: The indication and applicable no-combination requirements continue to be met; required controller or background therapy continues unless contraindicated; and the provider submits documentation of disease stability or a positive clinical response.Authorization period: 12 months

Response examples vary by indication and include improved lung function, fewer exacerbations or hospitalizations, reduced corticosteroid requirements, improved UAS7, reduced nasal polyps or obstruction, fewer EGPA symptoms or relapses, fewer HES flares, and fewer allergic reactions.

Reauthorization criteria for selected agents

Benralizumab, depemokimab-ulaa, mepolizumab, and reslizumab may be approved for reauthorization when all criteria are met.

Selected-agent reauthorization: Criteria 2, 4, 6, and 7 from the applicable initial criteria continue to be met, and documentation demonstrates disease stability or a positive clinical response.

Codes, Thresholds, and Dosing

Covered HCPCS CodesHCPCSCovered

J0517	Injection, benralizumab, 1 mg
J2361	Injection, depemokimab-ulaa, 1 mg
J2182	Injection, mepolizumab, 1 mg
J2356	Injection, tezepelumab-ekko, 1 mg
J2357	Injection, omalizumab, 5 mg
J2786	Injection, reslizumab, 1 mg

Omalizumab IgE ranges

Age 12 years or olderSerum total IgE ≥30 and ≤700 IU/mL

Age 6 to under 12 yearsSerum total IgE ≥30 and ≤1300 IU/mL

MeasurementPretreatment serum total IgE level

Moderate asthma lung function

Moderate asthma thresholdFEV1 greater than 60% and less than 80% predicted

MeasurementPercent predicted FEV1

Role in criteriaOne way moderate asthma may be established

Authorization, Documentation, and Denial Risks

Prior Authorization

Prior Authorization Required

Prior authorization is required for all covered monoclonal antibody agents in this policy before therapy is started or continued.

Covered agents include benralizumab (Fasenra), depemokimab-ulaa (Exdensur), mepolizumab (Nucala), omalizumab-igec (Omlyclo), omalizumab (Xolair), reslizumab (Cinqair), and tezepelumab-ekko (Tezspire).

Step Therapy

Preferred-Drug Trial Required

For a non-preferred agent, document an inadequate response or documented intolerance due to a severe adverse reaction or contraindication to at least two preferred agents. If only one preferred agent exists in the class, document inadequate response to that one agent.

Verify the current Apple Health Preferred Drug List (AHPDL) before submitting the request.
New-to-market drugs in this class are non-preferred and subject to these requirements.

Required Prior Treatments

Step	Applies to	Required prior therapy	Minimum duration	Exception or failure standard
1	Non-preferred agents	At least two preferred agents; if only one preferred agent exists, that sole preferred agent	Not specified	Inadequate response or documented intolerance due to severe adverse reaction or contraindication

Step	Indication	Required prior therapy	Minimum duration	Exception or failure standard
1	Chronic spontaneous urticaria	Two second-generation H1 antihistamines at maximally tolerated doses or titrated to 2–4 times the FDA-approved dose	At least 2 weeks for each antihistamine	Treatment failure; step therapy is not required if all second-generation H1 antihistamines are contraindicated

Step	Indication	Required prior therapy	Minimum duration	Exception or failure standard
1	Chronic rhinosinusitis with nasal polyps	Intranasal corticosteroids or oral systemic corticosteroids	Intranasal corticosteroids for at least 2 months, or oral systemic corticosteroids for 10–14 days within the preceding 24 months	Failure, contraindication, or intolerance

Step	Indication	Requested drug	Required prior biologic therapy	Minimum duration	Exception or failure standard
2	Chronic rhinosinusitis with nasal polyps	Mepolizumab	Dupilumab, omalizumab, and tezepelumab	Minimum 1 year	Ineffective, contraindicated, or not tolerated

Step	Indication	Requested drug	Required prior biologic therapy	Minimum duration	Exception or failure standard
2	COPD with eosinophilic phenotype	Mepolizumab	Dupilumab	Minimum 12 weeks	Ineffective, contraindicated, or not tolerated

