ModifiedColorado Rocky Mountain Health PlansPolicy 2026D0110K

Tezspire (tezepelumab-ekko) — Provider‑administered

Medical benefit policy for provider‑administered Tezspire (tezepelumab‑ekko) covering indications, medical necessity criteria, continuation/reauthorization criteria, and coding guidance for severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP). Affects providers prescribing/infusing Tezspire under the medical benefit.

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyTezspire (tezepelumab-ekko) — Provider‑administered

Policy CodePolicy 2026D0110K

Change TypeAdded CRSwNP criteriarevised continuation wordingcoding updates

Effective DateFeb 1, 2026

Next Review Date

Key ActionObtain prior authorization and document required diagnostic criteria and prior therapy trials for CRSwNP or evidence of positive clinical response for reauthorization.

SourceLink

POLICY UPDATE CHANGES

Replaced language indicating 'the [listed] criteria [must be met] for continuation of therapy' with 'authorization for continued use will be approved for patients currently on Tezspire for the treatment of severe asthma based on the [listed] criteria'.

Added detailed initial and continuation authorization criteria for Tezspire use in chronic rhinosinusitis with nasal polyps (CRSwNP), including required diagnostic features, prior therapies, concomitant therapy exclusions, prescribing specialist requirement, and 12-month authorization limits.

Added ICD-10 diagnosis codes J31.0, J32.0–J32.4, J32.8–J32.9, J33.0–J33.1, J33.8–J33.9 to the applicable codes list.

Clarified that Tezspire must not be used in combination with anti-IL-5, anti-IgE, or anti-IL-4 therapies for the same indication.

2indications covered

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12ICD-10 codes added

Coverage Criteria for Tezspire (tezepelumab-ekko)

Initial Therapy — Severe asthma initial therapy criteria (ALL required)

Severe asthma — Initial therapy: Covered when ALL of the following are met

Severe asthma diagnosis and use: Diagnosis of severe asthma; will be used as add-on maintenance therapy; dosing per FDA labeling; initial authorization will be for no more than 12 months; prescribed by a pulmonologist or allergist/immunologist.

Evidence of uncontrolled or inadequately controlled asthma: At least one of: poor symptom control (e.g., ACQ score consistently > 1.5 or ACT score consistently < 20); two or more bursts of systemic corticosteroids for ≥ 3 days each in the previous 12 months; asthma-related emergency treatment (ER visit, hospitalization, or unscheduled office visit for urgent/nebulizer treatment); airflow limitation (post-bronchodilator FEV1 < 80% predicted with reduced FEV1/FVC); or dependence on maintenance oral corticosteroids.

Concomitant controller therapy: Used in combination with either: one maximally-dosed (age-appropriate) ICS/LABA combination product; or a maximally-dosed ICS plus one additional controller medication.

Examples: fluticasone/salmeterol, budesonide/formoterol, ciclesonide plus a LABA or leukotriene receptor antagonist.

Biologic exclusivity: Patient is not receiving Tezspire in combination with any of the following for treatment of the same indication: anti‑interleukin‑5 therapies (e.g., reslizumab, benralizumab, mepolizumab), anti‑IgE therapy (omalizumab), or anti‑interleukin‑4 therapy (dupilumab).

Continuation Therapy — Severe asthma reauthorization/continuation criteria (ALL required)

Severe asthma — Reauthorization/Continuation: Covered when ALL of the following are met

Positive clinical response: Documentation of a positive clinical response demonstrated by at least one: reduction in frequency of exacerbations; decreased utilization of rescue medications; increase in percent predicted FEV1 from pretreatment baseline; or reduction in severity or frequency of asthma-related symptoms (e.g., wheezing, shortness of breath, coughing).

Concomitant ICS-containing maintenance medication: Used in combination with an ICS-containing maintenance medication.

Dosing and approval period:

CRSwNP Initial Therapy — Initial criteria for chronic rhinosinusitis with nasal polyps (ALL required)

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; dosing per FDA labeling; initial authorization will be for no more than 12 months.

Objective diagnostic criteria: 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 of the following endoscopy/CT findings: purulent mucus or edema in the middle meatus/ethmoid regions; polyps in the nasal cavity or middle meatus; or radiographic mucosal thickening/partial or complete opacification of paranasal sinuses.

