CurrentCignaPolicy N/A

Tezspire Prior Authorization Policy

Defines Cigna prior authorization requirements, coverage criteria, and exclusions for Tezspire (tezepelumab-ekko) subcutaneous injection for FDA‑approved indication of severe asthma in patients ≥12 years, plus not-covered indications and prescribing specialty requirement. Applies to Cigna-administered health benefit plans per stated instructions.

Policy Summary

PayerCigna

PolicyTezspire Prior Authorization Policy

Policy CodePolicy N/A

Change TypeClarified (conditions not covered)Revised (review date)

Effective Date

Next Review Date

Key ActionPrior authorization is recommended/required for Tezspire; initial approvals require specialist prescribing or consultation and are provided for specified durations (6 months initial, 1 year continuation).

SourceLink

POLICY UPDATE CHANGES

Conditions Not Covered: 'Concurrent use of Tezspire with another Monoclonal Antibody Therapy' updated to specify which monoclonal antibody therapies are included (Cinqair, Dupixent, Fasenra, Nucala, Xolair, and Adbry).

Review date updated to 02/19/2025 (annual revision).

1Covered Indication (Asthma)

4Uncontrolled asthma criteria options

5Not-covered indications listed

Coverage Summary

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Covered with criteria — Cigna prior authorization requirements for Tezspire (tezepelumab‑ekko) for the FDA‑approved indication as add‑on maintenance treatment of severe asthma in patients ≥ 12 years; applies to Cigna‑administered health benefit plans. Initial approvals are provided for 6 months (continuation approvals for 1 year when continuation criteria are met).

Key thresholds

Age>= 12 years

Initial therapy prior controller duration>= 3 consecutive months of combination therapy (ICS + another controller)

Initial approval duration6 months

Continuation approval duration1 year (requires >= 6 months prior Tezspire therapy)

Initial and Continuation Therapy Criteria

FDA-Approved Indication - Asthma

Approve Tezspire for the duration noted if the patient meets ONE of the following (A or B):

A) Initial Therapy

Approve for 6 months
Patient is ≥ 12 years of age>= 12 years
ALL of the following
- An inhaled corticosteroid
- At least one additional asthma controller or asthma maintenance medication (Examples: inhaled LABA, inhaled LAMA, leukotriene receptor antagonists, and monoclonal antibody therapies). Use of a combination inhaler containing both an inhaled corticosteroid and additional controller fulfills both criteria.
  Examples provided in policy
ANY of the following
- Patient experienced two or more asthma exacerbations requiring treatment with systemic corticosteroids in the previous yearTwo or more exacerbations in prior year
- Patient experienced one or more asthma exacerbation(s) requiring a hospitalization, an emergency department visit, or an urgent care visit in the previous yearOne or more exacerbations requiring hospital/ED/urgent care in prior year
- Patient has a forced expiratory volume in 1 second (FEV1) < 80% predictedFEV1 < 80% predicted
- Patient has an FEV1/forced vital capacity (FVC) < 0.80FEV1/FVC < 0.80
The medication is prescribed by or in consultation with an allergist, immunologist, or pulmonologist

B) Patient is Currently Receiving Tezspire (Continuation)

Approve for 1 year1 year
Patient has already received at least 6 months of therapy with Tezspire>= 6 months prior Tezspire therapy
Patient continues to receive therapy with one inhaled corticosteroid or one inhaled corticosteroid-containing combination inhaler
Patient has responded to therapy as determined by the prescriber (Examples: decreased exacerbations; decreased symptoms; decreased hospitalizations/ED/urgent care visits; improved lung function; decreased requirement for oral corticosteroids)
Examples of response provided in policy

Unproven / Not Covered

Not covered / exclusions: Tezspire is considered experimental, investigational, or unproven for any other use(s) beyond the FDA‑approved asthma indication (examples include atopic dermatitis, COPD, CRSwNP, chronic spontaneous urticaria, etc.). The policy specifically excludes the concurrent use of Tezspire with another monoclonal antibody therapy because efficacy and safety of combination use have not been established. The policy defines monoclonal antibody therapies for exclusion purposes to include (clarified list): Cinqair, Dupixent, Fasenra, Nucala, Xolair, and Adbry.