Step	Indication	Requested drug	Required prior biologic therapy	Minimum duration	Exception or failure standard
2	Eosinophilic granulomatosis with polyangiitis (EGPA) or hypereosinophilic syndrome (HES)	Mepolizumab	Benralizumab	Minimum 1 year	Ineffective, contraindicated, or not tolerated

Step	Requested drug	Indication	Required prior biologic therapy	Minimum duration	Exception or failure standard
2	Mepolizumab	Severe asthma with eosinophilic phenotype	Benralizumab, dupilumab, and reslizumab	Minimum 12 weeks for each agent	Ineffective, contraindicated, or not tolerated
2	Depemokimab-ulaa	Severe asthma with eosinophilic phenotype	Benralizumab, dupilumab, mepolizumab, and reslizumab	Minimum 12 weeks for each agent	Ineffective, contraindicated, or not tolerated

Step	Applies to	Required progression	Requirement for approval
1	Non-preferred drugs	Step through all less costly alternatives	All less costly alternatives must be tried before authorization

Dose, Frequency, and Quantity Limits

Reslizumab quantity and administration limits

Dose3 mg/kg

AdministrationIntravenous infusion over 20 to 50 minutes every 4 weeks

Container100 mg/10 mL vial; weight-based dosing

Depemokimab-ulaa quantity and administration limits

Dose100 mg subcutaneously every 6 months

QuantityOne 100 mg/mL prefilled syringe or pen per 6 months

Administration intervalOne device per six-month dose

Administration Setting

Billing Rule

Use office-based provider administration

For the listed omalizumab and tezepelumab indications, the drug must be administered subcutaneously by a health care provider in an office setting.

Clinical Terms and Abbreviations

UAS7 definition and policy threshold

Full termUrticaria Activity Score over 7 days

Scoring period7 days

Policy thresholdUAS7 ≥16 for initial CSU authorization

COPD with eosinophilic phenotype definition

Full conditionChronic obstructive pulmonary disease with an eosinophilic phenotype

Eosinophil criterionAbsolute blood eosinophil count ≥300 cells/µL within the last 12 months

Additional objective criteriaFEV1 20% to 80% predicted and two moderate or one severe exacerbation within 12 months

Policy Scope and Clinical Context

This policy governs biologic monoclonal antibody coverage and prior authorization for severe or uncontrolled asthma, asthma with an eosinophilic phenotype, COPD with an eosinophilic phenotype, eosinophilic granulomatosis with polyangiitis (EGPA), hypereosinophilic syndrome (HES), chronic rhinosinusitis with nasal polyps (CRSwNP), chronic spontaneous urticaria (CSU), and IgE-mediated food allergy. Eligibility generally depends on documented objective disease features—such as lung function, exacerbation history, eosinophil counts, IgE levels, diagnostic testing, or symptom scores—along with appropriate specialist management and required background therapy.

Policy Summary

PayerWashington State Health Care Authority

PolicyAsthma and COPD Agents: Monoclonal Antibodies

Policy CodePolicy 44.60.00-1

Change TypeModified

Effective DateOct 1, 2026

Next Review DateN/A

Key ActionSubmit prior authorization documentation showing the applicable diagnosis, eligibility criteria, prior treatment history, and required clinical evidence.

SourceLink

On This Page

Patient is at least 12 years old and meets the asthma-specialist, no-combination, severe-asthma, current-treatment, and continued-controller requirements.

CRSwNP initial therapy — drug-specific criteria

Omalizumab, omalizumab-igec, tezepelumab, and mepolizumab may be approved according to drug-specific criteria.

Base CRSwNP criteria: Meet the CRSwNP diagnosis, specialist, bilateral sinonasal polyposis, symptom, corticosteroid-treatment, continued-intranasal-corticosteroid, and no-combination requirements.Base age ≥18; tezepelumab age ≥12

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Mepolizumab-specific requirement

text

Treatment with dupilumab, omalizumab, and tezepelumab has been ineffective, contraindicated, or not tolerated for a minimum trial of 1 year.

threshold

Minimum trial: 1 year

children

}

CSU initial therapy criteria

Omalizumab and omalizumab-igec may be approved when all applicable criteria are met.

