Subject: Tezspire 5104-A SGM P2023

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.

          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 resulting in
                           hospitalization or emergency medical care visit.
                    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.


     V.  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.; February 2023.
2. Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2022 update. Available at: https://ginasthma.org/wp-content/uploads/2022/07/GINA-Main-Report-2022-FINAL-22-07-01-WMS.pdf. Accessed March 1, 2023.
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 27, 2023