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    v1.0.28
    OpenPayerPolicy UpdatesPharmacy & Specialty DrugsCareSource Georgia Xolair Prior Auth | OpenPayer
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    CurrentCareSource Georgia MedicaidPolicy GA-MED-P-366579

    Xolair (omalizumab) Coverage Criteria

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    This policy governs CareSource Georgia Medicaid coverage and prior authorization for Xolair (omalizumab) used for chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, moderate-to-severe persistent asthma, and IgE-mediated food allergy. It establishes indication-specific clinical criteria, dosing limits, documentation requirements, initial authorization periods, and reauthorization requirements.

    Policy Summary
    PayerCareSource Georgia Medicaid
    PolicyXolair (omalizumab) Coverage Criteria
    Policy CodePolicy GA-MED-P-366579
    Change TypeMaterial clinical and coverage update
    Effective DateJanuary 1, 2025
    Next Review DateN/A
    Key ActionSubmit prior authorization documentation meeting the indication-specific clinical criteria and dosing limits for Xolair coverage.
    SourceLink
    POLICY UPDATE CHANGES

    IgE-mediated food allergy was added as a covered Xolair indication.

    Chronic rhinosinusitis with nasal polyps criteria were revised to require at least two qualifying symptoms for 12 weeks or more.

    Chronic spontaneous urticaria terminology and authorization criteria were updated.

    4Covered Xolair indications
    6 monthsCRSwNP and CSU initial authorization

    OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

    16 weeksAsthma and food allergy initial authorization
    12 monthsAdditional authorization after reauthorization
    75-600 mgMaximum dose range for CRSwNP and food allergy
    6 yearsYoungest asthma indication age

    Indication-Specific Coverage Criteria

    CRSwNP Initial Therapy

    Covered when ALL of the following criteria are met:

    ALL of the following

    • Member is at least 18 years of age.
    • Medication is prescribed by or in consultation with an allergist, immunologist, or otorhinolaryngologist (ENT).
    • At least TWO of the following symptoms have been present for 12 weeks or more:

      • Nasal blockage, obstruction, or congestion.
      • Nasal discharge.
      • Facial pain or pressure.
      • Reduction in smell.
    • Chart notes document bilateral nasal polyps by direct examination, endoscopy, or sinus CT scan.
    • The member's weight in kilograms and baseline serum IgE level in IU/mL are documented in the chart notes.
    • Chronic rhinosinusitis symptoms persist after treatment with:

      • At least a 4-week trial of an intranasal corticosteroid, such as mometasone or fluticasone, in combination with nasal saline irrigation.
      • At least ONE of the following:

        • Prior sinonasal surgery.
        • Systemic corticosteroids.
    • Medication is used as an add-on maintenance treatment in combination with an intranasal corticosteroid.
    • Medication is not used in combination with other biologic therapies for CRSwNP.
    • Dosage is 75 mg to 600 mg subcutaneously every 2 or 4 weeks, based on serum total IgE level measured before treatment and body weight, according to the dose determination chart in the package insert.

    CRSwNP Continuation Therapy

    Covered when ALL of the following criteria are met:

    ALL of the following

    • Medication is used as add-on maintenance therapy in combination with intranasal corticosteroids.
    • Chart notes document improvement of signs and symptoms, such as reduced postnasal drip, reduced nasal polyp size, and/or reduced nasal congestion symptoms.

    CSU Initial Therapy

    Covered when ALL of the following criteria are met:

    ALL of the following

    • Member is at least 12 years of age.
    • Medication is prescribed by or under the recommendation of an allergist, dermatologist, or immunologist.
    • Member has a diagnosis of moderate to severe chronic spontaneous urticaria, with wheals, angioedema, or both, present for more than 6 weeks.
    • Member has trialed and failed a second-generation H1 antihistamine, such as loratadine, cetirizine, or fexofenadine, at 2 to 4 times the FDA-approved dosage for 14 days.
    • Member will continue to use a second-generation H1 antihistamine with Xolair.

    CSU Continuation Therapy

    Covered when the following criterion is met:

    ALL of the following

    • Chart notes support a positive clinical response, such as reduction in itch severity and/or hive count.

    Asthma Initial Therapy

    Covered when ALL of the following criteria are met:

    ALL of the following

    • Member is at least 6 years of age.
    • Medication is prescribed by or in consultation with an allergist, immunologist, or pulmonologist.
    • At least ONE of the following allergy-testing criteria is met:

      • Positive skin testing for a perennial aeroallergen.
      • Reactivity to at least one aeroallergen documented by an elevated serum IgE level.
    • The member's weight is documented and baseline plasma immunoglobulin E (IgE) is at least 30 IU/mL.

