TEZEPELUMAB-EKKO INJ,SOLN

Clinical Criteria Summary

Acute asthma exacerbation or status asthmaticus
Concurrent use with other biologics for asthma
Currently undergoing bronchial thermoplasty
Untreated parasitic (helminth) infection (treat before starting tezepelumab)
Treatment with live (attenuated) vaccines within the previous 30 days or concurrent use with live (attenuated) vaccines

Provider is a VA or VA Community Care asthma specialist (i.e., pulmonologist, allergist, immunologist)
Diagnosis of asthma
Receiving high-dose inhaled corticosteroid (or maximally tolerated dose) AND at least 3 months of a long-acting beta agonist and/or other controller medication such as tiotropium
Adherent to asthma medications as evidenced by a review of prescription refill history during the last 12 months
At least 2 exacerbations requiring systemic corticosteroids OR at least 1 hospitalization due to asthma exacerbation in the prior year OR inadequate asthma control
Inadequate asthma control examples: short-acting beta-agonist use more than 2 days per week, nighttime awakening due to asthma more than 1 time per week, limitation with normal activity, Asthma Control Test less than 19
Typically, pre-bronchodilator FEV1 <80%

Baseline blood eosinophil count <150 cells/µL
Baseline eosinophil ≥150 cells/µL and inadequate response or adverse event to 2 interleukin receptor monoclonal antibodies used for asthma (benralizumab, mepolizumab, dupilumab)

If a live (attenuated) vaccine is needed, do not administer within 90 days after receiving a dose of tezepelumab; consider risk versus benefit of interrupting therapy versus need for vaccine.
For patients with confirmed allergic asthma and blood eosinophils <150 cells/µL, omalizumab or tezepelumab may be considered. For patients with both allergic-eosinophilic asthma subtypes who cannot use omalizumab (e.g., inadequate response, adverse event, contraindication), a trial of benralizumab is recommended before using tezepelumab.
A treatment period of 4-6 months is generally needed to assess response; patients showing intermediate response may need to be treated for 6-12 months for optimal response.
Providers should observe patient’s inhaler use, as poor technique frequently is a cause of poor results in asthma.
Exceptions to inclusion/exclusion criteria should be adjudicated at the local facility per P&T committee and pharmacy services policy/procedures.

• Indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma
• Applicable regardless of eosinophilic phenotype or biomarker limitations
• Specifically indicated for patients with severe asthma without an eosinophilic phenotype (blood eosinophil count <150 cells/µL) receiving optimal therapy (inhaled corticosteroid and long-acting beta-agonist and/or long-acting anticholinergic) who have inadequate symptom control or asthma exacerbations
• May be used in patients with an inadequate response or adverse events to other biologics for asthma (benralizumab, mepolizumab, dupilumab, omalizumab)

• Contraindicated in patients with known hypersensitivity to tezepelumab or any excipients
• Monitor for hypersensitivity reactions (e.g., rash, allergic conjunctivitis); initiate appropriate treatment as clinically indicated if they occur
• Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation; decrease gradually if appropriate
• Treat pre-existing helminth infections prior to therapy; discontinue tezepelumab until parasitic infection resolves if infected and unresponsive to anti-helminth treatment
• Avoid concomitant use of live attenuated vaccines

• Did not demonstrate a statistically significant reduction in maintenance oral corticosteroids compared to placebo without loss of asthma control
• Formulary status: TBD