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
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The use of omalizumab (Xolair) must meet recommendations found in the FDA label or compendia (e.g., diagnosis, age, dosage, frequency, route);
and
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Must be prescribed by, or in consult with, an allergist/immunologist;
and
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The individual must have had a 30-day trial of a dose of at least 100 mg of either hydroxyzine or doxepin in addition to one of the following:
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leukotriene receptor antagonist (e.g., montelukast, zafirlukast, zileuton);
or
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histamine H2-receptor (e.g., ranitidine, famotidine, nizatidine, cimetidine);
and
-
The individual will only be on one (1) 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), thymic stromal lymphopoietic (TSLP) blocker (Tezspire)].
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 with omalizumab (Xolair);
and
-
The individual will only be on one (1) 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), thymic stromal lymphopoietic (TSLP) blocker (Tezspire)].
Eosinophilic Asthma
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The use of omalizumab (Xolair) must meet recommendations found in the FDA label or compendia (e.g., diagnosis, age, dosage, frequency, route);
and
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Must be prescribed by, or in consult with, a pulmonologist or allergist/immunologist;
and
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The individual must have had at least one exacerbation requiring use of oral corticosteroids in the previous year 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
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The individual has a serum total IgE level, measured before the start of treatment, of greater than or equal to 30 IU/mL and less than or equal to 700 IU/mL in individuals 12 years of age or older or greater than or equal to 30 IU/mL and less than or equal to 1300 IU/mL in individuals ages six (6) to less than 12 years old;
and
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The individual has had a positive skin test or in vitro reactivity to a perennial aeroallergen;
and
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The individual will only be on one (1) 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), thymic stromal lymphopoietic (TSLP) blocker (Tezspire)].
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 with omalizumab (Xolair) as evidenced by medical documentation (e.g., chart notes) attached to the request (subject to clinical review);
and
-
The individual will only be on one (1) 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), thymic stromal lymphopoietic (TSLP) blocker (Tezspire)].
Chronic Rhinosinusitis with Nasal Polyps
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The use of omalizumab (Xolair) must meet recommendations found in the FDA label or compendia (e.g., diagnosis, age, dosage, frequency, route);
and
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Must be prescribed by, or in consult with, an ear/nose/throat specialist or allergist/immunologist;
and
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The individual must have had a 12-week trial of intranasal corticosteroids;
and
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The individual must have trialed at least two courses of a 10-day trial of oral glucocorticoids in the past year;
and
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The individual must have bilateral polyps confirmed by sinus CT, anterior rhinoscopy, or nasal endoscopy;
and
-
The individual will only be on one (1) 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), thymic stromal lymphopoietic (TSLP) blocker (Tezspire)].
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 with omalizumab (Xolair);
and
-
The individual must be receiving intranasal steroids;
and
-
The individual will only be on one (1) 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), thymic stromal lymphopoietic (TSLP) blocker (Tezspire)].
Food Allergy
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The use of omalizumab (Xolair) must meet recommendations found in the FDA label or compendia (e.g., diagnosis, age, dosage, frequency, route);
and
-
Must be prescribed by, or in consult with, an allergist/immunologist;
and
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The provider must attest that the individual has access to injectable epinephrine, and that the individual/caregiver has been instructed and trained on its appropriate use;
and
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ONE of the following:
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The individual has a history of severe (type 1) allergic response requiring the use of epinephrine, an ER visit, or hospitalization;
or
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Allergic reaction produced during a provider observed intake of food allergen and attestation that food allergy is likely to produce anaphylaxis as determined by allergist/immunologist;
or
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ALL of the following:
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History of urticaria, angioedema, or wheeze;
and
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Skin prick wheal of at least three (3) mm or positive IgE test as determined by allergist/immunologist (at least 30 IU/mL for Xolair);
and
- Attestation that food allergy is likely to produce anaphylaxis as determined by allergist/immunologist.
The use of omalizumab (Xolair) vial for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Procedure Code
