CurrentViva HealthPolicy IC-P0347

Fasenra (benralizumab) (Subcutaneous)

Prior authorization policy for Fasenra (benralizumab) covering initial and renewal approval criteria, dosing/administration, allowed diagnoses, billing codes (HCPCS and NDC), concomitant therapy restrictions, and authorization duration for commercial members (non‑Medicare determinations guidance included).

Policy Summary

PayerViva Health

PolicyFasenra (benralizumab) (Subcutaneous)

Policy CodePolicy IC-P0347

Change TypeNo material change

Effective DateDec 12, 2017

Next Review Date

Key ActionPrior authorization required; initial and renewal approvals are valid for 12 months (365 days).

POLICY UPDATE CHANGES

No material clinical/coverage changes in this update

2Primary Indications Covered (Severe eosinophilic asthma; EGPA)

365Authorization length (days)

J0517Primary HCPCS code

Coverage Summary

This policy: covers Fasenra (benralizumab) with prior authorization and specific clinical criteria for commercial members. Primary indications covered are severe eosinophilic asthma and eosinophilic granulomatosis with polyangiitis (EGPA). Authorization length is 365 days for initial and renewal approvals. The policy scope includes prior authorization rules, dosing/administration and billing codes (primary HCPCS code J0517), allowed diagnoses, concomitant therapy restrictions, and applies to commercial members.

Quick facts / thresholds

Primary HCPCS codeJ0517

Authorization length365 days (initial and renewals)

Primary indications coveredSevere eosinophilic asthma; Eosinophilic granulomatosis with polyangiitis (EGPA)

Baseline blood eosinophil threshold (asthma)>= 150 cells/microliter

FeNO threshold>= 20 ppb (while on high‑dose ICS or daily OCS)

Sputum eosinophils threshold>= 2% (while on high‑dose ICS or daily OCS)

EGPA eosinophilia thresholds>= 1000 cells/microliter OR >= 10% eosinophils on WBC differential

Provider Actions & Prior Authorization

Prior Authorization

Prior authorization required

Prior authorization is required for Fasenra (benralizumab). Initial and renewal approvals are valid for 12 months (365 days).

Documentation Required

Document baseline labs and clinical history

Provide baseline laboratory and clinical documentation prior to or at initiation: baseline blood eosinophil counts; fraction of exhaled nitric oxide (FeNO) or sputum eosinophils where applicable; history of exacerbations and hospitalizations; baseline FEV1; complete medication history including prior biologic immunomodulators; and evidence of adherence to inhaled/controller therapies.

Baseline eosinophil counts
FeNO or sputum eosinophils
History of exacerbations/hospitalizations
FEV1 baseline
Medication history (including prior biologics)
Evidence of adherence to controller therapies

Denial Risk

Samples not approvable for continuation

Samples are not approvable for continuation of therapy. Continuation eligibility requires that the member has been treated with the requested agent (not including sample use) within the past 90 days; initiation on samples may result in denial.

Documentation Required

Support for combination immunomodulatory therapy

If the member will use Fasenra in combination with another immunomodulatory agent, submit documentation showing that the prescribing information does not limit concomitant use and provide clinical support (e.g., clinical trials, phase III studies, or guidelines) to justify combination therapy.

Billing Rule

HCPCS billing units

Bill J0517 at 1 unit = 1 mg. For dosing, adults receiving 30 mg should be billed as 30 units; pediatric weight-based dosing should be billed per specified mg (1 unit = 1 mg).

codes: J0517
1 unit = 1 mg; adults 30 mg = 30 units; pediatric weight-based dosing as specified

Applicable Codes

HCPCS codeHCPCSCovered

J0517

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

NDCsNDCCovered

00310-1745-xx	Fasenra 10 mg/0.5 mL single-dose prefilled syringe
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 Codes (Appendix 1)ICD-10Covered

J45.50	Severe persistent asthma, uncomplicated
J82.81	Chronic eosinophilic pneumonia
J82.82	Acute eosinophilic pneumonia
J82.83	Eosinophilic asthma
J82.89	Other pulmonary eosinophilia, not elsewhere classified
M30.1	Polyarteritis with lung involvement [Churg-Strauss]

Agents NOT to be used Concomitantly (list)mixedNot Covered

Abrilada	adalimumab-afzb
Actemra	tocilizumab
Adalimumab
Adbry	tralokinumab-ldrm

Contraindicated as Concomitant Therapy (extensive list)mixedNot Covered

Amjevita	adalimumab-atto
Arcalyst	rilonacept
Avsola	infliximab-axxq
Avtozma	tocilizumab-anoh
Benlysta	belimumab
Bimzelx	bimekizumab-bkzx
Cibinqo	abrocitinib
Cimzia	certolizumab
Cinqair	reslizumab
Cosentyx	secukinumab

1–10 of 82

1/9

Concomitant Therapy Restrictions & Exclusions

Concomitant use of other immunomodulatory agents is generally not allowed unless the prescriber documents that (1) the agent's prescribing information does not limit concurrent use and (2) there is clinical support for the combination (submitted clinical trials, phase III studies, or guidelines). The policy lists an extensive set of agents that are contraindicated as concomitant therapy and refers to an 'Agents NOT to be used Concomitantly' table and a long 'Contraindicated as Concomitant Therapy' list; combinations with any of those agents are not permitted. If combination therapy is proposed, the prescriber must submit the prescribing information showing no limitation and supporting clinical evidence (e.g., trials or guideline citations).

Clinical Evidence & References

Evidence cited includes the Fasenra prescribing information (AstraZeneca, September 2024) as the primary reference and the key EGPA trial: Wechsler M et al., Benralizumab versus Mepolizumab for Eosinophilic Granulomatosis with Polyangiitis (New England Journal of Medicine, 2024). The policy background notes alignment with FDA labeling and use of compendia (e.g., AHFS, DrugDex) and guideline sources for support.

Trial / evidence & prescriber

Key trial cited (EGPA)Wechsler M et al., NEJM 2024: Benralizumab vs Mepolizumab for EGPA

Compendia allowed (evidence)AHFS, DrugDex (1 or 2a level), or NCCN (1 or 2a recommended)

Prescriber specialty requirementPrescriber must be a specialist or consult a specialist (asthma: allergist/immunologist/pulmonologist; EGPA: allergist/immunologist/pulmonologist/rheumatologist)

Concomitant immunomodulatory useGenerally not allowed unless prescribing info does not limit and clinical support submitted

Background

Background: Fasenra (benralizumab) is an anti‑eosinophil biologic approved for treatment of severe eosinophilic asthma and for EGPA. The policy aligns with FDA labeling and recognized compendia/guidance and includes specific continuation/renewal criteria, dosing and billing guidance. The policy restricts concomitant use with many immunomodulatory agents unless the prescribing information permits combination and supporting clinical evidence (e.g., trials or guidelines) is submitted.

Definitions: High‑dose inhaled corticosteroids — not specifically quantified in this policy; refers to dosing consistent with guideline high‑dose ICS for asthma. Adherent — documented adherence for 90 days within the past 120 days as required by the policy for controller therapies.