CurrentColorado Rocky Mountain Health PlansPolicy CS2026D00110M

Tezspire (tezepelumab-ekko) — Medical benefit coverage criteria for severe asthma and CRSwNP

Defines medical benefit coverage criteria for provider‑administered Tezspire (vial and prefilled syringe) for severe asthma and chronic rhinosinusitis with nasal polyps (CRSwNP); excludes self‑administered prefilled pen (pharmacy benefit).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyTezspire (tezepelumab-ekko) medical benefit coverage criteria

Policy CodePolicy CS2026D00110M

Change TypeTemplate update — no material clinical changes

Effective DateApr 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization for provider‑administered Tezspire (HCPCS J2356); initial and reauthorization periods are limited to up to 12 months with required documentation of clinical response for continuation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization period (max)

J2356HCPCS code

≥12indication age

4-monthprior biologic trial

AGINA evidence

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Coverage Criteria for Tezspire (tezepelumab-ekko)

Initial Therapy - Severe Asthma

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

Severe asthma - initial: Diagnosis of severe asthma; classification as uncontrolled or inadequately controlled demonstrated by at least one of: poor symptom control (e.g., ACQ > 1.5 or ACT < 20), two or more systemic corticosteroid bursts (≥3 days each) in the prior 12 months, asthma-related emergency treatment (ER visit, hospitalization, or unscheduled urgent visit), airflow limitation (post-bronchodilator FEV1 < 80% predicted with reduced FEV1/FVC), or maintenance oral corticosteroid dependence

Concomitant maintenance therapy: Used in combination with either: (a) a maximally-dosed (age-appropriate) ICS/LABA combination product; OR (b) a maximally-dosed ICS plus an additional controller medication (examples: LABA, leukotriene receptor antagonist, theophylline)

Examples of agents provided in policy text.

Prior biologic therapy or phenotype exceptions: One of: (1) Eosinophilic asthma AND history of failure, contraindication, or intolerance to a 4-month trial of both an anti-IL-5 therapy and an anti-IL-4 therapy; OR (2) Persistent allergic asthma AND history of failure/contraindication/intolerance to a 4-month trial of omalizumab; OR (3) OCS-dependent asthma AND history of failure/contraindication/intolerance to a 4-month trial of dupilumab; OR (4) Asthma not of the eosinophilic/allergic/OCS-dependent phenotype; OR (5) Patient is currently on Tezspire4-month trial

Monotherapy exclusion & administration: Patient is not receiving Tezspire in combination with anti-IL-5, anti-IgE, or anti-IL-4 therapies for the same indication; AND one of: physician attestation that patient/caregiver cannot self-administer the FDA-labeled self-administration product; OR documented recent severe hypersensitivity to Tezspire requiring monitored administration; OR initial monitored dose for new-to-therapy patients (authorization for 1 dose)

Severe hypersensitivity defined in policy examples (e.g., anaphylaxis, angioedema, bronchospasm, hypotension).

Prescriber and dosing: Dosing in accordance with U.S. FDA-approved labeling; prescribed by a pulmonologist or allergist/immunologist; initial authorization limited to no more than 12 months

Continuation Therapy - Severe Asthma

Covered when ALL of the following are met for continuation/reauthorization:

Clinical response: Documentation of positive clinical response demonstrated by at least one of: reduction in exacerbation frequency; decreased rescue medication use; increase in percent predicted FEV1 from pretreatment baseline; or reduction in severity or frequency of asthma-related symptoms (e.g., wheezing, dyspnea, coughing)

Concomitant therapy: Continued use in combination with an ICS-containing maintenance medication

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

Administration/monitoring exceptions: Physician attestation that patient/caregiver cannot self-administer the FDA-labeled self-administration product; OR documented recent severe hypersensitivity to Tezspire requiring administration and direct monitoring by a healthcare professional

Initial Therapy - CRSwNP

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

Diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) defined by: at least two symptoms for longer than 12 weeks (nasal mucopurulent discharge; nasal obstruction/ congestion; facial pain/pressure/fullness; reduction or loss of sense of smell) AND endoscopy or CT findings (purulent mucus or edema in middle meatus/ethmoid, nasal cavity polyps, or radiographic mucosal thickening/opacification)12 weeks

Polyp burden or prior surgery: Presence of bilateral nasal polyposis OR prior requirement for surgical removal of bilateral nasal polyps

Prior treatments: One of: prior sinus surgery; OR systemic corticosteroids for CRSwNP within the previous 2 years; OR inadequate relief after trial of two classes (nasal saline irrigation, intranasal corticosteroids, antileukotriene agents)

Prior biologic trials or current therapy:

Continuation Therapy - CRSwNP

Covered when ALL of the following are met for continuation/reauthorization in CRSwNP:

Clinical response: Documentation of positive clinical response to Tezspire therapy

Concomitant therapy and exclusions: Continue 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 therapies for the same indication; dosing per U.S. FDA labeling; reauthorization limited to no more than 12 months

Informational coverage context and clinical criteria

Informational clinical criteria and outcomes referenced in support of tezepelumab use:

FDA indication: Patient is aged ≥ 12 years and has either severe asthma requiring add-on maintenance therapy OR inadequately controlled chronic rhinosinusitis with nasal polypsage >= 12 years

From FDA indication (informational).

