CurrentSecurity Health Plan of Wisconsin, Inc.Policy SHP-P0650

Tezspire® (tezepelumab-ekko) subcutaneous therapy

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Prior authorization coverage for Tezspire for severe asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and other FDA-labeled or compendia-supported indications, including medical-necessity criteria, dosing limits, authorization duration, continuation requirements, and concomitant-therapy restrictions.

Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicyTezspire® (tezepelumab-ekko) subcutaneous therapy

Policy CodePolicy SHP-P0650

Change TypeNo material clinical or coverage changes

Effective DateN/A

Last ReviewMar 3, 2026

Next Review DateN/A

Key ActionSubmit documentation confirming the applicable indication, treatment history, required controller or maintenance therapy, specialist involvement, and absence of contraindicated concomitant therapy.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsAuthorization duration

210 mg q4wMaximum dose

12+ weeksCRSwNP symptom duration

90/120 days

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CurrentSecurity Health Plan of Wisconsin, Inc.Policy SHP-P0650

Tezspire® (tezepelumab-ekko) subcutaneous therapy

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Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicyTezspire® (tezepelumab-ekko) subcutaneous therapy

Policy CodePolicy SHP-P0650

Change TypeNo material clinical or coverage changes

Effective DateN/A

Last ReviewMar 3, 2026

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsAuthorization duration

210 mg q4wMaximum dose

12+ weeksCRSwNP symptom duration

90/120 days

Asthma adherence period

22 agentsConcomitant restrictions

5Covered diagnosis codes

Medical Necessity and Coverage Criteria

Continuation therapy pathway

Covered when the requested agent is eligible for continuation therapy and ONE of the following is met:

Continuation eligibility

Qualifying continuation condition
- The member has been treated with the requested agent within the past 90 days.90 days
  Treatment initiated with samples does not qualify.
- The prescriber states that the member has been treated with the requested agent within the past 90 days and is at risk if therapy is changed.90 days
  Treatment initiated with samples does not qualify.

Severe asthma indication

Covered for severe asthma when ALL of the following are met:

Severe asthma criteria

ALL of the following
- Qualifying clinical feature
  - Frequent severe asthma exacerbations requiring two or more courses of systemic corticosteroids within the past 12 months.At least 2 systemic corticosteroid courses in 12 months
  - A serious asthma exacerbation requiring hospitalization, mechanical ventilation, or an emergency-room or urgent-care visit within the past 12 months.
  - Controlled asthma worsens when inhaled and/or systemic corticosteroid doses are tapered.
  - Baseline FEV1, before therapy with the requested agent, is less than 80% of predicted.FEV1 < 80% predicted

CRSwNP indication

Covered for CRSwNP when ALL of the following are met:

CRSwNP criteria

The member has chronic rhinosinusitis with nasal polyps.
Required symptoms
- The member is an adult with at least two of the following: nasal discharge, nasal obstruction or congestion, facial pressure or pain, or loss or decreased sense of smell.
- The member is a pediatric patient with at least two of the following: nasal discharge, nasal obstruction or congestion, facial pressure or pain, or cough.
Symptoms consistent with chronic rhinosinusitis have been present for at least 12 consecutive weeks.At least 12 consecutive weeks

Other labeled or compendia-supported indication

A member may qualify when the requested agent has another FDA-labeled indication or a compendia-supported indication for the requested route of administration.

Indication support

ALL of the following
- Age support
  - The member's age is within FDA labeling for the requested indication.
  - The prescriber provides information supporting use of the requested agent for the member's age and requested indication.
The requested agent has another indication supported in compendia for the requested agent and route of administration.
Allowed compendia include AHFS, DrugDex evidence level 1 or 2a, or NCCN recommended use level 1 or 2a.

