WHA
 

Tezspire (tezepelumab-ekko)

Indications for Prior Authorization

Tezspire (tezepelumab-ekko)
  • For diagnosis of Severe Asthma
    Indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. Limitations of Use: Tezspire is not indicated for the relief of acute bronchospasm or status asthmaticus.

  • For diagnosis of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
    Indicated for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).

Criteria

Tezspire

Prior Authorization (Initial Authorization)

Length of Approval: 6 Month(s) [A]
For diagnosis of Asthma

  • Diagnosis of severe asthma
    • AND
  • One of the following: [2,3]
    • 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 12 years of age or older
    • 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: [2,3]
      • High-dose inhaled corticosteroid (ICS) (i.e., greater than 500 mcg fluticasone propionate equivalent/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 500mcg/ salmeterol 50mcg], Symbicort [budesonide 160mcg/ formoterol 4.5mcg], Breo Ellipta [fluticasone 200mcg/ vilanterol 25mcg]) [B]
    AND
  • Prescribed by or in consultation with one of the following:
    • Pulmonologist
    • Allergist/Immunologist
Tezspire

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Asthma

  • Patient demonstrates positive clinical response to therapy (e.g., reduction in exacerbations, improvement in in forced expiratory volume in 1 second [FEV1], 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 [4]
    • AND
  • Prescribed by or in consultation with one of the following:
    • Pulmonologist
    • Allergist/Immunologist
Tezspire

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)
For diagnosis of Chronic rhinosinusitis with nasal polyps (CRSwNP)

  • Diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP)
    • AND
  • Patient is 12 years of age or older
    • AND
  • Unless contraindicated, the patient has had an inadequate response to 2 months of treatment with an intranasal corticosteroid (e.g., fluticasone, mometasone) [5, 6]
    • AND
  • Used in combination with another agent for CRSwNP [C]
    • AND
  • Prescribed by or in consultation with one of the following:
    • Allergist/Immunologist
    • Otolaryngologist
    • Pulmonologist
Tezspire

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)
For diagnosis of Chronic rhinosinusitis with nasal polyps (CRSwNP)

  • Patient demonstrates a positive clinical response to therapy (e.g., reduction in nasal polyps score [NPS; 0-8 scale], improvement in nasal congestion score [NCS; 0-3 scale])
    • AND
  • Used in combination with another agent for CRSwNP [C]
    • AND
  • Prescribed by or in consultation with one of the following:
    • Allergist/Immunologist
    • Otolaryngologist
    • Pulmonologist

  • Guideline ID
    GL-434333

  • Formulary
    Premium

  • Effective date
    Jan 1, 2026

  • P&T approval date
    Mar 16, 2022

P & T Revisions

2025-11-06, 2025-03-17, 2024-05-10, 2024-02-13, 2023-10-16, 2023-07-10, 2023-02-23, 2022-07-12, 2022-03-07

  1. Tezspire Prescribing Information. Amgen Inc. Thousand Oaks, CA. October 2025.
  2. Menzies-Gow A, Corren J, Bourdin A, et al. Tezepelumab in Adults and Adolescents with Severe, Uncontrolled Asthma. N Engl J Med. 2021;384(19):1800-1809.
  3. Corren J, Parnes JR, Wang L, et al. Tezepelumab in Adults with Uncontrolled Asthma. N Engl J Med. 2017;377(10):936-946.
  4. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention (2023 update). 2023 www.ginasthma.org. Accessed 13 February 2024.
  5. Peters AT, Spector S, Hsu J, et al. Diagnosis and management of rhinosinusitis: a practice parameter update. Ann Allergy Asthma Immunol. 2014;113(4):347-85.
  6. Orlandi RR, Kingdom TT, Smith TL, et al. International consensus statement on allergy and rhinology: rhinosinusitis 2021. Int Forum Allergy Rhinol. 2021;11(3):213-739.
  1. The Global Initiative for Asthma (GINA) Global Strategy for Asthma Management and Prevention update recommends that patients with asthma should be reviewed regularly to monitor their symptom control, risk factors and occurrence of exacerbations, as well as to document the response to any treatment changes. Ideally, after initiation of treatment, patients should be re-evaluated in 3 to 6 months. [4]
  2. The Global Initiative for Asthma (GINA) Global Strategy for Asthma Management and Prevention guideline recommend patients with severe asthma should be treated with maximal optimized high dose ICS-LABA therapy. [4]
  3. Other agents used for CRSwNP include intranasal corticosteroids and nasal saline.
  • 2025-11-06: Addition of criteria for CRSwNP
  • 2025-03-17: 2025 Annual Review. No criteria changes.
  • 2024-05-10: 2024 Annual Review. Background updates. Updated criteria language and formatting for asthma indication to align with other drugs within the class.
  • 2024-02-13: 2024 annual review. No changes to clinical criteria. Updated references.
  • 2023-10-16: Program update to standard reauthorization language. No changes to clinical intent.
  • 2023-07-10: Removal of trial requirements of other asthma biologics and removal of NF criteria
  • 2023-02-23: 2023 UM Annual Review. No changes. Added new formulation of pre-filled pen injector
  • 2022-07-12: Added embedded steps to the criteria based on asthma type; added drug-specific nonformulary criteria
  • 2022-03-07: New UM Program