Modifiedsierra health and lifePolicy 2025D0110J

Tezspire (tezepelumab-ekko) — provider‑administered therapy (Medical Benefit)

Medical benefit policy governing provider-administered Tezspire (tezepelumab-ekko) for add‑on maintenance treatment of severe asthma for eligible members; affects clinicians requesting prior authorization and medical administration under Sierra Health and Life / UnitedHealthcare Commercial plans.

Policy Summary

Payersierra health and life

PolicyTezspire (tezepelumab-ekko) — provider‑administered therapy

Policy CodePolicy 2025D0110J

Change TypeBenefit routing and combination‑therapy clarification

Effective DateDec 1, 2025

Next Review Date

Key ActionObtain prior authorization for provider‑administered Tezspire; initial and reauthorization approvals are limited to no more than 12 months and document required clinical criteria.

SourceLink

POLICY UPDATE CHANGES

Clarified that Tezspire prefilled pen for self-administration is obtained under the pharmacy benefit unless otherwise specified in the member's benefit plan documents; for certain UnitedHealthcare of California delegated reviews, self-administered Tezspire may be obtained under the medical benefit.

Revised coverage criteria by replacing criterion requiring 'the patient is not receiving Tezspire in combination with any of the [listed therapies]' with 'the patient is not receiving Tezspire in combination with any of the [listed therapies] for treatment of the same indication'.

Updated References section to reflect the most current information.

≥12minimum age for indicated use

≤12 monthsinitial auth duration

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1.2–2.4Msevere asthma population

12/01/2025policy revision

Coverage Criteria for Tezspire (tezepelumab-ekko)

Continuation Therapy Criteria

Covered when ALL of the following are met for continuation (reauthorization)

Continuation Therapy Main

Positive clinical response: Demonstrated by at least one: reduction in frequency of exacerbations; decreased utilization of rescue medications; increase in percent predicted FEV1 from pretreatment baseline; reduction in severity or frequency of asthma-related symptoms (e.g., wheezing, shortness of breath, coughing)
Examples provided in policy

Coverage rationale highlights

Policy addresses coverage for Tezspire as add-on maintenance therapy and clarifies combination-therapy restriction applies only when therapies are for the same indication.

Benefit routing: Self-administered Tezspire prefilled pen is obtained under the pharmacy benefit unless the member's benefit plan documents specify otherwise; for certain UnitedHealthcare of California delegated prior authorization reviews, self-administered Tezspire may be obtained under the medical benefit.

Operational routing affects authorization and billing.

Combination therapy restriction: Patient must not be receiving Tezspire in combination with any of the listed therapies for treatment of the same indication.

Revised language clarifies combination exclusion applies only when therapies treat the same condition.

Tezspire (tezepelumab-ekko) formulations intended for administration by a healthcare professional (vial and prefilled syringe) are governed by the medical benefit policy. The prefilled pen for self-administration is obtained under the pharmacy benefit unless the member's benefit plan documents or a delegated prior authorization review specify otherwise. For members enrolled in UnitedHealthcare of California plans with a delegated provider group conducting the prior authorization review, self-administered Tezspire delivered via prefilled pen may be obtained under the medical benefit.

Tezspire is indicated as an add‑on maintenance treatment for patients aged 12 years and older and is not indicated for relief of acute bronchospasm or status asthmaticus. Requests to combine Tezspire with other biologic therapies must document that the agents are being used for different indications; Tezspire should not be used in combination with listed anti‑IL‑5, anti‑IgE, or anti‑IL‑4 therapies for treatment of the same indication.

For reauthorization, documentation must show a positive clinical response to Tezspire by at least one of the policy‑specified outcomes (reduced exacerbation frequency, decreased rescue medication use, improved percent predicted FEV1 from baseline, or reduced severity/frequency of asthma symptoms). Continued coverage also requires ongoing use with an ICS‑containing maintenance medication, dosing consistent with FDA labeling, and that the patient is not receiving Tezspire in combination with any listed biologic therapies for the same indication.

Tezspire’s FDA approval covers add‑on maintenance therapy in patients ≥12 years and does not include treatment of acute bronchospasm or status asthmaticus; use for those acute settings is outside the labeled indication and inconsistent with the FDA‑approved intended use.