Asthma background therapy and specialist requirements

When the member has severe asthma, ALL applicable criteria below must be met:

Inhaled corticosteroid pathway
- The member is not currently treated with an asthma biologic immunomodulator, including the requested agent, and is treated with a maximally tolerated inhaled corticosteroid for at least 3 months with adherence for 90 days within the past 120 days.ICS for at least 3 months; adherence for 90 days within 120 days
- The member is currently treated with an asthma biologic immunomodulator, including the requested agent, and uses an adequately dosed inhaled corticosteroid for at least 3 months with adherence for 90 days within the past 120 days.ICS for at least 3 months; adherence for 90 days within 120 days
- The member is currently treated with an asthma biologic immunomodulator, including the requested agent, and uses a maximally tolerated inhaled corticosteroid for at least 3 months with adherence for 90 days within the past 120 days.

CRSwNP maintenance therapy and combination use

When the member has CRSwNP, ALL of the following are required:

Maintenance and combination therapy

The member is currently treated with standard nasal polyp maintenance therapy.
Examples include nasal saline irrigation and intranasal corticosteroids.
The member will continue standard nasal polyp maintenance therapy in combination with the requested agent.
Examples include nasal saline irrigation and intranasal corticosteroids.
Combination immunomodulator use
- The requested agent will not be used with another immunomodulatory agent.
- The requested agent will be used with another immunomodulatory agent, the prescribing information does not limit the combination, and support for combination therapy is submitted.

Renewal criteria

Renewal is covered when ALL of the following are met:

Renewal requirements

The member was previously approved for the requested agent through the plan's prior authorization process.
Members not previously approved require initial evaluation review.
The member has had clinical benefit with the requested agent.
For severe asthma, the member is currently treated within the past 90 days and is compliant with asthma control therapy.Treatment within the past 90 days
Applicable controller therapy includes ICS, ICS/LABA, LTRA, LAMA, or theophylline.
For CRSwNP, the member will continue standard nasal polyp maintenance therapy in combination with the requested agent.

Contraindicated concomitant therapy

Tezspire must not be used concomitantly with agents identified in the policy as contraindicated concomitant therapy.

Concomitant therapy restriction

The member is not receiving Tezspire concurrently with any agent identified by the policy as contraindicated concomitant therapy.
The restriction includes listed biologic, immunomodulatory, and targeted therapies.

Agents not to be used concomitantly

Tezspire must not be used concomitantly with the following agents:

Restricted concomitant agents

Do not use Tezspire concomitantly with Tofacitinib; Tofidence (tocilizumab-bavi); Tremfya (guselkumab); Truxima (rituximab-abbs); Tyenne (tocilizumab-aazg); Tyruko (natalizumab-sztn); Tysabri (natalizumab); Ustekinumab; Velsipity (etrasimod); Wezlana (ustekinumab-auub); Xeljanz (tofacitinib); Xeljanz XR (tofacitinib extended release); Xolair (omalizumab); Yesintek (ustekinumab-kfce); or Yuflyma (adalimumab-aaty).
The policy designates these agents as not to be used concomitantly and/or contraindicated as concomitant therapy.

Dosage and administration

For all indications:

Administration

Administer Tezspire 210 mg subcutaneously once every 4 weeks.210 mg every 4 weeks

Coverage is not approved when the member has an FDA-labeled contraindication to Tezspire. This requirement applies to both initial and renewal review.

Use of Tezspire with another immunomodulatory agent is not covered unless the requested agent’s prescribing information does not limit the combination and supporting evidence is submitted, such as clinical trials, phase III studies, or guidelines.

Concurrent use of Tezspire is identified as contraindicated with Fasenra (benralizumab), Hadlima (adalimumab-bwwd), Enbrel (etanercept), Entyvio (vedolizumab), Exdensur (depemokimab-ulaa), Hulio (adalimumab-fkjp), Humira (adalimumab), Hyrimoz (adalimumab-adaz), Idacio (adalimumab-aacf), Ilaris (canakinumab), Ilumya (tildrakizumab-asmn), Imuldosa (ustekinumab-srlf), Inflectra (infliximab-dyyb), infliximab, Kevzara (sarilumab), Kineret (anakinra), Leqselvi (deuruxolitinib), Litfulo (ritlecitinib), Nemluvio (nemolizumab-ilto), Nucala (mepolizumab), Olumiant (baricitinib), or Omlyclo (omalizumab-igec).

