CurrentCignaPolicy IP0412

Immunologicals - Tezspire

Defines Cigna medical benefit coverage, prior authorization, and clinical criteria for Tezspire (tezepelumab-ekko) for treatment of asthma in patients aged 12 and older; applies to Cigna-administered health benefit plans.

Policy Summary

PayerCigna

PolicyTezspire (tezepelumab-ekko) coverage criteria

Policy CodePolicy IP0412

Change TypeOperational revisions and clarifications

Effective DateMay 15, 2025

Next Review Date

Key ActionObtain prior authorization and document age, prior controller therapy, lung function/exacerbation history, and specialist prescribing to support an initial 6-month approval.

SourceLink

POLICY UPDATE CHANGES

Authorization Duration: initial therapy duration updated from 12 months to 6 months.

Asthma diagnostic criteria requirements were updated for confirmation of asthma.

Policy name updated from 'Tezepelumab-ekko' to 'Immunologicals - Tezspire.'

Conditions not covered: Eosinophilic Gastroenteritis, Eosinophilic Esophagitis, and Eosinophilic Colitis were removed from the not-covered list.

≥12Minimum age for indicated use

210 mg q4wFDA‑approved dosing

6 moInitial auth duration

J2356

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Coverage Criteria for Tezspire (tezepelumab-ekko)

Initial Therapy — Approve for Asthma (FDA-approved indication)

Approve for Asthma (FDA-approved indication) when ALL of the following are met for Initial Therapy:

Initial Therapy criteria: Patient is ≥ 12 years of age;age >=12

Prior controller therapy: Patient has received at least 3 consecutive months of combination therapy with BOTH: (a) a medium- or high-dose inhaled corticosteroid; AND (b) at least one additional asthma controller or asthma maintenance medication (use of a combination inhaler containing both a medium- or high-dose ICS and an additional controller fulfills both requirements).

Lung function or reversibility criteria: Patient has a history of ONE of the following options: (a) both (1) FEV1 < 80% predicted AND (2) FEV1/FVC < 0.80 (reduced FEV1 should not be due to smoking-related COPD); OR (b) one of: (1) increase of > 12% and > 200 mL in FEV1 following administration of a standard dose short-acting bronchodilator; (2) increase of > 12% and > 200 mL in FEV1 between prescriber visits; (3) increase of > 12% and > 200 mL in FEV1 from baseline to after ≥4 weeks of asthma treatment; (4) positive exercise challenge testing; OR (5) positive bronchial challenge testing. Note: these lung function criteria may be met anytime prior to or during asthma treatment.

Uncontrolled asthma/exacerbation history: Patient has uncontrolled asthma or was uncontrolled at baseline as defined by ONE of: (a) ≥2 asthma exacerbations requiring systemic corticosteroids in the previous year; OR (b) ≥1 exacerbation requiring hospitalization, emergency department visit, or urgent care in the previous year; OR (c) asthma that worsens upon tapering of systemic (oral) corticosteroid therapy.

Prescribing specialist: Medication is prescribed by or in consultation with an allergist, immunologist, or pulmonologist.

Initial approval duration 6 months

Continuation Therapy — Continuation (Currently Receiving Tezspire)

Continuation (Currently Receiving Tezspire):

Continuation criteria: Patient has already received at least 6 months of therapy with Tezspire; AND continues therapy with one inhaled corticosteroid or one inhaled corticosteroid-containing combination inhaler; AND has responded to therapy as determined by the prescriber (examples: decreased exacerbations, decreased symptoms, improved lung function, decreased healthcare utilization, or reduced oral corticosteroid requirement).prior Tezspire >=6 months

Continuation approval duration 1 year

Tezspire is considered not medically necessary when used for indications outside its FDA-approved asthma indication. Examples specifically listed in the policy include atopic dermatitis, chronic obstructive pulmonary disease (COPD), chronic rhinosinusitis with nasal polyposis (CRSwNP), and chronic spontaneous urticaria. The policy also states that the efficacy and safety of concurrent use of Tezspire with another monoclonal antibody therapy have not been established, and such combination use is therefore considered not medically necessary.

Use of Tezspire for conditions other than the FDA‑approved indication for asthma is considered not medically necessary. The policy provides specific examples where Tezspire is not indicated, including atopic dermatitis (clinical trials did not demonstrate statistically significant benefit), COPD (trials did not show a significant reduction in exacerbations), CRSwNP (additional data are needed despite some positive findings), and chronic spontaneous urticaria (trial results were not significant).

In addition, the policy explicitly notes that the efficacy and safety of Tezspire used concurrently with other monoclonal antibody therapies have not been established; therefore concurrent use with other biologics is not supported by the evidence in this policy.

