ModifiedUnitedHealthcarePolicy 2026D0110K

Tezspire (tezepelumab-ekko) — Provider-Administered Therapy

Medical benefit policy governing coverage and prior authorization criteria for provider-administered Tezspire (tezepelumab-ekko) for severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) for UnitedHealthcare commercial lines.

Policy Summary

PayerUnitedHealthcare

PolicyTezspire (tezepelumab-ekko) — Provider-Administered Therapy

Policy CodePolicy 2026D0110K

Change TypeMaterial — added CRSwNP criteriaclarified continuation language

Effective DateFeb 1, 2026

Next Review Date

Key ActionObtain prior authorization for provider-administered Tezspire; initial and reauthorization approvals are limited to up to 12 months with required documentation of diagnostic criteria and clinical response.

SourceLink

POLICY UPDATE CHANGES

Replaced language indicating continuation criteria 'must be met' with language authorizing continued use for patients currently on Tezspire based on the listed criteria.

Added detailed initial and continuation authorization criteria for Tezspire for CRSwNP including diagnostic requirements, prior therapy trials, concomitant therapy exclusions, prescriber specialty, dosing aligned with FDA labeling, and initial/reauthorization limits of 12 months.

Added ICD-10 diagnosis codes for chronic rhinosinusitis and nasal polyposis.

12 monthsmax approval period

≥ 12 yrsindicated minimum age

J2356HCPCS code

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12 codesICD-10 codes added

2indications addressed

Coverage Criteria for Tezspire (tezepelumab-ekko)

Severe Asthma — Initial Therapy

Covered when ALL of the following are met:

Initial severe asthma criteria: Diagnosis of severe asthma; will be used as add-on maintenance therapy; dosing is in accordance with U.S. FDA labeling; initial authorization will be for no more than 12 months

Evidence of uncontrolled asthma: Classification of asthma as uncontrolled or inadequately controlled defined by at least one of: poor symptom control (e.g., ACQ >1.5 or ACT <20), two or more bursts of systemic corticosteroids (≥3 days each) in the prior 12 months, asthma-related emergency treatment (ER visit, hospital admission, or unscheduled urgent visit), airflow limitation (post-bronchodilator FEV1 <80% predicted with reduced FEV1/FVC), or dependence on maintenance oral corticosteroids

Concomitant controller therapy: Used in combination with one of: a maximally-dosed ICS/LABA combination OR a maximally-dosed ICS plus an additional controller medication (e.g., LABA, leukotriene receptor antagonist, theophylline)

Monotherapy exclusion: Patient is not receiving Tezspire in combination with anti-IL-5, anti-IgE, or anti-IL-4 therapies for the same indication

Examples listed: reslizumab, benralizumab, mepolizumab, omalizumab, dupilumab

Prescriber and dosing: Dosing is in accordance with U.S. FDA labeling and prescribed by an appropriate specialist; initial authorization will be for no more than 12 months

Severe Asthma — Reauthorization/Continuation

Covered when ALL of the following are met:

Response documentation: Documentation of positive clinical response demonstrated by at least one of: reduction in exacerbation frequency, decreased rescue medication utilization, increase in percent predicted FEV1 from pretreatment baseline, or reduction in severity/frequency of asthma-related symptoms

Concomitant therapy and exclusions: Used in combination with an ICS-containing maintenance medication; not used in combination with anti-IL-5, anti-IgE, or anti-IL-4 therapies for the same indication; dosing per U.S. FDA labeling

Reauthorization will be for no more than 12 months

CRSwNP — Initial Therapy

Covered when ALL of the following are met:

Diagnosis and use: Diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP); will be used as add-on maintenance therapy; patient has had an inadequate response to previous therapies; initial authorization will be for no more than 12 months

Clinical diagnostic requirements: CRSwNP defined by: two or more symptoms for >12 weeks (nasal mucopurulent discharge; nasal obstruction/blockage/congestion; facial pain/pressure/fullness; reduction or loss of sense of smell) AND one endoscopy or CT finding (purulent mucus or edema in the middle meatus/ethmoid; polyps in the nasal cavity or middle meatus; or radiographic mucosal thickening/partial or complete opacification of paranasal sinuses) AND either presence of bilateral nasal polyposis or prior surgical removal of bilateral nasal polyps

Prior treatments: One of: prior sinus surgery; systemic corticosteroids for CRSwNP in the previous 2 years; or failure to obtain symptom relief after trial of two of the following classes: nasal saline irrigations, intranasal corticosteroids (e.g., fluticasone, mometasone, triamcinolone), antileukotriene agents (e.g., montelukast)

Trials of two distinct classes required unless surgery or systemic steroid criterion is met