Tezspire should not be used concomitantly with Idacio (adalimumab-aacf), Ilaris (canakinumab), Ilumya (tildrakizumab-asmn), Imuldosa (ustekinumab-srlf), Inflectra (infliximab-dyyb), infliximab, Kevzara (sarilumab), Kineret (anakinra), Leqselvi (deuruxolitinib), Litfulo (ritlecitinib), Nemluvio (nemolizumab-ilto), Nucala (mepolizumab), Olumiant (baricitinib), Omlyclo (omalizumab-igec), Omvoh (mirikizumab-mrkz), Opzelura (ruxolitinib), Orencia (abatacept), or Otezla (apremilast).

The policy explicitly restricts concomitant use of the listed agents. They are designated as not to be used concomitantly and/or contraindicated as concomitant therapy, including Inflectra, infliximab, Kevzara, Kineret, Leqselvi, Litfulo, Nemluvio, Nucala, Olumiant, Omlyclo, Omvoh, Opzelura, Orencia, Otezla, Otezla XR, and Otulfi.

The policy identifies concurrent use of Tezspire as contraindicated with Kevzara (sarilumab), Kineret (anakinra), Leqselvi (deuruxolitinib), Litfulo (ritlecitinib), Nemluvio (nemolizumab-ilto), Nucala (mepolizumab), Olumiant (baricitinib), Omlyclo (omalizumab-igec), Omvoh (mirikizumab-mrkz), Opzelura (ruxolitinib), Orencia (abatacept), Otezla (apremilast), Otezla XR (apremilast extended-release), Otulfi (ustekinumab-aauz), Rhapsido (remibrutinib), Riabni (rituximab-arrx), Rinvoq (upadacitinib), Rituxan (rituximab), Rituxan Hycela (rituximab/hyaluronidase human), Ruxience (rituximab-pvvr), Saphnelo (anifrolumab-fnia), Selarsdi (ustekinumab-aekn), Siliq (brodalumab), Simlandi (adalimumab-ryvk), Simponi (golimumab), Simponi ARIA (golimumab), Skyrizi (risankizumab-rzaa), Sotyktu (deucravacitinib), Spevigo subcutaneous injection, Starjemza (ustekinumab-hmny), Stelara (ustekinumab), Steqeyma (ustekinumab-stba), Taltz (ixekizumab), Tezspire (tezepelumab-ekko), Tofacitinib, Tofidence (tocilizumab-bavi), Tremfya (guselkumab), Truxima (rituximab-abbs), and Tyenne (tocilizumab-aazg).

The policy lists Spevigo subcutaneous injection, Starjemza, Stelara, Steqeyma, Taltz, Tezspire, Tofacitinib, Tofidence, Tremfya, Truxima, Tyenne, Tyruko, Tysabri, Ustekinumab, Velsipity, Wezlana, Xeljanz, and Xeljanz XR as contraindicated concomitant therapy. Tezspire must not be used at the same time as these agents.

Use of Tezspire with the restricted agents in the policy’s T-through-Y range is not covered when designated as contraindicated concomitant therapy. The list includes Tofacitinib, Tofidence (tocilizumab-bavi), Tremfya (guselkumab), Truxima (rituximab-abbs), Tyenne (tocilizumab-aazg), Tyruko (natalizumab-sztn), Tysabri (natalizumab), Ustekinumab, Velsipity (etrasimod), Wezlana (ustekinumab-auub), Xeljanz (tofacitinib), and Xeljanz XR (tofacitinib extended release).

Tezspire must not be used concomitantly with Tofacitinib; Tofidence (tocilizumab-bavi); Tremfya (guselkumab); Truxima (rituximab-abbs); Tyenne (tocilizumab-aazg); Tyruko (natalizumab-sztn); Tysabri (natalizumab); Ustekinumab; Velsipity (etrasimod); Wezlana (ustekinumab-auub); Xeljanz (tofacitinib); Xeljanz XR (tofacitinib extended release); Xolair (omalizumab); Yesintek (ustekinumab-kfce); or Yuflyma (adalimumab-aaty). These agents are designated as not to be used concomitantly and/or contraindicated as concomitant therapy.

