Pharmacy Prior Authorization Criteria

Tezspire (tezepelumab-ekko) - PA

Indications for Prior Authorization

Tezspire (tezepelumab-ekko) injection, for subcutaneous use

• 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.

Criteria

Tezspire

Prior Authorization (Initial Authorization)

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

• 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)

• 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

P & T Revisions

2024-05-10, 2024-02-13, 2023-10-16, 2023-07-10, 2023-02-23, 2022-07-12, 2022-03-07

References

1. Tezspire (tezepelumab-ekko) Prescribing Information. Amgen Inc, Thousand Oaks, CA. May 2023
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.

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End Notes

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]

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Revision History

• 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

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