ModifiedPremera BluecrossPolicy 5.01.627

Thymic Stromal Lymphopoietin (TSLP) Inhibitors (Tezspire — tezepelumab‑ekko)

Medical and pharmacy policy governing coverage, site-of-service medical necessity, and criteria for tezepelumab-ekko (Tezspire) for severe asthma and chronic rhinosinusitis with nasal polyposis for Premera Blue Cross members. Affects providers requesting authorization for administration and site-of-care reviews.

Policy Summary

PayerPremera Bluecross

PolicyThymic Stromal Lymphopoietin (TSLP) Inhibitors (Tezspire)

Policy CodePolicy 5.01.627

Change TypeCoverage criteria revised and additions (prescriber requirement, diagnostic alternatives, site-of-service review)indication expanded to CRSwNP

Effective DateDec 1, 2025

Next Review Date

Key ActionObtain prior authorization and document prescriber specialty and diagnostic criteria (exacerbation history or lung-function thresholds) to support approval.

SourceLink

POLICY UPDATE CHANGES

Included a prescriber requirement.

Diagnostic criteria expanded to include alternative: one or more asthma exacerbations requiring hospitalization, ED visit or urgent care in prior 12 months and FEV1 <80% predicted.

Medications in this policy are subject to the product's FDA dosage and administration prescribing information; nonformulary exception authorizations may be approved up to 12 months.

Asthma coverage criteria changed from using maximum doses of an inhaled corticosteroid to using maximum tolerated doses.

Added FEV1/FVC <0.80 and asthma that worsens upon tapering of oral corticosteroid therapy as an alternative criterion.

Added site of service review for Tezspire and clarified Site of Service Medical Necessity criteria can apply to injection drugs.

Updated coverage to include certain individuals with chronic rhinosinusitis with nasal polyposis.

Standardization edits: removed trademarks from brand products and changed 'patient' to 'individual'.

Trek Health ingests and normalizes Transparency in Coverage data and payer policy updates to give provider organizations a clear view of how commercial reimbursement behaves across markets, payers, and services. Our platform transforms raw payer disclosures into structured intelligence that supports contract evaluation, payer negotiations, and service line strategy. By combining market benchmarks with ongoing policy visibility, Trek helps teams identify variability, risk, and opportunity in commercial reimbursement. The result is faster insight, stronger negotiating positions, and more informed financial decisions.

Coverage Criteria for Tezspire (tezepelumab-ekko)

Initial coverage for severe asthma

Tezspire (tezepelumab-ekko) may be considered medically necessary as add-on maintenance treatment when ALL of the following are met:

Age: Individual is aged 12 years or older (indication) and age 13+ for site-of-service medical necessity

Age thresholds differ for coverage vs site-of-service review

Asthma severity criteria (one required): Two or more asthma exacerbations in the previous 12 months requiring oral or injectable corticosteroids OR one or more exacerbations requiring hospitalization, emergency department, or urgent care visit in the prior 12 months AND FEV1 <80% predicted OR FEV1 <80% predicted OR FEV1/FVC <0.80 OR asthma that worsens upon tapering of oral corticosteroid therapy

Any one of these alternatives suffices; prescriber requirement and diagnostic alternatives updated per policy history

Optimized baseline therapy: Using maximum tolerated doses of an inhaled corticosteroid AND using an inhaled long-acting beta-agonist (LABA)

Policy updated to require maximum tolerated ICS dosing rather than maximum doses

Concomitant biologics exclusion: Tezspire is not to be used in combination with Dupixent (dupilumab), Cinqair (reslizumab), Fasenra (benralizumab), Nucala (mepolizumab), or Xolair (omalizumab) when those medications are being used for the treatment of asthma

Concurrent use for the same indication is prohibited

Prescriber: Prescribed by or in consultation with an allergist/immunologist or pulmonologist

Prescriber requirement added effective January 3, 2025

Dose: Maintenance dose prescribed is 210 mg every 4 weeks

Initial coverage for CRSwNP

Tezspire may be considered medically necessary for inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP) when ALL of the following are met:

Age: Individual is aged 12 years or older

Diagnosis: Diagnosed with inadequately controlled bilateral chronic rhinosinusitis with nasal polyposis (CRSwNP) with symptoms such as facial pressure/pain, moderate to severe nasal congestion/obstruction, or significant loss of smell

Prior therapies: Adequate trial and failure of one intranasal corticosteroid monotherapy AND either prior systemic corticosteroids for nasal polyps in the last 2 years OR previous surgical removal of bilateral nasal polyps

Concomitant therapy: Tezspire is prescribed in combination with an intranasal corticosteroid

Site-of-service medical necessity

Site-of-service medical necessity rules for infusion/injection administration (medical benefit reviews):