Additional restricted agents include Tremfya (guselkumab), Truxima (rituximab-abbs), Tyenne (tocilizumab-aazg), Tyruko (natalizumab-sztn), Tysabri (natalizumab), Ustekinumab, Velsipity (etrasimod), Wezlana (ustekinumab-auub), Xeljanz (tofacitinib), Xeljanz XR (tofacitinib extended release), Xolair (omalizumab), Yesintek (ustekinumab-kfce), Yuflyma (adalimumab-aaty), and Yusimry (adalimumab-aqvh). Concurrent use with these agents is identified as not to be used concomitantly or contraindicated as concomitant therapy.

Coding, Dosing, and Utilization Parameters

HCPCS CodeHCPCSCovered

J2356

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

NDC(s)NDCCovered

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

J33.0	Polyp of nasal cavity
J33.1	Polypoid sinus degeneration
J33.8	Other polyp of sinus
J33.9	Nasal polyp, unspecified
J45.50	Severe persistent asthma, uncomplicated

Tezspire Maximum Dose

Maximum dose210 billable units (210 mg)

Administration intervalEvery 4 weeks

Billing-unit equivalent210 billable units equals 210 mg

Severe Asthma Steroid Bursts

Required exacerbation historyFrequent severe asthma exacerbations

Systemic corticosteroid thresholdTwo or more courses (steroid bursts)

Lookback period

Authorization, Documentation, and Denial Conditions

Prior Authorization

Authorization Duration

Initial authorization is valid for 12 months (365 days). Renewal authorization may be provided every 12 months (365 days thereafter).

Initial authorization: 12 months (365 days).
Renewal authorization: every 12 months (365 days).

Prior Authorization

Initial Approval Required

The requested agent must meet the applicable initial approval pathway. Continuation-of-therapy requests may qualify when the member has received the requested agent within the past 90 days, excluding samples, or the prescriber documents recent treatment and risk if therapy is changed; otherwise, the applicable diagnosis-specific criteria must be met.

Severe asthma: document uncontrolled asthma on control therapy, including qualifying exacerbations, hospitalization, mechanical ventilation, emergency or urgent care visits, worsening with corticosteroid taper, baseline FEV1 less than 80% predicted, or qualifying biologic immunomodulator use within the past 12 months.

Therapy Overview

Tezspire (tezepelumab-ekko) is a subcutaneous biologic covered under this policy for severe asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and other FDA-labeled or compendia-supported indications. Coverage focuses on clinically significant or uncontrolled disease despite appropriate controller therapy, required diagnostic confirmation and treatment history, continuation of applicable maintenance therapy, specialist involvement, and avoidance of unsupported immunomodulatory combinations.

Policy Definitions

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Required symptomsCompatible chronic rhinosinusitis symptoms; adults and pediatric members must have at least two qualifying symptoms

Minimum symptom durationAt least 12 consecutive weeks

Diagnostic confirmationAnterior rhinoscopy, nasal endoscopy, or computed tomography of the sinuses

Compendia Allowed

AHFSAllowed compendium

DrugDexLevel 1 or 2a evidence

NCCNLevel 1 or 2a recommended use

Policy Summary

PayerSecurity Health Plan of Wisconsin, Inc.

PolicyTezspire® (tezepelumab-ekko) subcutaneous therapy

Policy CodePolicy SHP-P0650

Change TypeNo material clinical or coverage changes

Effective DateN/A

Last ReviewMar 3, 2026

Next Review DateN/A

SourceLink

On This Page

The medication history, excluding sample use, indicates use of an FDA-labeled or compendia-supported biologic immunomodulator for asthma within the past 12 months.Within the past 12 months

Diagnostic confirmation

Confirmation by anterior rhinoscopy.
Confirmation by nasal endoscopy.
Confirmation by computed tomography of the sinuses.

