CurrentAnthemPolicy CC-0212

Tezspire (tezepelumab-ekko) — Medical necessity and prior authorization criteria

Medical necessity and prior authorization criteria for Tezspire (tezepelumab-ekko) as add-on maintenance therapy in individuals aged 12 years and older with severe asthma or chronic rhinosinusitis with nasal polyps (CRSwNP); includes approval durations, quantity limits, coding, and contraindicated combinations for Anthem members governed by this policy.

Policy Summary

PayerAnthem

PolicyTezspire (tezepelumab-ekko) — coverage criteria for severe asthma and CRSwNP

Policy CodePolicy CC-0212

Change TypeRevision — added CRSwNP criteriaadded Exdensur to exclusion list

Effective Date03/26/2026

Next Review Date

Key ActionSubmit prior authorization with documentation of required criteria; quantity limited to 1 prefilled syringe/vial per 28 days.

SourceLink

POLICY UPDATE CHANGES

Added Exdensur to the list of agents that Tezspire may not be used in combination with.

Added clinical criteria for the new indication for chronic rhinosinusitis with nasal polyps (CRSwNP).

Status updated to 'Revised' and guideline references were updated.

Age ≥12Minimum age for covered indications

6 monthsInitial approval

12 monthsContinuation approval

1/28 daysQuantity limit

J2356Drug billing code

Coverage Criteria for Tezspire (tezepelumab-ekko)

Initial Therapy — Severe Asthma

Covered when ALL of the following are met for severe asthma:

Age: Individual is 12 years of age or older

Diagnosis: Individual has a diagnosis of severe asthma

Objective evidence: Pretreatment FEV1 <80% predicted AND FEV1 reversibility ≥12% and ≥200 mL after albuterolFEV1 <80% predicted; ≥12% and ≥200 mL reversibility

Based on NAEPP 2008

Prior controller therapy:

Policy Summary

PayerAnthem

PolicyTezspire (tezepelumab-ekko) — coverage criteria for severe asthma and CRSwNP

Policy CodePolicy CC-0212

Change TypeRevision — added CRSwNP criteriaadded Exdensur to exclusion list

Effective Date03/26/2026

Next Review Date

Key ActionSubmit prior authorization with documentation of required criteria; quantity limited to 1 prefilled syringe/vial per 28 days.

SourceLink

On This Page

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.

Initial Therapy — CRSwNP

Covered when ALL of the following are met for CRSwNP:

Age: Individual is 12 years of age or older

Diagnosis: Individual has a diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP)

Objective evidence: Documentation of nasal polyps demonstrated on anterior rhinoscopy OR nasal endoscopy OR computed tomography (CT)

AAO‑HNS 2025

Prior therapy: Trial and inadequate response to maintenance intranasal corticosteroids

Refractory or ineligible: Individual is refractory to or ineligible/intolerant of systemic corticosteroids OR sinonasal surgery

AAAAI/ACAAI 2014; JTFPP 2022

Add‑on therapy: Requesting Tezspire as add‑on to maintenance intranasal corticosteroids

Coding and Diagnostic Codes

HCPCSHCPCS

J2356

Injection, tezepelumab-ekko, 1 mg [Tezspire]

ICD-10 DiagnosisICD-10

J32.0-J32.9	Chronic sinusitis
J33.0-J33.9	Nasal polyp
J45.50-J45.52	Severe persistent asthma

FEV1 reversibility — objective threshold (inv-10)

FEV1 reversibility criterionIncrease in FEV1 of ≥12% AND ≥200 mL after albuterol administration

Source guidanceNAEPP 2008 as cited in policy

Context of useRequired objective evidence for initial severe asthma approval

Pretreatment FEV1 — (inv-11)

Pretreatment FEV1 thresholdPretreatment FEV1 <80% predicted

Measurement timingMeasured prior to bronchodilator (pretreatment) as part of spirometry

Role in criteriaRequired objective evidence for initial severe asthma approval

Asthma exacerbations in prior 12 months — (inv-12)

Exacerbation thresholdTwo or more asthma exacerbations in the prior 12 months requiring systemic corticosteroid use or temporary increase in maintenance oral corticosteroid dose

Policy contextOne of the required criteria for initial severe asthma coverage

ERS/ATS alignmentERS/ATS defines frequent severe exacerbations as ≥2 bursts of systemic corticosteroids in the previous year

Provider Actions, Prior Authorization, and Limits

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tezspire (tezepelumab-ekko). Requests must document age, diagnosis, objective evidence of asthma or CRSwNP, prior therapy trials, and treatment response for continuation. Quantity is limited to 1 prefilled syringe/vial per 28 days.

