CurrentTexas Children's Health PlanPolicy 11062

Monoclonal Antibodies for Asthma and Allergic Conditions Guideline

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This guideline governs Texas Children's Health Plan prior authorization for selected monoclonal antibody therapies used for asthma, chronic idiopathic urticaria, eosinophilic disorders, and chronic rhinosinusitis with nasal polyps. It applies to providers requesting these injectable therapies for TCHP members and specifies initial-therapy, continuation, documentation, and medical-necessity requirements.

Policy Summary

PayerTexas Children's Health Plan

PolicyMonoclonal Antibodies for Asthma and Allergic Conditions Guideline

Policy CodePolicy 11062

Change TypeNo material clinical or coverage change

Effective DateMar 21, 2024

Next Review DateN/A

Key ActionSubmit the Special Medical Prior Authorization form, exact dosage, and supporting medical-necessity documentation for review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

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CurrentTexas Children's Health PlanPolicy 11062

Monoclonal Antibodies for Asthma and Allergic Conditions Guideline

Customize your policy alerts

Sign up for texaschildrenshealthplan Policy 11062 alerts

Get alerted when Policy 11062 changes without checking for updates manually.

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Policy Summary

PayerTexas Children's Health Plan

PolicyMonoclonal Antibodies for Asthma and Allergic Conditions Guideline

Policy CodePolicy 11062

Change TypeNo material clinical or coverage change

Effective DateMar 21, 2024

Next Review DateN/A

Key ActionSubmit the Special Medical Prior Authorization form, exact dosage, and supporting medical-necessity documentation for review.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

Monoclonal antibody therapies addressed

6 monthsDuration before continuation documentation

6+ yearsYoungest stated age for covered use

30 to <1300 IU/mLOmalizumab total IgE range

150 or 300Mepolizumab asthma eosinophil thresholds

Not medically necessaryAcute bronchospasm treatment with tezepelumab-ekko

General Coverage Criteria

Initial Therapy — Omalizumab for Moderate to Severe Asthma

Covered when ALL of the following criteria are met:

ALL of the following

Member is 6 years of age or older.
Member has a diagnosis of moderate to severe asthma as defined by the National Heart, Lung, and Blood Institute's Guidelines for the Diagnosis and Management of Asthma (diagnosis codes J4540 and J4550).
Member has a positive skin test or radioallergosorbent assay test (RAST) to a perennial, not seasonal, aeroallergen within the past 36 months.
Member has a total IgE level greater than 30 IU/mL but less than 1300 IU/mL within the past 12 months.> 30 IU/mL and < 1300 IU/mL
Member meets the additional medical-necessity criteria for prior authorization for asthma described below.

Initial Therapy — Omalizumab for Chronic Idiopathic Urticaria

Covered when ALL of the following criteria are met:

ALL of the following

Member is 12 years of age or older.
Member has a diagnosis of chronic idiopathic urticaria with symptoms despite H1 antihistamine treatment (diagnosis code L501).
Documented failure of, or contraindication to, antihistamine therapy.
Evidence of an evaluation that excludes other medical diagnoses associated with chronic urticaria.

Initial Therapy — Nasal Polyps

Covered when ALL of the following criteria are met:

ALL of the following

Member is 18 years of age or older.
Member has a diagnosis of nasal polyps with inadequate response to nasal corticosteroids (diagnosis codes J330, J331, J338, and J339).
Member has bilateral nasal polyposis confirmed by physical examination or nasal endoscopy.
Documented failure of, or contraindication to, prior corticosteroids as monotherapy.
Documented inadequate response to prior corticosteroid treatments.

Initial Therapy — Benralizumab

Covered when ALL of the following criteria are met:

ALL of the following

Member is 12 years of age or older.
Member has severe asthma with an eosinophilic phenotype (diagnosis codes J4450, J4451, and J4452).
Member meets the additional medical-necessity criteria for prior authorization for asthma described below.

Initial Therapy — Reslizumab

Covered when ALL of the following criteria are met:

ALL of the following

Member is 18 years of age or older.
Member has severe asthma with an eosinophilic phenotype (diagnosis codes J4450, J4451, and J4452).
Member meets the additional medical-necessity criteria for prior authorization for asthma described below.