Bilateral polyps or prior surgery: Either presence of bilateral nasal polyposis or prior surgical removal of bilateral nasal polyps.

Prior treatment failure:

CRSwNP Continuation Therapy — Reauthorization/continuation criteria for CRSwNP (ALL required)

CRSwNP — Reauthorization/Continuation: Covered when ALL of the following are met

Positive clinical response: Documentation of positive clinical response to Tezspire therapy.

Concomitant intranasal corticosteroid: Patient will continue Tezspire as add-on maintenance therapy in combination with intranasal corticosteroids (e.g., fluticasone, mometasone, triamcinolone).

Dosing and approval period: Tezspire dosing is in accordance with U.S. FDA approved labeling; reauthorization will be for no more than 12 months.

Initial CRSwNP — Added detailed initial CRSwNP criteria (ALL required)

Initial therapy for CRSwNP — Covered when ALL of the following are met

CRSwNP initial authorization: Diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) with required diagnostic features; will be used as add‑on maintenance therapy; inadequate response to previous therapies; patient is not receiving Tezspire in combination with anti‑IL‑5, anti‑IgE, or anti‑IL‑4 therapy for the same indication; dosing per FDA labeling; prescribed by an allergist/immunologist, otolaryngologist, or pulmonologist; initial authorization will be for no more than 12 months.

Diagnostic features include two or more symptoms >12 weeks and one objective endoscopy/CT finding; presence of bilateral polyposis or prior bilateral surgery; prior systemic corticosteroids or prior sinus surgery or failure of trials of two therapy classes (saline irrigation, intranasal corticosteroids, antileukotriene agents).

CRSwNP Continuation — Added continuation/reauthorization criteria for CRSwNP (ALL required)

Continuation/Reauthorization for CRSwNP — Covered when ALL of the following are met

CRSwNP continuation: Documentation of positive clinical response to Tezspire therapy; patient will continue Tezspire as add‑on maintenance therapy in combination with intranasal corticosteroids; patient is not receiving Tezspire in combination with anti‑IL‑5, anti‑IgE, or anti‑IL‑4 therapy for the same indication; dosing per FDA labeling; reauthorization will be for no more than 12 months.

Applies to patients currently on Tezspire for CRSwNP.

Severe Asthma Continuation — Updated continuation wording permitting continued authorization for current users when criteria met

Severe asthma continuation language change

Severe asthma continued authorization: Authorization for continued use will be approved for patients currently on Tezspire for treatment of severe asthma based on the listed criteria.

Policy wording revised from prior 'must be met' phrasing to 'authorization for continued use will be approved' wording to permit continued authorization for current users when criteria are met.

Self‑administered Tezspire (prefilled pen) is obtained under the pharmacy benefit unless the member's benefit plan specifies otherwise. An exception is noted for certain UnitedHealthcare of California delegated reviews where the self‑administered pen may be obtained under the medical benefit.

Tezspire must not be used in combination with anti‑IL‑5 therapies (e.g., reslizumab, benralizumab, mepolizumab), anti‑IgE therapy (omalizumab), or anti‑IL‑4 therapy (dupilumab) for treatment of the same indication.

Use of Tezspire concurrently with other specified biologics for the same indication is not permitted under this policy (examples listed include anti‑IL‑5 agents, anti‑IgE, and anti‑IL‑4). The policy does not provide additional washout period details or transition timing when stopping another biologic before initiating Tezspire; providers should document that the member is not receiving those other biologics at the time of request.

In a randomized trial of patients with severe, steroid‑dependent asthma, tezepelumab did not demonstrate a statistically significant reduction in maintenance oral corticosteroid dose versus placebo (cumulative odds ratio 1.28, 95% CI: 0.69–2.35). Note that Tezspire is indicated as add‑on maintenance therapy and is not indicated for relief of acute bronchospasm or status asthmaticus.

Provider Actions, Authorization, and Documentation Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for initiation of Tezspire and approvals are limited to a maximum 12-month authorization period for both initial and continuation requests.

Initial and reauthorization approvals limited to <= 12 months

Documentation Required

Required Documentation for CRSwNP Initial Authorization

For CRSwNP initial authorization, the following documentation must be provided: diagnosis with symptom duration and objective findings (endoscopy and/or CT), evidence of bilateral nasal polyposis or prior bilateral polyp surgery, prior sinus surgery or systemic corticosteroid use in the previous 2 years OR failure of trials of two medication classes (see step-therapy callout), planned use as add‑on maintenance with intranasal corticosteroids, prescriber specialty (allergist/immunologist, otolaryngologist, or pulmonologist), and Tezspire dosing consistent with FDA‑approved labeling.