CSU initial therapy: Meet the age, CSU-specialist, diagnosis, no-combination, duration, UAS7, and second-generation H1 antihistamine failure requirements.Age ≥12; urticaria ≥8 consecutive weeks; UAS7 ≥16; 2 antihistamines for at least 2 weeks each

Each antihistamine must fail at the maximally tolerated dose or after titration to two to four times the FDA-approved dose, unless all are contraindicated.

COPD initial therapy criteria

Mepolizumab may be approved when all applicable criteria are met.

COPD initial therapy: Meet the age, specialist, diagnosis, no-combination, eosinophil, FEV1, exacerbation, maximal inhaled therapy, and dupilumab step-therapy requirements.Age ≥18; eosinophils ≥300 cells/µL within 12 months; FEV1 20%–80% predicted within 12 months; 2 moderate or 1 severe exacerbation within 12 months

Dupilumab must have been ineffective after at least 12 weeks unless contraindicated or not tolerated.

EGPA initial therapy — benralizumab and mepolizumab step requirements

Benralizumab may be approved for EGPA; mepolizumab requires the benralizumab step.

Benralizumab for EGPA: Meet the age, specialist, EGPA diagnosis, no-combination, asthma and eosinophilia, relapsing or refractory disease, background corticosteroid, and at least two characteristic-feature requirements.Age ≥18; eosinophils ≥150 cells/µL or >10% of leukocytes; at least 2 characteristic features

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Mepolizumab for EGPA

text

Meet the benralizumab EGPA criteria and have ineffective benralizumab treatment after a minimum trial of 1 year, unless benralizumab is contraindicated or not tolerated.

threshold

Minimum benralizumab trial: 1 year

children

}

HES initial therapy — benralizumab and mepolizumab step requirements

Benralizumab may be approved for HES; mepolizumab requires the benralizumab step.

Benralizumab for HES: Meet the age, specialist, HES duration, flare history, FIP1L1-PDGFRα-negative status, secondary-cause exclusion, eosinophil, and no-combination requirements.Age ≥12; HES ≥6 months; at least 2 flares in 12 months; eosinophils ≥1,000 cells/µL within 12 months

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Mepolizumab for HES

text

Meet the benralizumab HES criteria and have ineffective benralizumab treatment after a minimum trial of 1 year, unless benralizumab is contraindicated or not tolerated.

threshold

Minimum benralizumab trial: 1 year

children

}

IgE-mediated food allergy initial therapy criteria

Omalizumab and omalizumab-igec may be approved when all applicable criteria are met.

Food allergy initial therapy: Meet the age, specialist, confirmed IgE-mediated food allergy, no-combination, and emergency epinephrine access requirements.Age ≥1

Confirmation may be by food-specific skin-prick testing, IgE antibody testing, or oral food challenge.

Severe eosinophilic asthma initial therapy — drug-specific criteria

Benralizumab, reslizumab, mepolizumab, and depemokimab-ulaa may be approved according to drug-specific criteria.

Base severe eosinophilic asthma criteria: Meet the age, specialist, severe-asthma, no-combination, eosinophil, high-dose or maximally tolerated ICS plus controller, and continued-controller requirements.Base age ≥6; eosinophils ≥150 cells/µL in the prior 6 weeks or ≥300 cells/µL in the prior 12 months

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Reslizumab

text

Meet the base criteria and be at least 18 years old.

threshold

Age ≥18

children

}

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Mepolizumab

text

Meet the base criteria and have ineffective benralizumab, dupilumab, and reslizumab treatment after a minimum trial of 12 weeks each, unless contraindicated or not tolerated.

threshold

Minimum trial: 12 weeks for each agent

children

}

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Depemokimab-ulaa

text

Be at least 12 years old, meet the base criteria, and have ineffective benralizumab, dupilumab, mepolizumab, and reslizumab treatment after a minimum trial of 12 weeks each, unless contraindicated or not tolerated.

threshold

Age ≥12; minimum trial: 12 weeks for each agent

children

}

Authorization period: 12 months

Positive response may include reduced asthma exacerbations, improved or maintained FEV1, reduced systemic corticosteroid requirements, or reduced hospitalizations.