    Asthma Continuation Therapy

    Covered when ALL of the following criteria are met:

    ALL of the following

    • Medication is not used as monotherapy for asthma.
    • Chart notes show improvement by at least ONE of the following:

      • Decreased frequency of emergency department visits or hospitalizations due to asthma exacerbations.
      • Improved functional ability, including decreased effect of asthma on exercise, school or work function, or quality of sleep.
      • Decreased utilization of rescue medications or oral corticosteroids.

    Food Allergy Initial Therapy

    Covered when ALL of the following criteria are met:

    ALL of the following

    • Member is at least 1 year of age.
    • Medication is prescribed by or in consultation with an allergist or immunologist.
    • Member has a diagnosis of IgE-mediated food allergy confirmed by clinical history of allergic reactions.
    • Chart notes document a positive skin prick test or positive serum IgE.
    • The member's weight in kilograms and baseline serum IgE level in IU/mL are documented in the chart notes.

    Food Allergy Continuation Therapy

    Covered when ALL of the following criteria are met:

    ALL of the following

    • Provider attests that medication will continue to be used with food allergen avoidance.
    • Chart notes show that the member is clinically benefiting from therapy and has not had anaphylaxis requiring advanced medical care.

    For CRSwNP, asthma, and food allergy indications, the medication must not be used concurrently with another biologic therapy when the applicable indication-specific criteria prohibit concurrent biologic use. For food allergy, the medication must not be used with Palforzia.

    CareSource considers Xolair (omalizumab) not medically necessary for the treatment of conditions that are not listed in this document. For any other indication, refer to the Off-Label policy.

    Clinical Thresholds and Coding Reference

    Asthma baseline IgE threshold
    Baseline testPlasma immunoglobulin E (IgE) level
    Minimum level30 IU/mL or higher
    DocumentationBaseline plasma IgE must be documented for asthma authorization
    CRSwNP symptom duration threshold
    Qualifying symptomsAt least 2 CRSwNP symptoms
    Minimum duration12 weeks or more
    ExamplesNasal blockage, nasal discharge, facial pain or pressure, or reduced sense of smell

    Authorization, Documentation, and Denial Risks

    Prior Authorization

    Initial Authorization Required

    Prior authorization is required for Xolair (omalizumab). The provider must submit the indication-specific criteria, required clinical documentation, dosing information, and applicable authorization period before treatment is approved.

    • Initial authorization periods: CRSwNP and CSU—6 months; asthma and IgE-mediated food allergy—16 weeks.
    • Dosing must follow the package-insert dose determination chart using pretreatment serum total IgE and body weight.
    • Approved dosing ranges: CRSwNP and food allergy 75–600 mg subcutaneously every 2 or 4 weeks; CSU 150 or 300 mg subcutaneously every 4 weeks; asthma 75–375 mg subcutaneously every 2 or 4 weeks.
    Prior Authorization

    Reauthorization Required

    Reauthorization is required for continued Xolair therapy. Submit evidence that the member remains on appropriate therapy and has demonstrated clinical benefit during the prior authorization period.

    • CRSwNP, CSU, asthma, and food allergy each require subsequent authorization.

    Policy Background

    Xolair (omalizumab) is an anti-IgE monoclonal antibody used for selected allergic and inflammatory conditions. This policy covers Xolair as add-on treatment for chronic rhinosinusitis with nasal polyps, chronic spontaneous urticaria, moderate-to-severe persistent asthma, and IgE-mediated food allergy. Coverage depends on the applicable age, specialist involvement, disease severity or diagnostic confirmation, prior therapy, laboratory values, dosing parameters, and documented response for continuation.

    Covered Condition Definitions

    CRSwNP definition
    ConditionChronic inflammatory condition involving the sinuses
    Anatomic findingBilateral nasal polyps
    Qualifying symptomsAt least 2 symptoms, including nasal obstruction or congestion, nasal discharge, facial pain or pressure, or reduced sense of smell, persisting for 12 weeks or more
    CSU definition
    ConditionModerate-to-severe chronic spontaneous urticaria
    ManifestationsSpontaneous wheals, angioedema, or both
    Duration

    Initial Authorization Criteria

    CRSwNP Initial Criteria

    CRSwNP initial authorization requires ALL listed clinical criteria.