Initial Therapy Requirements

Initial Therapy — Initial therapy approval rules

Initial therapy approval rules:

Initial therapy: Patient ≥12 years; Patient has received ≥3 consecutive months of medium- or high-dose inhaled corticosteroid plus ≥1 additional controller; Patient meets lung function or positive challenge/bronchodilator response criteria as specified in policy; Patient has uncontrolled asthma as defined by exacerbation history or steroid dependence; Medication is prescribed by or in consultation with an allergist, immunologist, or pulmonologist.

Initial approval duration 6 months

Continuation Therapy Requirements

Continuation Therapy — Continuation therapy requirements

Continuation therapy requirements for members currently receiving Tezspire:

Continuation: Patient has received at least 6 months of Tezspire; Patient continues inhaled corticosteroid therapy (single agent or combination inhaler); and prescriber documents response to therapy (examples: decreased exacerbations, improved symptoms or lung function, reduced oral corticosteroid requirement).

Continuation approval duration 1 year

Coding and Clinical Data

Considered Medically Necessary when criteria metHCPCSCovered

J2356

Injection, tezepelumab-ekko, 1 mg

FEV1 bronchodilator response

FEV1 bronchodilator response> 12% and > 200 mL increase in FEV1 following administration of a standard dose of a short-acting bronchodilator (or between visits or from baseline after ≥4 weeks of treatment)

Alternate positive testsPositive exercise challenge testing or positive bronchial challenge testing may also satisfy the reversible airflow criterion

Timing of assessmentLung function criteria may be met at any time prior to or during asthma treatment

Provider Actions, Authorization & Documentation

Prior Authorization

Prior Authorization Recommended

Prior Authorization is recommended for medical benefit coverage of Tezspire (J2356). Initial approvals are recommended for 6 months when the patient meets the policy Criteria and Dosing. Extended approvals may be allowed if the patient continues to meet Criteria and Dosing. Requests for doses outside the established dosing documented in the policy will be considered on a case-by-case basis by a clinician (e.g., Medical Director or Pharmacist). Initial therapy should be prescribed by or in consultation with a physician who specializes in the condition being treated (e.g., allergist, immunologist, or pulmonologist).

Prior authorization recommended for Tezspire (J2356).
Initial approval: 6 months when criteria met.
Initial prescribing by or in consultation with a specialist is required/recommended.

Step Therapy

Required Prior Controller Therapy

The patient must have received at least 3 consecutive months of combination therapy that includes BOTH: a medium- or high-dose inhaled corticosteroid AND at least one additional asthma controller or maintenance medication. Use of a combination inhaler containing both a medium- or high-dose inhaled corticosteroid and additional controller(s) fulfills this requirement.

Step Therapy Requirements

Step	Requirement
1	Member must have received at least 3 consecutive months of combination therapy that includes BOTH: (a) a medium- or high-dose inhaled corticosteroid, and (b) at least one additional asthma controller or maintenance medication (examples: inhaled LABA, inhaled LAMA, monoclonal antibody therapies). Use of a combination inhaler containing both components meets this requirement.

Quantity and Dosing Limits

Tezspire dosing

Strength per dose210 mg given subcutaneously once every 4 weeks

FrequencyOnce every 4 weeks (q4w)

Administration routeSubcutaneous injection

Site of Care and Administration

Note

Ensure clinically appropriate dosing, duration, frequency, and site of care; specialist initial prescriber recommended

Dose, frequency, duration, and site of care must be reasonable and clinically appropriate and supported by evidence; initial prescribing by a specialist is recommended due to monitoring requirements.

Approved dosing: 210 mg subcutaneously every 4 weeks.
Site of care, monitoring, and prescribing clinician should reflect clinical appropriateness.

Definitions and Clinical Thresholds

Severe asthma (ERS/ATS criteria)

Core definitionSevere asthma: asthma uncontrolled despite adherence to optimized high‑dose ICS/LABA therapy or that worsens when high‑dose treatment is decreased (requires high‑dose ICS plus second controller or remains uncontrolled despite this therapy)

Poor symptom controlAsthma Control Questionnaire ≥ 1.5 consistently or Asthma Control Test < 20

Frequent severe exacerbationsTwo or more bursts of systemic corticosteroids in the previous year

Serious exacerbationsAt least one hospitalization, ICU stay, or mechanical ventilation in the previous year

Airflow limitationFEV1 < 80% predicted after appropriate bronchodilator withholding

Background

Tezspire (tezepelumab‑ekko) is a monoclonal antibody directed against thymic stromal lymphopoietin (TSLP) and is approved as an add‑on maintenance treatment for severe asthma in patients aged 12 years and older. Clinical trials examined patients with a history of exacerbations despite medium‑ or high‑dose inhaled corticosteroid therapy plus another controller, and assessed exacerbation outcomes through 52 weeks. The policy references available trial data across multiple non‑asthma indications, noting that Tezspire is not indicated for several conditions where efficacy was not established.