Severe asthma lung function

Severe asthma thresholdFEV1 less than 60% predicted

MeasurementPercent predicted FEV1

Role in criteriaOne way severe asthma may be established

CSU duration

Required durationAt least 8 consecutive weeks

ConditionUrticaria

ApplicationInitial chronic spontaneous urticaria authorization

CSU severity

Required scoreUAS7 ≥16

AssessmentUrticaria Activity Score over 7 days

ApplicationInitial chronic spontaneous urticaria authorization

COPD eosinophil threshold

Required countAbsolute blood eosinophil count ≥300 cells/µL

Lookback periodWithin the last 12 months

IndicationCOPD with eosinophilic phenotype

COPD lung-function threshold

FEV1 range20% to 80% predicted

Measurement periodMeasured within the last 12 months

MeasurePercent predicted FEV1

COPD exacerbation requirement

Moderate exacerbationsTwo in the last 12 months

Severe exacerbationsOne in the last 12 months

RequirementTwo moderate or one severe exacerbation

EGPA eosinophilia threshold

Absolute count150 cells/µL or greater

Alternative percentageMore than 10% of leukocytes

ConditionHistory of asthma and eosinophilia is required

HES eosinophil threshold

Required countBlood eosinophil count ≥1,000 cells/µL

Lookback periodWithin the last 12 months

ConditionHypereosinophilic syndrome

Severe eosinophilic asthma eosinophil thresholds

Recent threshold≥150 cells/µL in the prior 6 weeks

Annual threshold≥300 cells/µL in the prior 12 months

Alternative ruleEither eosinophil threshold may qualify

Omalizumab asthma dosing

Dose range75 to 375 mg

Route and frequencySubcutaneous administration every 2 or 4 weeks

Dose determinationBased on pretreatment serum total IgE and body weight

Omalizumab IgE-mediated food allergy dosing

Dose range75 to 600 mg

Route and frequencySubcutaneous administration every 2 or 4 weeks

Dose determinationBased on pretreatment serum total IgE and body weight

Omalizumab CSU dosing

Approved doses150 or 300 mg

FrequencySubcutaneous administration every 4 weeks

IgE dependenceDose and frequency are not dependent on serum IgE

Tezepelumab dosing

Dose210 mg

FrequencyOnce every 4 weeks

RouteAdministration as specified in the dosage table

Prior Authorization

12-Month Authorization and Reauthorization

When initial criteria are met, authorization is issued for 12 months. Reauthorization is also issued for 12 months when the applicable continuation criteria are documented.

Submit a new reauthorization request before the current 12-month authorization expires.
The clinical reviewer may use reauthorization criteria for a patient previously established on therapy who is new to Apple Health.

Step Therapy

Step Through All Less Costly Alternatives

For a non-preferred drug, document failure, contraindication, or intolerance to all less costly clinically appropriate alternatives before requesting coverage.

Include the alternative agents tried, treatment duration, response, and the reason each alternative cannot be used.
This requirement is in addition to any indication-specific preferred-drug trial requirement.

Step Therapy

CSU Antihistamine Step Therapy

For chronic spontaneous urticaria, document trials of two second-generation H1 antihistamines at maximally tolerated doses, or after titration to two to four times the FDA-approved dose, for at least two weeks each, unless all are contraindicated.

Document the agents, doses, trial duration, outcome, and any contraindication.

Step Therapy

CRSwNP Corticosteroid Step Therapy

For CRSwNP, document failure, contraindication, or intolerance to intranasal corticosteroids for at least two months or oral systemic corticosteroid therapy for 10 to 14 days within the preceding 24 months. Intranasal corticosteroids must continue unless contraindicated.

Document the corticosteroid product, dose, dates, response, and reason for discontinuation or inability to use.
Continuation requests must document ongoing intranasal corticosteroid use unless contraindicated.

Unsupported block type: step_therapy

Step Therapy

COPD Biologic Step Therapy

For COPD with an eosinophilic phenotype, mepolizumab requires treatment with dupilumab that was ineffective after a minimum 12-week trial, unless contraindicated or not tolerated.