Coding and Related Clinical Keys

HCPCS / Drug BillingHCPCS

J2356

Injection, tezepelumab-ekko, 1 mg

Relevant Diagnosis CodesICD-10

J45.50	Severe persistent asthma, uncomplicated
J45.51	Severe persistent asthma with (acute) exacerbation
J45.52	Severe persistent asthma with status asthmaticus
J82.83	Eosinophilic asthma

No explicit codes listed in this document portionmixed

No codes listed

Eosinophil / FeNO guidance referenced

Eosinophil cutoffs referencedERS/ATS cites a blood eosinophil cut-point ≥150 μL^-1 to guide anti‑IL‑5 initiation; additional phenotype cutoffs (e.g., ≥260 μL^-1 eosinophils and FeNO ≥19.5 ppb) are noted for predicting response to other biologics

FeNO / eosinophil pairingsERS/ATS provides combined thresholds (eosinophils ≥260 μL^-1 and FeNO ≥19.5 ppb) to identify patients most likely to benefit from anti‑IgE therapy

Context for useGuidance referenced is intended to help phenotype selection for biologic therapies (ERS/ATS guidance) and is supplemental to clinical criteria in this policy

FDA minimum age — indicated age group

FDA minimum age (indication)Indicated for patients aged ≥ 12 years

Provider Actions, Prior Authorization, and Billing Guidance

Prior Authorization

Prior Authorization Required

Prior authorization is required for provider-administered Tezspire (tezepelumab-ekko). Initial authorization will be for no more than 12 months; reauthorization (continuation) requests must document ongoing clinical benefit and will also be approved for no more than 12 months.

Initial authorization length ≤ 12 months
Reauthorization requires documentation of positive clinical response and is ≤ 12 months

Billing Rule

Benefit / Route Clarification and Routing

The formulation and route determine benefit routing: Tezspire supplied as a vial or prefilled syringe administered by a healthcare professional is processed under the medical benefit. Tezspire prefilled pen for self-administration is processed under the pharmacy benefit unless the member's plan specifies otherwise. Exception: members enrolled in UnitedHealthcare of California plans with a delegated provider group conducting the prior authorization review may have self-administered prefilled pen obtained under the medical benefit.

Background and Context

Severe asthma is heterogeneous and affects an estimated 1.2–2.4 million people in the United States. Phenotypes include allergic and eosinophilic presentations; unlike many biologics that target downstream pathways, tezepelumab targets thymic stromal lymphopoietin (TSLP) upstream and has demonstrated reductions in exacerbations across a range of biomarker levels.

Definitions and Key Clinical Terms

Severe asthma — definition

Definition (policy)Severe asthma: asthma uncontrolled despite maximal optimized high‑dose ICS‑LABA treatment and management of contributory factors, or that worsens when high‑dose treatment is decreased

Clinical context (GINA)GINA defines severe asthma as uncontrolled despite adherence with maximal optimized high‑dose ICS‑LABA and management of contributory factors

Exclusion from severe classificationAsthma that markedly improves when contributory factors (eg, inhaler technique, adherence) are addressed is not classified as severe

Uncontrolled or inadequately controlled asthma — examples

Poor symptom control thresholdsACQ score consistently > 1.5 or ACT score consistently < 20 (examples of poor control)

Other indicators of inadequate control

Policy Revision History

2025-12-01policy_revisionLatest

Added language clarifying that Tezspire prefilled pen for self-administration is obtained under the pharmacy benefit unless the member's benefit plan specifies medical benefit; clarified that for certain UnitedHealthcare of California delegated reviews the self-administered product may be obtained under the medical benefit; and revised combination-therapy exclusion to apply only when therapies are for the same indication.

Policy Summary

Payersierra health and life

PolicyTezspire (tezepelumab-ekko) — provider‑administered therapy

Policy CodePolicy 2025D0110J

Change TypeBenefit routing and combination‑therapy clarification

Effective DateDec 1, 2025

Next Review Date

Key ActionObtain prior authorization for provider‑administered Tezspire; initial and reauthorization approvals are limited to no more than 12 months and document required clinical criteria.

