ModifiedPremera BluecrossPolicy N/A

Thymic Stromal Lymphopoietin (TSLP) Inhibitors (Tezspire)

Medical necessity, site-of-service, and coverage criteria for tezepelumab-ekko (Tezspire) as an add-on maintenance treatment for severe asthma and for chronic rhinosinusitis with nasal polyposis in members of Premera Bluecross plans, including site-of-service review for ages 13 and older.

Policy Summary

PayerPremera Bluecross

PolicyThymic Stromal Lymphopoietin (TSLP) Inhibitors (Tezspire)

Policy CodePolicy N/A

Change TypeCoverage criteria and administration updates (material changes included)

Effective DateApr. 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document specialist prescribing and required prior inhaled therapy; initial approvals may be up to 12 months.

SourceLink

POLICY UPDATE CHANGES

Included a prescriber requirement effective January 3, 2025.

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

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

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

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

Updated initial approval length for all other reviews from 6 months to 12 months.

Added FEV1/FVC <0.80 and asthma that worsens upon tapering OCS as an option to meet coverage criteria.

Updated Tezspire coverage criteria to include chronic rhinosinusitis with nasal polyposis.

210 mg q4wdose limit

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Coverage Criteria for Tezspire (tezepelumab-ekko)

Initial therapy criteria (asthma and CRSwNP)

Tezspire (tezepelumab‑ekko) is considered medically necessary when the following criteria are met for the indicated diagnosis.

Severe asthma initial therapy: Individual is aged 12 years or older AND meets ONE of: 2 or more asthma exacerbations in the previous 12 months requiring oral or injectable corticosteroids OR 1 or more asthma exacerbations in the previous 12 months resulting in hospitalization, emergency department, or urgent care visit OR pre‑bronchodilator FEV1 less than 80% predicted OR FEV1/FVC < 0.80 OR asthma that worsens upon tapering of oral corticosteroid therapy; AND is using maximum tolerated doses of an inhaled corticosteroid AND is using an inhaled long‑acting beta‑agonist (LABA); AND Tezspire is not 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; AND prescribed by or in consultation with an allergist, immunologist, or pulmonologist; AND dose limited to 210 mg every 4 weeks.dose 210 mg q4w

CRSwNP initial therapy: Individual is aged 12 years or older AND has inadequately controlled bilateral chronic rhinosinusitis with nasal polyposis AND has at least 2 of: facial pressure or pain, moderate to severe nasal congestion or obstruction (etc.); AND has had an adequate trial and failure of 1 intranasal corticosteroid as monotherapy AND has either prior systemic corticosteroids for nasal polyps in the last 2 years OR previous surgical removal of bilateral nasal polyps; AND Tezspire is prescribed in combination with an intranasal corticosteroid AND Tezspire is not used in combination with Dupixent (dupilumab), Nucala (mepolizumab), or Xolair (omalizumab) when those medications are being used for CRSwNP; AND prescribed by or in consultation with an allergist, immunologist, or otolaryngologist; AND dose limited to 210 mg every 4 weeks.

Length of approval and re-authorization

Approval duration and re-authorization

Approval length and reauthorization: Initial authorization may be approved up to 12 months. Re‑authorization may be approved up to 12 months provided drug‑specific coverage criteria are met and chart notes demonstrate continued positive clinical response: for severe asthma — decreased exacerbation frequency, ER/urgent care visits, hospitalizations, or corticosteroid requirement OR decreased symptom frequency/severity OR improved quality‑of‑life; for CRSwNP — decrease in nasal polyp size (unless previously removed), decrease in nasal congestion/obstruction, and improvement in sense of smell.12 months

Site-of-service (SOS) criteria

Site-of-service medical necessity criteria (applies to medical benefit reviews; SOS criteria do not apply to Alaska fully‑insured members)

Medically necessary sites: Preferred medically necessary sites include physician's office, outpatient infusion center, and home infusion (where applicable). Hospital‑based outpatient setting (outpatient hospital IV infusion department) is considered medically necessary for the initial 90 days or when indicated as described below.