Intranasal corticosteroid criterion

The member tried one intranasal corticosteroid and had an inadequate response after at least 4 weeks of therapy.At least 4 weeks
The member has intolerance or hypersensitivity to one intranasal corticosteroid.
The member has an FDA-labeled contraindication to all intranasal corticosteroids.

ICS for at least 3 months; adherence for 90 days within 120 days

The member has intolerance or hypersensitivity to one inhaled corticosteroid.

The member has an FDA-labeled contraindication to all inhaled corticosteroids.

Additional controller pathway

The member has been treated for at least 3 months, with adherence for 90 days within the past 120 days, with a LABA, LAMA, LTRA, or theophylline.At least 3 months; adherence for 90 days within 120 days
The member has intolerance or hypersensitivity to one LABA, LAMA, LTRA, or theophylline.
The member has an FDA-labeled contraindication to all LABA and LAMA therapy.

The member will continue asthma control therapy, such as an ICS, ICS/LABA, LTRA, LAMA, or theophylline, in combination with the requested agent.

The prescriber is a specialist in the area of the diagnosis, or has consulted with a relevant specialist.

Relevant specialists may include an allergist, immunologist, or pulmonologist.

Combination immunomodulator use

The requested agent will not be used in combination with another immunomodulatory agent.
The requested agent will be used with another immunomodulatory agent, the prescribing information does not limit the combination, and support for combination therapy is submitted.
Submit clinical trials, phase III studies, or guidelines supporting the combination.

The member does not have an FDA-labeled contraindication to the requested agent.

Submit clinical trials, phase III studies, or guidelines supporting the combination.

The prescriber is a specialist in the area of the diagnosis or has consulted with a relevant specialist.

Combination immunomodulator use

The requested agent will not be used in combination with another immunomodulatory agent.
The requested agent will be used with another immunomodulatory agent, the prescribing information does not limit the combination, and support for combination therapy is submitted.
Submit clinical trials, phase III studies, or guidelines supporting the combination.

The member does not have an FDA-labeled contraindication to the requested agent.

Within the past 12 months

CRSwNP Symptom Duration

ConditionSymptoms consistent with chronic rhinosinusitis

Minimum durationAt least 12 consecutive weeks

Required timingSymptoms must be present continuously for the qualifying period

CRSwNP Intranasal Corticosteroid Trial

TreatmentOne intranasal corticosteroid

Minimum trial durationAt least 4 weeks

Response requirementInadequate response after the trial, unless intolerance, hypersensitivity, or an FDA-labeled contraindication applies

Asthma Inhaled Corticosteroid Treatment

TreatmentInhaled corticosteroid therapy

Minimum treatment durationAt least 3 months

Applicable adherence periodAdherent for 90 days within the past 120 days, when applicable

Tezspire Dosage and Frequency

Dose210 mg

RouteSubcutaneous

FrequencyOnce every 4 weeks

HCPCS Billing Unit

HCPCS codeJ2356

Code descriptionInjection, tezepelumab-ekko, 1 mg

Billing-unit conversion1 billable unit equals 1 mg

CRSwNP: document the required symptoms, at least 12 consecutive weeks of symptoms, objective confirmation, and the required intranasal corticosteroid history.

Other FDA-labeled or compendia-supported indications and route of administration may qualify, subject to age or prescriber justification when applicable.

Meet asthma controller-therapy, maintenance-therapy, specialist, concomitant-therapy, and FDA contraindication requirements described below.

Prior Authorization

Renewal Required

Renewal requests require prior plan approval and documentation of continued clinical benefit. The member must continue required disease-specific maintenance or control therapy, meet specialist and concomitant-therapy requirements, and have no FDA-labeled contraindication.

The member was previously approved through the plan's prior authorization process; otherwise, an initial evaluation is required.
Document clinical benefit with the requested agent.
For severe asthma, document treatment and compliance with asthma control therapy within the past 90 days.
For CRSwNP, document continued standard nasal polyp maintenance therapy in combination with Tezspire.
Continue specialist involvement or documented specialist consultation.

