CurrentModa HealthPolicy IC-0347

Benralizumab (Fasenra) subcutaneous for severe eosinophilic asthma

Defines Moda Health coverage, authorization length, dosing, quantity limits, initial and renewal medical necessity criteria, billing codes (HCPCS J0517 and product NDCs), and CMS/MAC guidance for benralizumab (Fasenra) subcutaneous injections.

Policy Summary

PayerModa Health

PolicyBenralizumab (Fasenra) subcutaneous for severe eosinophilic asthma

Policy CodePolicy IC-0347

Change TypeClarified (review dates updated)

Effective Date

Next Review Date

Key ActionInitial coverage provided for 6 months and may be renewed; renewal requires meeting renewal criteria including evidence of clinical benefit and absence of unacceptable toxicity.

SourceLink

POLICY UPDATE CHANGES

Last Review Date updated to 10/03/2023; multiple review dates listed through 10/2023.

6 monthsInitial Authorization Length

>=12Minimum Age

>=150Eosinophil threshold

30 mgPer-dose amount

J0517Billing HCPCS

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Coverage Summary

Benralizumab (Fasenra) is an anti-eosinophil monoclonal antibody indicated as an add-on maintenance treatment for severe eosinophilic asthma per the FDA-approved indication; coverage is aligned with FDA indication and clinical guideline criteria and the policy coverage stance is covered_with_criteria. Patients must be receiving medium-to-high dose inhaled corticosteroids plus an additional controller medication as part of regular maintenance therapy.

Initial Approval Criteria

Renewal / Continuation Criteria

Exclusions / Not Covered Uses

Excluded uses and provider notes: Not to be used for treatment of other eosinophilic conditions (for example, allergic bronchopulmonary aspergillosis/mycosis, Churg-Strauss syndrome, hypereosinophilic syndrome); not to be used in combination with other anti-IgE, anti-IL4, anti-IL5, or IgG2 lambda monoclonal antibody agents (examples listed include omalizumab, mepolizumab, reslizumab, dupilumab, tezepelumab); and not for relief of acute bronchospasm or status asthmaticus.

Applicable Codes

Covered HCPCSHCPCSCovered

J0517

Injection, benralizumab, 1 mg; 1 billable unit = 1 mg

Product NDCs (formulary identifiers)NDCCovered

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

Covered Diagnosis CodesICD-10Covered

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

Provider Actions & Billing

Prior Authorization

Authorization length and renewal

Initial coverage provided for 6 months and may be renewed; renewal requires meeting the renewal criteria which include continued meeting of initial criteria, absence of unacceptable toxicity, and evidence of clinical benefit (e.g., decreased systemic corticosteroid use, reduced hospitalizations/ER visits, or improved FEV1).

Billing Rule

Quantity limits and dosing billing

Loading: administer 30 mg subcutaneously every 4 weeks for the first 3 doses (loading: 30 billable units every 28 days for 3 doses). Maintenance: 30 mg every 8 weeks (maintenance: 30 billable units every 56 days). Billing unit mapping: HCPCS J0517 = 1 mg; therefore 30 billable units = 30 mg. Use HCPCS code J0517 for billing.

J0517

Clinical Evidence & References

Evidence and references: Primary reference is the Fasenra package insert, AstraZeneca, February 2021 (accessed September 2023). Supporting guideline sources include NAEPP, GINA, and ERS/ATS guidelines and cited clinical studies (e.g., SIROCCO and CALIMA subanalyses) that inform patient selection and align with the FDA indication and guideline criteria.

Background & Definitions

Mechanism and indication summary: Benralizumab is an anti-eosinophil monoclonal antibody indicated as an add-on maintenance treatment for severe eosinophilic asthma. Use is specified for patients on medium-to-high dose inhaled corticosteroids plus an additional controller medication as part of regular maintenance therapy.

Severe disease: May include symptoms throughout the day, nighttime awakenings, frequent SABA use, extremely limited activities, percent predicted FEV1 <60%, and frequent/intense exacerbations.

Medicare / Payer Guidance

Medicare informational note: Medicare outpatient (Part B) drug guidance is provided in the Medicare Benefit Policy Manual, Chapter 15, 850; local NCDs/LCDs/LCAs may apply and should be checked in the CMS coverage database.

Revision History

12/2017document_reviewed

Document reviewed

03/2018document_reviewed

Document reviewed

06/2018document_reviewed

Document reviewed

Policy Summary

PayerModa Health

PolicyBenralizumab (Fasenra) subcutaneous for severe eosinophilic asthma

Policy CodePolicy IC-0347

Change TypeClarified (review dates updated)

Effective Date

Next Review Date

Key ActionInitial coverage provided for 6 months and may be renewed; renewal requires meeting renewal criteria including evidence of clinical benefit and absence of unacceptable toxicity.

SourceLink

On This Page

Documentation Required

Baseline and ongoing clinical measurements

Document a baseline measurement of at least one clinical status metric prior to initiation (examples below). For renewal, document continued meeting of criteria and demonstrate improvement in one or more measures or absence of unacceptable toxicity.

Systemic corticosteroid use
Inhaled corticosteroid use
Number of hospitalizations, ER visits, or unscheduled visits
Forced expiratory volume in 1 second (FEV1)

Billing Rule

Product administration setting and injector use

Fasenra single-dose prefilled syringe is intended for administration by a healthcare provider. The Fasenra Pen autoinjector may be administered by patients or caregivers after proper training and provider determination. Billing units map to HCPCS J0517 (1 mg = 1 billable unit).

J0517
00310-1730-xx
00310-1830-xx

10/2018document_reviewed

Document reviewed

11/2019document_reviewed

Document reviewed

01/2020document_reviewed

Document reviewed

10/2020document_reviewed

Document reviewed

03/2021document_reviewed

Document reviewed

08/2021document_reviewed

Document reviewed

10/2022document_reviewed

Document reviewed

10/03/2023last_review_date_updatedLatest

Last Review Date updated to 10/03/2023; multiple review dates listed through 10/2023.