SOS applies for ages 13+ for site‑of‑service review

Hospital‑based outpatient necessary conditions: Hospital‑based outpatient setting is considered medically necessary when no outpatient infusion center is within 50 miles and no contracted home infusion agency will travel to the home, OR the hospital is the only place offering the drug, OR the individual has a clinical condition increasing infusion/injection risk (e.g., known cardiac or significant pulmonary disease, unstable renal function, difficult vascular access, acute mental status changes, or history of severe adverse reactions/anaphylaxis). Also considered medically necessary for grade 3 or 4 cytokine release syndrome when inpatient admission is planned and physiologic criteria (fever ≥38°C, hypotension requiring vasopressors, or hypoxia requiring high‑flow/positive pressure ventilation) are present.

Also medically necessary when criteria in policy are met

Initial therapy coverage criteria

Covered when ALL of the following are met

Population and baseline therapy: Individual is ≥ 12 years with severe asthma and on regular treatment with medium or high‑dose inhaled corticosteroids plus at least one additional controller (with or without oral corticosteroids). Background therapy should be continued during treatment.age >=12; background therapy: medium/high‑dose ICS + >=1 controller

Reflects trial enrollment and policy step‑therapy requirement

Exacerbation history or functional criteria: One of the following must be present: (1) history of ≥2 asthma exacerbations in the past 12 months requiring oral or injectable corticosteroids or resulting in hospitalization; OR (2) one or more exacerbations requiring hospitalization/ED/urgent care in the previous 12 months AND pre‑bronchodilator FEV1 <80% predicted; OR (3) FEV1/FVC <0.80 and asthma that worsens upon tapering of oral corticosteroid therapy.exacerbation counts and lung function thresholds as specified

Diagnostic alternatives added in policy updates

Limitations of benefit — Not covered / limited efficacy statements

Not covered / limited efficacy

OCS‑sparing efficacy: Tezepelumab did not demonstrate a statistically significant reduction in maintenance oral corticosteroid dose compared with placebo in the OCS‑dependent trial (cumulative OR=1.28; 95% CI 0.69, 2.35).SOURCE trial results: cumulative OR=1.28 (95% CI 0.69, 2.35)

Policy notes limited evidence for OCS dose reduction

All other uses of tezepelumab-ekko (Tezspire) that are not specifically described in this policy are considered investigational. The medications addressed in this policy are subject to the product’s FDA-approved dosage and administration information; requests for indications outside the policy criteria should be treated as non-covered investigational uses unless otherwise authorized.

Providers should reference the specific coverage criteria for severe asthma and chronic rhinosinusitis with nasal polyposis in this policy when determining medical necessity; therapies or indications not enumerated in those sections do not meet coverage criteria.

This medical policy does not apply to Medicare Advantage members. Coverage for Medicare Advantage members is subject to the limits and conditions of the member’s benefit plan; providers and members should consult the member benefit booklet or contact customer service to determine whether any benefit limitations apply.

In addition, member contracts vary. Even when policy criteria are met, coverage remains subject to applicable member benefit plan provisions and exclusions described in the member’s contract.

Tezspire (tezepelumab-ekko) must not be used concomitantly with other biologic therapies when those agents are being used for the same indication. For asthma, concurrent use with Dupixent (dupilumab), Cinqair (reslizumab), Fasenra (benralizumab), Nucala (mepolizumab), or Xolair (omalizumab) is disallowed and may trigger denial.

For CRSwNP (chronic rhinosinusitis with nasal polyposis), concurrent use with Dupixent (dupilumab), Nucala (mepolizumab), or Xolair (omalizumab) when those medications are used for CRSwNP is disallowed and may trigger denial.

Use of tezepelumab solely for the purpose of reducing maintenance oral corticosteroid (OCS) dose is not supported by the available trial evidence. In the dedicated OCS-dependent trial, 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), and therefore using Tezspire only as an OCS-sparing strategy is not considered medically necessary under this policy.