Initial Therapy — Mepolizumab for Severe Eosinophilic Asthma

Covered when ALL of the following criteria are met:

ALL of the following

Member is 6 years of age or older.
Member has a diagnosis of severe asthma with an eosinophilic phenotype as defined by the National Heart, Lung, and Blood Institute's Guidelines for the Diagnosis and Management of Asthma (diagnosis codes J4550, J4551, and J4552).
ONE of the following blood eosinophil counts, in the absence of other potential causes of eosinophilia, including hypereosinophilic syndromes, neoplastic disease, and known or suspected parasitic infection:
- Blood eosinophil count at initiation of therapy is at least 150 cells/microliter.>= 150 cells/microliter at initiation
- Blood eosinophil count within 12 months before initiation of therapy is at least 300 cells/microliter.

Initial Therapy — Mepolizumab for EGPA

Covered when ALL of the following criteria are met:

ALL of the following

Member is 18 years of age or older.
Member has a confirmed diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA) (diagnosis code M301).
Member has a medical history of asthma.
Member has at least 2 of the following EGPA characteristics: histopathological findings of eosinophilic vasculitis, perivascular eosinophilic infiltration or eosinophil-rich granulomatous inflammation; neuropathy; pulmonary infiltrates; cardiomyopathy; glomerulonephritis; alveolar hemorrhage; palpable purpura; or antineutrophil cytoplasmic antibody.
Member uses an oral glucocorticoid and/or cyclophosphamide, azathioprine, methotrexate, or leflunomide.

Initial Therapy — Mepolizumab for Hypereosinophilic Syndrome

Covered when ALL of the following criteria are met:

ALL of the following

Member is 12 years of age or older.
Member has hypereosinophilic syndrome (HES) with symptoms for 6 months or longer without an identifiable non-hematologic secondary cause (diagnosis codes D72110, D72111, D72118, and D72119).>= 6 months
Member has a history of 2 or more HES flares within the 12 months before initiation of mepolizumab therapy. A flare is worsening clinical symptoms or blood eosinophil counts requiring an increase in prior therapy.>= 2 flares within 12 months
Prescribing physician attests that the member has been on a stable dose of HES therapy, including but not limited to corticosteroid, immunosuppressive, and cytotoxic therapy.

Initial Therapy — Mepolizumab for Chronic Rhinosinusitis with Nasal Polyps

Covered when ALL of the following criteria are met:

ALL of the following

Member is 18 years of age or older.
Member has a confirmed diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) (diagnosis codes J330, J331, J338, and J339).
Member has evidence of an inadequate response to nasal corticosteroids.
Member has received a minimum of 3 months of controller medication, including but not limited to a long-acting beta-2 agonist (LABA), inhaled or oral corticosteroid, leukotriene receptor antagonist (LTRA), or theophylline, unless intolerant of or medically contraindicated to such therapy.>= 3 months

Additional Asthma Medical-Necessity Criteria

Covered when ALL of the following criteria are met for prior authorization of omalizumab, benralizumab, mepolizumab, reslizumab, or tezepelumab-ekko for asthma:

ALL of the following

Symptoms are inadequately controlled despite combination controller therapy, including medium- or high-dose inhaled corticosteroid therapy together with an additional asthma controller such as a long-acting beta-2 agonist, leukotriene receptor antagonist, or theophylline.
Pulmonary function tests have been performed within the preceding 3 months and are documented.within 3 months
Member is not currently smoking.
Any preexisting helminth infection has been treated before receiving monoclonal antibody therapy.

Initial Therapy — Tezepelumab-ekko

Covered when ALL of the following criteria are met:

ALL of the following

Member is 12 years of age or older.
Member has a confirmed diagnosis of severe asthma (diagnosis codes J45.50 and J45.51).
Tezepelumab-ekko is requested as add-on maintenance therapy.
Current management includes regular treatment for severe asthma and the member is compliant with therapy consisting of medium- or high-dose inhaled corticosteroid therapy AND an additional asthma controller.

Tezepelumab-ekko is not to be used for relief of acute bronchospasm or status asthmaticus.

Tezepelumab-ekko is not to be used as a single or primary therapy; it must be prescribed as add-on maintenance therapy.

Monoclonal antibody agents should not be used in combination with anti-IgE, anti-IL4, or anti-IL5 monoclonal antibody agents, including benralizumab, omalizumab, mepolizumab, reslizumab, and dupilumab.

Therapy should not be administered when the member has an active, untreated helminth infection. The infection should be treated before initiation of omalizumab, benralizumab, mepolizumab, reslizumab, or tezepelumab-ekko.

Therapy should not be administered concurrently with a live attenuated vaccination.

Tezepelumab-ekko is not medically necessary for relief of acute bronchospasm or status asthmaticus.