Also document COPD diagnosis, eosinophils of at least 300 cells/μL within 12 months, FEV1 of 20–80% predicted within 12 months, qualifying exacerbations, and maximal inhaled therapy or double maintenance therapy when ICS is contraindicated.

Step Therapy

EGPA Biologic Step Therapy

For EGPA, mepolizumab requires that benralizumab was ineffective after a minimum one-year trial, unless contraindicated or not tolerated.

Document the benralizumab trial and outcome, along with the EGPA diagnosis and required clinical characteristics.

Step Therapy

HES Biologic Step Therapy

For HES, mepolizumab requires that benralizumab was ineffective after a minimum one-year trial, unless contraindicated or not tolerated.

Document HES duration, at least two flares in the prior 12 months, FIP1L1-PDGFRα-negative disease, absence of an identifiable non-hematologic secondary cause, and eosinophils of at least 1,000 cells/μL within 12 months.

Step Therapy

Severe Eosinophilic Asthma Biologic Step Therapy

For severe asthma with an eosinophilic phenotype, mepolizumab requires ineffective, contraindicated, or not-tolerated treatment with benralizumab, dupilumab, and reslizumab for a minimum 12-week trial of each. Depemokimab requires the same documentation plus a minimum 12-week trial of mepolizumab.

Document each required biologic, trial duration, outcome, and the reason it cannot be used.
Do not combine monoclonal antibodies indicated for severe eosinophilic asthma.

Step Therapy

Non-Preferred Drug Step Therapy

Requests for non-preferred drugs must show that all less costly clinically appropriate alternatives have been tried and failed, or are contraindicated or not tolerated.

Identify the preferred and less costly alternatives considered and provide patient-specific failure, intolerance, contraindication, or severe-adverse-reaction documentation.

Documentation Required

Clinical Eligibility Documentation

Submit patient-specific clinical documentation supporting the requested indication and every applicable criterion before review.

Document age, diagnosis, specialist prescribing or consultation, disease severity, relevant laboratory and pulmonary results, prior treatment history, and contraindications or intolerance.
Document the required indication-specific findings, including IgE and perennial aeroallergen reactivity for omalizumab asthma therapy; eosinophil counts and FEV1 where applicable; qualifying exacerbations or flares; and required background controller therapy.
Document that the requested agent will not be used with another monoclonal antibody indicated for the same condition.
For food allergy, document IgE-mediated confirmation by skin-prick testing, IgE antibody testing, or oral food challenge, and access to or prescription for epinephrine.

Documentation Required

Reauthorization Response Documentation

For reauthorization, submit documentation that the applicable diagnosis and non-duplication requirements remain satisfied, required background therapy continues, and the patient is stable or has demonstrated a positive clinical response.

Examples include improved FEV1, reduced asthma exacerbations or hospitalizations, reduced systemic corticosteroid requirements, improved nasal congestion or reduced polyps, improved UAS7, fewer COPD exacerbations, fewer EGPA symptoms or relapses, reduced HES flares, and reduced allergic reactions.
Document continued asthma controller, intranasal corticosteroid, or other required background therapy unless contraindicated.

Documentation Required

Food Allergy Confirmation and Epinephrine

For IgE-mediated food allergy, confirm the diagnosis with an accepted test and document emergency epinephrine access or prescription.

Acceptable confirmation: food-specific skin-prick test, IgE antibody testing, or oral food challenge.
The provider must attest that the patient has been prescribed or has access to epinephrine.

Documentation Required

Clinical Response Documentation

For continuation of therapy, document disease stability or a positive clinical response using indication-appropriate measures.

Include objective or clinical measures such as exacerbation frequency, FEV1, hospitalizations, systemic corticosteroid requirements, nasal obstruction or polyps, UAS7, COPD symptoms or exacerbations, EGPA relapses or symptom severity, HES flares, or allergic reactions.

Documentation Required

Continued Eligibility Documentation

Reauthorization requires continued eligibility for the requested indication, including ongoing diagnosis and compliance with applicable non-duplication and background-therapy criteria.

Document that criteria identified for continuation remain met, not merely that the medication was previously approved.
Document continued specialist involvement when required and any applicable ongoing controller or intranasal corticosteroid therapy.

