TEZSPIRE (tezepelumab-ekko)

TEZSPIRE (tezepelumab-ekko) 

Auto-injector: Self-Administered-subcutaneous injection

Vial/Prefilled syringe: Office-Administered – subcutaneous injection

Diagnosis considered for coverage:

• Asthma - 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.
  • Not for relief of acute bronchospasm or status asthmaticus.

Coverage Criteria:

For diagnosis of severe asthma:

• Diagnosis of severe asthma; AND
• Patient is age 12 years or older; AND
• Prescribed by or in consultation with a pulmonologist or allergist/immunologist; AND
• Medical record documents one of the following:
  • Patient has had two or more asthma exacerbations requiring systemic corticosteroids (e.g., prednisone) within the past 12 months OR
  • Prior asthma-related hospitalization within the past 12 months; AND
• Patient is currently being treated with one of the following unless there is a contraindication or intolerance to these medications:
  • BOTH of the following:
    • High dose inhaled corticosteroid (ICS) (i.e., greater than 500 mcg fluticasone propionate equivalents per day)
    • Additional asthma controller medication (e.g., leukotriene receptor antagonist [LTRA][e.g., montelukast]; long acting beta-2 agonist [LABA][e.g., salmeterol]; long-acting muscarinic antagonist [LAMA][e.g., tiotropium], OR
  • One maximally-dosed combination ICS/LABA product (e.g., Advair [fluticasone propionate 500 mcg/salmeterol 50 mcg], Symbicort [budesonide 160 mcg/formoterol 4.5 mcg], Breo Ellipta [fluticasone 200 mcg/vilanterol 25 mcg]).

Reauthorization Criteria:

For diagnosis of severe asthma:

• Documentation of positive clinical response to therapy as evidenced by ONE of the following:
  • A reduction in asthma exacerbations
  • Improvement in forced expiratory volume in 1 second (FEV1) from baseline
  • Decreased use of rescue medications; AND
• Patient continues to be treated with an inhaled corticosteroid (ICS) (e.g., fluticasone, budesonide) with or without additional asthma controller medication (e.g., leukotriene receptor antagonist [LTRA] [e.g., montelukast], long-acting beta-2 agonist [LABA] [e.g., salmeterol], long-acting muscarinic antagonist [LAMA] [e.g., tiotropium]) unless there is a contraindication or intolerance to these medications; AND
• Prescribed by or in consultation with a pulmonologist or allergist/immunologist.

Coverage Duration:

• Initial: 6 months
• Reauthorization: 1 year

Authorization is not covered for the following:

• The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information:

• TEZSPIRE vial and pre?filled syringe are intended for administration by a healthcare provider.
• TEZSPIRE pre-filled pen can be administered by patients/caregivers or healthcare providers. Patients/caregivers may administer TEZSPIRE pre-filled pen after proper training in subcutaneous injection technique and after the healthcare provider determines it is appropriate.

Policy Updates:

• 5/17/2022 – New policy.
• 9/1/2024 (policy effective date) – New policy approved by WHA P&T Committee. (P&T 8/20/2024) (P&T Meeting August) 

References:

1. Corren J, Gil EG, Griffiths JM, Parnes JR, van der Merwe R, Sa?apa K, O'Quinn S. Tezepelumab improves patient-reported outcomes in patients with severe, uncontrolled asthma in PATHWAY. Annals of Allergy, Asthma & Immunology. 2021 Feb 1;126(2):187-93.
2. Menzies-Gow A, Colice G, Griffiths JM, Almqvist G, Ponnarambil S, Kaur P, Ruberto G, Bowen K, Hellqvist Å, Mo M, Garcia Gil E. NAVIGATOR: a phase 3 multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma. Respiratory research. 2020 Dec;21(1):1-2.
3. Tezspire Prescribing Information. Amgen Inc. Thousand Oaks, CA. December 2021.