Blue Cross Blue Shield MA biologics Coverage Update

Coverage and Medical Necessity Criteria

Cinqair (reslizumab) — Initial coverage

Covered when ALL of the following are met

Cinqair (reslizumab) coverage criteria: 1. A diagnosis of severe asthma; AND 2. Used as an add-on maintenance treatment; AND 3. Age ≥ 18 years; AND 4. Diagnosis of an eosinophilic phenotype; AND 5. The drug is prescribed by a board-certified or board-eligible Allergist or Dermatologist

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

Fasenra (benralizumab) — Initial coverage

Covered when ALL of the following are met for each indication

Fasenra for Severe Asthma: 1. A diagnosis of severe asthma; AND 2. Used as an add-on maintenance treatment; AND 3. Age ≥ 6 years; AND 4. The drug is prescribed by a board-certified or board-eligible Allergist or Pulmonologist; AND 5. Diagnosis of an eosinophilic phenotype.

Fasenra for Eosinophilic Granulomatosis with Polyangiitis (EGPA): a. A diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA); AND b. Age ≥ 18 years

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

Nucala (mepolizumab) — Initial coverage across indications

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

Nucala for COPD: 1. A diagnosis of chronic obstructive pulmonary disease (COPD); AND 2. Used as an add-on maintenance treatment; AND 3. Age ≥ 18 years; AND 4. Diagnosis of an eosinophilic phenotype; AND 5. The drug is prescribed by a board-certified or board-eligible Allergist or Pulmonologist; AND 6. Inadequately controlled with current treatment

Nucala for Severe Asthma: 1. A diagnosis of severe asthma; AND 2. Used as an add-on maintenance treatment; AND 3. Age ≥ 6 years; AND 4. Diagnosis of an eosinophilic phenotype; AND 5. The drug is prescribed by a board-certified or board-eligible Allergist or Pulmonologist

Nucala for Eosinophilic Granulomatosis with Polyangiitis (EGPA): 1. A diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA); AND 2. Age ≥ 18 years

Nucala for Hypereosinophilic Syndrome (HES):

Tezspire (tezepelumab) — Initial coverage

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

Tezspire for Severe Asthma: 1. A diagnosis of severe asthma; AND 2. Used as an add-on maintenance treatment; AND 3. Age ≥ 12 years; AND 4. The drug is prescribed by a board-certified or board-eligible Allergist or Pulmonologist

Tezspire is NOT indicated for the relief of acute bronchospasm or status asthmaticus; such requests are not covered.

Tezspire for Chronic Rhinosinusitis with Nasal Polyps (CRSwNP): 1. A diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP); AND 2. Used as an add-on maintenance treatment; AND 3. Age ≥ 12 years; AND 4. Previous inadequate response to nasal corticosteroids

Severe Asthma (Tezspire / general biologics criteria)

Covered when ALL of the following are met

Severe Asthma criteria: 1. A diagnosis of severe asthma, AND 2. Used as an add-on maintenance treatment, AND 3. Age ≥ 12 years, AND 4. The drug is prescribed by a board-certified or board-eligible Allergist or Pulmonologist

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Covered when ALL of the following are met

CRSwNP criteria: 1. A diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP), AND 2. Used as an add-on maintenance treatment, AND 3. Age ≥ 12 years, AND 4. Previous inadequate response to nasal corticosteroids

Tezspire is NOT indicated for relief of acute bronchospasm or status asthmaticus (requests for that indication are NMN).

Xolair — Moderate to Severe Allergic Asthma

Covered when ALL of the following are met

Xolair asthma criteria: 1. A diagnosis of allergic mediated moderate-to-severe asthma caused by perennial aeroallergen; AND 2. Age ≥ 6 years; AND 3. Asthma symptoms are not adequately controlled by > 3 months of continuous high-dose inhaled or oral steroids; AND 4. Positive skin test or in vitro testing for one or more perennial aeroallergen; AND 5. Patient is not receiving Xolair in combination with anti-IL4, anti-IL5 therapies, or a TSLP inhibitor; AND 6. The drug is prescribed by a board-certified or board-eligible allergist/immunologist, pulmonologist, or otorhinolaryngologist; AND 7. Recent IgE testing within 6 months within age-based ranges (age 6-11: 30-1300 IU/mL; age ≥12: 30-700 IU/mL)IgE ranges specified

Initial authorization will be for no more than 12 months.