CRSwNP — Reauthorization/Continuation

Covered when ALL of the following are met:

Response documentation: Documentation of positive clinical response to Tezspire therapy; patient will continue Tezspire as add-on maintenance therapy in combination with intranasal corticosteroids; not receiving Tezspire with anti-IL-5, anti-IgE, or anti-IL-4 therapies for the same indication; dosing per U.S. FDA labeling

Reauthorization will be for no more than 12 months

Initial Therapy (CRSwNP) — Tezspire for CRSwNP

Tezspire for CRSwNP — Covered when ALL of the following are met for initial therapy:

Diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP)

Defined by two or more symptoms >12 weeks plus objective endoscopy or CT findings; presence of bilateral nasal polyposis or prior bilateral polyp surgery

Use: Will be used as add-on maintenance therapy in combination with intranasal corticosteroids

Patient must continue intranasal corticosteroids during therapy

Prior therapies or severity: Patient has required prior sinus surgery, or required systemic corticosteroids for CRSwNP in the previous 2 years, or failed to obtain symptom relief after trial of two of the following classes: nasal saline irrigations, intranasal corticosteroids, antileukotriene agents

Trials of two distinct classes required unless surgery/systemic steroid meets criterion

Concomitant biologics exclusion:

Continuation Therapy (CRSwNP and severe asthma—current users) — Tezspire

For patients currently on Tezspire for CRSwNP or severe asthma — Covered when ALL of the following are met for continuation:

Prior authorization for current users: Authorization for continued use will be approved for patients currently on Tezspire based on the listed criteria

Replaces prior 'must be met' language to allow continuation when documented

Clinical response: Documentation of positive clinical response to Tezspire therapy is required for reauthorization

Reauthorization will be for no more than 12 months

Therapy combination: Patient will continue to receive Tezspire as add-on maintenance therapy in combination with intranasal corticosteroids

Patient must not be receiving excluded concomitant biologics for same indication

The Tezspire prefilled pen for patient self-administration is obtained under the pharmacy benefit unless the member's benefit plan specifies otherwise. An exception applies for members enrolled in UnitedHealthcare of California plans when a delegated provider group is conducting the prior authorization review; in that case the self-administered prefilled pen may be obtained under the medical benefit.

Tezspire must not be used in combination with other biologic therapies targeting the same indication. Specifically, patients may not receive Tezspire concurrently with anti‑IL‑5 agents (for example, reslizumab, benralizumab, mepolizumab), anti‑IgE therapy (omalizumab), or anti‑IL‑4 therapy (dupilumab) for the same treatment indication. Use in combination with these agents is an exclusion and may result in denial of authorization.

Use of Tezspire is covered only when the policy's specified diagnostic and treatment requirements are met. Use without meeting the stated diagnostic criteria (e.g., criteria for severe asthma or for CRSwNP) or without the required concomitant controller therapy (such as an ICS-containing maintenance medication for asthma or intranasal corticosteroids for CRSwNP) is not supported by the medical necessity criteria and is considered not medically necessary.

Tezspire is indicated as an add-on maintenance therapy and is not indicated for the relief of acute bronchospasm or for treatment of status asthmaticus. Coverage for use in those acute settings is not supported by the FDA indication.

Coding — Procedure and Diagnosis Codes

Procedure/HCPCSHCPCS

J2356

Injection, tezepelumab-ekko, 1 mg.

Diagnosis/ICD-10ICD-10

J31.0	Chronic rhinitis
J32.0	Chronic maxillary sinusitis
J32.1	Chronic frontal sinusitis
J32.2	Chronic ethmoidal sinusitis
J32.3	Chronic sphenoidal sinusitis
J32.4	Chronic pansinusitis
J32.8	Other chronic sinusitis
J32.9	Chronic sinusitis, unspecified
J33.0	Polyp of nasal cavity
J33.1	Polypoid sinus degeneration

1–10 of 16

1/2

Applicable ICD-10 Diagnosis CodesICD-10

J31.0	Chronic rhinitis
J32.0	Chronic maxillary sinusitis
J32.1	Chronic frontal sinusitis
J32.2	Chronic ethmoidal sinusitis
J32.3	Chronic sphenoidal sinusitis
J32.4	Chronic pansinusitis
J32.8	Other chronic sinusitis
J32.9	Chronic sinusitis, unspecified
J33.0	Polyp of nasal cavity
J33.1	Polypoid sinus degeneration

1–10 of 12

1/2

ACQ/ACT — Control thresholds

ACQ/ACT thresholdACQ > 1.5 or ACT < 20 (indicative of poor symptom control)