Procedure and Diagnosis Coding

Omalizumab procedure codeHCPCSCovered

J2357

Omalizumab (Xolair)

Benralizumab procedure codeHCPCSCovered

J0517

Benralizumab (Fasenra)

Reslizumab procedure codeHCPCSCovered

J2786

Reslizumab (Cinqair)

Mepolizumab procedure codeHCPCSCovered

J2182

Mepolizumab (Nucala)

Tezepelumab-ekko procedure codeHCPCSCovered

J2356

Tezepelumab-ekko (Tezspire)

Omalizumab asthma diagnosis codesICD-10Covered

J4540	Moderate to severe asthma
J4550	Moderate to severe asthma

Chronic idiopathic urticariaICD-10Covered

L501	Chronic idiopathic urticaria

Nasal polyps and severe eosinophilic asthmaICD-10Covered

J330	Nasal polyps
J331	Nasal polyps
J338	Nasal polyps
J339	Nasal polyps
J4450	Severe asthma with eosinophilic phenotype
J4451	Severe asthma with eosinophilic phenotype
J4452	Severe asthma with eosinophilic phenotype

Mepolizumab severe eosinophilic asthmaICD-10Covered

J4550	Severe asthma with eosinophilic phenotype
J4551	Severe asthma with eosinophilic phenotype
J4552	Severe asthma with eosinophilic phenotype

Eosinophilic granulomatosis with polyangiitisICD-10Covered

M301	Eosinophilic granulomatosis with polyangiitis

Hypereosinophilic symptomsICD-10Covered

D72110	Hypereosinophilic symptoms
D72111	Hypereosinophilic symptoms
D72118	Hypereosinophilic symptoms
D72119	Hypereosinophilic symptoms

Tezepelumab-ekko severe asthmaICD-10Covered

J45.50	Severe asthma
J45.51	Severe asthma

Omalizumab total IgE

Total IgE minimumGreater than 30 IU/mL

Total IgE maximumLess than 1300 IU/mL

Testing lookbackThe qualifying total IgE level must be documented within the past 12 months

Perennial aeroallergen testing

Qualifying test

Prior Authorization and Submission Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for monoclonal antibody treatment. Submit the Special Medical Prior Authorization (SMPA) form, the exact requested dosage, and documentation supporting medical necessity.

Requests are reviewed under the TCHP Monoclonal Antibodies Guideline and applicable Texas Medicaid outpatient drug criteria.

Step Therapy

Failure of Conventional Therapy

The requested treatment must demonstrate inadequate control, documented failure, or a contraindication to conventional therapy, as applicable to the indication.

Asthma: document inadequate control despite required controller therapy.
Chronic idiopathic urticaria: document symptoms despite H1-antihistamine treatment and failure of, or contraindication to, antihistamine therapy.
Nasal polyps or CRSwNP: document inadequate response to, and failure of or contraindication to, corticosteroid therapy.

Policy Background

This guideline addresses injectable monoclonal antibodies that target allergic, eosinophilic, and other inflammatory pathways. Covered clinical roles include treatment of severe or inadequately controlled asthma, chronic idiopathic urticaria, eosinophilic granulomatosis with polyangiitis, hypereosinophilic syndrome, and chronic rhinosinusitis with nasal polyps. Authorization is based on the member’s age, diagnosis, disease phenotype or laboratory findings, prior treatment response, and ongoing clinical benefit.

Covered Monoclonal Antibodies

Omalizumab (Xolair)

IndicationModerate to severe persistent asthma

Age rangeMembers 6 years of age and older

Qualifying asthma characteristicsPositive skin test or in vitro reactivity to a perennial aeroallergen and symptoms inadequately controlled with inhaled corticosteroids

Benralizumab (Fasenra)

IndicationSevere asthma

Age rangeMembers 12 years of age and older

Qualifying phenotypeAsthma with an eosinophilic phenotype

Initial Therapy by Drug and Indication

Omalizumab — Asthma

Omalizumab asthma authorization requires all of the following.

Omalizumab asthma

Member is 6 years of age or older.
Member has moderate to severe asthma.
Member has a positive skin test or RAST/in vitro reactivity to a perennial aeroallergen within the past 36 months.
Member has a total IgE level greater than 30 IU/mL and less than 1300 IU/mL within the past 12 months.
Member meets the additional asthma medical-necessity criteria.

Continuation Therapy

Continuation of Omalizumab, Benralizumab, Mepolizumab, Reslizumab, or Tezepelumab-ekko

After 6 consecutive months of therapy, continuation requires all of the following.

