Is continuation of Tezspire (tezepelumab-ekko) 210mg subcutaneous injection every 28 days medically necessary and appropriate for the treatment of severe persistent asthma?

Continuation of Tezspire is NOT Medically Necessary Based on Current Documentation

The request for continuation of Tezspire should be denied because the patient demonstrates inadequate response to therapy, evidenced by two episodes of bronchitis requiring antibiotics and oral corticosteroids since the last visit, despite being on treatment since August 2022 (over 2.5 years). This pattern of recurrent infections requiring systemic steroids indicates failure to achieve the primary therapeutic goal of reducing exacerbations and oral corticosteroid burden.

Critical Analysis of Treatment Response

Evidence of Treatment Failure

• The patient has experienced two acute exacerbations requiring both antibiotics and systemic corticosteroids since the last visit, which directly contradicts the expected benefit of Tezspire in reducing exacerbations 1.
• The NAVIGATOR trial demonstrated that tezepelumab reduces annualized asthma exacerbation rates by 56% compared to placebo (0.93 vs 2.10 events per year), yet this patient continues to have frequent exacerbations despite 2.5 years of therapy 1.
• The patient requires rescue bronchodilator 1-2 times weekly, which indicates inadequate asthma control and suggests the need to step up treatment rather than continue an ineffective biologic 2.

Spirometry Does Not Support Continuation

• While the patient's spirometry shows FEV1 99% predicted, this normal lung function in the context of ongoing exacerbations and frequent rescue medication use suggests the patient may not have severe persistent asthma requiring biologic therapy 2.
• The FDA label for Tezspire specifies it is indicated for severe asthma, and the presence of near-normal lung function with ongoing exacerbations raises questions about whether the underlying diagnosis is primarily asthma versus recurrent respiratory infections related to the documented antibody deficiency 3.

Failure to Meet Continuation Criteria

Aetna Criteria Analysis

• Criterion B is NOT MET: The patient has not demonstrated "a reduction in the frequency and/or severity of symptoms and exacerbations" as evidenced by two bronchitis episodes requiring antibiotics and steroids since the last visit 1.
• Criterion B alternative is NOT MET: There is no evidence of "a reduction in the daily maintenance oral corticosteroid dose" - in fact, the patient required two courses of prednisone recently, suggesting increased rather than decreased corticosteroid burden 4.
• The clinical note explicitly states "Continues to have infection requiring ATB and prednisone," which directly documents treatment failure 5.

Minimum Treatment Duration Exceeded

• The patient has been on Tezspire since August 2022 (over 30 months), which far exceeds the recommended minimum 4-month trial period to determine efficacy 1.
• After 2.5 years of therapy, the lack of sustained improvement in exacerbation frequency represents definitive treatment failure 5.

Alternative Explanations for Poor Control

Antibody Deficiency as Primary Driver

• The patient has documented "antibody deficiency with near normal immunoglobulins" and laboratory values showing IgM 57 mg/dL (low), which may be the primary driver of recurrent infections rather than asthma exacerbations 6.
• The clinical note states "She must be on Gammagard 30gms Q4 weeks" and "Desperate to go back on Gammagard," suggesting the treating physician recognizes immunoglobulin replacement as the more appropriate therapy 4.
• The recurrent bronchitis episodes may represent bacterial infections secondary to immunodeficiency rather than asthma exacerbations, making Tezspire an inappropriate treatment choice 6.

ACT Score Indicates Poor Control

• The Asthma Control Test (ACT) score of 20 documented in the note indicates suboptimal control (well-controlled asthma requires ACT ≥20, but scores of 20-24 indicate partially controlled asthma) 2.
• This ACT score after 2.5 years of Tezspire therapy demonstrates failure to achieve adequate asthma control 2.

Recommended Management Strategy

Immediate Actions

• Discontinue Tezspire due to lack of efficacy after adequate trial duration 1.
• Optimize conventional controller therapy by ensuring adherence to Trelegy 200 mcg daily and Singulair, and verify proper inhaler technique 2.
• Prioritize approval and initiation of IVIG (Gammagard) to address the underlying antibody deficiency, which is likely the primary driver of recurrent infections 4.

Reassessment of Diagnosis

• Confirm the diagnosis of severe persistent asthma versus recurrent respiratory infections due to immunodeficiency, given the normal spirometry and low IgM 2.
• Consider that the patient may have mild-to-moderate asthma complicated by immunodeficiency rather than true severe asthma requiring biologic therapy 2.

Alternative Biologic Consideration

• If severe asthma is confirmed after addressing immunodeficiency and optimizing conventional therapy, consider alternative biologics such as omalizumab (if IgE-mediated) or dupilumab (for type 2 inflammation), as the patient has demonstrated non-response to tezepelumab 6.

Safety and Quality of Life Considerations

• Continuing an ineffective biologic therapy exposes the patient to unnecessary injection-related risks and delays appropriate treatment of the underlying immunodeficiency 1.
• The patient's quality of life is compromised by recurrent infections and repeated courses of antibiotics and corticosteroids, which will not improve with continued Tezspire therapy 1.
• Prioritizing IVIG therapy addresses the root cause of recurrent infections and has the potential to reduce both infection frequency and corticosteroid exposure, thereby improving morbidity and quality of life 4.