Exclusions

Operational exclusion: concurrent use of Tezspire with another monoclonal antibody therapy is not covered.

Exclusion: Concurrent Monoclonal Antibody Therapy: Concurrent use of Tezspire with another monoclonal antibody therapy is not covered.

The policy defines monoclonal antibody therapies for exclusion/interaction purposes to include Adbry, Cinqair, Dupixent, Ebglyss, Fasenra, Nemluvio, Nucala, and Xolair (clarified list: Cinqair, Dupixent, Fasenra, Nucala, Xolair, and Adbry).

Provider Actions & Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is recommended/required for prescription benefit coverage of Tezspire. Approvals are provided for specified durations: 6 months for initial therapy and 1 year for continuation.

Initial approval duration: 6 months
Continuation approval duration: 1 year

Documentation Required

Specialist Prescribing Requirement

Initial approval requires the medication to be prescribed by or in consultation with an allergist, immunologist, or pulmonologist.

Documentation Required

Baseline and Response Documentation

For initial therapy, document baseline uncontrolled asthma as defined by one of the following: ≥2 exacerbations requiring systemic corticosteroids in the previous year; ≥1 exacerbation requiring hospitalization/ED/urgent care in the previous year; FEV1 < 80% predicted; FEV1/FVC < 0.80; or asthma that worsens upon tapering of oral systemic corticosteroids. For continuation, document at least 6 months of prior Tezspire therapy and that the patient has responded to therapy as determined by the prescriber.

Examples of response: decreased asthma exacerbations; decreased asthma symptoms; decreased hospitalizations/ED/urgent care/clinic visits due to asthma; improved lung function parameters; decreased requirement for oral corticosteroid therapy
Baseline uncontrolled asthma options include exacerbations, hospitalization/ED/urgent care, FEV1 < 80% predicted, FEV1/FVC < 0.80, or worsening with steroid taper

Clinical Evidence

>=2Pivotal trial population: asthma exacerbations required in prior year

52 wksKey trial duration for exacerbation outcomes (with some improvements noted as early as 2 weeks)

Pivotal trials enrolled patients who had experienced two or more asthma exacerbations in the previous year despite treatment with medium‑ or high‑dose inhaled corticosteroid plus another controller; in trials, exacerbation outcomes were evaluated at 52 weeks, although some lung function and symptom improvements were noted as early as 2 weeks. Guidelines list tezepelumab as an add‑on option for uncontrolled severe asthma.

Background & Definitions

Tezspire is a thymic stromal lymphopoietin (TSLP) blocker indicated as add‑on maintenance treatment for severe asthma in patients ≥ 12 years. Clinical guidance (Global Initiative for Asthma and ERS/ATS) positions tezepelumab as an add‑on therapy for patients with uncontrolled severe asthma despite optimized high‑dose ICS/LABA (or who worsen when high‑dose treatment is decreased); higher blood eosinophils and fractional exhaled nitric oxide may predict better response.

Term	Definition
Baseline
Defined as prior to receiving Tezspire or another monoclonal antibody therapy for asthma.
Monoclonal antibody therapies (per policy)
Defined for exclusion/interaction purposes to include Adbry, Cinqair, Dupixent, Ebglyss, Fasenra, Nemluvio, Nucala, and Xolair (note: exclusion list clarified to name Cinqair, Dupixent, Fasenra, Nucala, Xolair, and Adbry).

Revision History

2025-02-19clarifiedLatest

Material clarification: 'Conditions Not Covered' entry for concurrent use with another monoclonal antibody therapy updated to specify the monoclonal antibody therapies included (Cinqair, Dupixent, Fasenra, Nucala, Xolair, and Adbry). No other criteria changes were made for this annual revision.

2024-02-14revised

Annual revision (review date 02/14/2024): no criteria changes were made.

2023-02-08revised

Annual revision (review date 02/08/2023): no criteria changes were made.