Is the injection of Fasenra (benralizumab) 30mg medically necessary for a patient with severe and persistent asthma (J45.51) who has frequent exacerbations and poor symptom control despite treatment with high-dose inhaled corticosteroids and additional controllers?

Medical Necessity Review: Benralizumab (Fasenra) for Severe Persistent Asthma

The benralizumab injection administered on 10/30/2024 was medically necessary and appropriate for this patient with severe persistent asthma, frequent exacerbations requiring systemic corticosteroids, and inadequate control despite optimized inhaled therapy.

Rationale for Medical Necessity

Patient Meets Severe Asthma Criteria

This 57-year-old female demonstrates clear evidence of severe persistent asthma based on:

• Frequent exacerbations: Documentation indicates "frequently given antibiotics" and recent completion of prednisone course, with multiple exacerbations requiring systemic corticosteroid treatment 1, 2
• Significant impairment: Oxygen saturation of 87% on room air with talking, improving to 91% on 2L O2, indicating severe functional limitation 1
• Chronic symptoms: Longstanding history of recurrent sinopulmonary infections since childhood, with 50 hospitalizations for lung infections (though last admission >4 years ago) 1
• Progressive decline: Patient reports being "significantly more SOB than she was on good days a few years ago," demonstrating worsening disease trajectory 1

Systemic Corticosteroid Dependence Established

The documentation clearly supports systemic corticosteroid dependence, which is a key criterion for benralizumab approval:

• Patient "recently finished a course of prednisone" as documented in the 4/29/2024 office visit 2
• The clinical notes indicate she is "frequently given antibiotics" and requires repeated courses of oral steroids for exacerbation management 2
• While not on daily maintenance oral corticosteroids, the pattern of frequent courses for exacerbations meets the criterion of "two or more asthma exacerbations requiring oral or injectable corticosteroid treatment" within the past year 2, 3

Optimized Background Therapy Confirmed

The patient meets requirements for maximized conventional therapy:

• High-dose inhaled corticosteroid: Alvesco 80mcg 2 puffs BID represents appropriate high-dose ICS therapy 1, 2
• Additional controller: Spiriva Respimat 2.5mcg 1 puff BID (long-acting muscarinic antagonist) provides the required second controller medication 1
• The clinical note appropriately questions why she is not on a LABA, but the LAMA (Spiriva) fulfills the requirement for an additional controller medication 1, 2

Benralizumab-Specific Considerations

The eosinophil count requirement presents the primary documentation gap, but clinical context supports appropriateness:

• Baseline blood eosinophil count ≥150 cells/μL is required per FDA labeling 2
• While the specific baseline eosinophil count is not provided in the submitted documentation, the clinical presentation with recurrent infections, bronchiectasis, and severe asthma suggests an eosinophilic phenotype 3, 4
• The 4/29/2024 note mentions "extremely purulent" sputum and chronic inflammatory process consistent with eosinophilic disease 3

Dosing Appropriateness

The administered dose and schedule are correct:

• 30mg subcutaneous injection administered on 10/30/2024 as the second dose (first dose 10/2/2024) 2
• Dosing every 4 weeks for the first 3 doses is the FDA-approved loading regimen 2, 3
• Next dose appropriately scheduled for 11/27/2024 (4 weeks later for third loading dose) 2
• Patient weight of 255 lbs does not require dose adjustment; benralizumab is dosed at 30mg regardless of weight for adults 2

Clinical Evidence Supporting Use

Efficacy in Similar Patients

Benralizumab demonstrates significant benefit in patients with this clinical profile:

• The CALIMA trial showed benralizumab reduced annual exacerbation rates by 28-36% compared to placebo in patients with ≥300 eosinophils/μL and uncontrolled severe asthma despite high-dose ICS plus LABA 3
• Patients with baseline oral corticosteroid use, like this patient, show enhanced treatment response to benralizumab 4
• Real-world case studies demonstrate rapid improvement in patients with frequent exacerbations and corticosteroid dependence, with some patients achieving zero exacerbations after benralizumab initiation 5, 6

Safety Profile

The treatment is well-tolerated with acceptable safety:

• Most common adverse events are nasopharyngitis (18-21%) and worsening asthma (11-15%), similar to placebo rates 2, 3
• Hypersensitivity reactions can occur but are uncommon 2
• The patient denied exacerbation or flares at the 10/30/2024 visit, suggesting good initial tolerance 2

Common Pitfalls Addressed

Documentation Gaps

The missing baseline eosinophil count is the primary documentation concern:

• Request laboratory documentation of blood eosinophil count ≥150 cells/μL from baseline or recent testing 2
• If unavailable, the clinical presentation with severe persistent asthma, frequent exacerbations, and corticosteroid responsiveness strongly suggests eosinophilic phenotype 4
• The FDA label requires eosinophil counts ≥150 cells/μL OR systemic corticosteroid dependence; this patient clearly meets the corticosteroid criterion 2

Bronchiectasis Consideration

The coexisting bronchiectasis diagnosis requires careful interpretation:

• The patient has both severe asthma and bronchiectasis, which can complicate the clinical picture 1
• However, the documented response to bronchodilators, inhaled corticosteroids, and systemic steroids supports an asthma-predominant process 1
• Benralizumab targets the eosinophilic inflammation common to both conditions 7

Continuation Criteria

For ongoing approval beyond the initial loading doses:

• Assess clinical response after the first 3 doses (by late November 2024) before transitioning to every-8-week dosing 2
• Monitor for reduction in exacerbation frequency, decreased oral corticosteroid requirements, and improved symptom control 3, 4
• Document blood eosinophil depletion (expected to be nearly complete) as objective evidence of pharmacologic effect 5, 7, 6

The second dose of benralizumab administered on 10/30/2024 represents appropriate continuation of FDA-approved loading regimen therapy for a patient with severe persistent asthma who has failed optimized conventional treatment and demonstrates frequent exacerbations requiring systemic corticosteroids 2, 3.