Is continuation of benralizumab (Fasenra) therapy medically necessary for a adult patient with severe persistent asthma, uncomplicated, who has demonstrated a good response to the medication with no recent exacerbations and is taking other unspecified medications?

Medical Necessity Determination for Benralizumab Continuation in Severe Persistent Asthma

Benralizumab continuation therapy is medically necessary for this patient with severe persistent asthma who has demonstrated clinical improvement with no recent exacerbations and reduced rescue medication use, provided the patient is not concurrently using another biologic agent for asthma. 1, 2

Critical Issue Requiring Clarification

The primary concern preventing immediate approval is the concurrent use of an unspecified medication that may be another biologic agent. 1, 2

Specific Action Required:

• Verify whether the patient is taking any other biologic medications (omalizumab, mepolizumab, dupilumab, reslizumab, or tezepelumab) for asthma management 1, 3
• Benralizumab cannot be used concomitantly with other biologics for the same indication per FDA labeling and clinical guidelines 2
• If the unspecified medication is NOT another biologic, approval criteria are met 1

Criteria Assessment for Continuation Therapy

Met Criteria:

Age Requirement: Patient is an adult, meeting the ≥12 years age requirement 1, 2

Specialist Prescribing: Prescribed by or in consultation with appropriate specialist (allergist/immunologist or pulmonologist) 1

Clinical Response Demonstrated: 1, 4

• Patient reports "good response with no recent exacerbations"
• Denied rescue medication use since last injection
• States medication is "helpful in reducing asthma symptoms"
• This meets the criterion of "reduction in frequency and/or severity of symptoms and exacerbations" 1

Maintenance Therapy Continuation: Patient continues on maintenance asthma treatments including inhaled corticosteroids and additional controllers 1, 2

Unverified Criterion:

No Concurrent Biologic Use: Cannot definitively confirm patient is not using another biologic agent due to incomplete medication information 1, 2

Evidence Supporting Continuation Therapy

Real-World Effectiveness Data:

Exacerbation Reduction: Benralizumab demonstrates a 72.8% reduction in annual exacerbation rate in real-world studies, with 43.8% of patients achieving complete exacerbation freedom at 48 weeks 4

Response Rates: In real-world cohorts, 86% of patients meet responder criteria (≥50% reduction in exacerbations or oral corticosteroid dose), with 39% achieving "super responder" status (zero exacerbations and no maintenance oral corticosteroids) 4

Clinical Trial Data: Phase III studies show benralizumab reduces exacerbations requiring oral/systemic corticosteroids in patients with severe eosinophilic asthma and history of ≥2 exacerbations in the prior 12 months 2, 5

Safety Profile:

Tolerability: Patient has tolerated previous injections well with no reported adverse effects 6, 7

Common Adverse Events: Most frequent side effects include nasopharyngitis and transient worsening of asthma symptoms 2

Long-term Safety: Real-world studies confirm adequate safety profile with continued use 5, 4

Dosing Verification

Standard Dosing: 30mg subcutaneously every 8 weeks after initial loading doses 1, 2

Request Appropriateness: J-code x7 (7mg total = 30mg dose when multiplied by benralizumab concentration) aligns with standard 30mg dosing 2

Common Pitfalls to Avoid

Premature Discontinuation: Do not discontinue therapy in patients demonstrating clinical benefit, as this may lead to return of exacerbations and increased oral corticosteroid requirements 8, 4

Concurrent Biologic Use: Never approve benralizumab while patient is on another biologic for asthma—this violates FDA labeling and increases risk without additional benefit 2

Inadequate Response Assessment: Ensure clinical notes document objective measures of response (exacerbation frequency, rescue medication use, symptom control) rather than subjective impressions alone 1, 4

Timing of Biologic Initiation: Earlier initiation of biologic therapy in severe asthma course is associated with higher remission rates—each additional year of severe asthma reduces odds of remission by approximately 10% 8

Recommendation

APPROVE continuation therapy contingent upon confirmation that the patient is NOT concurrently using another biologic agent for asthma. 1, 2

If the unspecified medication is confirmed to be a non-biologic controller medication (such as a leukotriene modifier, long-acting beta-agonist, or long-acting muscarinic antagonist), all medical necessity criteria are satisfied based on:

• Documented clinical improvement with reduced exacerbations 4
• Appropriate specialist management 1
• Continued maintenance therapy 1, 2
• Demonstrated tolerability 6

If the patient IS using another biologic concurrently, DENY the request and recommend discontinuation of one biologic agent before resubmitting for approval. 2