Documentation Required

Prior Authorization Factors

Prior authorization is considered using indication, safety and efficacy, misuse or abuse potential, and drug-cost factors. The NQTL utilization-management approach is applied comparably, and not more stringently, to MH/SUD and medical/surgical prescription drugs.

Indication: considered for prior authorization.
Safety and efficacy: not a priority for prior authorization.
Potential for misuse or abuse: not a priority for prior authorization.
Cost of drug: considered for prior authorization.

Documentation Required

Indication and Treatment History

Document the member's diagnosis and applicable treatment history before requesting Tezspire. The record should support response or failure, intolerance, contraindication, adherence, specialist involvement, and any relevant prior biologic or immunomodulator use.

Diagnosis and applicable FDA-labeled or compendia-supported indication and route.
Prior treatment, response or inadequate response, intolerance or hypersensitivity, and contraindications.
For continuation, treatment with the requested agent within the past 90 days; sample-only use is not approvable.
For asthma, exacerbation history, lung function, controller therapy, adherence, and biologic history.
For CRSwNP, symptom history, duration, objective findings, and intranasal corticosteroid history.

Documentation Required

CRSwNP Diagnostic Documentation

For CRSwNP, document the required symptom pattern, symptom duration, and objective diagnostic confirmation before approval can be considered.

Adults: at least two of nasal discharge, nasal obstruction or congestion, facial pressure or pain, or loss or decreased sense of smell.
Pediatric members: at least two of nasal discharge, nasal obstruction or congestion, facial pressure or pain, or cough.
Symptoms consistent with chronic rhinosinusitis must have persisted for at least 12 consecutive weeks.
Diagnosis must be confirmed by anterior rhinoscopy, nasal endoscopy, or CT of the sinuses.

Step Therapy

CRSwNP Intranasal Corticosteroid Requirement

For CRSwNP, the member must have tried one intranasal corticosteroid for at least 4 weeks with inadequate response, or have a qualifying intolerance, hypersensitivity, or FDA-labeled contraindication to all intranasal corticosteroids.

Examples include fluticasone nasal spray, mometasone nasal spray, and Sinuva.
Document inadequate response after at least 4 weeks of therapy, intolerance or hypersensitivity, or contraindication to all intranasal corticosteroids.
The member must also continue standard nasal polyp maintenance therapy, such as saline irrigation or intranasal corticosteroids, when applicable.

Step Therapy

Asthma Controller Therapy Requirement

For severe asthma, document adequate controller therapy and adherence before approval. The required therapy history varies depending on whether the member is currently receiving another asthma biologic immunomodulator.

Without another asthma biologic: maximally tolerated ICS for at least 3 months and adherence for 90 days within the past 120 days.
With another asthma biologic: adequately dosed ICS for at least 3 months with adherence for 90 days within the past 120 days, or maximally tolerated ICS for at least 3 months with adherence for 90 days within the past 120 days.
Document qualifying intolerance or hypersensitivity to one ICS, or an FDA-labeled contraindication to all ICS, when relied upon.
Also document at least 3 months of treatment and adherence for 90 days within the past 120 days with a LABA, LAMA, LTRA, or theophylline, unless a qualifying intolerance, hypersensitivity, or contraindication applies.
The member must continue asthma control therapy in combination with Tezspire.

Documentation Required

Asthma Controller Therapy and Adherence

For asthma requests, document the controller therapy, dose adequacy, duration, adherence, and use or nonuse of other biologic immunomodulators. The record must support the applicable initial or renewal pathway.

Identify ICS therapy as maximally tolerated or adequately dosed, as applicable.
Document at least 3 months of therapy and adherence for 90 days within the past 120 days.
Identify LABA, LAMA, LTRA, or theophylline therapy, or document the applicable intolerance, hypersensitivity, or contraindication.
Document whether another asthma biologic immunomodulator is currently being used.
For renewals, document current treatment within the past 90 days and compliance with asthma control therapy.

Documentation Required

Specialist and Combination-Therapy Support

The prescriber must be a specialist in the member's diagnosis or document consultation with an appropriate specialist. Combination use with another immunomodulator requires prescribing-information support and clinical evidence or guideline support.

