Overview

This document addresses the use of Tezspire (tezepelumab-ekko), a thymic stromal lymphopoietin (TSLP) blocker, human monoclonal antibody (IgG2λ), approved by the Food and Drug Administration (FDA) for add-on maintenance treatment of adult and pediatric individuals aged 12 years and older with severe asthma.

Clinical criteria

In 2013, the European Respiratory Society/American Thoracic Society (ERS/ATS) released guidance for defining, evaluating and treating severe asthma. The guidelines recommend to start by confirming the asthma diagnosis, including a spirometry assessment, and then differentiating severe asthma from milder asthma. The guidelines define severe asthma as asthma which has required treatment with high dose inhaled corticosteroids and a long-acting beta agonist, leukotriene modifier or theophylline for the previous year in order to prevent asthma symptoms from becoming uncontrolled. Alternatively, severe asthma can be defined as asthma that has required systemic corticosteroid treatment for over 50% of the previous year.

ERS/ATS guidance defines uncontrolled asthma as meeting one of the following:

• Poor symptom control: Asthma Control Questionnaire (ACQ) consistently >1.5, Asthma Control Test (ACT) <20
• Frequent severe exacerbations: two or more bursts of systemic corticosteroids in the previous year
• History of serious exacerbation: at least one hospitalization, intensive care unit stay or mechanical ventilation in the previous year
• Airflow limitation: after appropriate bronchodilator withhold FEV 1 <80% predicted

The safety and effectiveness of Tezspire for the treatment of severe asthma was established in two randomized, double-blind, placebo-controlled trials (PATHWAY, NAVIGATOR). The trials included individuals with severe asthma on medium or high-dose inhaled corticosteroids and at least one additional asthma controller with or without oral corticosteroids. Participants were required to have history of asthma exacerbations in the last 12 months. Study data confirms the efficacy of Tezspire in reducing asthma exacerbations and improving asthma control and quality of life measures.

The 2022 Global Initiative for Asthma (GINA) guidelines include Tezspire as a treatment option in Step 5 of their asthma management algorithm. Add-on targeted biologic therapy should be considered for individuals with exacerbations or poor symptom control despite taking at least high-dose inhaled corticosteroid/long acting beta 2–agonists and who have allergic or eosinophilic biomarkers or need maintenance oral corticosteroids. Tezspire is an option for individuals who do not have evidence of Type 2 airway inflammation.

Comparative Doses for Inhaled Corticosteroids (Adults and Adolescents)

(Wenzel 2021)

DPI = dry powder inhaler, MDI = metered dose inhaler.

Clinical Criteria

When a drug is being reviewed for coverage under a member's medical benefit plan or is otherwise subject to clinical review (including prior authorization), the following criteria will be used to determine whether the drug meets any applicable medical necessity requirements for the intended/prescribed purpose.

Tezspire (tezepelumab-ekko)

Initial requests for Tezspire (tezepelumab-ekko) may be approved if the following criteria are met:

1. Individual is 12 years of age or older; AND
2. Individual has a diagnosis of severe asthma; AND
3. Evidence of asthma is demonstrated by the following (NAEPP 2008):
   • A pretreatment forced expiratory volume in 1 second (FEV1) less than 80% predicted; AND
   • FEV1 reversibility of at least 12% and 200 milliliters after albuterol administration; AND
4. Documentation is provided that individual has had a 3 month trial and inadequate response or intolerance to combination controller therapy (high dose inhaled corticosteroids plus long acting beta2 –agonists, leukotriene modifiers, long-acting muscarinic antagonists or oral corticosteroids) (GINA 2022); AND
5. Individual has experienced two or more asthma exacerbations in the prior 12 months requiring use of a systemic corticosteroid or temporary increase in the individual’s usual maintenance dosage of oral corticosteroids (ERS/ATS 2013).

Continuation requests for Tezspire (tezepelumab-ekko) may be approved if the following criteria are met:

1. Treatment with Tezspire has resulted in clinical improvement in one or more of the following:
   • Decreased utilization of rescue medications; OR
   • Decreased frequency of exacerbations (defined as worsening of asthma that requires an increase in inhaled corticosteroid dose or treatment with systemic corticosteroids); OR
   • Increase in percent predicted FEV1 from pretreatment baseline; OR
   • Reduction in reported asthma-related symptoms, including asthmatic symptoms upon awakening, coughing, fatigue, shortness of breath, sleep disturbance or wheezing.

Tezspire (tezepelumab-ekko) may not be approved for the following:

1. In combination with Cinqair, Dupixent, Fasenra, Nucala or Xolair; OR
2. May not be approved when the above criteria are not met and for all other indications.

Approval Duration

• Initial Requests: 6 months
• Continuation Requests: 12 months

Quantity Limits

Tezspire (tezepelumab-ekko) Quantity Limit

Drug: Tezspire (tezepelumab-ekko) 210 mg/1.91 mL prefilled pen/prefilled syringe/vial

Limit: 1 prefilled syringe/vial per 28 days

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

HCPCS
J2356

ICD-10 Diagnosis
Injection, tezepelumab-ekko, 1 mg [Tezspire]

• J45.50-J45.52 Severe persistent asthma

Document History

Revised: 2/24/2023