Is continuation of Tezspire (tezepelumab-ekko) 210mg subcutaneous injection every 28 days medically necessary and appropriate for a patient with severe persistent asthma and antibody deficiency?

Continuation of Tezspire is NOT Medically Necessary

Based on the clinical documentation provided, continuation of Tezspire should be denied because the patient demonstrates treatment failure after 2.5 years of therapy, as evidenced by recurrent infections requiring multiple courses of antibiotics and steroids, suboptimal asthma control (ACT score 20), and ongoing need for rescue bronchodilator 1-2 times weekly. 1

Evidence of Treatment Failure

The patient's clinical course demonstrates clear failure to achieve adequate asthma control despite prolonged Tezspire therapy:

• Recurrent exacerbations: The patient has experienced bronchitis twice since the last visit, requiring two rounds of antibiotics and oral corticosteroids, which directly contradicts the expected benefit of biologic therapy 1
• Suboptimal ACT score: An ACT score of 20 after 2.5 years of treatment indicates inadequate control; scores ≥20 suggest well-controlled asthma, but this patient continues to have frequent exacerbations despite this borderline score 1
• Frequent rescue medication use: Requiring bronchodilator 1-2 times weekly indicates poor asthma control and suggests the need to step up conventional therapy rather than continue an ineffective biologic 2, 1
• Continued oral corticosteroid dependence: The patient remains dependent on systemic steroids for acute exacerbations, which Tezspire should have reduced or eliminated 3, 4

Diagnostic Uncertainty

The clinical picture raises significant concerns about whether this patient truly has severe persistent asthma requiring biologic therapy:

• Normal spirometry: FEV1 99% predicted with FEV1/FVC 100% does not support severe persistent asthma 1
• Immunodeficiency as primary driver: The patient has documented antibody deficiency (IgM 57 mg/dL, which is low) and requires IVIG therapy, suggesting recurrent infections may be due to immunodeficiency rather than uncontrolled asthma 1
• Misclassification concern: The combination of normal lung function with recurrent infections suggests mild-to-moderate asthma complicated by immunodeficiency rather than true severe asthma 1

Failure to Meet Continuation Criteria

The Aetna criteria require demonstration of improved asthma control, which this patient has not achieved:

• Criterion B is NOT met: The patient has not demonstrated "a reduction in the frequency and/or severity of symptoms and exacerbations" - in fact, exacerbations have continued with two episodes of bronchitis requiring antibiotics and steroids since the last visit 2
• No reduction in oral corticosteroid use: The patient continues to require rescue courses of prednisone, indicating failure to achieve the steroid-sparing effect that biologics should provide 4
• Persistent symptoms: Ongoing need for rescue bronchodilator 1-2 times weekly demonstrates inadequate symptom control 2, 1

Expected Outcomes with Tezspire

Clinical trials demonstrate what should be expected from effective Tezspire therapy:

• Exacerbation reduction: Tezepelumab reduces annualized asthma exacerbation rates by 56-71% compared to placebo 3, 5
• Steroid-sparing effect: The SOURCE trial specifically demonstrated that tezepelumab allows reduction in oral corticosteroid maintenance doses 4
• Timeframe for efficacy: A minimum of 4 months of treatment is suggested to determine efficacy, and this patient has received over 2.5 years without achieving control 6
• Sustained benefit: Long-term studies show sustained efficacy over 104 weeks in responders, which this patient has not demonstrated 6

Alternative Management Strategy

Rather than continuing ineffective biologic therapy, this patient requires:

• Optimization of conventional therapy: Verify adherence to Trelegy 200 mcg daily and Singulair, and confirm proper inhaler technique before considering any biologic therapy 2, 1
• Address immunodeficiency: The patient's recurrent infections requiring antibiotics are more consistent with antibody deficiency than uncontrolled asthma; IVIG therapy (Gammagard 30 grams every 4 weeks as noted in the plan) should be prioritized 1
• Reassess asthma severity: With normal spirometry (FEV1 99%), consider whether this patient has mild-to-moderate asthma rather than severe persistent asthma 1
• Consider alternative biologic: If severe asthma is confirmed after addressing the above issues, consider switching to a different biologic agent rather than continuing a failed therapy 2

Safety and Resource Considerations

Continuing ineffective therapy poses both clinical and resource allocation concerns:

• Delayed appropriate treatment: Continuing Tezspire delays addressing the underlying immunodeficiency that appears to be driving recurrent infections 1
• Cost-effectiveness: Biologic therapies are expensive; continuing treatment in a non-responder is not cost-effective when the patient requires IVIG for immunodeficiency 2
• Guideline recommendations: Current asthma guidelines recommend stepping up conventional therapy and addressing comorbidities before continuing biologics in patients who fail to respond 2

Common Pitfalls to Avoid

• Do not confuse normal spirometry with adequate control: This patient has normal FEV1 but continues to have exacerbations, suggesting the primary problem is not severe asthma 1
• Do not ignore the immunodeficiency: Low IgM and recurrent bacterial infections requiring antibiotics point to antibody deficiency as the primary driver of "exacerbations" 1
• Do not continue failed biologic therapy indefinitely: After 2.5 years without achieving control, continuing the same therapy is not justified 1, 6