Symptoms ≥12 weeks (two or more of: nasal mucopurulent discharge; nasal obstruction/blockage/congestion; facial pain/pressure/fullness; reduction or loss of smell)

Applicable Coding and Clinical Thresholds

Applicable HCPCSHCPCS

J2356

Injection, tezepelumab-ekko, 1 mg.

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 16

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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	Polyp of ethmoid

1–10 of 12

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inv-15: Asthma control scores

Asthma control scoresACQ consistently > 1.5 OR ACT consistently < 20

ContextUsed as evidence of poor symptom control for eligibility for provider‑administered Tezspire

Source examplePolicy text: 'Poor symptom control (e.g., ACQ score consistently greater than 1.5 or ACT score consistently less than 20)'

inv-16: Systemic corticosteroid bursts

Systemic corticosteroid bursts threshold≥ 2 bursts of systemic corticosteroids, each ≥ 3 days, in the previous 12 months

RoleCounts as evidence of uncontrolled asthma for Tezspire initial eligibility

Background and Context

Asthma is a chronic inflammatory airway disease; approximately 5–10% of patients have severe asthma that may require biologic therapy. Chronic rhinosinusitis with nasal polyps (CRSwNP) is a persistent inflammatory condition of the nasal passages and paranasal sinuses lasting ≥12 weeks, commonly managed with intranasal corticosteroids, systemic corticosteroids, surgery, and, for selected patients, biologic agents. Tezepelumab is a human monoclonal antibody that binds thymic stromal lymphopoietin (TSLP) and, by acting upstream in the inflammatory cascade, can be used across asthma phenotypes; the policy adds explicit initial and continuation criteria for Tezspire use in CRSwNP and limits authorizations to no more than 12 months when medical necessity criteria are met.

Definitions and Mechanism of Action

inv-28: Eosinophilic asthma

Phenotype definitionEosinophilic asthma: characterized by increased blood and sputum eosinophil levels; FeNO indicates eosinophilic airway inflammation

BiomarkersBlood eosinophils, sputum eosinophils, fractional exhaled nitric oxide (FeNO)

Clinical relevancePhenotypic biomarkers inform use of targeted biologic therapies; tezepelumab acts upstream and is suitable across phenotypes

inv-29: Tezepelumab mechanism

Mechanism of actionTezepelumab is a human monoclonal antibody that binds thymic stromal lymphopoietin (TSLP), blocking its receptor interaction

Downstream effectsReduces downstream markers of airway and mucosal inflammation including blood eosinophils, IgE, FeNO, IL‑5, and IL‑13

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyTezspire (tezepelumab-ekko) — Provider‑administered

Policy CodePolicy 2026D0110K

Change TypeAdded CRSwNP criteriarevised continuation wordingcoding updates

Effective DateFeb 1, 2026

Next Review Date

Key ActionObtain prior authorization and document required diagnostic criteria and prior therapy trials for CRSwNP or evidence of positive clinical response for reauthorization.

SourceLink

On This Page

Tezspire dosing is in accordance with U.S. FDA approved labeling; reauthorization will be for no more than 12 months.

Either prior sinus surgery; or systemic corticosteroids for CRSwNP in the previous 2 years; or failed trial of two classes of agents (nasal saline irrigations, intranasal corticosteroids, antileukotriene agents).

Concomitant intranasal corticosteroid: Patient will receive Tezspire as add-on maintenance therapy in combination with intranasal corticosteroids (e.g., fluticasone, mometasone, triamcinolone).

Prescriber specialty: Prescribed by an allergist/immunologist, otolaryngologist, or pulmonologist.