Continuation response

Treatment compliance is documented.
Clinical improvement is documented through one or more of the following: decreased rescue-medication utilization, increased predicted FEV1 from pretreatment baseline, or reduced frequency or magnitude of asthma-related symptoms, including asthma attacks, chest tightness or heaviness, coughing or throat clearing, difficulty taking a deep breath or breathing out, shortness of breath, sleep disturbance or night wakening, tiredness, or wheezing/heavy breathing/fighting for air.
No symptoms of hypersensitivity or anaphylaxis occur after administration of omalizumab, benralizumab, mepolizumab, or reslizumab, including bronchospasm, hypotension, syncope, urticaria, or angioedema.

Conventional Therapy Requirements

Therapy or indication	Prior or current conventional therapy	Required response or documentation
Asthma monoclonal antibodies	Controller medication for at least 3 months, including a LABA, inhaled or oral corticosteroid, LTRA, or theophylline, unless the member is intolerant or has a medical contraindication.	Symptoms remain inadequately controlled despite controller therapy; document the treatment history and medical necessity.
Omalizumab for chronic idiopathic urticaria	H1 antihistamine treatment.	Symptoms persist despite treatment, with documented failure of or contraindication to antihistamine therapy.
Nasal-polyps indications	Nasal corticosteroid or prior corticosteroid treatment.	Inadequate response to corticosteroids, including documented failure of or contraindication to corticosteroids as monotherapy and inadequate response to prior corticosteroid treatment.
Tezepelumab-ekko for severe asthma	Current, regular, compliant medium- or high-dose inhaled corticosteroid therapy plus an additional asthma controller.	The member must require add-on maintenance therapy; tezepelumab-ekko must not be used as single or primary therapy.

Policy Summary

PayerTexas Children's Health Plan

PolicyMonoclonal Antibodies for Asthma and Allergic Conditions Guideline

Policy CodePolicy 11062

Change TypeNo material clinical or coverage change

Effective DateMar 21, 2024

Next Review DateN/A

Key ActionSubmit the Special Medical Prior Authorization form, exact dosage, and supporting medical-necessity documentation for review.

SourceLink

On This Page

>= 300 cells/microliter within 12 months before initiation

Member meets the additional medical-necessity criteria for prior authorization for asthma described below.

Disease is refractory or the member has a history of EGPA relapse.

Exceptions to these criteria may be considered case by case and require a letter from the prescribing provider stating the medical necessity for therapy, the member's asthma severity level, the duration of current and past therapies, and the lack of asthma control.

Positive skin test or radioabsorbent assay test (RAST) to a perennial aeroallergen

Allergen typeThe aeroallergen must be perennial, not seasonal

Testing lookbackTesting must be completed within the past 36 months

Mepolizumab blood eosinophils

At initiationBlood eosinophil count greater than or equal to 150 cells/microliter

Alternative lookback thresholdBlood eosinophil count greater than or equal to 300 cells/microliter within 12 months before initiation

ExclusionThe count must be assessed in the absence of other potential causes of eosinophilia, including hypereosinophilic syndromes, neoplastic disease, and known or suspected parasitic infection

Hypereosinophilic syndrome duration

Minimum durationHypereosinophilic symptoms must be present for 6 months or longer

Secondary causeSymptoms must occur without an identifiable non-hematologic secondary cause

Covered populationThe member must be 12 years of age or older

HES flares

Minimum number of flaresTwo or more HES flares

Pre-initiation periodFlares must occur within the 12 months before initiation of mepolizumab therapy

Flare definitionA flare is worsening clinical symptoms or blood eosinophil counts requiring an increase in prior therapy

Continuation period

Therapy periodContinuation is evaluated after 6 consecutive months of therapy

Compliance documentationDocumentation of treatment compliance is required

Clinical responseDocumentation must show a satisfactory clinical response, such as decreased rescue-medication use, increased predicted FEV1, or reduced asthma-related symptoms

Unsupported block type: documentation

Note

Submission and Review Process

Prior authorization requests are received and processed by the Utilization Management Department during normal business hours. The reviewing Utilization Management professional evaluates whether the submitted documentation supports the requested medication as an eligible service.

Submit by fax, mail, or electronically to the Utilization Management Department.
Requests are reviewed against the TCHP Monoclonal Antibodies Guideline and applicable Texas Medicaid outpatient drug policies and procedures.

Documentation Required

Asthma Clinical Documentation

For asthma requests, document the diagnosis, severity and phenotype, required testing, controller therapy, and pulmonary function testing supporting medical necessity.

