CurrentBlue Cross Blue Shield - IowaPolicy 05.04.59

Tezspire (tezepelumab-ekko) for severe asthma

Covers prior authorization criteria, dosing limits, documentation and billing codes for tezepelumab (Tezspire) use as add-on maintenance therapy in patients aged 12 years and older with severe asthma for Wellmark Blue Cross and Blue Shield members.

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyTezspire (tezepelumab-ekko) for severe asthma

Policy CodePolicy 05.04.59

Change TypeNo material changes

Effective DateJan 1, 2026

Next Review Date

Key ActionSubmit prior authorization with chart notes or claims history documenting prior medications tried and, for continuation requests, documentation of improved asthma control.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12Minimum age for coverage

210 mg/28dFDA-recommended dosing

1/28dQuantity limit per formulation

6/12 moTypical auth durations (initial/cont)

Medical Necessity Criteria for Tezspire (tezepelumab-ekko)

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Initial authorization 97 severe asthma (6 months)

Authorization of 6 months may be granted when ALL of the following are met:

Member is 12 years of age or older

ANY of the following

Two or more asthma exacerbations requiring oral or injectable corticosteroid treatment
One or more asthma exacerbation resulting in hospitalization or emergency medical care visit
Poor symptom control (frequent symptoms or reliever use, activity limited by asthma, night waking due to asthma)

ALL of the following

Medium-to-high dose inhaled corticosteroid
Additional controller (e.g., long-acting beta2-agonist, long-acting muscarinic antagonist, leukotriene modifier, or sustained-release theophylline)

Member will continue to use maintenance asthma treatments (e.g., inhaled corticosteroid, additional controller) in combination with Tezspire

Member will not use Tezspire concomitantly with other biologics indicated for asthma (e.g., Cinqair, Dupixent, Fasenra, Nucala, Xolair)

Continuation authorization 97 severe asthma (12 months)

Authorization of 12 months may be granted when ALL of the following are met:

Member is 12 years of age or older

ANY of the following

A reduction in the frequency and/or severity of symptoms and exacerbations
A reduction in the daily maintenance oral corticosteroid dose

Member will continue to use maintenance asthma treatments (e.g., inhaled corticosteroid, additional controller) in combination with Tezspire

Member will not use Tezspire concomitantly with other biologics indicated for asthma (e.g., Cinqair, Dupixent, Fasenra, Nucala, Xolair)

Not medically necessary

Tezspire is considered not medically necessary when the criteria above are not met:

ANY of the following

Member does not meet the age requirement (under 12 years)
Member does not have documentation of uncontrolled asthma as defined
Member has not failed/been intolerant to medium-to-high dose inhaled corticosteroid plus an additional controller at maximally tolerated doses
Member is using Tezspire concomitantly with another biologic indicated for asthma

Key thresholds

Minimum age>= 12 years

Dosing interval210 mg every 4 weeks

Quantity limit1 vial/syringe/pen per 28 days

Billing Codes for Tezspire

HCPCS / J-codes and unclassified codes for Tezspire billingmixedCovered

J2356	Injection, tezepelumab-ekko, 1 mg
J3590	Unclassified biologics
C9399	Unclassified drugs or biologics

HCPCS / J-codes and unclassified codes for Tezspire billingmixedCovered

J2356	Injection, tezepelumab-ekko, 1 mg
J3590	Unclassified biologics
C9399	Unclassified drugs or biologics

Billing Rule

Dosing and quantity limits for billing

Approvals may be subject to dosing limits in accordance with FDA labeling, compendia, or evidence-based practice guidelines; quantity limits apply (210 mg per dose, 1 vial/syringe/pen per 28 days; FDA‑recommended dosing 210 mg every 4 weeks).

Authorization, Documentation, and Prescriber Requirements

Prior Authorization

Prior authorization required

Prior authorization is required; submit chart notes, medical records, or claims history documenting prior medications tried (drug, dose, frequency, duration) for initial requests, and documentation of improved asthma control for continuation requests.

Documentation Required

Required documentation for initial and continuation requests

Initial requests: chart notes, medical record documentation, or claims history supporting previous medications tried including drug, dose, frequency, and duration. Continuation requests: chart notes or medical record documentation supporting improvement in asthma control.

Note

Prescriber specialty requirement

Must be prescribed by or in consultation with an Allergist/Immunologist or Pulmonologist.

Denial Risk

Denial if criteria unmet

Requests will be considered not medically necessary (denied) if the coverage criteria are not met, including age under 12 years, lack of documentation of uncontrolled asthma, failure to trial medium‑to‑high dose inhaled corticosteroid plus an additional controller at maximally tolerated doses, or concomitant use of another biologic indicated for asthma.

Clinical Context and Scope

Tezspire (tezepelumab-ekko) is an FDA-approved biologic indicated as an add-on maintenance treatment for adult and pediatric patients aged 12 years and older with severe asthma. Per the FDA-approved labeling and this policy, Tezspire is intended for maintenance therapy and is not indicated for relief of acute bronchospasm or status asthmaticus.

This policy covers prior authorization criteria, dosing limits, required documentation, prescriber specialty requirements, and applicable billing codes for Tezspire when used as add-on maintenance therapy for members aged 12 years and older with severe asthma. Initial authorizations may be granted for 6 months when all clinical criteria are met, and continuation authorizations may be granted for up to 12 months when improvement in asthma control is documented. Approvals are subject to dosing limits consistent with FDA labeling and quantity limits of one 210 mg vial/syringe/pen per 28 days. Prior authorization requires submission of chart notes or claims history documenting prior controller therapy and, for continuation requests, documentation of improved asthma control. Tezspire must be prescribed by or in consultation with an Allergist/Immunologist or Pulmonologist and must not be used concomitantly with other biologics indicated for asthma.

Additional notes & references

Dosing noteApprovals may be subject to dosing limits per FDA labeling, compendia, or evidence-based guidelines.

ReferencesTezspire [package insert] Amgen Inc.; February 2023; Global Initiative for Asthma (GINA) 2021; 2020 National Asthma Education and Prevention Program guideline update; SOURCE trial reference

Smoking/vaping noteIf the member is a current smoker or vaper, they should be counseled on cessation options.

Other noteTezspire is not indicated for relief of acute bronchospasm or status asthmaticus.

Policy Information & Metrics

Policy details

Policy number05.04.59

Effective dateJanuary 1, 2026

Last reviewOctober 2025

Next review

Scope summaryCovers prior authorization criteria, dosing limits, documentation and billing codes for tezepelumab (Tezspire) use as add-on maintenance therapy in patients aged 12 years and older with severe asthma for Wellmark Blue Cross and Blue Shield members.

12 yearsMinimum age for coverage

210 mg/28 daysFDA-recommended dosing

1 vial per 28 daysQuantity limit per formulation

6 months / 12 monthsTypical initial and continuation authorization durations

Policy Summary

PayerBlue Cross Blue Shield - Iowa

PolicyTezspire (tezepelumab-ekko) for severe asthma

Policy CodePolicy 05.04.59

Change TypeNo material changes

Effective DateJan 1, 2026

Next Review Date

Key ActionSubmit prior authorization with chart notes or claims history documenting prior medications tried and, for continuation requests, documentation of improved asthma control.

SourceLink

On This Page

OpenPayer

Tezspire (tezepelumab-ekko) for severe asthma

Medical Necessity Criteria for Tezspire (tezepelumab-ekko)

Billing Codes for Tezspire

Authorization, Documentation, and Prescriber Requirements

Clinical Context and Scope

Defined Terms

Policy Information & Metrics