    ALL listed clinical criteria

    • Member is at least 18 years of age.
    • Medication is prescribed by or in consultation with an allergist, immunologist, or otorhinolaryngologist (ENT).
    • At least TWO symptoms for 12 weeks or more

      • Nasal blockage, obstruction, or congestion.
      • Nasal discharge.

    Reauthorization Criteria

    CRSwNP Continuation Criteria

    CRSwNP reauthorization requires ALL of the following.

    ALL of the following

    • Continue Xolair as add-on maintenance therapy with an intranasal corticosteroid.
    • Document improvement in signs or symptoms.12 additional months

      Examples include reduced postnasal drip, reduced nasal polyp size, or reduced nasal congestion.

    CSU Continuation Criteria

    CSU reauthorization requires the following.

    Required criterion

    Required Prerequisite Therapy

    StepRequired therapyDurationCoverage requirement
    1Intranasal corticosteroid, such as mometasone or fluticasone, in combination with nasal saline irrigation, plus prior sinonasal surgery or systemic corticosteroidsAt least 4 weeksPersistent CRSwNP symptoms after treatment
    StepRequired therapyDurationCoverage requirement
    1Second-generation H1 antihistamine, such as loratadine, cetirizine, or fexofenadine, at 2–4 times the FDA-approved dosage14 daysTrialed and failed antihistamine therapy
    StepRequired therapyDurationCoverage requirement
    1Medium- to high-dose inhaled corticosteroid plus long-acting beta-2 agonist conventional therapy3 monthsAsthma remains inadequately controlled after treatment

    Dosing and Quantity Limits

    Xolair dosing for CRSwNP
    Dose range75 mg to 600 mg
    Route and frequencySubcutaneously every 2 or 4 weeks
    Dose determinationBased on serum total IgE measured before treatment and body weight; use the package-insert dose determination chart
    Xolair dosing for CSU
    Dose options150 mg or 300 mg
    RouteSubcutaneous injection
    FrequencyEvery 4 weeks
    Policy Summary
    PayerCareSource Georgia Medicaid
    PolicyXolair (omalizumab) Coverage Criteria
    Policy CodePolicy GA-MED-P-366579
    Change TypeMaterial clinical and coverage update
    Effective DateJanuary 1, 2025
    Next Review DateN/A
    Key ActionSubmit prior authorization documentation meeting the indication-specific clinical criteria and dosing limits for Xolair coverage.
    SourceLink
    On This Page
    Indication-Specific Coverage CriteriaClinical Thresholds and Coding ReferenceAuthorization, Documentation, and Denial RisksPolicy BackgroundCovered Condition DefinitionsInitial Authorization CriteriaReauthorization CriteriaRequired Prerequisite TherapyDosing and Quantity Limits
    Dosage is 150 mg or 300 mg by subcutaneous injection every 4 weeks.
  1. At least ONE of the following exacerbation criteria is met:

    • At least two documented severe asthma exacerbations requiring oral corticosteroids within the last year.
    • At least one documented severe asthma exacerbation requiring hospitalization within the last year.
  2. Asthma has been inadequately controlled after 3 months of conventional treatment with medium to high doses of inhaled corticosteroids (ICS) and long-acting beta 2-agonists (LABA).
  3. Medication is used as add-on maintenance treatment to conventional asthma therapies, such as ICS and LABA.
  4. Medication is not used in conjunction with any other biologic therapy for asthma.
  5. Dosage is 75 mg to 375 mg by subcutaneous injection every 2 or 4 weeks, based on serum total IgE level measured before treatment and body weight, according to the dose determination chart in the package insert.
  6. Provider attests that medication will be used concomitantly with food allergen avoidance.
  7. Medication will not be used with Palforzia.
  8. Dosage is 75 mg to 600 mg subcutaneously every 2 or 4 weeks, based on serum total IgE level measured before treatment and body weight, according to the dose determination chart in the package insert.
  9. CRSwNP intranasal corticosteroid trial
    Required therapyIntranasal corticosteroid in combination with nasal saline irrigation
    Minimum trialAt least 4 weeks
    Failure criterionChronic rhinosinusitis symptoms persist after the trial
    Asthma conventional treatment trial
    Required therapyMedium- to high-dose inhaled corticosteroids and long-acting beta 2-agonists
    Minimum trial3 months
    Failure criterionAsthma remains inadequately controlled after conventional treatment
    Asthma severe exacerbation thresholds
    Oral corticosteroid thresholdAt least 2 severe exacerbations requiring oral corticosteroids
    Hospitalization thresholdAt least 1 severe exacerbation requiring hospitalization
    Look-back periodWithin the last year
    CSU duration threshold
    ConditionModerate-to-severe chronic spontaneous urticaria
    Minimum durationMore than 6 weeks
    Qualifying manifestationsWheals, angioedema, or both
    CSU antihistamine trial
    Medication classSecond-generation H1 antihistamine
    Treatment duration14 days
    Dose2-4 times the FDA-approved dosage
  10. Each reauthorization period is an additional 12 months when all applicable criteria are met.
  11. Step Therapy

