CurrentAmeriHealthPolicy N/A

Omalizumab (Xolair) prior authorization for allergic asthma and chronic urticaria

Form and criteria governing prior authorization and delivery of omalizumab (Xolair) for patients with allergic asthma or chronic spontaneous urticaria; intended for prescribing physicians submitting requests to AmeriHealth.

Policy Summary

PayerAmeriHealth

PolicyOmalizumab (Xolair) prior authorization for allergic asthma and chronic urticaria

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionComplete and fax the prior authorization form with diagnosis (ICD-10), required clinical answers, baseline serum IgE (for allergic asthma) and a copy of the prescription.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

2indications

baseline serum IgEbaseline IgE required

≥4 weeksantihistamine trial

≥2 weeksalternative agent trials

Coverage criteria for Omalizumab (Xolair)

Allergic asthma (initial/continued therapy)

Covered when ALL of the following are met

Allergic asthma criteria: 1) Positive skin test or in vitro reactivity to a perennial aeroallergen (documented on form); 2) Patient has failed, is unresponsive to, or is inadequately controlled on high‑dose inhaled corticosteroids in combination with a long‑acting beta‑agonist (documented on form); 3) Baseline serum IgE level drawn prior to initiation of Xolair is provided with the request; plus diagnosis (ICD‑10) and a copy of the prescription are included.

Baseline serum IgE must be drawn prior to initiation and faxed with the form; answers must be documented on the form.

Chronic urticaria (initial/continued therapy)

Covered when ALL of the following are met

Chronic urticaria criteria: 1) Documented failure, contraindication, or intolerance to at least a 4‑week trial of a second‑generation non‑sedating H1 antihistamine (drug, dose, and duration must be listed on the form); 2) When applicable, documented failure, contraindication, or intolerance to at least a 2‑week trial of any checked alternative agents (leukotriene receptor antagonist; H2‑receptor antagonist; first‑generation H1 antihistamine; short‑term systemic glucocorticosteroids; substitution to a different second‑generation non‑sedating H1 antihistamine; or cyclosporine) with drug/dose/duration provided; plus diagnosis (ICD‑10) and a copy of the prescription are included.

Policy Summary

PayerAmeriHealth

PolicyOmalizumab (Xolair) prior authorization for allergic asthma and chronic urticaria

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionComplete and fax the prior authorization form with diagnosis (ICD-10), required clinical answers, baseline serum IgE (for allergic asthma) and a copy of the prescription.

SourceLink

On This Page

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Codes and trial durations

Form codemixed

H18554

Prior authorization / form indicator appearing throughout the document

Second-generation non-sedating H1 antihistamine trial duration

Required duration>= 4 weeks

Example agentsSecond-generation non-sedating H1 antihistamines (e.g., cetirizine [Zyrtec], fexofenadine [Allegra], loratadine [Claritin])

Dose requirementAt maximum recommended dose as stated on form

Alternative agent trial duration (listed drugs)

Required duration>= 2 weeks

Listed alternative agentsLeukotriene receptor antagonist (e.g., montelukast [Singulair]); Histamine H2-receptor antagonist (e.g., famotidine [Pepcid], ranitidine [Zantac]); First‑generation (sedating) H1 antihistamine (e.g., diphenhydramine [Benadryl]); Short‑term systemic glucocorticosteroids; Substitution to a different second‑generation non‑sedating H1 antihistamine; Cyclosporine

DocumentationCheck applicable agent(s) and list drug/dose/duration on form

Provider requirements and actions

Prior Authorization

Prior Authorization Required

Prior authorization is required. Complete and submit the prior authorization form indicating diagnosis (include ICD-10), whether this is a new start or continued treatment, and supporting clinical information. Only completed requests will be reviewed.

Check one: New start or Continued treatment
Include diagnosis with ICD-10 on the PA form
Attach supporting clinical documentation (see items below)

Step Therapy

Step Therapy Required for Chronic Urticaria

For chronic urticaria, document failure, contraindication, or intolerance to a trial of a second-generation non-sedating H1 antihistamine at maximum recommended dose for at least 4 weeks (e.g., cetirizine, fexofenadine, loratadine). List the drug, dose and duration on the form.

At least one ≥4-week trial of a second-generation non-sedating H1 antihistamine at maximum recommended dose must be documented
Provide drug name, dose, and duration

Documentation Required

Required Documentation

A copy of the prescription must accompany the medication request for delivery. For allergic asthma, provide documentation of positive allergen testing (skin test or in vitro) and baseline serum IgE drawn prior to initiation; include the numeric IgE value on the form and fax the baseline IgE level. For chronic urticaria, include documentation of trials listed on the form (e.g., leukotriene receptor antagonist, H2 antagonist, first-generation H1, systemic glucocorticosteroids, substitution to a different second-generation H1, cyclosporine) as applicable. Include prescription quantity, refills, dosing instructions, and physician signature.

Attach copy of prescription for medication delivery
For allergic asthma: document allergen testing result (yes/no) and provide baseline serum IgE (IU/mL) drawn prior to initiation; fax IgE result
For chronic urticaria: document prior medication trials and provide drug/dose/duration for each checked item
Include quantity, number of refills, dosing instructions, and physician signature on the form

Denial Risk

Denial Risk — Missing or Incomplete Information

Applications may be denied if required clinical questions or data are missing — for example: missing indication/ICD-10, missing start vs continuation indicator, no documentation of allergen testing for allergic asthma, absent baseline serum IgE, or lack of documentation of 4-week antihistamine trial for chronic urticaria. Ensure all checklist items on the form are completed to avoid denial.

Missing diagnosis or ICD-10 code
No indication whether request is new start or continuation
Absent baseline serum IgE for allergic asthma
No documentation of positive allergen testing when required
No documentation of ≥4-week second-generation H1 antihistamine trial for chronic urticaria

Key definitions

Positive skin test or in vitro reactivity to a perennial aeroallergen

DefinitionPositive skin test or in vitro reactivity to a perennial aeroallergen is documented by answering 'Yes' to the form question for allergic asthma.

Requirement for allergic asthma criteriaA documented positive skin test or in vitro reactivity to a perennial aeroallergen is required for coverage consideration.

Form actionProvider must indicate Yes/No on the prior authorization form (checkbox) and include supporting documentation as requested.

Baseline serum IgE

DefinitionBaseline serum IgE is the patient’s total serum IgE level measured prior to initiation of Xolair (omalizumab).

Requirement for allergic asthmaBaseline serum IgE level must be drawn prior to initiation and provided with the prior authorization request (fax the level with the form).

Form fieldThe form requests the numeric IgE value in IU/mL and instructs to fax the baseline serum IgE level along with the form.

OpenPayer

Omalizumab (Xolair) prior authorization for allergic asthma and chronic urticaria

Coverage criteria for Omalizumab (Xolair)

Codes and trial durations

Provider requirements and actions

Background

Key definitions