Coding and Dose Thresholds

HCPCSHCPCSCovered

J2356

Injection, tezepelumab-ekko (Tezspire), 1 mg

Historical/Unlisted HCPCSHCPCS

J3590

Unlisted biologic HCPCS code (previously used to report Tezspire)

Covered HCPCS CodesHCPCSCovered

J2356

HCPCS code added to report Tezspire

High Dose Regimens of Inhaled Corticosteroids

Beclomethasone HFA (Qvar) — high dose>320 mcg/day

Budesonide DPI (Pulmicort Flexhaler) — high dose>720 mcg/day

Ciclesonide HFA (Alvesco) — high dose>320 mcg/day

Fluticasone propionate HFA (Flovent HFA) — high dose>440 mcg/day

Mometasone DPI (Asmanex) — high dose>440 mcg/day

Age

Provider Actions, Prior Authorization, and Documentation

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tezspire (tezepelumab-ekko). Initial authorizations may be approved for up to 12 months. Re-authorizations may also be approved for up to 12 months provided drug-specific coverage criteria continue to be met and documentation demonstrates continued clinical benefit.

Initial approval length: up to 12 months
Re-authorization: up to 12 months if ongoing clinical response documented

Billing Rule

Coding / Prior Authorization Codes Affected

Billing and coding updates relevant to this policy should be followed. Tezspire is assigned a specific HCPCS code for reporting.

Background and Clinical Context

Asthma is an inflammatory airway disease characterized by symptoms such as dyspnea, wheeze, chest tightness, and cough and by expiratory airflow limitation. A subset of patients have severe asthma that remains uncontrolled despite optimized inhaled corticosteroid–long-acting beta-agonist (ICS–LABA) therapy and management of contributory factors. Tezspire (a thymic stromal lymphopoietin [TSLP] inhibitor) targets an upstream cytokine to reduce airway inflammation and has been evaluated as an add-on maintenance treatment in this population.

Pivotal trials (PATHWAY and NAVIGATOR) evaluated tezepelumab’s efficacy over 52 weeks in patients with severe, uncontrolled asthma and demonstrated reductions in exacerbation rates and improvements in lung function and symptom measures. Tezspire is positioned as an add-on therapy for individuals who have not achieved control despite medium- or high-dose ICS plus at least one additional controller, and who meet the policy’s exacerbation history or lung-function criteria.

Definitions

Severe asthma definition

DefinitionSevere asthma: uncontrolled asthma with poor symptom control despite adherence to good inhaler technique and maximal optimized high-dose ICS-LABA therapy, or that worsens when high-dose treatment is decreased.

Clinical featuresMay include frequent exacerbations, reduced lung function (FEV1 <80% in adults), or worsening when tapering oral corticosteroids.

Therapeutic implicationSevere asthma is the population for which tezepelumab is considered as add-on maintenance therapy per policy criteria.

Site of service (SOS) definition

DefinitionSite of service (SOS): the location where the drug is administered (e.g., hospital-based outpatient setting, infusion center, physician's office, or at home).

Policy application

Policy Summary

PayerPremera Bluecross

PolicyThymic Stromal Lymphopoietin (TSLP) Inhibitors (Tezspire)

Policy CodePolicy N/A

Change TypeCoverage criteria and administration updates (material changes included)

Effective DateApr. 1, 2026

Next Review DateN/A

Key ActionObtain prior authorization and document specialist prescribing and required prior inhaled therapy; initial approvals may be up to 12 months.

SourceLink

On This Page

Documentation Required

Re-authorization — Evidence of Clinical Response Required

For re-authorization, chart notes must document continued clinical response to therapy. Requirements differ by diagnosis and must include objective or patient-reported improvements compared to baseline.

Severe asthma: documentation of decreased exacerbation frequency, ER/urgent care visits or hospitalizations, or reduced requirement for corticosteroids; OR decreased frequency/severity of asthma symptoms; OR improved quality-of-life and ability to perform activities of daily living.
CRSwNP: documentation of decreased nasal polyp size from baseline (unless prior surgical removal), decreased nasal congestion/obstruction from baseline, and improved sense of smell from baseline.

Clinically significant asthma exacerbation definition

DefinitionClinically significant asthma exacerbation: worsening of asthma requiring use of or increase in oral or injectable corticosteroids for at least 3 days, or a single depo-injection of corticosteroids, and/or emergency department visits requiring corticosteroids and/or hospitalization.

Use in coverage criteriaExacerbation history (counts or events meeting this definition) is required to meet initial therapy coverage criteria for severe asthma.

Trial endpointThis definition was the primary endpoint measure for PATHWAY and NAVIGATOR over 52 weeks.