Objective finding on nasal endoscopy and/or sinus CT (purulent mucus/edema in middle meatus or ethmoid, nasal/middle meatal polyps, or mucosal thickening/opacification on imaging)

Bilateral nasal polyposis or prior bilateral polyp removal

Prior sinus surgery OR systemic corticosteroids for CRSwNP within past 2 years OR inability to obtain symptom relief after trial of two medication classes

Prescriber specialty and planned concomitant intranasal corticosteroid use

Step Therapy

CRSwNP Prior Therapy Requirements

Prior to initiating Tezspire for CRSwNP, patients must have an inadequate response to prior therapies. Specifically, the patient must have required prior sinus surgery, required systemic corticosteroids for CRSwNP in the previous 2 years, or been unable to obtain symptom relief after trials of two of the listed classes.

Evidence of prior sinus surgery OR systemic corticosteroid use for CRSwNP within 2 years OR inadequate response to prior medical therapies

Step Therapy

Required Prior Therapy Trials

Before starting Tezspire for CRSwNP, documentation of trials of two of the following classes is required unless the patient meets the alternative criteria above (prior surgery or recent systemic corticosteroids): nasal saline irrigations; intranasal corticosteroids (e.g., fluticasone, mometasone, triamcinolone); or antileukotriene agents (e.g., montelukast, zafirlukast, zileuton).

Two classes required: nasal saline irrigations; intranasal corticosteroids; antileukotriene agents

Documentation Required

Reauthorization Documentation

For reauthorization/continuation of therapy (CRSwNP and severe asthma), documentation of a positive clinical response to Tezspire is required. Examples of acceptable evidence include reduction in frequency of exacerbations, decreased rescue medication use, increase in percent predicted FEV1 from baseline, or reduction in severity/frequency of disease‑related symptoms.

Documented clinical improvement (examples: fewer exacerbations, less rescue use, improved FEV1, reduced symptom severity)
Continuation to be used as add‑on maintenance with required concomitant controller therapy (e.g., intranasal corticosteroids for CRSwNP; ICS-containing maintenance therapy for severe asthma)

Denial Risk

Concomitant Therapy Exclusion

Tezspire must not be used concurrently with other biologic agents that target overlapping pathways for the same indication. If the patient is receiving any of the listed agents for the same diagnosis, Tezspire will not be approved.

Concomitant biologic agents prohibited for same indication: anti‑IL‑5 agents (reslizumab, benralizumab, mepolizumab), anti‑IgE agent (omalizumab), anti‑IL‑4/13 agent (dupilumab)

Policy quote'Two or more bursts of systemic corticosteroids for at least 3 days each in the previous 12 months'

inv-17: Airflow limitation

Airflow limitation thresholdPost‑bronchodilator FEV1 < 80% predicted with reduced FEV1/FVC (less than lower limit of normal)

UseIncluded as objective evidence of airflow limitation supporting uncontrolled asthma eligibility

Policy wording'after appropriate bronchodilator withhold FEV1 less than 80% predicted (in the face of reduced FEV1/FVC defined as less than the lower limit of normal)'

inv-18: Asthma exacerbation frequency

Asthma exacerbation frequency≥ 2 exacerbations per year (frequent exacerbations) used to define uncontrolled asthma

Definition contextGINA defines uncontrolled asthma as poor control and/or frequent exacerbations (≥2/year) requiring OCS

Policy applicationFrequent exacerbations are listed among criteria indicating insufficient control for Tezspire consideration

Clinical noteActs upstream in the inflammatory cascade, making it suitable across asthma phenotypes

inv-30: Uncontrolled asthma

Uncontrolled asthma definitionAsthma with poor symptom control and/or frequent exacerbations (≥2/year requiring OCS) or serious exacerbations (≥1/year requiring hospitalization)

Policy markersMay include poor ACQ/ACT scores, frequent steroid bursts, ER visits, or airflow limitation as evidence

Use in policyUsed to determine eligibility for add‑on Tezspire therapy when other optimized treatments fail

inv-31: Difficult-to-treat asthma

Difficult-to-treat asthmaAsthma uncontrolled despite medium- or high-dose ICS plus a second controller or maintenance OCS, or requiring high-dose treatment to maintain control

Clinical implicationRequires evaluation of adherence, inhaler technique, and contributory factors before labeling as difficult-to-treat

Relation to biologicsMay prompt consideration of add‑on therapies if optimization fails

inv-32: Severe asthma

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

ExclusionAsthma that improves markedly when contributory factors (inhaler technique, adherence) are addressed is not classified as severe

Policy implicationSevere asthma patients who remain uncontrolled despite optimization are candidates for add‑on biologic therapy such as Tezspire per policy criteria