Omalizumab (Xolair) prior authorization for allergic asthma and chronic urticaria
Customize your policy alerts
Sign up for all AmeriHealth policy alerts
Know when AmeriHealth releases new policies or updates existing guidance.
Monitor payer policy activity
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.
No material clinical or coverage changes in this revision.
Coverage criteria for Omalizumab (Xolair)
Allergic asthma (initial/continued therapy)
Covered when ALL of the following are met
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
Trials and durations must be documented on the form; for allergic asthma items (prescription copy) also required.
Requests that are not fully completed on the AmeriHealth prior authorization form will not be reviewed. The form collects patient and prescriber identifiers, diagnosis (including ICD‑10), and clinical responses required for each indication; missing any of these required elements may result in the request being returned without review.
ONLY COMPLETED REQUESTS WILL BE REVIEWED. The form requires the requester to indicate whether this is a New start or Continued treatment before the submission will be considered.
Codes and trial durations
| H18554 | Prior authorization / form indicator appearing throughout the document |
Provider requirements and actions
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 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
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 — 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
Background
The form is intended to document eligibility for omalizumab (Xolair) in two clinical contexts: allergic asthma and chronic urticaria. For allergic asthma the form requests evidence of positive skin test or in vitro reactivity to a perennial aeroallergen, documentation of inadequate control on high‑dose inhaled corticosteroid plus a long‑acting beta‑agonist, and the patient’s baseline serum IgE drawn prior to initiation (to be faxed with the form). For chronic urticaria the form captures required prior antihistamine and alternative agent trials (including durations) and other documentation needed to support medical necessity.
Key definitions
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.