Prior Authorization Criteria — Xolair (omalizumab)
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Defines clinical prior authorization requirements, step therapy, and continuation criteria for Xolair (omalizumab) for WV Bureau for Medical Services members across indicated conditions (asthma, chronic idiopathic urticaria, nasal polyps, IgE-mediated food allergy). Affects prescribers requesting PA for Xolair.
No material clinical or coverage changes in this revision.
Coverage Criteria for Xolair (omalizumab)
Moderate to severe persistent asthma — Initial Therapy
Covered when ALL of the following are met
Initial approval may be for 90 days; continuation requires ongoing benefit and adherence.
Chronic Idiopathic Urticaria (CIU) — Initial Therapy
Covered when ALL of the following are met
Prior authorization granted for 3 months initially; additional 12 months may be authorized with documentation of satisfactory clinical improvement.
Nasal polyps — Initial Therapy
Covered when ALL of the following are met
Continuation of coverage requires documentation of reduction/elimination of nasal polyps and patient adherence to therapy (including the original agent Xolair was supplementing).
IgE-mediated food allergy — Initial Therapy
Covered when ALL of the following are met
Continuation of Therapy
Covered when ALL of the following are met
Xolair may be initially approved for 90 days. Continuation of therapy approvals may be approved for 1 year after criteria has been met.
Prefilled syringe formulations of Xolair are non-preferred. Approval of a prefilled syringe requires documentation that class criteria have been met, including a documented trial of each preferred agent indicated for the requested diagnosis per the pharmacy benefit list.
A prefilled syringe formulation may be approved only when the prescribing clinician determines it is appropriate and the member or caregiver will be the individual administering Xolair. Candidates for self-administration must have previously received at least 3 doses of Xolair prior to authorization for self-administration.
Use of prefilled syringe formulations without meeting the required class criteria (i.e., without documented trials of each preferred agent for the diagnosis) is considered non-preferred and is not approvable unless the self-administration conditions are satisfied.
Requests for prefilled syringes must include documentation that the prescriber has determined self-administration is appropriate and that the member or caregiver will perform administration, and must show the member has received at least 3 prior doses of Xolair.
Dosing, Age, and Test Thresholds
Authorization, Documentation, and Step Therapy
Prior authorization required with indication‑specific criteria
Prior authorization (PA) is required for Xolair and may be approved only when the specific clinical criteria for the requested indication are met (asthma, chronic idiopathic urticaria, nasal polyps, or IgE‑mediated food allergy). Initial approvals may be for 90 days with continuation approvals up to 1 year when continuation criteria are satisfied. PA decisions require documentation that the indication-specific requirements (including specialist prescribing/consultation and prior therapy trials) are met.
- Asthma: age ≥6, specialist prescriber, weight 20–150 kg, positive perennial aeroallergen test, pretreatment IgE ≥30 IU/mL, symptomatic despite high‑dose ICS+LABA
- CIU: diagnosis documentation, age ≥12, specialist prescriber, required antihistamine trials and combination therapy per step therapy
- Nasal polyps: specialist prescribing/consultation, ≥3 months intranasal steroid trial, FDA age range, Xolair as add‑on
- Food allergy: age ≥1, allergist/immunologist involvement, required testing (skin/IgE/DBPCFC), baseline IgE ≥30 IU/mL, history of severe Type I reaction, epinephrine prescribed
Formulation and self‑administration conditions
Prefilled syringe formulations are non‑preferred and require meeting class criteria before approval; self‑administration is allowed only if the medical provider determines it appropriate and the member or caregiver will administer, and the candidate has previously received at least 3 doses of Xolair.
- Class criteria requires trial of each preferred agent indicated for the requested diagnosis (see updated PDL).
- Candidates for self‑administration must have previously received ≥3 doses.
Step therapy required for chronic idiopathic urticaria (CIU)
For chronic idiopathic urticaria (CIU) PA requires documented step therapy: Step 1 is a 2nd‑generation H1 antihistamine titrated to 2x–4x the usual dose; if inadequate, Step 2 requires at least 30 days of combination therapy (maximized 2nd‑gen H1 plus one or more listed agents) prior to Xolair approval.
- Step 1: Start a 2nd‑generation H1 antihistamine and titrate to 2x–4x usual dose; insufficient improvement after ≥30 days supports progression to Step 2.
- Step 2: Combine a maximized 2nd‑gen H1 with one or more: different 2nd‑gen H1, H2 antihistamine, 1st‑gen H1 at night, montelukast (or other LTRA), or hydroxyzine/doxepin titrated as tolerated for ≥30 days.
- Initial PA for CIU is granted for 3 months; an additional 12 months may be authorized with documentation of satisfactory clinical improvement.
Documentation required with prior authorization
Provide documentation with the PA request that demonstrates the diagnosis, patient age, prescriber specialty or consultation, and any tests required for dosing or indication confirmation (including weight and pretreatment serum IgE for asthma and food allergy, and allergen testing or food‑specific testing as applicable).
- Asthma: current body weight and pretreatment serum IgE (≥30 IU/mL) must be provided for dosing review; positive perennial aeroallergen skin or blood test results.
- CIU: documentation supporting chronic idiopathic urticaria diagnosis and records of antihistamine trials/titrations and combination therapy.
- Food allergy: reports of skin prick (≥4 mm) and/or food‑specific IgE (≥6 kUA/L) or DBPCFC results, baseline serum IgE ≥30 IU/mL, and documentation of prior severe Type I reaction and epinephrine prescription.
Denial risk if required information or prior therapy trials are missing
Requests that lack required elements may be denied. Ensure PA submissions include patient age, specialist prescriber or documented consultation, diagnostic confirmation, required prior therapy trials/titrations, weight and pretreatment IgE (for dosing), and documentation of intolerance or failure of step therapies when applicable.
- Missing age or prescriber specialty/consultation for the indication (e.g., allergist/pulmonologist for asthma, allergist/immunologist/dermatologist for CIU) risks denial.
- Absence of documented prior therapy trials (e.g., antihistamine titration and combination steps for CIU; ≥3 months intranasal steroid for nasal polyps) or missing test results (IgE, skin testing, DBPCFC) risks denial.
Background and Indications
Omalizumab (Xolair) is an anti-IgE monoclonal antibody approved for multiple IgE-mediated indications including moderate-to-severe persistent asthma (patients ≥6 years with positive perennial aeroallergen testing and inadequate control on inhaled corticosteroids), chronic idiopathic urticaria (adults and adolescents ≥12 years symptomatic despite H1 antihistamines), add-on maintenance treatment of nasal polyps in adults, and IgE-mediated food allergy for patients aged ≥1 year to reduce allergic reactions including anaphylaxis when used with allergen avoidance.
For the asthma indication, dosing requires weight and pretreatment IgE information and confirmation of perennial aeroallergen reactivity; for self-administration considerations, candidates must have tolerated at least 3 doses of Xolair before being approved to self-administer.
Clinical Definitions and Reaction Severity
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