CurrentModa HealthPolicy IC-0650

Tezepelumab (Tezspire) — Coverage Criteria for Severe Asthma

Policy governing coverage and medical necessity criteria for subcutaneous tezepelumab (Tezspire) as add-on maintenance therapy in patients (age >=12) with severe asthma, including dosing, quantity limits, and renewal requirements for Moda Health members.

Policy Summary

PayerModa Health

PolicyTezepelumab (Tezspire) — Coverage Criteria for Severe Asthma

Policy CodePolicy IC-0650

Change TypeNo material change

Effective DateN/A

Next Review DateMar 2, 2023

Key ActionObtain prior authorization demonstrating patient is ≥12 years old, meets severe asthma criteria, and is on medium-to-high dose inhaled corticosteroid plus an additional controller.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

210 mgdose per administration

1 q4wfrequency / quantity limit

6 molength of authorization

Age ≥12minimum patient age

J2356HCPCS code

Coverage Criteria for Tezepelumab (Tezspire)

Policy Summary

PayerModa Health

PolicyTezepelumab (Tezspire) — Coverage Criteria for Severe Asthma

Policy CodePolicy IC-0650

Change TypeNo material change

Effective DateN/A

Next Review DateMar 2, 2023

Key ActionObtain prior authorization demonstrating patient is ≥12 years old, meets severe asthma criteria, and is on medium-to-high dose inhaled corticosteroid plus an additional controller.

SourceLink

On This Page

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Initial Therapy

Covered when ALL of the following are met:

Age: Patient is at least 12 years of age>=12 years

Universal concurrent-use and indication restrictions: Will not be used in combination with other anti-IgE, anti-IL4, or anti-IL5 monoclonal antibody agents; will not be administered concurrently with live vaccines; will not be used for relief of acute bronchospasm or status asthmaticus.

Examples of other agents include benralizumab, omalizumab, mepolizumab, reslizumab, dupilumab.

Severity and background controller therapy: Patient has severe asthma and will be used as add-on maintenance treatment in patients regularly receiving BOTH: (1) medium- to high-dose inhaled corticosteroids AND (2) an additional controller medication (e.g., long-acting beta agonist, leukotriene modifier).

Components of severe asthma include symptoms throughout the day, frequent nighttime awakenings, frequent SABA use, markedly limited activities, percent predicted FEV1 <60%, and more frequent/intense exacerbations.

Exacerbation history: Either two or more exacerbations in the previous year requiring oral or injectable corticosteroid treatment (in addition to regular maintenance therapy) OR one exacerbation resulting in hospitalization.>=2 exacerbations in prior year OR >=1 hospitalization

Baseline clinical assessment: Baseline measurement documented of at least one: systemic corticosteroid use; inhaled corticosteroid use; number of hospitalizations/ER/unscheduled visits due to asthma; or FEV1.

Used to assess clinical status prior to initiation.

Renewal Therapy

Renewal (coverage may be renewed when):

Ongoing eligibility and safety: Patient continues to meet universal and indication-specific criteria from the initial approval and has absence of unacceptable toxicity to the drug (e.g., parasitic/helminth infection, severe hypersensitivity reactions).

Clinical benefit: Either improvement in asthma symptoms or exacerbations as evidenced by decreased use of systemic corticosteroids; a two-fold or greater decrease in inhaled corticosteroid use for at least 3 days; decreased hospitalizations, ER visits, or unscheduled visits; OR improvement from baseline in FEV1.

Document clinical response compared with baseline measures.

The medication must not be used in combination with other anti‑IgE, anti‑IL4, or anti‑IL5 monoclonal antibody agents (for example, benralizumab, omalizumab, mepolizumab, reslizumab, dupilumab). Additionally, concurrent administration with live vaccines is prohibited. These concurrent-use restrictions are considered universal criteria and violation of them may result in denial of coverage.

Tezspire is not indicated for relief of acute bronchospasm or status asthmaticus. Administration for the purpose of treating an acute asthma exacerbation or status asthmaticus is explicitly not medically necessary and is excluded from coverage under this policy.