Severe asthma definition: Severe asthma: asthma uncontrolled despite optimized high-dose ICS-LABA and management of contributory factors (use guideline definitions for uncontrolled/difficult-to-treat/severe asthma)as per guideline definitions

Use GINA/ERS-ATS definitions to identify candidates for biologic therapy.

Guideline recommendations: Add-on biologic therapy recommended per phenotype: anti-IgE for allergic asthma; anti-IL-5/5R for eosinophilic asthma; anti-IL4/13 for eosinophilic or steroid-dependent asthma; anti-TSLP (tezepelumab) for severe asthma age ≥12

The Tezspire prefilled pen intended for self-administration is obtained through the pharmacy benefit and is therefore not covered under this medical benefit policy. This medical policy addresses provider‑administered Tezspire formulations (vial and prefilled syringe) given by a healthcare professional. Providers must verify member benefit design and obtain prior authorization per payer processes before scheduling provider administration (HCPCS J2356).

Tezepelumab (Tezspire) is not indicated for relief of acute bronchospasm or status asthmaticus. Use of Tezspire for immediate relief of acute asthma symptoms or for management of status asthmaticus is outside the FDA‑labeled indication and is not an appropriate use of this maintenance biologic.

Use of Tezspire for diagnoses or clinical presentations that do not meet the policy’s specified severity, phenotype, diagnostic, or prior‑therapy requirements is considered not medically necessary. Examples include CRSwNP cases without the required symptom duration and endoscopy/CT findings, or asthma that does not meet the policy criteria for severe/uncontrolled disease (see required documentation such as ACQ/ACT scores, systemic corticosteroid bursts, ER/hospital events, or objective airflow limitation).

Applicable Codes and Coding Notes

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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Exacerbation frequency — thresholds for prior exacerbations

Exacerbation frequency threshold>= 2 systemic corticosteroid bursts (each >=3 days) in the previous 12 months

Serious exacerbation threshold>= 1 serious exacerbation requiring hospitalization in the previous 12 months

Emergency treatment as indicatorAsthma-related emergency treatment (ER visit, hospital admission, or unscheduled urgent visit) counts toward exacerbation-based criteria

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for provider‑administered Tezspire (HCPCS J2356). Initial authorizations will be issued for up to 12 months; reauthorization (continuation) reviews are required no more than every 12 months and must document ongoing clinical benefit.

Prior authorization required for provider‑administered Tezspire (HCPCS J2356).
Initial authorization: up to 12 months.
Reauthorization/continuation: reauthorization reviews no more than every 12 months and must document continued clinical response.

Prior Authorization

Prior Authorization for Tezepelumab (Tezspire)

Coverage/authorization for tezepelumab (Tezspire) follows indication‑ and age‑specific criteria. Tezspire is indicated as add‑on maintenance therapy for: severe asthma and inadequately controlled CRSwNP in patients aged ≥ 12 years. Approval requires documentation that the member meets the applicable diagnostic and severity/control criteria for the treated indication.

Indications: severe asthma and CRSwNP for patients aged ≥ 12 years.

Background and Clinical Context

Asthma is a chronic inflammatory airway disease; approximately 5–10% of people with asthma have severe disease requiring advanced therapies. Phenotypes relevant to biologic selection include allergic and eosinophilic patterns, and biomarkers such as blood eosinophils, FeNO, and IgE can help guide therapy choices. Tezepelumab is a monoclonal antibody targeting thymic stromal lymphopoietin (TSLP) and is indicated as add‑on maintenance therapy for patients aged 12 years and older with severe asthma. Clinical guidelines recognize use of add‑on biologics by phenotype when asthma remains uncontrolled despite optimized high‑dose inhaled corticosteroid–LABA therapy and management of contributory factors.

Definitions and Key Terms

Uncontrolled / severe asthma (per GINA)

Definition of uncontrolled asthmaPoor symptom control (frequent symptoms or reliever use, activity limitation, night waking) and/or frequent exacerbations (>=2/year requiring OCS) or serious exacerbations (>=1/year requiring hospitalization)

Definition of difficult-to-treat asthmaAsthma uncontrolled despite medium- or high-dose ICS plus a second controller or maintenance OCS, or that requires high-dose treatment to maintain control

Definition of severe asthmaAsthma uncontrolled despite adherence with maximal optimized high-dose ICS-LABA and management of contributory factors, or that worsens when high-dose treatment is decreased

Uncontrolled / Difficult-to-treat / Severe asthma — distinctions

Uncontrolled asthma (clinical signs)Poor symptom control (e.g., frequent symptoms, reliever use, activity limitation, night waking) and/or frequent exacerbations (>=2/year requiring OCS) or >=1/year hospitalization)

Revision History

2026-04-01policy_revisionLatest

Policy effective date and template update; removed Louisiana-specific language and archived previous policy version CS2026D00110L.

