Omalizumab (Xolair) prior authorization criteria
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Defines Alaska Medicaid prior authorization clinical criteria, dosing limits, approval durations, and denial/precaution language for Xolair (omalizumab) across its labeled indications.
No material clinical or coverage changes in this revision.
Coverage Criteria for Omalizumab (Xolair)
Initial therapy — Moderate to severe asthma
Moderate to Severe Asthma — Covered when ALL of the following are met
Initial therapy — Chronic idiopathic urticaria / CSU
Chronic Idiopathic/Spontaneous Urticaria — Covered when ALL of the following are met
Initial therapy — Nasal polyps (CRSwNP)
Chronic Rhinosinusitis with Nasal Polyps — Covered when ALL of the following are met
Initial therapy — IgE-mediated food allergy
IgE-mediated Food Allergy — Covered when ALL of the following are met
To be used in conjunction with food allergen avoidance per FDA indication.
Patients currently using an anti‑interleukin‑4 or anti‑interleukin‑5 inhibitor are ineligible for approval under these criteria.
Requests for omalizumab where the patient has failed to meet the stated approval criteria are subject to denial.
Coding, Dosing, and Quantity Limits
Prior Authorization Requirements and Provider Responsibilities
Prior authorization: meet indication criteria; duration and quantity limits
Prior authorization is required and will only be approved when the request meets the indication-specific clinical criteria listed in the Coverage Criteria section. Initial approvals are granted for up to 3 months; reauthorization may be granted for up to 12 months. Quantity limits apply per the policy (see dosing limits).
- Prior authorization requires meeting the indication-specific criteria in the Coverage Criteria sets (asthma, CSU, nasal polyps, IgE-mediated food allergy).
- Initial approval duration: up to 3 months; Reauthorization: up to 12 months.
- Quantity limits: up to eight 150 mg vials per 30 days (max dose 600 mg every 2 or 4 weeks) or two 75 mg vials per 30 days.
Specialist prescribing and required prior therapies
For asthma, chronic spontaneous/idiopathic urticaria, and nasal polyps, the medication must be prescribed by or in consultation with an allergist, immunologist, or pulmonologist, and patients must have failed or been intolerant to the specified prior therapies described in each indication's criteria.
- Asthma: prescribed by or in consultation with an allergist, immunologist, or pulmonologist and inadequate control despite optimized therapies for at least 3 months.
- CSU: prescribed by or in consultation with an allergist, immunologist, or pulmonologist and symptoms despite antihistamine titration and failure/intolerance to adjunct leukotriene plus antihistamine therapy.
- Nasal polyps: prescribed by or in consultation with an allergist, immunologist, or pulmonologist and inadequate response/intolerance to a 3-month trial of two nasal corticosteroid sprays.
Documentation required for food allergy requests
Requests for IgE‑mediated food allergy must include the patient's baseline serum IgE level and current weight as part of the prior authorization documentation.
- Provide baseline IgE value.
- Provide current patient weight.
Denial grounds: unmet criteria or concurrent IL‑4/IL‑5 inhibitor therapy
Requests must be denied when the patient does not meet the stated approval criteria or when the patient is currently receiving an anti‑interleukin‑4 or anti‑interleukin‑5 inhibitor.
- Denial if the patient has failed to meet the approval criteria for the requested indication.
- Denial if the patient is currently using an anti‑interleukin 4 or 5 inhibitor.
Background
Omalizumab (Xolair) is an anti‑IgE monoclonal antibody with FDA‑approved indications that include moderate to severe persistent asthma (age ≥6), chronic rhinosinusitis with nasal polyps (age ≥18), IgE‑mediated food allergy (age ≥1), and chronic spontaneous/idiopathic urticaria (age ≥12). The policy references indication‑specific requirements such as age thresholds, the need for positive allergen testing for the asthma indication, and baseline serum IgE thresholds where applicable.
Definitions and Clinical Terms
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