Medically necessary sites: Physician's office OR outpatient infusion center OR home infusion (when available)

Preferred medically necessary sites

Hospital outpatient setting (initial/complex cases): Hospital-based outpatient clinical level of care is medically necessary for the first 90 days for the initial course of infusion/injection or re-initiation after ≥6 months, or when no outpatient infusion center is available within 50 miles and no contracted home infusion agency will travel, or when the individual's clinical condition increases infusion risk (e.g., significant cardiac or pulmonary disease, unstable renal function, difficult vascular access, cognitive issues, or history of severe adverse reactions/anaphylaxis)

Also applicable for higher-risk clinical scenarios

Authorization durations and re-authorization

Authorization durations and re-authorization criteria:

Initial authorization duration: Initial reviews may be approved up to 6 months; non-formulary exception reviews may be approved up to 12 months

Re-authorization may be approved up to 12 months if drug-specific criteria are met and chart notes document ongoing positive clinical response (as specified per diagnosis)

Chart notes should document decreases in exacerbations, ER/urgent care visits/hospitalizations, reduced corticosteroid requirement, improved symptoms or quality of life for asthma; for CRSwNP, decreased polyp size and congestion

Initial Therapy

Covered when ALL of the following are met

Eligibility: Individual is aged 12 years or olderage >= 12 years

Severity and prior therapy: History of severe asthma with inadequate control despite regular treatment with medium or high-dose inhaled corticosteroid (using maximum tolerated dose) plus at least one additional asthma controller (with or without oral corticosteroids)use of medium/high-dose ICS + >=1 controller

Policy updated to require maximum tolerated ICS dosing rather than maximum dose

Exacerbation/Function alternatives: Must meet one of the diagnostic alternatives: (A) History of >=2 exacerbations requiring systemic corticosteroids or >=1 exacerbation resulting in hospitalization in the prior 12 months OR (B) One or more exacerbations requiring hospitalization, ED, or urgent care in the prior 12 months AND FEV1 <80% predicted OR (C) FEV1/FVC <0.80 and asthma worsens upon tapering of oral corticosteroid therapy

Any uses not specifically outlined in this policy are considered investigational and are not covered under the criteria set forth for Tezspire (tezepelumab‑ekko).

Medications in this policy, including Tezspire (tezepelumab‑ekko), are subject to the product's FDA dosage and administration prescribing information. Uses outside the FDA‑approved dosing and administration are not covered unless a nonformulary exception is reviewed and approved; nonformulary exception authorizations may be approved for up to 12 months per policy update.

Hospital‑based outpatient settings are considered not medically necessary for infusion and injectable therapy services when the site‑of‑service criteria in this policy are not met. The policy identifies preferred medically necessary sites (physician office, outpatient infusion center, or home infusion when appropriate) and limits hospital‑based outpatient use to situations defined elsewhere in the Site‑of‑Service Medical Necessity criteria (for example, initial complex courses or specific clinical risk factors).

In the SOURCE trial evaluating tezepelumab for maintenance oral corticosteroid (OCS) reduction, tezepelumab did not demonstrate a statistically significant reduction in maintenance OCS dose compared with placebo (cumulative OR = 1.28; 95% CI 0.69, 2.35); therefore use solely for OCS dose reduction without meeting other policy criteria is not supported by that trial's results.

Initial Therapy Criteria

Initial Authorization

Initial authorization for Tezspire requires documentation of severe asthma and previous treatment failure.

Age and trial background: Age >=12 and history consistent with trial populations (e.g., ACQ-6 >=1.5 at screening and reduced lung function such as pre-bronchodilator FEV1 below 80% predicted in adults or below 90% predicted in adolescents) where applicableage >=12; ACQ-6 >=1.5 optional per trial reference

Trials required history of ≥2 exacerbations or ≥1 hospitalization in prior 12 months and background medium/high-dose ICS + ≥1 controller

Continuation / re-authorization criteria

Re-authorization requires documentation of continued benefit.

Asthma response metrics: Decrease in exacerbation frequency, emergency/urgent care visits, or hospitalizations OR decrease in corticosteroid requirement OR decrease in frequency/severity of asthma symptoms OR increase in quality-of-life measures/ability to perform activities of daily living

Continuation and Re-authorization Criteria

Continuation Therapy

Continuation/maintenance considerations

Efficacy monitoring: Clinical benefit may be inferred from reductions in exacerbation rate and improvements in ACQ-6 and AQLQ responder rates; continuation should be based on maintained clinical response as documented by the prescriber and consistent with product labelingclinical benefit observed

Trials (PATHWAY, NAVIGATOR) demonstrated reduced exacerbations and improved PROs over 52 weeks

Continuation / re-authorization

Re-authorization requires documentation of continued benefit and adherence to documentation requirements in the policy.