Unsupported block type: denial_risk

Benralizumab quantity limits for EGPA and HES

IndicationsEGPA and HES

Dose and frequency30 mg subcutaneously once every 4 weeks

QuantityOne 30 mg/mL prefilled syringe or autoinjector; 1 mL per 28 days

Benralizumab quantity limits for severe eosinophilic asthma, age 6–11 and weight below 35 kg

PopulationAge 6 to 11 years and weight below 35 kg

Loading schedule10 mg subcutaneously every 4 weeks for the first 3 doses

Maintenance quantity0.5 mL per 56 days after the first 3 doses; 0.5 mL per 28 days initially

Benralizumab quantity limits for severe eosinophilic asthma, age 6–11 and weight at least 35 kg or age at least 12

PopulationAge 6 to 11 years and weight at least 35 kg, or age at least 12 years

Loading schedule30 mg subcutaneously every 4 weeks for the first 3 doses

Maintenance quantity1 mL per 56 days after the first 3 doses; 1 mL per 28 days initially

Nucala 100 mg quantity limit

Dose100 mg every 4 weeks subcutaneously

Vial quantityOne 100 mg single-dose vial per 28 days

Prefilled syringe or autoinjector1 mL per 28 days

Nucala 300 mg quantity limit

Dose300 mg every 4 weeks subcutaneously

Vial quantityThree 100 mg single-dose vials per 28 days

Prefilled syringe or autoinjector3 mL per 28 days

Nucala 40 mg quantity limit

PopulationSevere asthma with eosinophilic phenotype, age 6 to 11 years

Dose40 mg every 4 weeks

Quantity0.4 mL per 28 days

Xolair CSU 150 mg quantity limit

Dose150 mg every 4 weeks for CSU

Prefilled syringe quantity1 mL per 28 days

Vial quantityOne vial per 28 days

Xolair CSU 300 mg quantity limit

Dose300 mg every 4 weeks for CSU

Quantity2 mL per 28 days

Dosage form300 mg/2 mL prefilled syringe

Tezspire quantity limit

Dose210 mg once every 4 weeks

Device quantityOne vial, syringe, or pen per 28 days

Volume quantity1.91 mL per 28 days

EGPA definition

Full termEosinophilic granulomatosis with polyangiitis

Core clinical featuresAsthma and eosinophilia with relapsing or refractory disease

Characteristic featuresAt least two, such as pulmonary infiltrates, sinus abnormality, cardiomyopathy, neuropathy, glomerulonephritis, alveolar hemorrhage, palpable purpura, biopsy findings, or ANCA positivity

HES definition

Full termHypereosinophilic syndrome

Duration and flaresDisease for at least 6 months and at least 2 flares in the past 12 months

Additional definition elementsFIP1L1-PDGFRα-negative disease, no identifiable non-hematologic secondary cause, and blood eosinophils ≥1,000 cells/µL within 12 months

CRSwNP clinical definition

Full conditionChronic rhinosinusitis with nasal polyps

Structural findingBilateral sinonasal polyposis shown by endoscopy or computed tomography

Clinical symptomsOngoing moderate-to-severe nasal congestion, blockage, or obstruction with nasal discharge, facial pain or pressure, or reduced or lost smell

CRSwNP abbreviation

AbbreviationCRSwNP

Expanded termChronic rhinosinusitis with nasal polyps

Policy useUsed for the indication involving bilateral sinonasal polyposis and related nasal symptoms

CSU abbreviation

AbbreviationCSU

Expanded termChronic spontaneous urticaria

Policy thresholdInitial authorization requires urticaria for at least 8 consecutive weeks and UAS7 ≥16

EGPA abbreviation

AbbreviationEGPA

Expanded termEosinophilic granulomatosis with polyangiitis

Policy useThe indication requires asthma, eosinophilia, relapsing or refractory disease, and at least two characteristic features

HES abbreviation

AbbreviationHES

Expanded termHypereosinophilic syndrome

Policy thresholdThe indication requires disease for at least 6 months, at least 2 flares in 12 months, and eosinophils ≥1,000 cells/µL within 12 months