Document the applicable asthma diagnosis and severity, including eosinophilic phenotype when required.
For omalizumab, document a positive perennial-allergen skin or RAST test within 36 months and total IgE greater than 30 IU/mL but less than 1,300 IU/mL within 12 months.
For mepolizumab, document the qualifying blood eosinophil count: at least 150 cells/microliter at initiation or at least 300 cells/microliter within the prior 12 months, absent other causes of eosinophilia.
Document at least 3 months of controller medication, such as a LABA, inhaled or oral corticosteroid, LTRA, or theophylline, unless intolerance or a medical contraindication applies.
Document pulmonary function testing performed within the preceding 3 months.
Document that the member is not currently smoking and that any preexisting helminth infection has been treated before therapy.

Unsupported block type: documentation

Denial Risk

Criteria Not Met

Requests that do not meet the established criteria are referred to a TCHP Medical Director or Physician Reviewer, and the Denial Policy is followed. Prior authorization is based on medical necessity and does not guarantee benefits or eligibility; benefit limitations, exclusions, regulatory requirements, audits, and potential recoupment still apply.

Ensure the submission addresses every applicable criterion before requesting review.

Unsupported block type: denial_risk

Reslizumab (Cinqair)

IndicationSevere asthma

Age rangeMembers 18 years of age and older

Qualifying phenotypeAsthma with an eosinophilic phenotype

Mepolizumab (Nucala)

Severe eosinophilic asthmaIndicated for members 6 years of age and older

Eosinophilic granulomatosis with polyangiitisIndicated for members 18 years of age and older

Hypereosinophilic symptomsIndicated for members 12 years of age and older

Chronic rhinosinusitis with nasal polypsAdd-on maintenance treatment for members 18 years of age and older

Tezepelumab-ekko (Tezspire)

IndicationAdd-on maintenance therapy for severe asthma

Age rangePediatric and adult clients 12 years of age and older

Use requirementRequested as add-on maintenance therapy, not as single or primary therapy

Omalizumab — Chronic Idiopathic Urticaria

Omalizumab chronic idiopathic urticaria authorization requires all of the following.

Chronic idiopathic urticaria

Member is 12 years of age or older.
Member has chronic idiopathic urticaria with symptoms despite H1 antihistamine treatment.
Failure of, or contraindication to, antihistamine treatment is documented.
An evaluation excludes other medical diagnoses associated with chronic urticaria.

Benralizumab or Reslizumab

The request must meet the applicable severe eosinophilic asthma criteria for the selected agent.

Benralizumab or reslizumab

Benralizumab
- Member is 12 years of age or older.
- Member has severe asthma with an eosinophilic phenotype.
- Member meets the additional asthma medical-necessity criteria.
Reslizumab
- Member is 18 years of age or older.
- Member has severe asthma with an eosinophilic phenotype.
- Member meets the additional asthma medical-necessity criteria.

Mepolizumab — Covered Indications

Mepolizumab authorization requires all criteria for one covered indication.

Mepolizumab indications

Severe eosinophilic asthma
- Member is 6 years of age or older.
- Member has severe asthma with an eosinophilic phenotype.
- ANY of the following
  - Blood eosinophil count is at least 150 cells/microliter at initiation of therapy.
  - Blood eosinophil count is at least 300 cells/microliter within 12 months before initiation of therapy.
- The eosinophilia is not attributable to hypereosinophilic syndromes, neoplastic disease, or known or suspected parasitic infection.
- Member meets the additional asthma medical-necessity criteria.
EGPA
- Member is 18 years of age or older.
- Member has confirmed eosinophilic granulomatosis with polyangiitis and a medical history of asthma.
- At least 2 specified EGPA characteristics are present.
- Member uses an oral glucocorticoid and/or cyclophosphamide, azathioprine, methotrexate, or leflunomide.
- Member has refractory disease or a history of EGPA relapse.
HES
- Member is 12 years of age or older.
- Member has HES symptoms for 6 months or longer without an identifiable non-hematologic secondary cause.
- Member has at least 2 HES flares within the 12 months before mepolizumab initiation.
- The prescribing physician attests that the member has been on a stable dose of HES therapy, including corticosteroids, immunosuppressive therapy, or cytotoxic therapy.
CRSwNP
- Member is 18 years of age or older.
- Member has a confirmed diagnosis of chronic rhinosinusitis with nasal polyps.
- Member has an inadequate response to nasal corticosteroids.

Tezepelumab-ekko

Tezepelumab-ekko initiation requires all of the following.

Member is 12 years of age or older.
Member has a confirmed diagnosis of severe asthma.
Tezepelumab-ekko is requested as add-on maintenance therapy and not as single or primary therapy.
Current management includes regular, compliant medium- or high-dose inhaled corticosteroid therapy.
Current management includes an additional asthma controller.