Clinical roleUsed as evidence of uncontrolled asthma to qualify for tezepelumab add-on maintenance therapy

Assessment frequencyScores should be consistently >1.5 (ACQ) or <20 (ACT) documenting persistent poor control

Alternative uncontrolled criteriaOr alternatively: ≥2 systemic corticosteroid bursts in prior 12 months, asthma-related emergency treatment, airflow limitation, or maintenance oral corticosteroid dependence

Age — Minimum patient age for indicated use

Minimum age

Provider Actions, Prior Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization and Duration

Prior authorization is required for Tezspire (provider administration). Initial authorizations are limited to no more than 12 months; reauthorization/continuation approvals are also granted for periods of no more than 12 months when continuation criteria are met.

Initial and reauthorization duration: <= 12 months
Prior authorization required before initiation

Prior Authorization

Prior Authorization for Tezspire (CRSwNP)

For Chronic Rhinosinusitis with Nasal Polyps (CRSwNP), prior authorization requires documentation that the patient meets the detailed diagnostic and prior therapy criteria and that Tezspire will be used as add-on maintenance therapy in combination with intranasal corticosteroids.

Indication: CRSwNP diagnosis required
Tezspire to be used as add-on maintenance therapy with intranasal corticosteroids
Initial authorization limited to no more than 12 months

Background and Rationale

Asthma is a chronic inflammatory disease of the airways; a minority of patients have disease that is severe or difficult to control despite optimized inhaled therapy. Estimates indicate approximately 1.2–2.4 million people have severe asthma, which is associated with substantial morbidity and increased healthcare utilization. Chronic rhinosinusitis with nasal polyps (CRSwNP) is a chronic inflammatory condition of the paranasal sinuses persisting for ≥12 weeks, characterized by symptoms such as nasal discharge, nasal obstruction, facial pressure, and reduced or lost sense of smell; management options include intranasal corticosteroids, systemic corticosteroids, surgery, and biologic therapies. Tezepelumab, a monoclonal antibody that targets thymic stromal lymphopoietin (TSLP), reduces downstream airway and mucosal inflammation markers and is used as add-on maintenance therapy across asthma phenotypes and for inadequately controlled CRSwNP in patients aged ≥12 years.

Definitions and Clinical Terms

Severe asthma — Definition and clinical context

DefinitionAsthma that is uncontrolled despite adherence with maximal optimized high‑dose ICS‑LABA and management of contributory factors, or that worsens when high‑dose treatment is decreased

PrevalenceRepresents about 5–10% of the asthma population (approximately 1.2–2.4 million people)

Clinical contextAssociated with substantial morbidity and may span multiple phenotypes (allergic, eosinophilic, non‑eosinophilic)

Biologic suitabilityTezepelumab targets TSLP upstream in the inflammatory cascade and is suitable across asthma phenotypes

CRSwNP — Definition and diagnostic criteria

DefinitionChronic rhinosinusitis with nasal polyps (CRSwNP): inflammatory condition of the paranasal sinuses persisting ≥12 weeks with nasal polyps

Policy Summary

PayerUnitedHealthcare

PolicyTezspire (tezepelumab-ekko) — Provider-Administered Therapy

Policy CodePolicy 2026D0110K

Change TypeMaterial — added CRSwNP criteriaclarified continuation language

Effective DateFeb 1, 2026

Next Review Date

SourceLink

On This Page

Concomitant therapy and exclusions: Will receive Tezspire as add-on maintenance therapy in combination with intranasal corticosteroids; not receiving Tezspire in combination with anti-IL-5, anti-IgE, or anti-IL-4 therapies for the same indication; dosing per U.S. FDA labeling; prescribed by an allergist, immunologist, otolaryngologist, or pulmonologist

Patient is not receiving Tezspire in combination with anti-IL-5, anti-IgE, or anti-IL-4 therapies for the same indication

Examples: reslizumab, benralizumab, mepolizumab, omalizumab, dupilumab

Prescriber and dosing: Dosing is in accordance with U.S. FDA labeling and prescribed by an allergist, immunologist, otolaryngologist, or pulmonologist

Initial authorization up to 12 months

Trial populationsSevere asthma pivotal trials enrolled patients aged 12 years and older

CRSwNP trial ageWAYPOINT included participants aged 18 years and older (CRSwNP-specific)

Prescribing implicationTherapy should be prescribed consistent with FDA labeling for age indications

Denial Risk

Failure to Meet Specified Diagnosis or Documentation

Authorization may be denied if the required diagnostic criteria, prior therapy trials, or documentation of response (for continuation) are not provided, or if the patient is receiving Tezspire in combination with disallowed biologic therapies for the same indication.