SourceLink

On This Page

Policy age statisticMinimum age for indicated use in this policy: ≥ 12 years

Pediatric population coveredIncludes adolescent and adult patients (12 years and older) per FDA indication

Vial or prefilled syringe (provider-administered) = medical benefit
Prefilled pen (self-administered) = pharmacy benefit unless member plan states otherwise
UnitedHealthcare of California with delegated PA review: prefilled pen may be medical benefit

Documentation Required

Required Clinical Documentation

Providers must submit required clinical documentation with PA requests: diagnosis of severe asthma, evidence the asthma is uncontrolled or inadequately controlled (e.g., ACQ >1.5 or ACT <20, exacerbation history, ER visits/hospitalizations, airflow limitation, or maintenance oral corticosteroid dependence), objective baseline measures, documentation of prior controller therapies and current concomitant controller use, and evidence of positive clinical response for reauthorization.

Diagnosis: severe asthma
Evidence of uncontrolled asthma (ACQ/ACT scores, exacerbation history, ER/hospital visits, airflow limitation, or maintenance oral corticosteroid dependence)
Documentation of prior and current controller therapies (see concomitant controller requirement)
For reauthorization: objective evidence of clinical benefit (reduction in exacerbations, decreased rescue med use, improved FEV1, or symptom reduction)

Prior Authorization

Concomitant Controller Therapy Requirement

Tezspire must be used concomitantly with an inhaled corticosteroid (ICS)-containing maintenance medication. For initial therapy, use with a maximally-dosed ICS/LABA combination or with a maximally-dosed ICS plus an additional controller is required as specified in the criteria.

Use in combination with a maximally-dosed ICS/LABA product OR a maximally-dosed ICS plus an additional controller medication
Must be used with an ICS-containing maintenance medication for continuation therapy

Denial Risk

Triggers for Denial

Common triggers for denial include: absence of a severe asthma diagnosis, insufficient documentation that asthma is uncontrolled or inadequately controlled, lack of required prior or concomitant controller therapy documentation, dosing that does not match FDA labeling, or failure to document positive clinical response for continuation requests.

No documented severe asthma diagnosis
No evidence of uncontrolled asthma (e.g., missing ACQ/ACT scores or exacerbation history)
Missing documentation of maximally-dosed ICS/LABA or equivalent controller therapy
Dosing inconsistent with FDA labeling
Reauthorization without documented clinical benefit

Note

Member-Specific Benefit Verification and Benefit Routing Mismatch Risk

Verify the member-specific benefit plan document before submitting PA requests. If the member-specific plan conflicts with this policy, the member-specific benefit document governs. Failure to confirm member-specific benefit and routing may result in benefit routing mismatch and coverage denial.

Member-specific benefit plan governs in case of conflict with standard policy
Confirm whether self-administered prefilled pen is covered under pharmacy or medical benefit per member plan
Failure to verify member documents may lead to incorrect routing and potential denial

≥2 systemic corticosteroid bursts (≥3 days each) in prior 12 months, asthma‑related ED/hospital visits, or airflow limitation (post‑bronchodilator FEV1 <80% predicted with reduced FEV1/FVC)

Maintenance OCS dependenceCurrent dependence on maintenance oral corticosteroids for asthma qualifies as uncontrolled disease

Tezspire indication — add‑on maintenance treatment

Indication statementTezspire is indicated as add‑on maintenance treatment for severe asthma

Not for acute reliefTezspire is not indicated for relief of acute bronchospasm or status asthmaticus

Use in combinationIntended as add‑on to background controller therapy (policy requires combination with ICS‑containing maintenance medication)

Medicare coverage context

Medicare NCD/LCD statusNo Medicare National Coverage Determination (NCD) or Local Coverage Determinations (LCDs/LCAs) exist for Tezspire

Part B coverage considerationMedicare may cover outpatient (Part B) drugs furnished 'incident to' a physician's service if the drugs are not usually self‑administered

Reference guidanceRefer to Medicare Benefit Policy Manual, Chapter 15, §50 for rules on drugs and biologicals furnished 'incident to' physician services