Subject: Tezspire 5104-A SGM P2024

Drug

TEZSPIRE  (tezepelumab-ekko)

Policy:

      I.  INDICATIONS

          The indications below including FDA-approved indications and compendial uses are
          considered a covered benefit provided that all the approval criteria are met and the member
          has no exclusions to the prescribed therapy.

          FDA-Approved Indication
          Tezspire is indicated for add-on maintenance treatment of adult and pediatric patients aged 12
          years and older with severe asthma.

          Limitations of use: Not for relief of acute bronchospasm or status asthmaticus

          All other indications are considered experimental/investigational and not medically necessary.


    II.  DOCUMENTATION

          Submission of the following information is necessary to initiate the prior authorization review:
          A.  Initial requests: Chart notes, medical record documentation, or claims history supporting
               previous medications tried including drug, dose, frequency and duration.
          B.  Continuation requests: Chart notes or medical record documentation supporting
               improvement in asthma control.


   III.  PRESCRIBER SPECIALTIES

          This medication must be prescribed by or in consultation with an allergist/immunologist or
          pulmonologist.


  IV.  CRITERIA FOR INITIAL APPROVAL

          A.  Authorization of 6 months may be granted for members 12 years of age or older who have
               previously received a biologic drug (e.g., Dupixent, Nucala) indicated for asthma in the past
               year.

          B.  Authorization of 6 months may be granted for treatment of severe asthma when all of the
               following criteria are met:
               1.  Member is 12 years of age or older.
               2.  Member has uncontrolled asthma as demonstrated by experiencing at least one of the
                    following within the past year:
                    i.     Two or more asthma exacerbations requiring oral or injectable corticosteroid
                           treatment
                    ii.    One or more asthma exacerbation(s) resulting in hospitalization or emergency
                           medical care visit(s)
                    iii.   Poor symptom control (frequent symptoms or reliever use, activity limited by asthma,
                           night waking due to asthma)
               3.  Member has inadequate asthma control despite current treatment with both of the
                    following medications at optimized doses:
                    i.     High-dose inhaled corticosteroid
                    ii.    Additional controller (i.e., long-acting beta₂-agonist, long-acting muscarinic
                           antagonist, leukotriene modifier, or sustained-release theophylline)
               4.  Member will continue to use maintenance asthma treatments (e.g., inhaled
                    corticosteroid, additional controller) in combination with the requested medication.


    V.  CONTINUATION OF THERAPY

          Authorization of 12 months may be granted for members for continuation of treatment of severe
          asthma when all of the following criteria are met:
          A.  Member is 12 years of age or older.
          B.  Asthma control has improved on the requested medication as demonstrated by at least one
               of the following:
               1.  A reduction in the frequency and/or severity of symptoms and exacerbations
               2.  A reduction in the daily maintenance oral corticosteroid dose
          C.  Member will continue to use maintenance asthma treatments (e.g., inhaled corticosteroid,
                additional controller) in combination with the requested medication.


   VI.  OTHER

          Member cannot use the requested medication concomitantly with any other biologic drug or
          targeted synthetic drug for the same indication.

          Note: If the member is a current smoker or vaper, they should be counseled on the harmful
          effects of smoking and vaping on pulmonary conditions and available smoking and vaping
          cessation options.

 

Place of Service:

Outpatient

The above policy is based on the following references:

1. Tezspire [package insert]. Thousand Oaks, CA: Amgen Inc.; May 2023.
2. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2023 update. Available at: https://ginasthma.org/wp-content/uploads/2023/07/GINA-Full-Report-23_07_06-WMS.pdf. Accessed March 8, 2024.
3. Cloutier MM, Dixon AE, Krishnan JA, et al. Managing asthma in adolescents and adults: 2020 asthma guideline update from the National Asthma Education and Prevention Program. 2020;324(22): 2301-2317.
4. Wechsler ME, Colice G, Griffiths JM, et al. SOURCE: a phase 3, multicentre, randomized, double-blind, placebo-controlled, parallel group trial to evaluate the efficacy and safety of tezepelumab in reducing oral corticosteroid used in adults with oral corticosteroid dependent asthma. Respir Res. 2020;21(1):264.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

September 25, 2024