ModifiedCentenePolicy CP.PHAR.576

Tezepelumab-ekko (Tezspire) — Coverage Criteria

Covers medical necessity and prior authorization criteria for Tezspire as add-on maintenance treatment for patients ≥12 years with severe asthma or inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP) for Centene lines of business (Commercial, Medicaid).

Policy Summary

PayerCentene

PolicyTezepelumab-ekko (Tezspire) — Coverage Criteria

Policy CodePolicy CP.PHAR.576

Change TypeAdded CRSwNP indicationupdated dosing options and approval durations

Effective DateJun 1, 2022

Next Review Date

Key ActionSubmit prior authorization with documentation showing indication, prior exacerbation history, background controller therapy and device suitability for self-administration when requesting coverage.

SourceLink

POLICY UPDATE CHANGES

Added new dosage form (single-dose pre-filled pen) and updated Dosing and Administration to indicate the pen can be self-administered.

Revised initial approval duration for asthma for Medicaid from 6 to 12 months and for Commercial to include 'or to the member's renewal date, whichever is longer' for maintenance therapy.

Added new indication for CRSwNP per updated prescribing information.

≥2asthma exacerbations required

210 mg q4wmaximum dose

≥12minimum age

6 months

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approval duration (Commercial)

12 monthsapproval duration (Medicaid)

pre-filled penself-administration option

Coverage and Medical Necessity Criteria

Continued Therapy — CRSwNP

Continued Therapy — CRSwNP (ALL must be met):

CRSwNP continued: 1. Member currently receiving medication via Centene benefit or previously met initial approval criteria OR continuity of care applies; 2. Demonstrated adherence to an intranasal corticosteroid unless contraindicated; 3. Member is responding positively to therapy (examples: reduced nasal polyp size, reduced need for systemic corticosteroids, improved sense of smell, improved quality of life); 4. Tezspire is not prescribed concurrently with Cinqair, Dupixent, Fasenra, Nucala, or Xolair; 5. If request is for a dose increase, new dose does not exceed 210 mg every 4 weeks.

Approval duration: Medicaid 12 months; Commercial 6 months or member's renewal period, whichever is longer

Other Indications/Off-label

Other/Off-label Uses:

Other indications: 1. If the drug label recently changed within the last 6 months and the change is not yet reflected in this policy, follow the applicable no-coverage or non-formulary policy for the line of business (see CP.CPA.190, CP.PMN.255, CP.PMN.16 as applicable); 2. For requested uses not specifically listed in section III and not covered by criterion 1 above, refer to the off-label use policy for the relevant line of business: CP.CPA.09 (commercial) and CP.PMN.53 (Medicaid).

Non-FDA approved indications not addressed in this policy require sufficient documentation per off-label policies

Initial Therapy - CRSwNP

Covered when criteria for CRSwNP are met per updated prescribing information:

CRSwNP indication - summary: Patient has chronic rhinosinusitis with nasal polyps consistent with prescribing information and policy updates, AND dosing planned as 210 mg subcutaneously every 4 weeks, AND provider documents prior treatments per local practice/guidelines (including prior intranasal corticosteroid trials and systemic corticosteroid history).

RT4 added CRSwNP indication

Dosage and Administration

Administration: Dosing: 210 mg subcutaneously once every 4 weeks. The single-dose vial and pre-filled syringe are intended for administration by a healthcare provider. The single-dose pre-filled pen may be administered by patients/caregivers or healthcare providers. Product availability includes single-dose vial, single-dose pre-filled syringe, and single-dose pre-filled pen (each 210 mg).

Maximum dose: 210 mg every 4 weeks

Coverage is NOT authorized for treatment of acute bronchospasm or status asthmaticus. Tezepelumab-ekko is indicated as an add‑on maintenance therapy and is not appropriate for management of acute, life‑threatening bronchospastic events.