    CRSwNP Prerequisite Therapy

    For CRSwNP, document persistent symptoms after appropriate prerequisite treatment before requesting initial authorization. Xolair must be used as add-on maintenance therapy with an intranasal corticosteroid.

    • At least a 4-week trial of an intranasal corticosteroid, such as mometasone or fluticasone, in combination with nasal saline irrigation is required.
    • Symptoms must persist after the trial and one of the following: prior sinonasal surgery or systemic corticosteroids.
    • Xolair must not be combined with another biologic therapy for CRSwNP.
    Step Therapy

    CSU Antihistamine Failure

    For CSU, document failure of a second-generation H1 antihistamine before requesting Xolair. The member must continue the antihistamine with Xolair.

    • Trial must be at 2–4 times the FDA-approved dosage for 14 days.
    • Examples include loratadine, cetirizine, and fexofenadine.
    Step Therapy

    Asthma Conventional Therapy Failure

    For asthma, document inadequate control despite conventional inhaled therapy before requesting Xolair. Xolair must be added to, not substituted for, conventional asthma treatment.

    • Asthma must remain inadequately controlled after 3 months of medium- to high-dose inhaled corticosteroid therapy with a long-acting beta-2 agonist.
    • Xolair must be used as add-on maintenance treatment with conventional therapies, such as ICS and LABA.
    • Xolair must not be used with another biologic therapy for asthma.
    Documentation Required

    CRSwNP Clinical Documentation

    For initial CRSwNP authorization, submit clinical documentation supporting the diagnosis, severity, treatment history, and required specialist involvement.

    • Member must be at least 18 years old and the medication must be prescribed by or used in consultation with an allergist, immunologist, or otorhinolaryngologist (ENT).
    • Document at least 2 symptoms present for 12 weeks or more: nasal blockage/obstruction/congestion, nasal discharge, facial pain/pressure, or reduced smell.
    • Document bilateral nasal polyps by direct examination, endoscopy, or sinus CT scan.
    • Record weight in kilograms and baseline serum IgE in IU/mL.
    • Document the required intranasal corticosteroid plus saline trial and prior sinonasal surgery or systemic corticosteroid treatment.
    Documentation Required

    CRSwNP Response Documentation

    For CRSwNP reauthorization, provide chart-note evidence that the member is benefiting from continued add-on treatment with an intranasal corticosteroid.

    • Document improvement such as reduced postnasal drip, reduced nasal polyp size, and/or reduced nasal congestion symptoms.
    Documentation Required

    CSU Clinical Documentation

    For CSU initial authorization, submit records establishing the diagnosis, severity, duration, specialist management, and required antihistamine treatment failure.

    • Member must be at least 12 years old and treatment must be prescribed by or under the recommendation of an allergist, dermatologist, or immunologist.
    • Document moderate-to-severe chronic spontaneous urticaria with wheals, angioedema, or both, present for more than 6 weeks.
    • Document the second-generation H1 antihistamine trial at 2–4 times the FDA-approved dosage for 14 days and the plan to continue it with Xolair.
    Documentation Required

    CSU Response Documentation

    For CSU reauthorization, provide chart notes demonstrating a positive clinical response to Xolair.

    • Document reduction in itch severity and/or hive count.
    Documentation Required

    Asthma Clinical Documentation

    For initial asthma authorization, submit documentation supporting allergic asthma, disease severity, prior treatment, and specialist management.

    • Member must be at least 6 years old and treatment must be prescribed by or in consultation with an allergist, immunologist, or pulmonologist.
    • Document positive skin testing for a perennial aeroallergen or reactivity to at least one aeroallergen by elevated serum IgE.
    • Record weight and baseline plasma IgE of at least 30 IU/mL.
    • Document at least 2 severe exacerbations requiring oral corticosteroids or at least 1 hospitalization within the previous year.
    • Document 3 months of inadequate control despite medium- to high-dose ICS and LABA therapy and the planned add-on use of Xolair.
    Documentation Required

    Asthma Response Documentation

    For asthma reauthorization, provide chart notes showing continued benefit and confirm that Xolair is not being used as monotherapy.

