TEZSPIRE (tezepelumab-ekko)
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:
- Dose does not exceed 210 mg administered by subcutaneous injection once every 4 weeks; 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 exacerbations requiring systemic corticosteroids (e.g., prednisone) within the past 12 months.
- Patient has been hospitalized due to asthma-related symptoms within the past 12 months; AND
- Patient is currently being treated with one of the following:
- High dose inhaled corticosteroid (ICS) (i.e., greater than 500 mcg fluticasone propionate equivalents per day) with at least one additional asthma medication (e.g., leukotriene receptor antagonist [LTRA][e.g., montelukast, Singulair]; long acting beta-2 agonist [LABA][e.g., salmeterol, Serevent; formoterol, Foradil]; long-acting muscarinic antagonist [LAMA][e.g., tiotropium, Spiriva).
- One maximally-dosed combination ICS/LABA product (e.g., Advair, AirDuo [fluticasone/salmeterol], Symbicort [budesonide/formoterol], Breo Ellipta [fluticasone/vilanterol], Trelegy Ellipta [fluticasone/umeclidinium/vilanterol], Dulera [mometasone/formoterol]).
Reauthorization Criteria:
For diagnosis of severe asthma:
- Dose does not exceed 210 mg administered by subcutaneous injection once every 4 weeks; AND
- 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; AND
- Patient continues to be treated with an inhaled corticosteroid (ICS) -containing medication; AND
- Continues to be 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 210 mg/1.91 mL (110 mg/mL) is intended for administration by a healthcare provider using a single-dose vial or pre-filled syringe.
Policy Updates:
- 05/17/2022 – New policy approved by P&T.
References:
- 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.
- 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.
- Tezspire Prescribing Information. Amgen Inc. Thousand Oaks, CA. December 2021.
Last review date: May 17, 2022