CurrentModa HealthPolicy IC-0347

Benralizumab (Fasenra) subcutaneous injection — Coverage Criteria

Policy governs coverage and authorization criteria for subcutaneous benralizumab (Fasenra) for severe eosinophilic asthma and select eosinophilic pulmonary diagnoses for Moda Health members in North Carolina.

Policy Summary

PayerModa Health

PolicyBenralizumab (Fasenra) subcutaneous injection — Coverage Criteria

Policy CodePolicy IC-0347

Change TypeNo material change

Effective DateOct 3, 2023

Next Review DateOct 3, 2023

Key ActionObtain prior authorization; submit HCPCS J0517 with clinical documentation to authorize 6 months of coverage (loading then maintenance dosing per policy).

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

6 monthsinitial authorization period

30 mgdose per administration

every 8 weeksmaintenance interval

≥150 cells/µLeosinophil threshold

≥2required prior-year exacerbations

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Initial Approval - Severe Eosinophilic Asthma

Covered when ALL of the following are met:

Age: Patient is at least 12 years of age

Concurrent biologics: Will not be used in combination with other anti-IgE, anti-IL4, anti-IL5, or IgG2 lambda monoclonal antibody agents

Examples: omalizumab, mepolizumab, reslizumab, dupilumab, tezepelumab

Excluded uses: Must NOT be used for treatment of other eosinophilic conditions or for relief of acute bronchospasm/status asthmaticus

Examples: allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome

Severity: Patient must have severe asthma

See definitions for components of severe disease

Phenotype: Asthma with eosinophilic phenotype indicated by blood eosinophils ≥150 cells/µL within 6 weeks of dosing≥150 cells/µL within 6 weeks

Background therapy: Used as add-on maintenance treatment in patients regularly receiving BOTH: medium- to high-dose inhaled corticosteroids AND an additional controller medication

Additional controller examples: long-acting beta agonist, leukotriene modifiers

Exacerbation history: Two or more exacerbations in the previous year requiring daily oral corticosteroids for at least 3 days (in addition to regular maintenance therapy)≥2 exacerbations

Baseline measurement of at least one of: systemic corticosteroid use, inhaled corticosteroid use, number of hospitalizations/ER/unscheduled visits due to condition, or FEV1

For assessment of clinical status

Renewal Criteria

Renewal provided when ALL of the following are met:

Continued criteria: Patient continues to meet the universal and indication-specific criteria identified for initial approval

Toxicity: Absence of unacceptable toxicity from the drug

Examples: parasitic (helminth) infection, severe hypersensitivity such as anaphylaxis, angioedema, urticaria, rash

Clinical improvement: Demonstrated improvement in asthma symptoms or exacerbations as evidenced by a decrease in systemic corticosteroid use; OR two-fold or greater decrease in inhaled corticosteroid use for at least 3 days; OR reduction in hospitalizations, ER visits, or unscheduled visits; OR improvement from baseline in FEV1

Either clinical event reduction OR FEV1 improvement required

Benralizumab must not be used for the treatment of other eosinophilic conditions beyond the covered indications. Examples of excluded eosinophilic disorders include allergic bronchopulmonary aspergillosis/mycosis (ABPA), Churg–Strauss syndrome (eosinophilic granulomatosis with polyangiitis), and hypereosinophilic syndrome. The policy also excludes use for relief of acute bronchospasm or status asthmaticus.

Benralizumab will not be covered when used in combination with other monoclonal biologic therapies that target IgE, IL‑4, IL‑5, or are IgG2 lambda antibodies. Examples include omalizumab, mepolizumab, reslizumab, dupilumab, and tezepelumab. Use of benralizumab for excluded indications or in combination with these listed biologics is considered not medically necessary.

Provider Requirements, Prior Authorization, and Billing

Prior Authorization

Prior Authorization Required

Prior authorization is required for benralizumab (IC-0347). Initial authorization is provided for 6 months and may be renewed if renewal criteria are met. Submit documentation that supports the clinical criteria (age, eosinophil count, maintenance therapy, and exacerbation history).

Prior authorization required (initial approval up to 6 months)
Include clinical documentation: age, recent blood eosinophil count (≥150 cells/µL within 6 weeks), current maintenance therapy (medium–high dose inhaled corticosteroid AND additional controller), exacerbation history (≥2 exacerbations in past year requiring systemic steroids ≥3 days)
HCPCS: J0517 — Injection, benralizumab, 1 mg

Documentation Required

Background Controller Therapy Required

Benralizumab must be used as add-on maintenance therapy in patients who are regularly receiving BOTH a medium to high-dose inhaled corticosteroid and an additional controller medication (for example, a long-acting beta agonist or leukotriene modifier).

Required background therapy: medium–high dose inhaled corticosteroid + an additional controller agent

Denial Risk

Concurrent Biologic Therapy Prohibited

Benralizumab must NOT be used concurrently with other biologic therapies targeting IgE, IL-4, IL-5, or related pathways. Requests indicating concurrent use will be denied.

Concurrent biologics that preclude approval: omalizumab, mepolizumab, reslizumab, dupilumab, tezepelumab, and other anti-IgE/anti-IL4/anti-IL5 monoclonal antibodies

Key Definitions

inv-15: Severe asthma

Core requirementPatient must have severe asthma (see components of severity)

Eosinophilic phenotypeAsthma with blood eosinophils ≥150 cells/µL within 6 weeks of dosing

Background therapyRegularly receiving both medium- to high-dose inhaled corticosteroid AND an additional controller medication

Exacerbation historyTwo or more exacerbations in the previous year requiring daily oral corticosteroids for at least 3 days

Baseline assessmentBaseline measurement of at least one: systemic corticosteroid use, inhaled corticosteroid use, number of hospitalizations/ER/unscheduled visits, or FEV1

Severity components (examples)Symptoms throughout the day; frequent nighttime awakenings; frequent SABA use; very limited activities; FEV1 percent predicted <60%; frequent/intense exacerbations

00310-1730-xx	Fasenra 30 mg/mL single-dose prefilled syringe NDC
00310-1830-xx	Fasenra 30 mg/mL single-dose autoinjector (FASENRA PEN) NDC

J45.50	Severe persistent asthma, uncomplicated
J82.81	Eosinophilic pneumonia, NOS
J82.82	Acute eosinophilic pneumonia
J82.83	Eosinophilic asthma
J82.89	Other pulmonary eosinophilia, not elsewhere classified

OpenPayer

Benralizumab (Fasenra) subcutaneous injection — Coverage Criteria

Coverage and Medical Necessity Criteria

Coding and Diagnosis Codes

Provider Requirements, Prior Authorization, and Billing

Background and Mechanism

Key Definitions