Requests for uses that are non‑FDA approved and are not specifically addressed in this policy will not be covered unless the provider submits sufficient documentation of efficacy and safety in accordance with the applicable off‑label use policies: CP.CPA.09 for commercial plans and CP.PMN.53 for Medicaid.

Known hypersensitivity to tezepelumab‑ekko or any of its excipients is a contraindication and is exclusionary for therapy with this agent.

What Providers Must Do

Prior Authorization

Prior Authorization Required

Prior authorization is required. Requests must demonstrate the member meets the applicable initial or continuation criteria for the requested indication (see Initial Approval Criteria and Continued Therapy sections).

Prior authorization required for Tezspire (tezepelumab) per CP.PHAR.576
Approval durations vary by line of business and indication (see policy for Medicaid vs Commercial durations)

Prior Authorization

Prior Authorization and Approval Duration

Approval durations and dosing limits must be verified against the indication. Dosing for both asthma and CRSwNP is 210 mg subcutaneously every 4 weeks; approval durations differ by plan and indication.

Dose limit: 210 mg every 4 weeks
Approval duration: Medicaid — 12 months for continued therapy; Commercial — 6 months or member's renewal period, whichever is longer (see policy details)

Billing and Coding

HCPCS CodesHCPCS

J2356

Injection, tezepelumab-ekko, 1 mg

PDC adherence threshold (proportion)

Threshold>= 0.8 proportion of days covered (PDC) in the last 6 months

TimeframeLast 6 months (180 days)

Clinical useRequired to demonstrate adherence to asthma controller therapy for continued therapy criteria

PDC adherence threshold (days equivalent)

Equivalent days coveredAt least 144 of 180 days (≈5 of last 6 months) to meet PDC >= 0.8

Calculation basisPDC = days covered ÷ days in timeframe (144 ÷ 180 = 0.8)

Intended use

Clinical Background

Tezepelumab‑ekko (Tezspire) is a human monoclonal antibody that functions as a thymic stromal lymphopoietin (TSLP) blocker and is indicated as an add‑on maintenance treatment for patients aged ≥12 years with severe asthma and for inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP). It is intended for maintenance use and is not indicated for acute bronchospasm or status asthmaticus. Known hypersensitivity to the drug or its excipients is a contraindication to treatment.

Definitions and Terms

Tezepelumab-ekko (Tezspire) — definition & mechanism

Generic name / brandTezepelumab-ekko (Tezspire)

Drug class / typeHuman monoclonal antibody (IgG2 λ)

Mechanism of actionThymic stromal lymphopoietin (TSLP) blocker

Indications (per FDA)Add-on maintenance treatment for patients ≥12 years with severe asthma and for inadequately controlled CRSwNP

PDC — definition and usage

DefinitionProportion of days covered (PDC): pharmacy adherence metric equal to days covered divided by days in the timeframe.

Clinical role

Policy Revision History

2023-02-23operational

Added new dosage form: single-dose pre-filled pen and updated Dosing and Administration to indicate the pen can be self-administered.

2025-11-18clinicalLatest

Added new clinical indication: chronic rhinosinusitis with nasal polyposis (CRSwNP) per updated prescribing information.

Policy Summary

PayerCentene

PolicyTezepelumab-ekko (Tezspire) — Coverage Criteria

Policy CodePolicy CP.PHAR.576

Change TypeAdded CRSwNP indicationupdated dosing options and approval durations

Effective DateJun 1, 2022

Next Review Date

SourceLink

On This Page

Prior Authorization

Concurrent and Prior Therapy Requirements

Concurrent background controller therapies are required for coverage. For severe asthma, Tezspire must be prescribed with an inhaled corticosteroid plus either a long-acting beta-2 agonist (LABA) or a leukotriene modifier (LTRA). For CRSwNP, Tezspire must be prescribed with an intranasal corticosteroid.

