CurrentAnthemPolicy N/A

TEZSPIRE (tezepelumab-ekko) prior authorization for severe asthma and CRSwNP

This PA form governs prior authorization requirements for TEZSPIRE (tezepelumab-ekko) for members (age 12+) with severe asthma or chronic rhinosinusitis with nasal polyps (CRSwNP) under Anthem HealthKeepers products in Virginia.

Policy Summary

PayerAnthem

PolicyTEZSPIRE (tezepelumab-ekko) prior authorization for severe asthma and CRSwNP

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionSubmit a completed prior authorization with documented age ≥12, diagnosis (severe asthma or CRSwNP), evidence of prior controller therapy and exacerbation history or intranasal steroid trial, and avoid coadministration with other biologics.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

>=12minimum member age for therapy

6-monthinitial approval duration

12-monthrenewal approval duration

Do not coadministercoadministration

Coverage Criteria for TEZSPIRE (tezepelumab-ekko)

Initial therapy — Severe asthma

Covered when ALL of the following are met

age: Member is 12 years of age or older>=12 years

diagnosis: Member has diagnosis of severe asthma

See policy definition of severe asthma (uncontrolled despite optimized high-dose ICS-LABA, requires high-dose ICS-LABA to prevent being uncontrolled, frequent symptoms, low FEV1, or frequent exacerbations)

no_coadministration: Coadministration with another monoclonal antibody will be avoided

Examples listed include omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab

background_therapy: Used as add-on maintenance treatment in members regularly receiving medium- to high-dose inhaled corticosteroids plus an additional controller medication (e.g., LABA, leukotriene modifier)

exacerbation_history: Member had ≥2 exacerbations in the previous year requiring oral or injectable systemic corticosteroids (in addition to maintenance) or ≥1 exacerbation resulting in hospitalization>=2 exacerbations or >=1 hospitalization

objective_assessment: Member has at least one objective assessment of clinical status (systemic corticosteroid use, inhaled corticosteroid use, hospitalizations/ER/unscheduled visits, or FEV1) documented

preferred_trials: Member tried and failed an adequate trial of the 2 different preferred products (Fasenra and Xolair) OR documents reasons for N/A (lack of eosinophilic phenotype with blood eosinophils <150 cells/μL, serum IgE <30 IU/mL, or predicted intolerance to preferred agents)

If N/A is selected, document the reason(s)

Initial therapy — CRSwNP

Covered when ALL of the following are met

age: Member is 12 years of age or older>=12 years

diagnosis: Diagnosis of bilateral symptomatic sinonasal polyposis (CRSwNP) with symptoms lasting at least 8 weeks>=8 weeks

no_coadministration: Coadministration with another monoclonal antibody will be avoided

Examples include omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab

intranasal_steroid_trial: Member tried and failed an 8-week trial of intranasal corticosteroid therapy8 weeks

concomitant_intranasal: Tezspire will be used in combination with intranasal corticosteroids unless intolerant or contraindicated

preferred_trial_xolair: Member tried and failed an adequate trial of the preferred product Xolair unless contraindicated or clinically inappropriate

Renewal criteria — Severe asthma and CRSwNP

Covered when ALL of the following are met

toxicity_assessment: Member has been assessed for toxicity

Documentation of toxicity assessment required for renewal

clinical_response_asthma: For asthma: improvement in symptoms or exacerbations evidenced by decrease in systemic corticosteroid use, hospitalizations, ER visits, or unscheduled visits to a healthcare provider, or improvement in FEV1 from baseline

Renewal approvals are for 12 months

clinical_response_csrwnp: For CRSwNP: disease response evidenced by improvement in signs or symptoms (nasal obstruction), improvement in sinus opacifications on CT, improvement on disease activity scoring tools (e.g., NPS, nasal congestion score, SNOT-22), reduction in polyp size, or reduced need for systemic corticosteroids

Renewal approvals are for 12 months

Coadministration of TEZSPIRE with other biologic monoclonal antibodies is not permitted. The Virginia Department of Medical Assistance Services considers concomitant therapy with agents such as Cinqair®, Dupixent®, Fasenra®, Nucala®, Tezspire™, and Xolair® to be experimental and investigational because safety and efficacy of these combinations have not been established; such combinations will not be approved.

Key Coding and Clinical Thresholds

inv-05: Age — Minimum member age for therapy

Minimum age>= 12 years

Initial approval duration6-month approval for initial therapy

Applicable indicationsSevere asthma or CRSwNP (member must meet diagnosis-specific criteria)

inv-06: Asthma exacerbation history — required prior-year exacerbations/hospitalization threshold

Required exacerbation history>= 2 exacerbations in the previous year requiring oral or injectable corticosteroids (in addition to maintenance) OR >=1 exacerbation resulting in hospitalization

Context of useApplies to initial prior authorization for severe asthma to qualify for 6-month approval

DocumentationProvider must document exacerbation events in medical records as part of PA submission

inv-07: Eosinophil threshold (for N/A reasoning) — blood eosinophils criterion

Eosinophil threshold for N/A reasoningBlood eosinophils >=150 cells/µL (used to justify N/A to preferred product trials)

PurposeOne acceptable reason to mark prior preferred-product trials as N/A when assessing eligibility

Supporting lab dataSerum IgE < 30 IU/mL is another documented criterion referenced alongside eosinophil level

inv-08: CRSwNP symptom duration — symptom duration threshold

Minimum symptom durationSymptoms lasting at least 8 weeks

IndicationRequired for diagnosis of bilateral symptomatic sinonasal polyposis (CRSwNP) for initial approval

