CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Tezspire (tezepelumab-ekko) for severe asthma

Covers prior-authorization and medical benefit coverage criteria for Tezspire as add-on maintenance therapy for patients with severe asthma, affecting Medicaid, Commercial, and Medicare members of Neighborhood Health Plan of Rhode Island.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyTezspire (tezepelumab-ekko) for severe asthma

Policy CodePolicy N/A

Change TypeNo material change

Effective DateJun 1, 2022

Next Review DateMay 5, 2022

Key ActionObtain prior authorization; initial approvals are for 6 months with continuation approvals for 12 months.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12+minimum age for coverage

210 mg q4wrecommended dosing

Init 6m / Cont 12mcoverage durations

J2356HCPCS code

Coverage Criteria for Tezspire (tezepelumab-ekko)

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Initial Criteria: Member is 12 years of age or older; Tezspire is prescribed by, or in consultation with, a pulmonologist, allergist, or immunologist; Member has documentation of severe asthma (see Appendix); Member is adherent to current treatment with both of the following medications at optimized doses for at least 3 months with or without oral corticosteroids: (1) High-dose inhaled corticosteroid; and (2) Additional controller medication (e.g., long acting beta2-agonist, long-acting muscarinic antagonist, leukotriene modifier); Member has inadequate asthma control with two or more exacerbations in the previous year requiring systemic corticosteroid treatment in addition to the regular maintenance therapy defined above OR one asthma exacerbation resulting in hospitalization; Member will use Tezspire as add-on maintenance treatment (not as monotherapy); Documentation of baseline blood eosinophil level is provided; If baseline blood eosinophil level is ≥ 150 cells/µL, member has had an inadequate treatment response or intolerance to treatment with at least one biologic indicated for asthma (e.g., Cinqair, Dupixent, Fasenra, Nucala, Xolair); Member will not use Tezspire in combination with another biologic agent indicated for asthma (e.g., Cinqair, Dupixent, Fasenra, Nucala, Xolair); Baseline measurement of at least one of the following for assessment of clinical status: use of systemic corticosteroids, use of inhaled corticosteroids, number of hospitalizations/ER visits/unscheduled visits to healthcare provider due to asthma condition, or forced expiratory volume in 1 second (FEV1); Member will not receive concurrently with live vaccines; Member does not have an active or untreated parasitic (helminth) infection; Tezspire will not be used for the relief of acute bronchospasm or status asthmaticus.

All bullets from Initial Criteria must be satisfied

Continuation Therapy Criteria

Covered when ALL of the following are met

Continuation Criteria: Member is 12 years of age or older; Tezspire is prescribed by, or in consultation with, a pulmonologist, allergist, or immunologist; Member has documentation of severe asthma (see Appendix); Member is tolerating treatment; Member has achieved and maintained a positive clinical response with Tezspire therapy for asthma with documentation of improvement as evidenced by either a decrease in one or more of the following: use of systemic corticosteroids, hospitalizations, ER visits, or unscheduled visits to healthcare provider; OR improvement from baseline in forced expiratory volume in 1 second (FEV1); Member will use Tezspire as add-on maintenance treatment (not as monotherapy); Member will not use Tezspire in combination with another biologic agent indicated for asthma (e.g., Cinqair, Dupixent, Fasenra, Nucala, Xolair).

All bullets from Continuation of Therapy Criteria must be satisfied

Investigational use: Therapies administered at a dose or for a condition other than an FDA‑approved indication are considered investigational and are not covered. Neighborhood defines investigational use by reference to standard compendia and peer‑reviewed literature (e.g., AHFS‑DI, Micromedex DrugDex, Clinical Pharmacology, Lexi‑Drugs) and will not provide coverage for drugs used for investigational purposes.

Tezspire is not covered when used as monotherapy or in combination with another biologic indicated for asthma (examples include Cinqair, Dupixent, Fasenra, Nucala, and Xolair). It is also not indicated for relief of acute bronchospasm or status asthmaticus. These exclusions apply both to initiation and continuation of therapy.