Clinical response documentation: Chart notes document ongoing positive clinical response as evidenced by decreases in exacerbations, ER/urgent care visits, hospitalizations, or corticosteroid requirement; or improved symptoms/quality of life for asthma; for CRSwNP, decreased polyp size and congestion

Provider Actions and Documentation Requirements

Prior Authorization

Authorization requirement and duration

Prior authorization is required for Tezspire (tezepelumab‑ekko). Initial authorizations for non‑formulary exception reviews may be approved for up to 12 months. All other initial authorizations may be approved up to 6 months. Re‑authorization (continuation) reviews — including non‑formulary exception and all other reviews — may be approved for up to 12 months when drug‑specific coverage criteria are met and documentation demonstrates continued positive clinical response.

Initial authorization: non‑formulary exception reviews — up to 12 months
Initial authorization: all other reviews — up to 6 months
Re‑authorization/continuation: up to 12 months with documentation of clinical response

Billing Rule

Prior authorization and coding

Coding and Clinical Thresholds

HCPCS codesHCPCS

J2356

Injection, tezepelumab‑ekko (Tezspire), 1 mg

HCPCS codes referencedHCPCS

J2356	Tezepelumab injection, 1 mg (HCPCS listed in policy history)
J3590	Unlisted biologic (previously used to report Tezspire; removed 07/01/22)

inv-12: FEV1 percent predicted

ThresholdFEV1 less than 80% predicted

Adolescent adjustmentPolicy notes FEV1 <90% predicted for adolescents in some thresholds (policy distinguishes adult vs adolescent values)

Role in diagnostic alternativesFEV1 <80% predicted can satisfy the lung-function alternative for meeting coverage when paired with exacerbation history

inv-13: FEV1/FVC ratio

ThresholdFEV1/FVC ratio less than 0.80

Use as alternative criterionFEV1/FVC <0.80 may be used as an alternative diagnostic criterion when asthma worsens upon tapering oral corticosteroids

Step Therapy Positioning

Step	Requirement
1
Tezspire used as add-on maintenance after optimization of inhaled therapy: individual is using maximum tolerated doses of an inhaled corticosteroid AND an inhaled long‑acting beta‑agonist (LABA); tezepelumab is not used in combination with Dupixent, Cinqair, Fasenra, Nucala, or Xolair when those medications are used for asthma; prescribed by or in consultation with an allergist/immunologist or pulmonologist; dose 210 mg every 4 weeks.

Step

Requirement

Tezspire used as add-on maintenance after optimization of inhaled therapy: individual is using maximum tolerated doses of an inhaled corticosteroid AND an inhaled long‑acting beta‑agonist (LABA); tezepelumab is not used in combination with Dupixent, Cinqair, Fasenra, Nucala, or Xolair when those medications are used for asthma; prescribed by or in consultation with an allergist/immunologist or pulmonologist; dose 210 mg every 4 weeks.

Step	Failure / Inadequate response required
1
Failure of or inadequate response to standard controller therapy prior to approval of tezepelumab: inadequate control despite regular treatment with medium or high‑dose inhaled corticosteroid (using maximum tolerated dosing) plus at least one additional controller (with or without oral corticosteroids), or clinical need demonstrated by exacerbation history or abnormal lung function per policy (e.g., ≥2 exacerbations requiring systemic corticosteroids or ≥1 exacerbation requiring hospitalization/ED/urgent care in prior 12 months; or FEV1 <80% predicted; or FEV1/FVC <0.80 with asthma that worsens on tapering oral corticosteroids).

Step

Failure / Inadequate response required

Failure of or inadequate response to standard controller therapy prior to approval of tezepelumab: inadequate control despite regular treatment with medium or high‑dose inhaled corticosteroid (using maximum tolerated dosing) plus at least one additional controller (with or without oral corticosteroids), or clinical need demonstrated by exacerbation history or abnormal lung function per policy (e.g., ≥2 exacerbations requiring systemic corticosteroids or ≥1 exacerbation requiring hospitalization/ED/urgent care in prior 12 months; or FEV1 <80% predicted; or FEV1/FVC <0.80 with asthma that worsens on tapering oral corticosteroids).

Site of Care and Site-of-Service Review

Note

Medically necessary sites: office, infusion center, home; hospital outpatient limited

Preferred medically necessary administration sites are physician office, outpatient infusion center, or home infusion when appropriate; hospital‑based outpatient is medically necessary for the initial 90 days of an infusion course, for re‑initiation after ≥6 months, or when no infusion center/home infusion is available or clinical risk factors increase infusion risk.