Prior therapy requirementMember must have tried and failed an 8-week trial of intranasal corticosteroid therapy

Provider Actions and Prior Authorization Requirements

Prior Authorization

Initial prior authorization requirements

Prior authorization (PA) is required for initial courses of therapy. For initial PA for severe asthma (6-month approval), the prescriber must document: member is ≥12 years old; a diagnosis of severe asthma; avoidance of coadministration with another monoclonal antibody (e.g., omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab); that therapy will be used as add-on maintenance with medium- to high-dose inhaled corticosteroids plus an additional controller (unless contraindicated); history of ≥2 exacerbations in the prior year requiring oral/injectable corticosteroids or ≥1 exacerbation resulting in hospitalization; and at least one objective assessment of clinical status (systemic corticosteroid use, inhaled corticosteroid use, number of hospital/ER/unscheduled visits, or FEV1). If relevant, document trials of two preferred products (Fasenra and Xolair) or provide rationale (e.g., lack of eosinophilic phenotype [eosinophils <150 cells/μL], serum IgE <30 IU/mL, or intolerance). Include completed member and prescriber information, weight (kg), drug name/form/strength/dosing frequency/length of therapy/quantity, and supporting clinical records.

Member age, DOB, Medicaid/ID, weight in kg
Prescriber name, NPI, phone, fax
Drug name, form, strength, dosing frequency, duration, quantity
Clinical documentation: diagnosis, exacerbation history, objective assessments, prior therapy trials or rationale for exception

Prior Authorization

Renewal prior authorization requirements

For renewals (12-month approval), document interval assessment for toxicity and evidence of clinical benefit. The renewal request must confirm the member has been assessed for toxicity and demonstrate improvement in asthma symptoms or exacerbations (reduced systemic corticosteroid use, fewer hospitalizations/ER visits/unscheduled visits, or improved FEV1) compared to baseline. For CRSwNP renewal, document toxicity assessment and improvement in signs/symptoms (e.g., NPS, NC score, SNOT-22, or CT findings).

Assessment of toxicity (yes/no)
Evidence of clinical improvement vs baseline (one or more): decreased systemic steroid use, fewer hospitalizations/ER visits, fewer unscheduled visits, improved FEV1
For CRSwNP: improvement in nasal polyposis scores, symptom scores, or imaging

Denial Risk

Combination biologic prohibition

Coadministration of Tezspire with other biologic monoclonal antibodies is not permitted. The use of concomitant therapy with Cinqair, Dupixent, Fasenra, Nucala, Tezspire, and Xolair (or other listed biologics) is considered experimental/investigational and will not be approved. The PA form requires confirmation that coadministration with another monoclonal antibody will be avoided.

Do not prescribe Tezspire with omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab, etc.
PA will be denied if concomitant biologic therapy is documented without appropriate justification

Documentation Required

Incomplete documentation risk

Incomplete, illegible, or missing documentation may delay or prevent PA approval. Ensure all required fields on the PA form are completed and supporting records (hospitalizations, ER visits, steroid prescriptions, prior trial documentation, objective test results) are attached. Missing member or prescriber identifiers, weight, drug details, or clinical evidence of severity/response increases risk of denial or processing delays.

Illegible or incomplete forms may be returned or denied
Attach supporting medical records and prior trial documentation
Include clear identifiers: member name, ID, DOB; prescriber name and NPI

Documentation Required

Provider form and administrative requirements

Complete and accurate member and prescriber information is required on the PA form. Include member last/first name, Medicaid/ID number, date of birth, and current weight in kilograms. Include prescriber last/first name, NPI, phone, and fax. Provide precise drug information (name, form, strength, dosing frequency, length of therapy, quantity per day) and ensure all sections relevant to the indication (severe asthma or CRSwNP) are answered.

Member: name, ID, DOB, weight (kg)
Prescriber: name, NPI, phone, fax
Drug: name, form, strength, dosing frequency, length of therapy, quantity

Background

TEZSPIRE (tezepelumab‑ekko) is requested as an add‑on maintenance biologic for members aged 12 years and older with either severe asthma or chronic rhinosinusitis with nasal polyps (CRSwNP). For severe asthma, the form is used to document prior controller therapy (regular medium‑ to high‑dose inhaled corticosteroid plus an additional controller), exacerbation history (e.g., ≥2 exacerbations in the prior year or ≥1 hospitalization), objective assessments (such as FEV1 or systemic corticosteroid use), and trials of preferred products or reasons they are not applicable. For CRSwNP, the form documents bilateral symptomatic sinonasal polyposis with symptoms for at least 8 weeks, failure of an 8‑week intranasal corticosteroid trial, and avoidance of concomitant biologic therapy. Initial approvals for eligible members are for 6 months, with renewals requiring documentation of toxicity assessment and clinical improvement and typically granted for 12 months.

Definitions

inv-16: Severe asthma definition — uncontrolled despite optimized high-dose ICS-LABA or requires high-dose ICS-LABA to prevent uncontrolled disease

Core definitionAsthma that remains uncontrolled despite optimized treatment with high-dose ICS-LABA or requires high-dose ICS-LABA to prevent being uncontrolled

Clinical featuresMay include frequent symptoms, nighttime awakenings, high SABA use, severely limited activities, or percent predicted FEV1 < 60%

Exacerbation patternExacerbations requiring oral systemic corticosteroids are generally more frequent and intense compared to moderate asthma

Policy Summary

PayerAnthem

PolicyTEZSPIRE (tezepelumab-ekko) prior authorization for severe asthma and CRSwNP

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

SourceLink

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