Is tezepelumab-ekko (Tezspire) 210 mg every 28 days medically necessary for a patient with severe persistent asthma with acute exacerbation and eosinophilic asthma, currently on albuterol-budesonide (Airsupra), fluticasone-umeclidinium-vilanterol (TRELEGY ELLIPTA), and ipratropium-albuterol (DUO-NEB)?

Medical Necessity Determination for Tezepelumab (Tezspire)

Recommendation

The request for tezepelumab-ekko (Tezspire) J2356 and administration code 96372 does NOT meet medical necessity criteria based on insufficient documentation of treatment failure with high-dose inhaled corticosteroids plus additional controller medications.

Critical Documentation Gaps

The submitted records fail to demonstrate several essential criteria required for tezepelumab approval:

Inadequate Evidence of Uncontrolled Asthma Despite Maximal Therapy

The documentation does not establish that the patient remains uncontrolled despite appropriate high-dose inhaled corticosteroid (ICS) plus second controller therapy. While the patient is prescribed TRELEGY ELLIPTA (fluticasone 200 mcg-umeclidinium-vilanterol) and AIRSUPRA (albuterol-budesonide 90-80 mcg), there is no objective documentation of:

• Peak expiratory flow measurements demonstrating inadequate control 1
• Frequency of rescue medication use (a key indicator of asthma control) 2
• Asthma Control Test (ACT) scores or similar validated control measures 3
• Documentation of exacerbation frequency requiring systemic corticosteroids in the past year 4
• Spirometry results showing persistent airflow limitation 5

Missing Baseline Disease Severity Markers

No baseline biomarkers or phenotypic characterization are documented, which are essential for determining appropriateness of biologic therapy. The diagnosis includes "eosinophilic asthma" (J82.83), but there is no documentation of:

• Blood eosinophil counts (tezepelumab reduces eosinophils as a pharmacodynamic effect) 5, 6
• Fractional exhaled nitric oxide (FeNO) levels 6
• Total IgE levels 6
• Documentation of Type 2 inflammatory phenotype versus Type 2-low asthma 4, 7

Lack of Treatment History Documentation

The records do not demonstrate adequate trial and failure of conventional controller therapy. Required documentation includes:

• Duration of treatment with high-dose ICS plus long-acting beta-agonist (LABA) 4
• Whether oral corticosteroid (OCS) maintenance therapy has been required 4
• Trial of leukotriene modifiers or other second-line controllers 2
• Adherence assessment and inhaler technique verification 3
• Whether previous biologic therapies were attempted 4

Absence of Safety Screening

Critical safety exclusions are not addressed in the documentation:

• No documentation ruling out active parasitic infection (tezepelumab can impair helminth immunity) 5
• No confirmation that live vaccines are not being administered concurrently 5
• No assessment for immunodeficiency given the severe asthma presentation 3

Evidence-Based Requirements for Tezepelumab

Established Efficacy Profile

Tezepelumab has demonstrated significant efficacy across multiple severe asthma phenotypes when appropriately selected:

• Eosinophilic severe asthma: 63-71% reduction in annualized exacerbation rates versus placebo 4
• Allergic severe asthma: 58-68% reduction in exacerbations 4
• Type 2-low asthma: 34-49% reduction in exacerbations 4
• OCS-dependent asthma: 31-41% reduction in exacerbations 4

The NAVIGATOR trial showed an 85% reduction in exacerbations in patients with comorbid nasal polyps and 51% in those without 6. However, these benefits were demonstrated in patients with documented severe uncontrolled asthma despite maximal conventional therapy 4, 5.

Proper Patient Selection Criteria

Tezepelumab is indicated for patients aged ≥12 years with severe asthma who remain uncontrolled despite high-dose ICS plus additional controller medications 4, 7. The medication works by blocking thymic stromal lymphopoietin (TSLP), an upstream epithelial cytokine that orchestrates multiple inflammatory pathways 7.

Unlike other biologics that target specific downstream inflammatory mediators, tezepelumab's mechanism allows efficacy across phenotypes, but this does not eliminate the requirement for documented treatment failure with conventional therapy 4, 7.

Required Documentation for Approval

To establish medical necessity, the following must be documented:

Objective Asthma Control Measures

• ACT score <20 or equivalent validated measure demonstrating poor control 3
• Peak flow diary showing variability >20% or persistent reduction <80% predicted 1
• ≥2 exacerbations requiring systemic corticosteroids in the past 12 months 4

Adequate Treatment Trial Documentation

• Minimum 3-6 months of high-dose ICS (fluticasone ≥500 mcg/day or equivalent) plus LABA 4
• Trial of additional controller (LAMA, leukotriene modifier, or OCS) 2
• Documented adherence >80% and proper inhaler technique 3

Phenotypic Characterization

• Blood eosinophil count (any level acceptable, but helps predict response magnitude) 4, 6
• FeNO measurement 6
• Spirometry with bronchodilator response 5

Safety Documentation

• Negative parasitic infection screening or treatment completion 5
• Confirmation no live vaccines planned during treatment 5
• Assessment for immunodeficiency if recurrent infections present 3

Clinical Pitfalls to Avoid

The most common error in biologic prescribing is inadequate documentation of conventional therapy failure 3. Simply having a diagnosis of "severe persistent asthma" is insufficient without objective evidence of uncontrolled disease despite appropriate treatment.

Underuse of systemic corticosteroids during exacerbations is a preventable cause of asthma morbidity 1, 2. Before escalating to biologics, ensure the patient has received appropriate courses of oral prednisone 30-60 mg daily for 1-3 weeks during exacerbations 2.

Normal spirometry does not exclude severe asthma, but when present alongside inadequate documentation of exacerbations and rescue medication use, it raises questions about whether the patient truly has severe uncontrolled disease requiring biologic therapy 3.

Conclusion on Medical Necessity

This request cannot be approved without additional documentation establishing that the patient has severe uncontrolled asthma despite maximal conventional therapy. The current records show medication prescriptions but lack objective evidence of disease severity, treatment failure, or appropriate patient selection for this high-cost biologic therapy costing approximately $5,000-6,000 per monthly dose.

The prescriber should submit:

• Objective asthma control measures (ACT scores, peak flow diaries, exacerbation frequency) over the past 6-12 months
• Documentation of adequate trials of high-dose ICS plus additional controllers with adherence verification
• Baseline biomarkers (eosinophils, FeNO, spirometry)
• Safety screening results (parasitic infection, immunodeficiency assessment)