Xolair — Chronic Idiopathic Urticaria (CIU)

Covered when ALL of the following are met

CIU criteria: 1. A diagnosis of chronic idiopathic urticaria (CIU); AND 2. Age ≥ 12 years; AND 3. At least a 6-week history of urticaria; AND 4. Documented failure, contraindication, or intolerance to a four-week trial of one second-generation non-sedating H1 antihistamine; AND 5. Patient is not receiving Xolair in combination with anti-IL4/anti-IL5 therapies or a TSLP inhibitor; AND 6. The drug is prescribed by a board-certified or board-eligible allergist/immunologist, pulmonologist, otorhinolaryngologist or dermatologist; AND 7. Documented failure, contraindication, or intolerance to at least a two-week trial of ONE of: leukotriene receptor antagonist OR H2 antagonist OR first-generation H1 OR substitution to a different second-generation H1 antihistamine

Initial authorization will be for no more than 12 months.

Xolair — Reduction of type I allergic reactions to food

Covered when ALL of the following are met

Food allergy criteria: 1. A diagnosis of IgE-mediated food allergy; AND 2. Age ≥ 1 year; AND 3. Patient is not receiving Xolair in combination with anti-IL4, anti-IL5 therapies or a TSLP inhibitor; AND 4. The drug is prescribed by a board-certified or board-eligible allergist/immunologist/pulmonologist/otorhinolaryngologist; AND 5. Xolair will be used in conjunction with food allergen avoidance; AND 6. Patient has been prescribed epinephrine for emergency treatment; AND 7A. For cashew/egg/hazelnut/wheat: documented IgE-mediated allergy confirmed by history of a type I reaction plus one of SPT, in vitro IgE, or oral food challenge; AND 8A. For milk/peanut/tree nuts: documented IgE-mediated allergy confirmed by one of SPT, in vitro IgE, or oral food challenge

Specific food lists and confirmation methods required.

Xolair — Nasal Polyps

Covered when ALL of the following are met

Nasal polyps criteria: 1. A diagnosis of nasal polyps; AND 2. Age ≥ 18 years; AND 3. Concurrent use of nasal corticosteroids; AND 4. The drug is prescribed by a board-certified or board-eligible allergist or immunologist, pulmonologist or otorhinolaryngologist

Xolair is NOT covered except for the conditions listed above. Initial authorization will be for no more than 12 months.

Requests for treatment of eosinophilic conditions or acute respiratory events that are not included in the product-specific indications are considered not medically necessary. For example, Cinqair and Fasenra are not indicated for management of other eosinophilic disorders or for relief of acute bronchospasm or status asthmaticus; such uses will be denied as NOT MEDICALLY NECESSARY.

When submitting prior authorization requests, ensure the indication matches one of the policy-listed conditions and that supporting documentation (diagnosis, specialty of prescriber, age, and evidence of add‑on maintenance intent where required) is provided; requests for off‑indication eosinophilic conditions or acute bronchospasm/status asthmaticus lack coverage per policy.

Tezspire is NOT indicated for relief of acute bronchospasm or status asthmaticus; requests for that use are considered NOT MEDICALLY NECESSARY and will be denied. Similarly, Xolair is covered only for the indications listed in this policy (e.g., allergic asthma, CIU, IgE‑mediated food allergy under specified conditions, and nasal polyps); requests for Xolair for indications not enumerated in the policy are also considered NOT MEDICALLY NECESSARY and are not covered.

Coverage requests for uses outside the FDA‑approved and policy‑listed indications — for example, treating other eosinophilic disorders or using these agents for relief of acute bronchospasm or status asthmaticus — are NOT MEDICALLY NECESSARY and will not be approved. Providers should request coverage only for the specific conditions and patient criteria described in this policy and include documentation that meets those criteria.

