CurrentBlue Cross Blue Shield - MassachusettsPolicy 017

Injectable biologic agents for asthma and related eosinophilic conditions

Prior authorization, quantity limits, and medical necessity criteria for selected injectable biologic therapies used to treat severe asthma and certain related eosinophilic conditions for BCBSMA commercial members.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyInjectable biologic agents for asthma and related eosinophilic conditions

Policy CodePolicy 017

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and document prior trials of formulary alternatives or clinical rationale when alternatives cannot be tried.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6+Agents named

PA requiredPrior auth

12 monthsInit auth max

multipleIndications

J2357HCPCS example

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Coverage Criteria for Biologic Therapies

Cinqair - Severe asthma (eosinophilic)

Covered when ALL of the following are met

Cinqair criteria: 1. A diagnosis of severe asthma; 2. Used as an add-on maintenance treatment; 3. Age > 18 years; 4. Diagnosis of an eosinophilic phenotype; 5. Prescribed by a board-certified or board-eligible Allergist or Dermatologist; 6. Documented dose and frequency must be submitted and must be within the FDA-approved dosing and frequency.

Cinqair is NOT indicated for treatment of other eosinophilic conditions or for the relief of acute bronchospasm or status asthmaticus; coverage requests for those indications are not covered.

Fasenra - Severe asthma and EGPA

Covered when ALL of the following are met (per indication)

Fasenra - Severe asthma: 1. A diagnosis of severe asthma; 2. Used as an add-on maintenance treatment; 3. Age > 6 years; 4. Prescribed by a board-certified or board-eligible Allergist or Pulmonologist; 5. Documented dose and frequency must be submitted and must be within the FDA-approved dosing and frequency; 6. Diagnosis of an eosinophilic phenotype.

Fasenra - EGPA: 1. A diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA); 2. Age > 18 years; 3. Documented dose and frequency must be submitted and must be within the FDA-approved dosing and frequency.

Fasenra is NOT indicated for treatment of other eosinophilic conditions or for the relief of acute bronchospasm or status asthmaticus; coverage requests for those indications are not covered.

Nucala - Multiple indications (COPD, Severe asthma, EGPA, HES, CRSwNP)

Covered when ALL of the following are met for each corresponding indication

Nucala - COPD: 1. A diagnosis of chronic obstructive pulmonary disease (COPD); 2. Used as an add-on maintenance treatment; 3. Age > 18 years; 4. Diagnosis of an eosinophilic phenotype; 5. Prescribed by a board-certified or board-eligible Allergist or Pulmonologist; 6. Documented dose and frequency must be submitted and must be within the FDA-approved dosing and frequency and patient is inadequately controlled with current treatment.

Nucala - Severe asthma: 1. A diagnosis of severe asthma; 2. Used as an add-on maintenance treatment; 3. Age >= 6 years; 4. Prescribed by a board-certified or board-eligible Allergist or Pulmonologist; 5. Diagnosis of an eosinophilic phenotype; 6. Documented dose and frequency must be submitted and must be within the FDA-approved dosing and frequency.

Nucala - EGPA: 1. A diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA); 2. Age >= 18 years; 3. Documented dose and frequency must be submitted and must be within the FDA-approved dosing and frequency.

Tezspire - Severe asthma (broad phenotype)

Covered when ALL of the following are met

Tezspire - Severe asthma: 1. A diagnosis of severe asthma; 2. Used as an add-on maintenance treatment; 3. Age > 12 years; 4. Prescribed by a board-certified or board-eligible Allergist or Pulmonologist; 5. Documented dose and frequency must be submitted and must be within the FDA-approved dosing and frequency.

Tezspire is NOT indicated for the relief of acute bronchospasm or status asthmaticus.

Xolair - Moderate to severe allergic asthma

Covered when ALL of the following are met for moderate-to-severe allergic asthma

Xolair - Moderate to severe allergic asthma: 1. A diagnosis of allergic-mediated moderate-to-severe asthma caused by perennial aeroallergen; 2. Age > 6 years; 3. Asthma symptoms not adequately controlled by > 3 months of continuous therapy of high-dose inhaled steroids or oral steroids; 4. Positive skin test or in vitro testing for one or more perennial aeroallergen (e.g., dust mites, mold, pet dander); 5. Patient is not receiving Xolair in combination with specified biologics (e.g., dupilumab, tezepelumab, mepolizumab, reslizumab, benralizumab).

Documented dose and frequency must be submitted and must be within the FDA-approved dosing and frequency; recent IgE testing within defined age-based ranges is required when applicable; initial authorization up to 12 months.