Billing, Codes, and Quantity Limits

Covered HCPCS CodesHCPCSCovered

J2356

Injection, tezepelumab-ekko, 1 mg; 1 billable unit = 1 mg

NDC CodesNDCCovered

55513-0123-xx	Tezspire 210 mg/1.91 mL single-dose prefilled pen
55513-0112-xx	Tezspire 210 mg/1.91 mL single-dose prefilled syringe
55513-0100-xx	Tezspire 210 mg/1.91 mL single-dose vial

Covered Diagnosis CodesICD-10Covered

J45.50

Severe persistent asthma, uncomplicated

Max dose per period — unitization

Max dose per period210 billable units (210 mg) every 4 weeks

Quantity limit (pen)Tezspire 210 mg single‑dose prefilled pen: 1 pen every 4 weeks

Quantity limit (syringe)Tezspire 210 mg single‑dose prefilled syringe: 1 syringe every 4 weeks

Quantity limit (vial)Tezspire 210 mg single‑dose vial: 1 vial every 4 weeks

Provider Requirements and Documentation

Prior Authorization

Prior Authorization Required for Severe Asthma

Prior authorization is required for treatment of severe asthma in patients aged 12 years and older. The request must document background controller therapy and disease severity, and include required baseline clinical measurements and exacerbation history. Therapy must not be used concurrently with other anti-IgE/anti-IL4/anti-IL5 biologics, with live vaccines, or for acute bronchospasm/status asthmaticus.

Prior authorization required for severe asthma (age ≥ 12)
Background controller therapy required: failure or inadequate control on medium-to-high dose inhaled corticosteroid PLUS an additional controller (e.g., long-acting beta agonist, leukotriene modifier)
Required clinical documentation: at least two exacerbations in the prior 12 months requiring oral/injectable corticosteroids OR one exacerbation resulting in hospitalization; baseline measures such as systemic corticosteroid use, inhaled corticosteroid use, number of hospitalizations/ER/unscheduled visits, and FEV1

Documentation Required

Background Controller Therapy Requirement

Requests must show that the patient is receiving add-on maintenance treatment while regularly taking BOTH of the following background therapies: medium- to high-dose inhaled corticosteroids AND an additional controller medication (for example, long-acting beta agonist, leukotriene modifiers).

Medium- to high-dose inhaled corticosteroid documented
Additional controller therapy documented (e.g., LABA, leukotriene modifier)

Documentation Required

Required Clinical Documentation

Clinical documentation supporting the prior authorization must include baseline assessment and response data: documentation of exacerbation history (≥2 exacerbations requiring systemic corticosteroids in prior 12 months OR ≥1 hospitalization), baseline and follow-up measures such as systemic corticosteroid use, inhaled corticosteroid use, number of hospitalizations/ER/unscheduled visits, and FEV1. For renewals, provide evidence of clinical improvement or absence of unacceptable toxicity.

Exacerbation history: two or more in prior year requiring oral/injectable corticosteroids OR one resulting in hospitalization
Baseline measurements: systemic corticosteroid use, inhaled corticosteroid use, hospitalizations/ER/unscheduled visits, FEV1
Renewal evidence: improved symptoms/exacerbations (reduced systemic steroid use, decreased inhaled steroid use, fewer hospitalizations/ER/unscheduled visits) OR improvement in FEV1
Document absence of unacceptable toxicity (e.g., parasitic infection, severe hypersensitivity)

Denial Risk

Contraindicated Concurrent Uses and Acute Use Limitation

Do not authorize use when the patient will receive another anti-IgE, anti-IL4, or anti-IL5 monoclonal antibody concurrently. Do not authorize concurrent administration with live vaccines. The agent is not indicated for acute relief of bronchospasm or status asthmaticus.

Contraindicated concurrent uses: other anti-IgE/anti-IL4/anti-IL5 biologics (e.g., benralizumab, omalizumab, mepolizumab, reslizumab, dupilumab)
Do not administer concurrently with live vaccines
Not for acute bronchospasm or status asthmaticus

OpenPayer

Tezepelumab (Tezspire) — Coverage Criteria for Severe Asthma

Coverage Criteria for Tezepelumab (Tezspire)

Billing, Codes, and Quantity Limits

Provider Requirements and Documentation

Background on Tezspire

Definitions and Clinical Severity