    • Document at least one improvement: fewer emergency department visits or hospitalizations for exacerbations; improved ability to exercise, function at school or work, or sleep; or reduced rescue-medication or oral-corticosteroid use.
    Documentation Required

    Food Allergy Clinical Documentation

    For initial IgE-mediated food-allergy authorization, submit records confirming the allergic diagnosis, testing, dosing inputs, and required allergen-avoidance plan.

    • Member must be at least 1 year old and treatment must be prescribed by or in consultation with an allergist or immunologist.
    • Document a clinical history of allergic reactions and a positive skin-prick test or positive serum IgE.
    • Record weight in kilograms and baseline serum IgE in IU/mL.
    • Provider must attest that Xolair will be used with food-allergen avoidance and not with Palforzia.
    Documentation Required

    Food Allergy Response Documentation

    For food-allergy reauthorization, document continued allergen avoidance and clinical benefit from Xolair.

    • Provider must attest that food-allergen avoidance will continue.
    • Chart notes must show clinical benefit and no anaphylaxis requiring advanced medical care.
    Denial Risk

    CRSwNP Criteria Not Met

    CRSwNP is not medically necessary when the initial or continuation requirements are not met. Requests may be denied for failure to satisfy age, specialist, diagnostic, treatment, dosing, or response criteria.

    • Initial denial conditions include age under 18; no allergist, immunologist, or ENT involvement; fewer than 2 qualifying symptoms for at least 12 weeks; or no documented bilateral polyps.
    • Denial may result from missing weight or baseline IgE, failure to complete the required intranasal corticosteroid and saline trial with surgery or systemic corticosteroid history, lack of concurrent intranasal corticosteroid use, or use with another biologic.
    • Reauthorization may be denied without documented improvement in postnasal drip, polyp size, or nasal congestion, or without continued add-on intranasal corticosteroid therapy.
    Denial Risk

    CSU Criteria Not Met

    CSU requests may be denied when the member does not meet the age, diagnosis, duration, severity, specialist, antihistamine-failure, or continuation requirements.

    • Initial denial conditions include age under 12; no qualifying allergist, dermatologist, or immunologist involvement; or no documented moderate-to-severe CSU with wheals or angioedema for more than 6 weeks.
    • Denial may result from failure to document a 14-day trial of a second-generation H1 antihistamine at 2–4 times the FDA-approved dosage or failure to continue that antihistamine with Xolair.
    • Reauthorization may be denied without chart-note evidence of positive clinical response, such as reduced itch severity or hive count.
    Denial Risk

    Asthma Criteria Not Met

    Asthma requests may be denied when required age, specialist, allergy-testing, IgE, exacerbation, conventional-therapy, add-on, or response criteria are not documented.

    • Initial denial conditions include age under 6; no allergist, immunologist, or pulmonologist involvement; or no qualifying perennial aeroallergen testing or elevated serum IgE reactivity.
    • Denial may result from missing weight, baseline plasma IgE below 30 IU/mL, fewer than 2 OCS-treated exacerbations or 1 hospitalization in the prior year, or inadequate documentation of 3 months of medium- to high-dose ICS/LABA failure.
    • Xolair must not be used as monotherapy or with another asthma biologic; reauthorization requires documented clinical improvement, including reduced acute-care use, improved function or sleep, or reduced rescue medication or OCS use.
    Denial Risk

    Food Allergy Criteria Not Met

    Food-allergy requests may be denied when the diagnosis, testing, dosing inputs, allergist or immunologist involvement, allergen-avoidance, or therapy requirements are not met.

    • Initial denial conditions include age under 1; no clinical history of IgE-mediated allergic reactions; or no positive skin-prick test or serum IgE.
    • Denial may result from missing weight or baseline serum IgE, failure to attest to food-allergen avoidance, or planned use with Palforzia.
    • Reauthorization requires continued allergen avoidance, documented clinical benefit, and no anaphylaxis requiring advanced medical care.
    Denial Risk

    Unlisted Indication

    Xolair is not medically necessary for conditions or indications not listed in this policy. For another indication, the provider should refer to the applicable Off-Label policy for review.

