Background

Tezepelumab-ekko (Tezspire™) is a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody (IgG2λ), indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma.

Policy (Criteria)

Coverage is provided when the criteria below are met and there has been a trial and failure of preferred therapy (if applicable). 

Tezspire (Tezepelumab) is considered MEDICALLY NECESSARY for individuals with moderate to severe persistent asthma who meet all of the following criteria:

• 12 years of age or older
• Symptoms are inadequately controlled after a minimum of three months of combination controller therapy (medium to high doses of inhaled corticosteroids plus long-acting beta₂-agonists or leukotriene modifiers) or cannot tolerate the medications
• Shows a positive skin test or in vitro reactivity to a perennial aeroallergen
• A forced expiratory volume in one second (FEV₁) less than 80 percent predicted
• A serum Immunoglobulin E (IgE) level equal to or greater than 30 IU/ml

Continued treatment with Tezepelumab beyond 12 months is considered MEDICALLY NECESSARY when the following criteria are met:

• Criteria for omalizumab therapy, as set forth above, had been met at the time of initiation of therapy.
• Treatment with omalizumab has resulted in clinical improvement as documented by one or more of the following:
  • Decreased utilization of rescue medications
  • Decreased frequency of exacerbations (defined as worsening of asthma that requires increase in inhaled corticosteroid dose or treatment with systemic corticosteroids)
  • Increase in percent predicted FEV₁from pretreatment baseline
  • Reduction in reported asthma-related symptoms, such as, but not limited to, wheezing, shortness of breath, coughing, fatigue, sleep disturbance or asthmatic symptoms upon awakening
• Patient is currently being treated with one of the following unless there is a contraindication or intolerance to these medications:
  • Inhaled corticosteroid (ICS) (e.g., fluticasone, budesonide)
  • Additional asthma controller medication (e.g., leukotriene receptor antagonist, long-acting beta-2 agonist [LABA], theophylline)
  • A combination ICS/LABA product (e.g., Advair [fluticasone propionate/salmeterol], Dulera [mometasone/formoterol], Symbicort [budesonide/formoterol]).

References

1.  Tezspire prescribing information. - Amgen, Inc, Thousand Oaks, California 91320

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each Policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, technology assessment program (TEC) and other non-affiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

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