Asthma specialists may include an allergist, immunologist, or pulmonologist.
CRSwNP specialists may include an otolaryngologist, allergist, immunologist, or pulmonologist.
If combination immunomodulator therapy is proposed, submit prescribing information showing that use is not limited and supporting clinical trials, phase III studies, or guidelines.
Compendia support is limited to AHFS, DrugDex level 1 or 2a evidence, or NCCN level 1 or 2a recommended use.

Documentation Required

Renewal Response and Ongoing Therapy

Renewal requests must show prior plan authorization, clinical benefit, ongoing compliance, and continued maintenance or control therapy. The member must remain eligible under the concomitant-therapy and contraindication requirements.

Document prior authorization through the plan and continued clinical benefit.
For severe asthma, document current treatment and compliance with asthma control therapy within the past 90 days.
For CRSwNP, document continued standard nasal polyp maintenance therapy in combination with Tezspire.
Document specialist involvement or consultation and any permitted combination-therapy support.
Document absence of FDA-labeled contraindications.

Denial Risk

Failure to Meet Indication-Specific Criteria

Approval may be denied when the member does not meet the applicable indication-specific criteria. Submit complete evidence for the selected indication, including diagnosis, symptom or disease severity, treatment history, response, adherence, and required maintenance therapy.

Severe asthma requests must satisfy the asthma diagnosis, severity or treatment-history, controller-therapy, adherence, and continuation requirements.
CRSwNP requests must satisfy symptom, duration, objective confirmation, intranasal corticosteroid, and maintenance-therapy requirements.
Other indications must be FDA labeled or supported in compendia for the requested agent and route.
Failure to document the applicable criteria creates denial risk.

Denial Risk

FDA-Labeled Contraindication

Do not approve the requested agent when the member has an FDA-labeled contraindication to Tezspire or when the requested use otherwise fails the policy's contraindication requirement.

Initial and renewal requests require documentation that the member does not have an FDA-labeled contraindication.
A labeled contraindication to the requested agent is an approval exclusion.

Denial Risk

Unsupported Combination Immunomodulator Therapy

Combination use with another immunomodulatory agent is not automatically approvable. If combination therapy is requested, the prescribing information must not limit the combination and supporting clinical evidence or guidelines must be submitted.

Restricted examples include TNF inhibitors, JAK inhibitors, and IL-4 inhibitors.
Submit a copy of clinical trials, phase III studies, or guidelines supporting the combination.
Without prescribing-information support and clinical support, deny or do not approve the combination.

Denial Risk

Prohibited Concomitant Biologic or Immunomodulatory Therapy

Do not use Tezspire concomitantly with another prohibited biologic or immunomodulatory agent listed in the policy. Confirm the complete medication list at initial approval and renewal.

The restriction includes biologics and immunomodulators in the policy's Agents NOT to be used Concomitantly list.
Examples include TNF inhibitors, JAK inhibitors, interleukin-directed agents, other asthma biologics, and other listed biologic or immune-modifying therapies.
Combination use is permitted only when the policy's prescribing-information and supporting-evidence requirements are met.

Denial Risk

Exceeding Dosing Limit

Requests exceeding the policy dosing limit should not be approved. The maximum is 210 billable units, corresponding to 210 mg, every 4 weeks.

Maximum: 210 billable HCPCS units (210 mg) every 4 weeks.
Dosing above 210 mg every 4 weeks presents denial risk.

Denial Risk

Avoid Contraindicated Concomitant Agents: E-H

Avoid concurrent use of Tezspire with the listed contraindicated agents. The alphabetical portion reflected here includes agents from Enbrel through Hulio.

Enbrel (etanercept); Entyvio (vedolizumab); Exdensur (depemokimab-ulaa); Fasenra (benralizumab).
Hadlima (adalimumab-bwwd); Hulio (adalimumab-fkjp); Humira (adalimumab).

Denial Risk

Concurrent Use of Contraindicated Agents: I-O

Concurrent use with the listed agents is contraindicated under the policy and may result in non-approval. Verify the member's medication list before authorization.