Physician office
Infusion center
Home infusion (when available)
Hospital outpatient (limited conditions: initial 90 days, re‑initiation after ≥6 months, no infusion center within 50 miles/no travel home infusion, or increased clinical risk)

Note

Site‑of‑service review applies to infusion center, office, other injection settings

Policy includes a site‑of‑service review for Tezspire; ensure administration setting (infusion center, physician office, or other injection setting) complies with the Site of Service Medical Necessity criteria to avoid denials.

Background

Asthma is a variable inflammatory airway disease; severe asthma refers to disease that remains uncontrolled despite adherence, good inhaler technique, and maximal optimized inhaled controller therapy (including high‑dose inhaled corticosteroid plus an additional controller). Thymic stromal lymphopoietin (TSLP) is an upstream cytokine that activates multiple downstream inflammatory pathways; blocking TSLP with tezepelumab has been shown to reduce inflammatory markers and improve clinical outcomes in trials of severe asthma and in certain individuals with chronic rhinosinusitis with nasal polyposis (CRSwNP).

Key Definitions

inv-24: Severe asthma

DefinitionSevere asthma: asthma that remains uncontrolled despite adherence, good inhaler technique, and maximal optimized high‑dose ICS‑LABA therapy and management of contributory factors, or that worsens when high-dose treatment is decreased

Typical featuresOften requires medium or high-dose inhaled corticosteroids plus at least one additional controller and may have recurrent exacerbations

Mechanism noteTSLP inhibition (tezepelumab) targets upstream inflammatory pathways and is an option for severe asthma

inv-25: Site of service (SOS)

Medically necessary sites (preferred)Physician's office, outpatient infusion center, or home infusion (when available)

Hospital outpatient (limited)Hospital-based outpatient clinical level of care is medically necessary for the first 90 days for initial course or re-initiation after ≥6 months, or when no infusion center within 50 miles and no home infusion available, or clinical risk increases infusion risk

Policy Summary

PayerPremera Bluecross

PolicyThymic Stromal Lymphopoietin (TSLP) Inhibitors (Tezspire)

Policy CodePolicy 5.01.627

Change TypeCoverage criteria revised and additions (prescriber requirement, diagnostic alternatives, site-of-service review)indication expanded to CRSwNP

Effective DateDec 1, 2025

Next Review Date

Key ActionObtain prior authorization and document prescriber specialty and diagnostic criteria (exacerbation history or lung-function thresholds) to support approval.

SourceLink

On This Page

Documentation Required

Clinical response documentation for re-authorization

For re‑authorization, submit chart notes demonstrating continued positive clinical response to therapy. For severe asthma this may include decreased exacerbation frequency (ER/urgent care visits, hospitalizations, or systemic corticosteroid courses), reduced symptom frequency/severity, or improved quality‑of‑life/ADL measures. For CRSwNP provide reduction in polyp size (unless surgically removed previously) and decreased nasal congestion/obstruction from baseline.

Severe asthma: decreased exacerbations, ER/urgent care visits, hospitalizations, corticosteroid use OR decreased symptom frequency/severity OR improved quality of life/ADLs
CRSwNP: decrease in nasal polyp size (unless prior surgical removal) AND decrease in nasal congestion/obstruction

Note

Use as add-on after optimized inhaled therapy

Tezspire is positioned as an add‑on maintenance therapy for individuals with inadequately controlled disease who remain symptomatic despite optimized inhaled therapy. Prior to initiation, members should be using maximum tolerated doses of an inhaled corticosteroid and an inhaled long‑acting beta‑agonist (LABA); other inhaled controller agents (e.g., leukotriene modifiers) may be used per guideline‑directed optimization.

Use only after optimization of inhaled therapy: maximum tolerated inhaled corticosteroid AND an inhaled LABA
Tezspire is an add‑on biologic option for inadequately controlled disease despite optimized inhaled regimens

Step Therapy

Step therapy positioning

Step therapy positioning: Tezspire is intended for individuals with moderate to severe persistent disease who have not achieved control with guideline‑directed inhaled therapies and other appropriate controller agents. Authorization decisions require documentation that prior, appropriate inhaled controller strategies were tried and optimized.

Policy requires documentation of prior use and optimization of guideline‑recommended inhaled controllers before biologic initiation
Applicable when members have inadequate control on prior therapies

Documentation Required

Site-of-service and prescriber requirements

Site‑of‑service reviews may apply for Tezspire and other injectable drugs; the request must specify the intended administration setting. For Alaska fully‑insured members, the SOS medical necessity criteria do not apply; see policy header for exceptions. When applicable, document prescriber specialty (allergist/immunologist or pulmonologist) and prescribed dose (e.g., 210 mg every 4 weeks where indicated).

Site‑of‑service review applies to injections like Tezspire (confirm administration site)
Alaska fully‑insured members: SOS criteria do not apply
Prescriber requirement: document specialist involvement and prescribed dose (e.g., 210 mg q4w when indicated)