Asthma — Moderate to Severe Asthma

Moderate to Severe Asthma — Covered when ALL of the following are met:

Asthma diagnosis and etiology: A diagnosis of allergic-mediated moderate-to-severe asthma caused by perennial aeroallergen

Age > 6 years

Inadequate control on steroids: Asthma symptoms are not adequately controlled by > 3 months of continuous therapy of high-dose inhaled steroids or oral steroids>3 months

Allergy testing: Positive skin test or in vitro testing for one or more perennial aeroallergen

examples: dust mites, mold, pet dander

Chronic Idiopathic Urticaria (CIU)

Chronic Idiopathic Urticaria (CIU) — Covered when ALL of the following are met:

Diagnosis: A diagnosis of chronic idiopathic urticaria (CIU)

Age >= 12 years

Duration: At least a 6-week history of urticaria (presence of hives)>=6 weeks

Prior H1 trial: Documented failure, contraindication, or intolerance to a four-week trial of one second-generation non-sedating H1 antihistamine (e.g., loratadine, cetirizine)4 weeks

IgE-mediated Food Allergy

Reduction of IgE-mediated food allergic reactions — Covered when ALL of the following are met:

Diagnosis: A diagnosis of IgE-mediated food allergy

Age > 1 year

Concurrent biologics exclusion: Patient is not receiving Xolair in combination with specified biologics (e.g., dupilumab, tezepelumab, mepolizumab, reslizumab, benralizumab)

Prescriber: Prescribed by a board-certified or board-eligible allergist/immunologist, pulmonologist, or otorhinolaryngologist

Adjunctive measures: Used in conjunction with food allergen avoidance and patient has been prescribed epinephrine for emergency treatment

Nasal Polyps

Nasal Polyps — Covered when ALL of the following are met:

Diagnosis: A diagnosis of nasal polyps

Age >= 18 years

Concomitant therapy: Concurrent use of nasal corticosteroids

Prescriber: Prescribed by a board-certified or board-eligible allergist/immunologist, pulmonologist, or otorhinolaryngologist

Dose and frequency: Documented dose and frequency must be submitted and must be within the FDA-approved dosing and frequency

Initial authorization up to 12 months

These biologic agents are NOT indicated for the relief of acute bronchospasm or status asthmaticus. Coverage requests submitted for the purpose of treating acute bronchospasm or status asthmaticus will be considered not covered and may be denied.

Xolair (omalizumab) is only covered for the specific indications listed in this policy. Requests for Xolair for any other diagnoses or uses are considered not medically necessary and are not covered.

Coverage requests for uses of the biologics outside the FDA‑approved indications enumerated in this policy (for example, other eosinophilic conditions or acute bronchospasm/status asthmaticus) are considered not medically necessary and are not covered.

Requests for biologic therapy for indications other than the covered conditions of asthma, chronic idiopathic urticaria (CIU), IgE‑mediated food allergy, and nasal polyps are considered not medically necessary and will not be covered.

Coding and Diagnosis Codes

HCPCS Codes (informational)HCPCS

J0517	Injection, benralizumab mg.
J2182	Injection, mepolizumab; mg (Nucala).
J2357	Injection, omalizumab, 5 mg (Xolair).
J2786	Injection, reslizumab; mg (Cinqair).

ICD-10 Diagnosis Codes (informational list)ICD-10

J44.9	Chronic obstructive pulmonary disease, unspecified.
J45.40	Moderate persistent asthma, uncomplicated.
J45.42	Moderate persistent asthma with status asthmaticus.
J45.50	Severe persistent asthma, uncomplicated.
J45.51	Severe persistent asthma with (acute) exacerbation.
J45.52	Severe persistent asthma with status asthmaticus.
J45.901	Unspecified asthma with (acute) exacerbation.
J45.902	Unspecified asthma with status asthmaticus.
J45.909	Unspecified asthma, uncomplicated.
J45.991	Cough variant asthma.

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IgE level ranges for asthma — age-based thresholds

Age 6-11 yearsIgE 30 to 1300 IU/mL

Age 12 years and olderIgE 30 to 700 IU/mL

Timing of testRecent IgE testing defined as within 6 months prior to treatment

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required / Coverage Limited

Prior authorization is required for the biologics listed. Coverage is limited to the specific indications and criteria detailed in this policy. Requests for use of these medications for indications not listed in this policy are considered NOT MEDICALLY NECESSARY and will be denied.

PA required for covered biologics per formulary (see policy formulary list).
Coverage limited to indications and clinical criteria specified in this policy; non-listed indications are NOT MEDICALLY NECESSARY.
Initial authorizations will be for no more than 12 months where specified.

Documentation Required

Required Documentation for Prior Authorization

Providers must submit documentation to support the prior authorization request. Required documentation includes specifics about prior use of formulary alternatives or clinical reasons that prevent trial of formulary options.

Name and strength of each formulary alternative tried and failed (include dates if available).
Specifics regarding the treatment failure (reason for discontinuation, adverse effects, lack of efficacy).
If a formulary alternative was not tried, provide clinical justification explaining why a trial is contraindicated or not appropriate.

Documentation Required

Provider Documentation and Prior Use Evidence

The plan will use prescription claims records to verify prior use and trial/failure of formulary alternatives when available. When claims data are insufficient or unavailable, the provider must supply evidence supporting prior use or clinical contraindication.

The plan reviews prescription claim records for the previous 130 days to establish prior use or trial/failure of formulary alternatives.
If prescription claims do not demonstrate required trials, the provider must submit chart notes, prescription records, or other documentation showing dates, drug names, strengths, and reasons for failure.
Provide clinical documentation when the provider asserts a contraindication or intolerance preventing trial of a formulary alternative.