Idacio (adalimumab-aacf); Ilaris (canakinumab); Ilumya (tildrakizumab-asmn); Imuldosa (ustekinumab-srlf).
Inflectra (infliximab-dyyb); Infliximab; Kevzara (sarilumab); Kineret (anakinra).
Leqselvi (deuruxolitinib); Litfulo (ritlecitinib); Nemluvio (nemolizumab-ilto); Nucala (mepolizumab).
Olumiant (baricitinib); Omlyclo (omalizumab-igec); Omvoh (mirikizumab-mrkz); Opzelura (ruxolitinib); Orencia (abatacept); Otezla and Otezla XR (apremilast).

Denial Risk

Avoid Contraindicated Concomitant Agents: P-R

Do not use Tezspire concurrently with the following policy-listed agents in the P-R range. Such concurrent therapy creates denial or non-approval risk.

Otulfi (ustekinumab-aauz); Rhapsido (remibrutinib); Riabni (rituximab-arrx); Rinvoq (upadacitinib).
Rituxan (rituximab); Rituxan Hycela (rituximab/hyaluronidase human); Ruxience (rituximab-pvvr).
Saphnelo (anifrolumab-fnia).

Denial Risk

Concurrent Use of Contraindicated Agents: S-T

The policy prohibits concurrent use of additional listed biologic and immunomodulatory agents in the S-O range. Confirm that none is being used with Tezspire unless the policy's combination exception is documented.

Spevigo (spesolimab-sbzo); Starjemza (ustekinumab-hmny); Stelara (ustekinumab); Steqeyma (ustekinumab-stba).
Taltz (ixekizumab); Tezspire (tezepelumab-ekko); Tofacitinib; Tofidence (tocilizumab-bavi).
Tremfya (guselkumab); Truxima (rituximab-abbs); Tyenne (tocilizumab-aazg).

Denial Risk

Avoid Contraindicated Concomitant Agents: T-Y

Avoid the remaining listed agents in the T-Y range when used concurrently with Tezspire. Concurrent therapy may result in denial or non-approval.

Tyruko (natalizumab-sztn); Tysabri (natalizumab); Ustekinumab; Velsipity (etrasimod).
Wezlana (ustekinumab-auub); Xeljanz and Xeljanz XR (tofacitinib); Xolair (omalizumab).
Yesintek (ustekinumab-kfce); Yuflyma (adalimumab-aaty); Yusimry (adalimumab-aqvh).

Denial Risk

Prohibited Concomitant Therapy: Tremfya-Tysabri

The policy's prohibited concomitant-therapy list specifically includes Tremfya, Truxima, Tyenne, Tyruko, and Tysabri. Do not approve concurrent use with these agents.

Tremfya (guselkumab).
Truxima (rituximab-abbs).
Tyenne (tocilizumab-aazg).
Tyruko (natalizumab-sztn).
Tysabri (natalizumab).

Continuation of Therapy

Recent treatmentThe member was treated with the requested agent within the past 90 days

Sample useTreatment starting on samples is not approvable

Prescriber attestation alternativeThe prescriber may state that the member was treated within the past 90 days and is at risk if therapy is changed

Contraindicated as Concomitant Therapy

MeaningTherapy that must not be administered at the same time as Tezspire

Policy basisThe policy identifies the combination as contraindicated

ApplicationThe restriction applies to agents listed as contraindicated concomitant therapy

Concomitant Therapy

MeaningTherapy involving Tezspire and one of the listed agents at the same time

TimingThe therapies are administered concurrently

Policy treatmentListed combinations are identified as not to be used concomitantly and/or contraindicated

Concomitant Therapy Restrictions

MeaningTezspire is administered at the same time as another listed agent

Restricted agentsThe listed agents include Tofacitinib, Tofidence, Tremfya, Truxima, Tyenne, Tyruko, Tysabri, Ustekinumab, Velsipity, Wezlana, Xeljanz, Xeljanz XR, Xolair, Yesintek, and Yuflyma

Policy designationThe listed agents are not to be used concomitantly or are contraindicated as concomitant therapy