Explicit examples of non‑covered requests include: a request for Tezspire to treat an episode of acute bronchospasm or status asthmaticus, and any request for Xolair for indications other than the conditions listed in this policy (allergic asthma per criteria, chronic idiopathic urticaria, specified food allergy indications, or nasal polyps when criteria are met). Such requests are considered NOT MEDICALLY NECESSARY and will be denied.

Procedure and Diagnosis Codes

HCPCS CodesHCPCS

J0517	Injection, benralizumab, 1 mg.
J2182	Injection, mepolizumab, 1 mg (Nucala®).
J2357	Injection, omalizumab, 5 mg (Xolair™).
J2786	Injection, reslizumab, 1 mg (Cinqair®).

ICD-10 Diagnosis Codes (asthma/COPD)ICD-10

J44.9	Chronic obstructive pulmonary disease, unspecified.
J45.40	Moderate persistent asthma, uncomplicated.
J45.41	Moderate persistent asthma with (acute) exacerbation.
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.

1–10 of 12

1/2

IgE level ranges by age

Age 6-1130 to 1300 IU/mL

Age ≥1230 to 700 IU/mL

Testing timeframeIgE testing must be recent (any time prior to treatment but within 6 months)

Provider Requirements, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior Authorization is required for all requests. Providers must obtain prior authorization through Pharmacy Operations (Tel: 1-800-366-7778; Fax: 1-800-583-6289) or via the Formulary Exception/Prior Authorization form. Initial authorizations, when applicable, will be issued for no more than 12 months. Providers may call, fax, or mail the completed form to request coverage.

Pharmacy Operations: Tel: 1-800-366-7778; Fax: 1-800-583-6289
Providers may call, fax, or mail the Formulary Exception/Prior Authorization form to request coverage
Initial authorization will be for no more than 12 months (when specified)

Denial Risk

Acute Use and Off‑Label Exclusion

Requests for use of these drugs for acute relief (e.g., relief of acute bronchospasm or status asthmaticus) or for indications not listed in the policy (off-label/unsupported indications) are considered NOT MEDICALLY NECESSARY and are NOT COVERED.

Clinical Background and Scope

Biologic therapies target specific inflammatory mediators to improve outcomes in severe asthma subtypes. These agents act on pathways such as IL‑4, IL‑5, IL‑13, IgE, and TSLP to reduce eosinophilic inflammation and improve control. Accurate phenotyping of asthma is important because response varies by mechanism; note that Tezspire (tezepelumab) is approved for severe asthma without phenotype or biomarker restriction, while other biologics have phenotype‑ or biomarker‑based indications.

Definitions and Product Notes

Biologics (in context)

DefinitionTargeted therapies that inhibit key cells and mediators driving inflammatory responses in asthma (e.g., IL-4, IL-5, IL-13, IgE, TSLP) to reduce eosinophils and improve control.

PurposeImprove outcomes in specific severe asthma subtypes by matching biologic mechanism to patient phenotype.

ConsiderationsRequire exclusion of alternative diagnoses, treatment of comorbidities, removal of triggers, and assessment of adherence before initiation.

Tezspire specific note

Tezspire (tezepelumab) label noteApproved for severe asthma without phenotype or biomarker limitation within its label.

TargetTSLP (thymic stromal lymphopoietin) inhibition.

Policy Updates and Material Changes

2026-03-15added indication/administrativeLatest

Added expanded FDA indication for Tezspire and removed drugs from Cotivity program.

2025-09-15revised indication/authorization

Added COPD as an add-on treatment indication for Nucala and updated Prior Authorization, policy text, and references.

2025-01clarified indications

OpenPayer

Injectable biologic agents for asthma and related eosinophilic conditions

Coverage and Medical Necessity Criteria

Procedure and Diagnosis Codes

Provider Requirements, Prior Authorization, and Documentation

Clinical Background and Scope

Definitions and Product Notes

Policy Updates and Material Changes