Billing and Coding

Applicable HCPCS/CPT CodesHCPCSCovered

J2356

Injection, tezepelumab-ekko, 1 mg

Baseline blood eosinophil threshold

Baseline blood eosinophil threshold>= 150 cells/µL

Documentation requiredBaseline blood eosinophil level must be provided with prior authorization request

If >=150 cells/µLMember must have had inadequate response or intolerance to at least one other biologic indicated for asthma

Provider Requirements and Actions

Prior Authorization

Prior Authorization Required

Prior authorization is required for Tezspire (tezepelumab‑ekko). Requests will be reviewed prospectively through the prior authorization process. Initial approvals are limited to 6 months; if criteria for continuation are met, reauthorization may be granted for 12 months. For Medicare members, this policy applies only in the absence of an applicable NCD or LCD.

Initial prior authorization duration: 6 months
Continuation prior authorization duration: 12 months
Medicare note: criteria apply only in absence of NCD/LCD

Step Therapy

Medicare Step Therapy Exemption

Medicare members who have received Tezspire within the prior 365 days are exempt from the step therapy requirements described in this policy.

Applies only to Medicare members with documented receipt of Tezspire within the past 365 days

Documentation Required

Required Clinical Documentation

Providers must submit specific clinical documentation with prior authorization requests to demonstrate medical necessity for initiation or continuation of Tezspire.

Documentation of severe asthma (see Appendix)
Baseline blood eosinophil level
Evidence of adherence to optimized therapy for ≥3 months: high‑dose inhaled corticosteroid plus an additional controller (e.g., LABA, LAMA, leukotriene modifier)
For baseline eosinophils ≥150 cells/µL: documentation of inadequate response or intolerance to ≥1 biologic indicated for asthma (e.g., Cinqair, Dupixent, Fasenra, Nucala, Xolair)
Baseline measurement of at least one clinical status metric: systemic corticosteroid use, inhaled corticosteroid use, number of hospitalizations/ER/unscheduled visits for asthma, or FEV1
For continuation: documentation of tolerability and sustained clinical improvement (decrease in systemic corticosteroid use, hospitalizations, ER visits, unscheduled visits, or improvement in FEV1)
Prescriber specialty: prescribed by or in consultation with a pulmonologist, allergist, or immunologist
Statement that Tezspire will be used as add‑on maintenance therapy (not monotherapy) and will not be used concomitantly with another asthma biologic
Documentation that member will not receive concurrent live vaccines and does not have an active/untreated parasitic (helminth) infection

Denial Risk

Noncompliant Use May Be Denied

Use of Tezspire outside the criteria outlined (for example, for acute bronchospasm/status asthmaticus, concurrent use with another asthma biologic, or without required documentation) may be denied or result in non‑payment. Prior authorization review will assess compliance with policy criteria.

Noncompliant uses include: acute bronchospasm/status asthmaticus, concurrent use with another asthma biologic, lack of required baseline or follow‑up documentation
Requests lacking required documentation or not meeting clinical criteria may be denied

Background

Tezspire (tezepelumab‑ekko) is indicated as an add‑on maintenance treatment for patients with severe asthma aged 12 years and older. Coverage is limited to use prescribed by or in consultation with a pulmonologist, allergist, or immunologist and requires documentation of severe asthma (see Appendix for components of severity such as frequent daytime symptoms, nightly awakenings, frequent SABA use, or FEV1 <60% predicted).

Per the coverage criteria, Tezspire must be used as add‑on therapy to optimized controller treatment (high‑dose inhaled corticosteroid plus an additional controller) with documented adherence for at least 3 months, and members must have evidence of inadequate control (≥2 exacerbations requiring systemic corticosteroids in the prior 12 months or ≥1 exacerbation resulting in hospitalization). Baseline blood eosinophil level is required; if eosinophils are ≥150 cells/µL the member must have had inadequate response or intolerance to at least one other asthma biologic.

For continuation of therapy, members must be tolerating treatment and demonstrate a sustained clinical benefit, evidenced by reductions in systemic corticosteroid use, hospitalizations, ER or unscheduled visits, or improvement in FEV1. Tezspire must not be given concurrently with another asthma biologic or live vaccines, and patients with active or untreated parasitic (helminth) infection are excluded.

Definitions — Severe Asthma

Severe asthma (components of severity)

Symptom frequencySymptoms throughout the day may indicate severe asthma

Nighttime awakeningsNighttime awakenings, often up to 7 times per week

SABA useShort-acting beta agonist use for symptom control occurs several times per day

Activity limitationExtremely limited normal activities

FEV1 thresholdPercent predicted FEV1 < 60%