Subject: Tezspire SGM 5104-A P2026

Drug

TEZSPIRE  (tezepelumab-ekko)

Policy:

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 Indications¹

·        Add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma

·        Add-on maintenance treatment of adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP)

Limitations of Use

Not indicated for the relief of acute bronchospasm or status asthmaticus

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

Documentation

Submission of the following information is necessary to initiate the prior authorization review:

Asthma

Initial requests

Chart notes, medical record documentation, or claims history supporting previous medications tried including drug, dose, frequency, and duration.

Continuation requests

Chart notes or medical record documentation supporting improvement in asthma control.

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Initial requests

·        Chart notes or medical record documentation showing nasal endoscopy, anterior rhinoscopy, or computed tomography (CT) details (e.g., polyps location, size), Meltzer Clinical Score, or endoscopic nasal polyp score (NPS) (where applicable).

·        Chart notes, medical record documentation, or claims history supporting previous medications tried including drug, dose, frequency, and duration. If therapy is not advisable, documentation of clinical reason to avoid therapy.

Continuation requests

Chart notes or medical record documentation supporting positive clinical response.

Prescriber Specialties

This medication must be prescribed by or in consultation with one of the following:

·        Asthma: allergist/immunologist or pulmonologist

·        Chronic rhinosinusitis with nasal polyps (CRSwNP): allergist/immunologist or otolaryngologist

Coverage Criteria

Asthma^1-4

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 12 months. Member will continue to use maintenance asthma treatments (e.g., inhaled corticosteroid [ICS] and additional controller) in combination with the requested medication.

Authorization of 6 months may be granted for treatment of severe asthma when all of the following criteria are met:

·        Member is 12 years of age or older.

·        Member has uncontrolled asthma as demonstrated by experiencing at least one of the following within the past 12 months:

§  Two or more asthma exacerbations requiring oral or injectable corticosteroid treatment

§  One or more asthma exacerbation(s) resulting in hospitalization or emergency medical care visit(s)

§  Poor symptom control (frequent symptoms or reliever use, activity limited by asthma, night waking due to asthma)

·        Member has inadequate asthma control despite adherence to current treatment with both of the following medications at optimized doses:

§  High-dose ICS (see Appendix)

§  Additional controller (i.e., long-acting beta2-agonist [LABA], long-acting muscarinic antagonist [LAMA], leukotriene modifier, or sustained-release theophylline)

·        Member will continue to use maintenance asthma treatments (e.g., ICS and additional controller) in combination with the requested medication.

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)^1,5,6

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, Xolair,) indicated for CRSwNP in the past 12 months. Member will continue to use a daily intranasal corticosteroid while being treated with the requested medication, unless contraindicated or not tolerated.

Authorization of 6 months may be granted for treatment of CRSwNP in members 12 years of age or older when all of the following criteria are met:

·        Member has bilateral nasal polyposis and chronic symptoms of sinusitis despite intranasal corticosteroid treatment for at least 4 weeks unless contraindicated or not tolerated.

·        Member has CRSwNP despite one of the following:

§  Prior sino-nasal surgery

§  Prior treatment with systemic corticosteroids within the past 24 months was ineffective, unless contraindicated or not tolerated

·        Member has one of the following:

§  A bilateral nasal endoscopy, anterior rhinoscopy, or computed tomography (CT) showing polyps reaching below the lower border of the middle turbinate or beyond in each nostril

§  Meltzer Clinical Score of 2 or higher in both nostrils

§  A total endoscopic nasal polyp score (NPS) of at least 5 with a minimum score of 2 for each nostril

·        Member has symptoms of nasal blockage, congestion, or obstruction plus one of the following additional symptoms:

§  Rhinorrhea (anterior/posterior)

§  Reduction or loss of smell

§  Facial pain or pressure

·        Member will continue to use a daily intranasal corticosteroid while being treated with the requested medication, unless contraindicated or not tolerated.

Continuation of Therapy

Asthma

Authorization of 12 months may be granted for f treatment of severe asthma when all of the following criteria are met:

·        Member is 12 years of age or older.

·        Asthma control has improved on the requested medication as demonstrated by at least one of the following:

§  A reduction in the frequency and/or severity of symptoms and exacerbations

§  A reduction or discontinuation in the daily maintenance oral corticosteroid dose

·        Member will continue to use maintenance asthma treatments (e.g., ICS and additional controller) in combination with the requested medication.

Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

Authorization of 12 months may be granted for treatment of CRSwNP in members 12 years of age or older when both of the following are met:

·        Member has achieved or maintained a positive clinical response with the requested medication as evidenced by an improvement in signs and symptoms of CRSwNP (e.g., improvement in nasal congestion, nasal polyp size, loss of smell, anterior or posterior rhinorrhea, sino-nasal inflammation, hyposmia or facial pressure or pain, reduction in corticosteroid use).

·        Member will continue to use a daily intranasal corticosteroid while being treated with the requested medication, unless contraindicated or not tolerated.

Other

For all indications: 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.

Appendix

Table. Examples of High-Dose ICS (Alone or in Combination with LABA) for Adults and Adolescents (12 Years and Older)²

Drug	Dosage Form	Total Daily Dose
Beclomethasone dipropionate	Pressurized metered-dose inhaler (pMDI), standard particle size hydrofluoroalkane propellant (HFA)	>1000 mcg
Beclomethasone dipropionate	Dry-powder inhaler (DPI) or pMDI, extra-fine particle size HFA	>400 mcg
Budesonide	DPI or pMDI, standard particle size HFA	>800 mcg
Ciclesonide	pMDI, extra-fine particle size HFA	>320 mcg
Fluticasone furoate	DPI	200 mcg
Fluticasone propionate	DPI or pMDI, standard particle size HFA	>500 mcg
Mometasone furoate	DPI or pMDI, standard particle size HFA	>400 mcg

Place of Service:

Outpatient

The above policy is based on the following references:

1.      Tezspire [package insert]. Thousand Oaks, CA: Amgen Inc.; October 2025.

2.     Global Initiative for Asthma (GINA). Global Strategy for Asthma Management and Prevention. 2025 update. Available at:  https://ginasthma.org/reports/.Accessed March 9, 2026.

3.     Cloutier MM, Dixon AE, Krishnan JA Lemanske Jr RF, Pace W, Schatz M,  Managing asthma in adolescents and adults: 2020 asthma guideline update from the National Asthma Education and Prevention Program. JAMA. 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.

5.     Fokkens WJ, Lund VJ, Hopkins C, et al. European position paper on rhinosinusitis and nasal polyps 2020. Rhinology. 2020;58(Suppl S29):1-464.

6.     Lipworth BJ, Han JK, Desrosiers M, et al. Tezepelumab in adults with severe chronic rhinosinusitis with nasal polyps. N Engl J Med. 2025;392 (12): 1178-1188.

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.

October 03, 2026