2026-04-01administrative_update

Supporting information updated alongside template changes (informational updates to supporting sections).

Policy Summary

PayerColorado Rocky Mountain Health Plans

PolicyTezspire (tezepelumab-ekko) medical benefit coverage criteria

Policy CodePolicy CS2026D00110M

Change TypeTemplate update — no material clinical changes

Effective DateApr 1, 2026

Next Review DateN/A

SourceLink

On This Page

Prescriber and dosing: Dosing in accordance with U.S. FDA-approved labeling; prescribed by appropriate specialist; reauthorization limited to no more than 12 months

History of failure, contraindication, or intolerance to a 4-month trial of two of: anti-IL-5 therapy, anti-IL-4 therapy, or anti-IgE therapy; OR patient is currently on Tezspire therapy

Concomitant therapy and exclusions: Will be used as add-on maintenance therapy in combination with intranasal corticosteroids; not to be used 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 allergist/immunologist, otolaryngologist, or pulmonologist; initial authorization for no more than 12 months

per GINA/ERS-ATS statements

GINA lists Evidence A for several biologics including anti-TSLP (tezepelumab).

CRSwNP observed outcome: In a trial subgroup, tezepelumab-treated patients had lower rates of need for nasal-polyp surgery or systemic glucocorticoids (5.7%) versus placebo (31.4%)trial-reported event rates

Supports clinical benefit in CRSwNP (informational).

Authorization requires documentation of diagnosis and severity/control per policy criteria.

Denial Risk

Eligibility / Documentation Risk

Lack of required documentation (diagnosis, severity/control measures, prior therapy trials, or verification of benefits) may result in denial of the request. Ensure medical record documentation (e.g., ACQ/ACT scores, systemic corticosteroid history, imaging/endoscopy reports, prior surgery) is present and retained.

Missing documentation of diagnosis or disease severity/control (e.g., ACQ/ACT, exacerbation history, OCS dependence) may trigger denial.
Retain supporting records such as spirometry, imaging, endoscopy, operative reports, and steroid prescription history.

Documentation Required

Required Benefit Verification

Verify federal, state, and contractual benefit plan requirements before submission. Coverage decisions must adhere to the member's specific plan language; in case of conflict, federal, state, or contractual requirements govern. Retain copies of any third‑party payer verifications used to establish benefit eligibility.

Confirm member eligibility and benefits, including any federal or state program rules.
Document and retain third‑party payer verifications and plan‑specific coverage rules.
When plan language conflicts with this policy, the federal/state/contractual requirements control.

Step Therapy

Required Prior Biologic or Therapy Trials

For certain severe asthma phenotypes, prior trial(s) of specified biologics or therapies are required unless there is documented contraindication or intolerance. Typically a trial of approximately 4 months is expected for the comparator biologic(s) before Tezspire is approved, unless the patient is already on Tezspire or has documented contraindication/intolerance.

Eosinophilic asthma: documented failure/contraindication/intolerance to a ~4‑month trial of both an anti‑IL‑5 agent (e.g., mepolizumab, benralizumab) and an anti‑IL‑4/13 agent (dupilumab) unless contraindicated.
Persistent allergic asthma: documented failure/contraindication/intolerance to a ~4‑month trial of omalizumab (Xolair) unless contraindicated.
Oral corticosteroid–dependent asthma: documented failure/contraindication/intolerance to a ~4‑month trial of dupilumab unless contraindicated.
Patients already receiving Tezspire do not require prior biologic trials for continuation.

Note

Therapy Optimization Expectations

Before considering Tezspire, guideline‑recommended optimization of therapy should be demonstrated where applicable. This includes optimized high‑dose ICS‑LABA therapy, assessment and correction of adherence and inhaler technique, and trials of other add‑on biologics or controller agents as appropriate. Low‑dose chronic oral corticosteroids should be reserved as a last resort after optimization and consideration of biologic options.

Demonstrate optimization of maximal therapy (e.g., maximal/optimized high‑dose ICS‑LABA) and management of contributory factors prior to Tezspire initiation.
Assess and document inhaler technique and adherence, and try appropriate additional controller medications as indicated.
Use of chronic oral corticosteroids should be minimized and considered only after optimization and consideration of available biologics.

Difficult-to-treat asthma (management context)Uncontrolled despite medium- or high-dose ICS plus a second controller (usually LABA) or maintenance OCS, or requiring high-dose treatment to maintain control

Severe asthma (confirmation and exclusions)Uncontrolled despite adherence with optimized maximal high-dose ICS-LABA and management of contributory factors; not classified as severe if symptoms markedly improve when adherence/technique are addressed

Tezepelumab (Tezspire) — drug definition and FDA indication age

Drug class and targetMonoclonal antibody targeting thymic stromal lymphopoietin (TSLP)

Brand and generic nameTezspire (tezepelumab)

FDA-indicated minimum ageAged 12 years and older for severe asthma and for inadequately controlled CRSwNP

Not indicated forRelief of acute bronchospasm or status asthmaticus