PA required for initial and continuation requests
Quantity limit: 1 prefilled syringe/vial per 28 days

Step Therapy

Required Prior Therapy Trials

For severe asthma initial approvals the following trials must be documented: age ≥12, diagnosis of severe asthma, objective evidence of asthma (FEV1 <80% predicted and ≥12% & 200 mL reversibility after bronchodilator), a 3-month trial with inadequate response or intolerance to combination controller therapy (high‑dose inhaled corticosteroid + long‑acting beta2‑agonist, leukotriene modifiers, LAMA or oral corticosteroids), and ≥2 asthma exacerbations in the prior 12 months requiring systemic corticosteroids or increased maintenance oral corticosteroid dose. For CRSwNP initial approvals document age ≥12, confirmed nasal polyps (anterior rhinoscopy, nasal endoscopy, or CT), trial and inadequate response to maintenance intranasal corticosteroids, and refractory/intolerant or ineligible to systemic corticosteroids or sinonasal surgery.

Severe asthma: required prior therapy trial of at least 3 months on combination controller therapy
CRSwNP: trial and inadequate response to maintenance intranasal corticosteroids; refractory/intolerant to systemic corticosteroids or sinonasal surgery

Documentation Required

Required Documentation and Denial Triggers

Documentation must include the individual’s age, diagnosis (severe asthma or CRSwNP), objective measures (pre‑treatment FEV1 and bronchodilator reversibility for asthma; documentation of nasal polyps for CRSwNP), details of prior therapies and durations, and evidence of clinical response for continuation (reduced reliever use, fewer exacerbations, improved % predicted FEV1, or reduced symptoms). Requests lacking required documentation or proposing combination use with the listed biologics/agents will be denied.

Include dates and durations of prior therapy trials and reason for failure or intolerance
For continuation, document clinical improvement on Tezspire and ongoing use with inhaled or intranasal corticosteroid maintenance therapy
Do not prescribe in combination with Cinqair, Dupixent, Exdensur, Fasenra, Nucala, or Xolair

Definitions

Definition — Severe asthma criteria (inv-18)

DefinitionAsthma requiring high‑dose inhaled corticosteroids plus an additional controller (e.g., long‑acting beta agonist, leukotriene modifier or theophylline) for the previous year to prevent uncontrolled symptoms, OR systemic corticosteroids for >50% of the prior year.

Guideline sourceERS/ATS 2013 guidance cited in policy

Clinical implicationUsed to distinguish severe asthma from milder disease when confirming diagnosis and eligibility for biologic therapy

Definition — Uncontrolled asthma (inv-19)

Uncontrolled asthma — symptom controlPoor symptom control defined as ACQ consistently >1.5 or ACT <20

Uncontrolled asthma — exacerbationsFrequent severe exacerbations: two or more bursts of systemic corticosteroids in the previous year

Uncontrolled asthma — airflow limitationPost‑bronchodilator FEV1 <80% predicted after appropriate bronchodilator withhold

Revision History and Policy Changes

2026-02-20Annual reviewLatest

Added Exdensur to the list of agents that Tezspire may not be used in combination with; guideline references updated.

2025-11-14Select review

Added clinical criteria and documentation for the new indication chronic rhinosinusitis with nasal polyps (CRSwNP); ICD-10-CM codes J32.0-J32.9 and J33.0-J33.9 were added.

2025-02-21Annual review

Updated guideline references (coding reviewed; no changes noted).

2024-02-23Annual review

Updated continuation criteria and made wording and formatting changes; guideline references updated (coding reviewed; no changes).

2023-02-24Annual review

Added a quantity limit for a new Tezspire dosage form and updated wording, formatting, and guideline references (coding reviewed; no changes).

2022-02-25Annual review

Added clinical criteria and quantity limit for Tezspire; coding changes included adding HCPCS J3590 and C9399 initially, then effective 7/1/2022 added HCPCS J2356 and removed J3590 and C9399; ICD-10-CM J45.50-J45.52 added.

OpenPayer