    • Listed indications are CRSwNP, CSU, allergic asthma, and IgE-mediated food allergy.
    • An unlisted indication does not qualify for coverage under this policy.
    Present for more than 6 weeks
    IgE-mediated food allergy definition
    ConditionIgE-mediated food allergy
    Clinical confirmationHistory of allergic reactions
    Supporting testingPositive skin-prick test or positive serum IgE testing
    Facial pain or pressure.
  12. Reduction in smell.
  13. Bilateral nasal polyps are documented by direct examination, endoscopy, or sinus CT scan.
  14. Weight and baseline serum IgE are documented.
  15. Symptoms persist after at least a 4-week intranasal corticosteroid plus nasal saline trial.
  16. ONE of the following

    • Prior sinonasal surgery.
    • Systemic corticosteroids.
  17. Medication is used as add-on maintenance treatment with an intranasal corticosteroid.
  18. Medication is not used with another biologic therapy for CRSwNP.75-600 mg subcutaneously every 2 or 4 weeks
  19. CSU Initial Criteria

    CSU initial authorization requires ALL listed clinical criteria.

    ALL listed clinical criteria

    • Member is at least 12 years of age.
    • Medication is prescribed by or under the recommendation of an allergist, dermatologist, or immunologist.
    • Member has moderate-to-severe chronic spontaneous urticaria with wheals, angioedema, or both present for more than 6 weeks.
    • Member has failed a second-generation H1 antihistamine at 2 to 4 times the FDA-approved dosage for 14 days.
    • Member will continue the second-generation H1 antihistamine with Xolair.150 or 300 mg subcutaneously every 4 weeks

    Asthma Initial Criteria

    Asthma initial authorization requires ALL listed clinical criteria.

    ALL listed clinical criteria

    • Member is at least 6 years of age.
    • Medication is prescribed by or in consultation with an allergist, immunologist, or pulmonologist.
    • Qualifying allergy testing

      • Positive skin testing for a perennial aeroallergen.
      • Reactivity to at least one aeroallergen documented by elevated serum IgE.
    • Weight is documented and baseline plasma IgE is at least 30 IU/mL.>= 30 IU/mL
    • Qualifying severe exacerbations within the last year

      • At least two requiring oral corticosteroids.
      • At least one requiring hospitalization.
    • Asthma remains inadequately controlled after 3 months of medium- to high-dose inhaled corticosteroid and long-acting beta-2 agonist therapy.
    • Medication is used as add-on maintenance treatment.
    • Medication is not used with another biologic for asthma.75-375 mg subcutaneously every 2 or 4 weeks

    Food Allergy Initial Criteria

    Food allergy initial authorization requires ALL listed clinical criteria.

    ALL listed clinical criteria

    • Member is at least 1 year of age.
    • Medication is prescribed by or in consultation with an allergist or immunologist.
    • IgE-mediated food allergy is confirmed by a clinical history of allergic reactions.
    • Positive skin-prick or serum IgE testing is documented.
    • Weight and baseline serum IgE are documented.
    • Provider attests that medication will be used with food allergen avoidance.
    • Medication will not be used with Palforzia.75-600 mg subcutaneously every 2 or 4 weeks
    Provide chart notes supporting a positive clinical response, including reduced itch severity or hive count.12 additional months

    Asthma Continuation Criteria

    Asthma reauthorization requires ALL of the following.

    ALL of the following

    • Do not use Xolair as monotherapy for asthma.
    • At least ONE documented improvement

      • Reduced emergency department visits or hospitalizations due to asthma exacerbations.
      • Improved functional ability, including exercise, school or work function, or quality of sleep.
      • Reduced rescue medication or oral corticosteroid use.12 additional months

    Food Allergy Continuation Criteria

    Food allergy reauthorization requires ALL of the following.

    ALL of the following

    • Continue food allergen avoidance.
    • Document clinical benefit and that the member has not experienced anaphylaxis requiring advanced medical care.12 additional months
    Xolair dosing for asthma
    Dose range75 mg to 375 mg
    Route and frequencySubcutaneous injection every 2 or 4 weeks
    Dose determinationBased on serum total IgE measured before treatment and body weight; use the package-insert dose determination chart
    Xolair dosing for IgE-mediated food allergy
    Dose range75 mg to 600 mg
    Route and frequencySubcutaneously every 2 or 4 weeks
    Dose determinationBased on serum total IgE measured before treatment and body weight; use the package-insert dose determination chart