Criteria
Coverage is subject to the specific terms of the member's benefit plan.
Omalizumab (Xolair) vial may be approved when the following are met:
Chronic Idiopathic Urticaria
- The individual must meet label recommendations for indication and age; and
- Must be prescribed by, or in consult with, an allergist/immunologist; and
- The individual must have had a 30-day trial of a type 1 (H1) antihistamine at maximally tolerated dose either nonsedating (e.g., cetirizine, fexofenadine, loratadine, desloratadine, or levocetirizine) or sedating (e.g., diphenhydramine, chlorpheniramine, cyproheptadine) in addition to one of the following:
- leukotriene receptor antagonist (e.g., montelukast, zafirlukast, zileuton); or
- histamine H2-receptor (e.g., ranitidine, famotidine, nizatidine, cimetidine); and
- The individual will only be on one strength of omalizumab (Xolair) at a time; and
- The individual will NOT be using omalizumab (Xolair) in combination with another biologic agent [e.g., injectable IL-5 inhibitor (Cinqair, Fasenra, Nucala), injectable IL-4 inhibitor (Dupixent)].
Initial Authorization: 3 months
Reauthorization Criteria
Continuation of therapy with omalizumab (Xolair) vial may be considered medically necessary when the following are met:
- The prescriber must provide documentation showing that the individual has achieved a clinical benefit since treatment
initiation; and
- The individual will only be on one strength of omalizumab (Xolair) at a time; and
- The individual will NOT be using omalizumab (Xolair) in combination with another biologic agent [e.g., injectable IL-5 inhibitor (Cinqair, Fasenra, Nucala), injectable IL-4 inhibitor (Dupixent)].
Continuation Authorization: 12 months
Eosinophilic Asthma
- The individual must meet label recommendations for indication and age; and
- Must be prescribed by, or in consult with, a pulmonologist or allergist/immunologist; and
- The individual must have had at least one exacerbation despite continued compliant use of a high dose inhaled steroid in combination with a long-acting beta agonist (LABA) and long-acting muscarinic antagonist (LAMA) as evidenced by paid claims or pharmacy printouts; and
- The individual has a serum total IgE level, measured before the start of treatment, of ≥ 30 IU/mL and ≤ 700 IU/mL in individuals age ≥ 12 years or ≥ 30 IU/mL and ≤ 1300 IU/mL in individuals ages 6 to < 12 years; and
- The individual has had a positive skin test or in vitro reactivity to a perennial aeroallergen; and
- The individual will only be on one strength of omalizumab (Xolair) at a time; and
- The individual will NOT be using omalizumab (Xolair) in combination with another biologic agent [e.g., injectable IL-5 inhibitor (Cinqair, Fasenra, Nucala), injectable IL-4 inhibitor (Dupixent)].
Initial Authorization: 3 months
Reauthorization Criteria
Continuation of therapy with omalizumab (Xolair) vial may be considered medically necessary when the following is met:
- The prescriber must provide documentation showing that the individual has achieved a significant reduction in asthma
exacerbations and utilization of rescue medications since treatment initiation; and
- The individual will only be on one strength of omalizumab (Xolair) at a time; and
- The individual will NOT be using omalizumab (Xolair) in combination with another biologic agent [e.g., injectable IL-5 inhibitor (Cinqair, Fasenra, Nucala), injectable IL-4 inhibitor (Dupixent)].
Continuation Authorization: 12 months
Nasal Polyps
- The individual must meet label recommendations for indication and age; and
- Must be prescribed by, or in consult with, an ear/nose/throat specialist or allergist/immunologist; and
- The individual must have had a 12-week trial of intranasal or oral corticosteroid; and
- The individual must have bilateral polyps confirmed by sinus CT, sinus MRI, or nasal endoscopy; and
- The individual must have documentation of at least two of the following symptoms:
- Nasal blockade/obstruction/congestion or nasal discharge (anterior/posterior nasal drip)
- Facial pain/pressure
- Reduction or loss of smell; and
- The individual will only be on one strength of omalizumab (Xolair) at a time; and
- The individual will NOT be using omalizumab (Xolair) in combination with another biologic agent [e.g., injectable IL-5 inhibitor (Cinqair, Fasenra, Nucala), injectable IL-4 inhibitor (Dupixent)].
Initial Authorization: 3 months
Reauthorization Criteria
Continuation of therapy with omalizumab (Xolair) vial may be considered medically necessary when ALL of the following are met:
- The prescriber must provide documentation showing that the individual has achieved a significant reduction in nasal
polyp size and symptoms since treatment initiation; and
- The individual must be receiving intranasal steroids; and
- The individual will only be on one strength of omalizumab (Xolair) at a time; and
- The individual will NOT be using omalizumab (Xolair) in combination with another biologic agent [e.g., injectable IL-5 inhibitor (Cinqair, Fasenra, Nucala), injectable IL-4 inhibitor (Dupixent)].
Continuation Authorization: 12 months
The use of omalizumab (Xolair) vial for any indication not listed on this policy is considered experimental/investigational, and therefore, not covered. Scientific evidence does not support the use of omalizumab (Xolair) vial for any other indications.
Procedure Codes