Key Definitions

Biologic — definition

DefinitionBiologic: targeted therapy that inhibits immune mediators (e.g., interleukins, IgE, TSLP) driving inflammatory responses in asthma.

PurposeUsed as add-on maintenance therapy for severe or specific asthma phenotypes to reduce airway inflammation.

Target examplesCommon targets include IL-4, IL-5, IL-13; examples also include IgE (omalizumab) and TSLP (tezepelumab).

Perennial aeroallergen–mediated moderate-to-severe asthma — definition and requirements

DefinitionPerennial aeroallergen-mediated moderate-to-severe asthma: allergic-mediated moderate-to-severe asthma caused by perennial aeroallergens (e.g., dust mites, mold, pet dander).

Age thresholdAge > 6 years for coverage consideration.

Prior therapy requirementSymptoms not adequately controlled by >3 months continuous high-dose inhaled or oral steroids and positive skin or in vitro testing to one or more perennial aeroallergens.

Concurrent biologics exclusionPatient must not be receiving Xolair in combination with specified biologics (e.g., dupilumab, tezepelumab, mepolizumab, reslizumab, benralizumab).

Chronic Idiopathic Urticaria (CIU) — definition and prior therapy requirements

DefinitionChronic idiopathic urticaria (CIU): urticaria (hives) persisting at least 6 weeks.

Age thresholdAge ≥ 12 years for coverage consideration.

Prior H1 antihistamine trialDocumented failure, contraindication, or intolerance to a 4-week trial of one second-generation non-sedating H1 antihistamine (e.g., loratadine, cetirizine).

Additional medication trialsDocumented failure, contraindication, or intolerance to at least a 2-week trial of one of: leukotriene receptor antagonist, H2-receptor antagonist, first-generation sedating H1, or substitution to a different second-generation non-sedating H1; prescriber may be allergist, pulmonologist, otorhinolaryngologist, or dermatologist.

Background

Biologic therapies referenced in this policy are targeted, add‑on maintenance treatments for severe or specific eosinophilic airway and related conditions. They act by inhibiting immune pathways (for example, interleukins, IgE, or TSLP) to reduce airway or systemic eosinophilic inflammation. Clinical response varies by asthma phenotype and biomarker status; therefore accurate phenotyping and optimization of background therapy are required before initiating a biologic. These agents are intended for chronic management and are not indicated for acute bronchospasm or status asthmaticus. Initial authorizations are documented for maintenance dosing and are limited to a maximum of 12 months where specified.

Policy Summary

PayerBlue Cross Blue Shield - Massachusetts

PolicyInjectable biologic agents for asthma and related eosinophilic conditions

Policy CodePolicy 017

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain prior authorization and document prior trials of formulary alternatives or clinical rationale when alternatives cannot be tried.

SourceLink

On This Page

Nucala - HES: 1. A diagnosis of hypereosinophilic syndrome (HES); 2. Age >= 12 years; 3. No identifiable non-hematologic secondary cause for at least 6 months; 4. Documented dose and frequency must be submitted and must be within the FDA-approved dosing and frequency.

Nucala - CRSwNP: 1. A diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP); 2. Used as an add-on maintenance treatment; 3. Age >= 18 years; 4. Previous inadequate response to nasal corticosteroids; 5. Documented dose and frequency must be submitted and must be within the FDA-approved dosing and frequency.

Prescriber: Prescribed by a board-certified or board-eligible allergist/immunologist, pulmonologist, or otorhinolaryngologist

IgE range: Recent IgE testing within 6 months with age-based thresholdsAge 6-11: 30-1300 IU/mL; Age >=12: 30-700 IU/mL

Concurrent biologics exclusion: Patient is not receiving Xolair in combination with specified biologics (e.g., dupilumab, tezepelumab, mepolizumab, reslizumab, benralizumab)

Dose and frequency: Documented dose and frequency must be submitted and must be within the FDA-approved dosing and frequency

Initial authorization up to 12 months

Additional medication trials: Documented failure, contraindication, or intolerance to at least a two-week trial of one of: leukotriene receptor antagonist OR H2-receptor antagonist OR first-generation sedating H1 OR substitution to a different second-generation non-sedating H12 weeks

Prescriber may be allergist, pulmonologist, otorhinolaryngologist, or dermatologist

Concurrent biologics exclusion: Patient is not receiving Xolair in combination with specified biologics (e.g., dupilumab, tezepelumab, benralizumab)

Dose and frequency: Documented dose and frequency must be submitted and must be within the FDA-approved dosing and frequency

Initial authorization up to 12 months

Confirmed food allergy: Documented IgE-mediated allergy to specified foods (examples: milk, peanut, tree nuts, cashew, egg, hazelnut, wheat) confirmed by history plus one confirmatory test (SPT, OFC, or serum-specific IgE)

Initial authorization up to 12 months

Dose and frequency: Documented dose and frequency must be submitted and must be within the FDA-approved dosing and frequency