Denial triggers: missing or incomplete documentation of diagnosis or prior therapies
Denial triggers: patient receiving Tezspire concurrently with anti-IL‑5, anti‑IgE, or anti‑IL‑4 therapies for same indication

Documentation Required

Required Documentation for Initial and Continued CRSwNP Therapy

Required documentation must be provided for both initial and continued therapy for CRSwNP. For initial requests include diagnostic findings (symptoms >12 weeks and endoscopy/CT findings), prior surgical history or systemic corticosteroid use, documentation of inadequate response to prior therapies (as specified), prescribing specialist, and planned concomitant intranasal corticosteroid therapy. For reauthorization include documentation of positive clinical response and ongoing use with intranasal corticosteroids.

Initial documentation: two or more symptoms >12 weeks (nasal mucopurulent discharge; obstruction/ congestion; facial pain/pressure/fullness; reduction/loss of smell)
Initial documentation: one endoscopy or CT finding (purulent mucus/edema in middle meatus or ethmoid; polyps in nasal cavity/middle meatus; radiographic mucosal thickening or opacification)
Initial documentation: bilateral nasal polyposis or prior bilateral polyp removal
Initial documentation: prior sinus surgery OR systemic corticosteroids for CRSwNP in past 2 years OR inability to obtain symptom relief after trial of two classes (nasal saline irrigations, intranasal corticosteroids, antileukotriene agents)
Prescriber specialty: allergist/immunologist/otolaryngologist/pulmonologist
Reauthorization documentation: evidence of positive clinical response (e.g., reduced exacerbations, decreased rescue medication use, improved symptoms or objective measures)

Step Therapy

For CRSwNP, Patient Must Have Had Inadequate Response to Previous Therapies

For CRSwNP, the patient must have had an inadequate response to previous therapies before initiating Tezspire. The policy specifies trials or history that demonstrate prior therapy failure or need for escalation.

Inadequate response defined by prior sinus surgery, prior systemic corticosteroids for CRSwNP within 2 years, OR failure to obtain symptom relief after trials of two listed medication classes
Tezspire must be added to intranasal corticosteroids as maintenance therapy

Step Therapy

Required Prior Therapy Classes for CRSwNP

Before initiation of Tezspire for CRSwNP, documentation must show trials of at least two of the following classes (or surgical/systemic steroid history) unless there is prior sinus surgery or recent systemic corticosteroid use: nasal saline irrigations; intranasal corticosteroids (e.g., fluticasone, mometasone, triamcinolone); antileukotriene agents (e.g., montelukast, zafirlukast, zileuton).

Required prior therapy classes (trial of two): nasal saline irrigations; intranasal corticosteroids; antileukotriene agents
Alternative triggers satisfying prior therapy requirement: prior sinus surgery OR systemic corticosteroids for CRSwNP in previous 2 years

Required symptomsTwo or more symptoms for >12 weeks: nasal mucopurulent discharge; nasal obstruction/blockage/congestion; facial pain/pressure/fullness; reduction or loss of smell

Objective diagnostic findingsAt least one endoscopy or CT finding: purulent mucus/edema in the middle meatus or ethmoid, visible polyps, or radiographic mucosal thickening/opacification

Polyp criteriaPresence of bilateral nasal polyposis or prior bilateral nasal polyp surgery is required as part of diagnostic criteria

Uncontrolled asthma — Definition (exacerbation thresholds, systemic steroid use)

Uncontrolled asthma — exacerbation thresholdsFrequent exacerbations defined as ≥2 systemic corticosteroid bursts (≥3 days each) in prior 12 months or ≥1 serious exacerbation requiring hospitalization per year

Other markersAsthma-related emergency treatment (ER visit, hospital admission, or unscheduled urgent visit) qualifies as uncontrolled

Objective airflow criteriaPost‑bronchodilator FEV1 <80% predicted with reduced FEV1/FVC (less than lower limit of normal) may indicate uncontrolled disease

Symptom scoresPoor symptom control evidenced by ACQ >1.5 or ACT <20

Severe asthma — Additional definition content (treatment-resistant despite maximal therapy)

Treatment‑resistant definitionAsthma that remains uncontrolled despite adherence with maximal optimized high‑dose ICS‑LABA and management of contributory factors (i.e., resistant to maximal therapy)

Maintenance OCS dependenceIncludes patients currently dependent on maintenance oral corticosteroids for asthma management

When not severeAsthma is not classified as severe if it markedly improves when contributory factors (inhaler technique, adherence) are addressed

Implication for biologic therapySevere, treatment‑resistant patients are candidates for add‑on biologic therapies such as tezepelumab per guideline recommendations