Severe asthma: concurrent ICS + (LABA or LTRA) required
CRSwNP: concurrent intranasal corticosteroid required

Note

Therapy Positioning

Tezspire is positioned as adjunctive therapy for uncontrolled severe asthma despite optimized maximal therapy and for CRSwNP meeting specified criteria. Requests should show the member remains symptomatic despite appropriate background therapy.

Referenced GUIDELINES: GINA recommends tezepelumab as adjunct therapy for patients ≥12 with uncontrolled severe asthma despite optimized therapy

Documentation Required

Supporting Documentation Required

Provider must submit supporting clinical documentation to validate that the member meets all approval criteria. Acceptable documentation includes office chart notes, relevant laboratory results, pulmonary function testing, documentation of exacerbations or ER/hospital visits, and medication fill/adherence records.

Submit office notes, labs, PFTs, ER/hospital records, and prior authorization history when applicable
If self-administration is requested, submit documentation of patient/caregiver training and competency

Documentation Required

Required Clinical Documentation

Requests must include the indication, prior exacerbation history, details of controller therapy usage (including adherence/PDC when applicable), and documentation of clinical response for continuation requests. For CRSwNP include documentation of intranasal corticosteroid trials and systemic corticosteroid use within the prior 2 years when applicable.

Indication and prescriber specialty (allergist, immunologist, pulmonologist, or otolaryngologist as applicable)
For asthma: ≥2 exacerbations in past 12 months despite controller therapy, or evidence of prior approval/continuity of care
For CRSwNP: bilateral nasal polyps, ≥12 weeks of symptoms, prior use of systemic corticosteroids within 2 years, failure of two intranasal corticosteroids (one must be Xhance™ in adults) unless contraindicated
Adherence evidence: PDC ≥ 0.8 for asthma controller therapy (≈144 of last 180 days)
If request involves dose change or self-administration, include rationale and training documentation

Denial Risk

Documentation and Indication Risks

Lack of required documentation or requests for non‑FDA indications without sufficient evidence may result in denial. Use applicable off‑label policies for non‑FDA uses. Requests that do not meet prescriber, age, dosing, concurrent therapy, or exacerbation criteria risk denial.

Non‑FDA approved indications require sufficient supporting evidence per CP.CPA.09 (commercial) or CP.PMN.53 (Medicaid)
California Exchange Plans: follow HIM.PA.176 criteria rather than this policy where indicated
Inadequate documentation of exacerbations, controller therapy adherence, prescriber specialty, or concurrent therapy may lead to denial

Billing Rule

Coding Inclusion Disclaimer

Coding information is provided for reference only. Inclusion or exclusion of codes does not guarantee coverage; verify current coding guidance prior to claim submission.

HCPCS: J2356 — Injection, tezepelumab-ekko, 1 mg
Codes are informational; confirm with up-to-date professional coding resources

Used to demonstrate adherence to asthma controller therapy for continued approval

Used as evidence of adherence to asthma controller therapy (ICS plus LABA or LTRA) for continued therapy criteria.

Acronym referencePDC listed in Appendix A: Abbreviation/Acronym Key

PDC calculation example

PDC threshold examplePDC >= 0.8 corresponds to receiving controller therapy for at least 144 of the last 180 days (~5 of 6 months)

FormulaPDC = (days covered in timeframe) ÷ (number of days in timeframe); e.g., 144 ÷ 180 = 0.8

Use caseApplied to assess adherence for continued approval of tezepelumab in severe asthma

Asthma exacerbation (trial definition)

Operational definitionClinically significant asthma exacerbation defined as worsening requiring use of or increase in oral or injectable corticosteroids for ≥3 days, or a single depo-injection of corticosteroids, and/or emergency department visits requiring corticosteroids, and/or hospitalization.

Trial contextDefinition used as the primary endpoint marker in the NAVIGATOR phase 3 pivotal study.

RelevanceUsed to establish prior exacerbation history required for initial approval (e.g., ≥2 in prior 12 months).