Initial Evaluation (Moderate to Severe Persistent Asthma)

1. Has the patient been previously treated with Xolair (omalizumab)?

            If yes, see renewal criteria.

            If no, continue to 2.

  2.   Does the patient meet all of the following requirements?

            a.   6 years of age or older

            b.   Pretreatment IgE level ≥ 30 IU/mL

            c.   Weight ≥ 20 kg (≥ 44 lbs.)

            d.   Allergic asthma confirmed by skin testing or in vitro reactivity (RAST) testing

            If yes to a-d, continue to 3.

            If no (1 or more not met), do not approve.

3.  Is the patient currently using an inhaled corticosteroid?

If yes, continue to 5 (verify in prescription claims history within last 90 days).

If no, continue to 4.

4.  Does the patient have an allergy, contraindication, intolerance, or documented failure to corticosteroids?

            If yes, further review is required.

            If no, do not approve.

5.   Is the patient currently treated with a long-acting β₂-agonist?

      If yes, continue to 7.

            If no, continue to 6.

6.  Does the patient have an allergy, intolerance, contraindication, or documented failure to long-acting β₂-agonist?

            If yes, continue to 7.

            If no, do not approve.

 7.   Does the patient experience exacerbations of asthma symptoms requiring increased inhaled corticosteroid dosing, increased daily use of β₂-agonist rescue medication, or systemic steroids?

            If yes, continue 8.

            If no, do not approve.

 8.   Dosing guidelines are based on IgE levels and weight, please provide the patient’s weight, IgE level and requested quantity per month.  (See Table 1)

            Continue to 9.

9.  Is the request for Xolair vial?

   If yes, has the patient experienced failure, intolerance or trial of self administered?

   If no, preferred product is Xolair auto-injector or pre-filled syringe

   Continue to 10

10. Is the requested dose above the dosing parameters provided in product labeling?

            If yes, do not approve and forward to physician reviewer.

            If no, approve for 12 months for the requested quantity of vials per month.

Renewal Evaluation (Moderate to Severe Persistent Asthma)

      1.   Has the patient been previously treated with Xolair (omalizumab)?

            If yes, continue to 2.

            If no, see initial evaluation provided above.

      2.   Does the patient meet all of the following requirements?

            a.   6 years of age or older

            b.   Pretreatment IgE level ≥ 30 IU/mL

            c.   Weight ≥ 20 kg (≥ 44 lbs.)

            d.   Allergic asthma confirmed by skin testing or in vitro reactivity (RAST) testing

            If yes to a-d, continue to 3.

            If no (1 or more not met), do not approve.

      3.   Does the physician’s assessment of the patient indicate that Xolair (omalizumab) is contributing to improvement in asthma symptoms or maintenance of asthma control?

            If yes, continue to 4.

            If no, do not approve.

      4.   Is the patient continuing inhaled corticosteroid therapy?

If yes, continue to 5 (verify in prescription claims history within last 90 days).

            If no, further review required.

      5.   Has there been a change in weight requiring a dose adjustment?

            If yes, continue to 6.

            If no, approve for 12 months for previous quantity per month.

      6.   Has the dose of Xolair (omalizumab) been adjusted for any significant weight changes? (See Table 1)  New amount requested must be provided.

            If yes, continue to 7.

            If no, do not approve and forward to physician reviewer.

      7.  Is the request for Xolair vial?

   If yes, has the patient experienced failure, intolerance or trial of self administered?

   If no, preferred product is Xolair auto-injector or pre-filled syringe

   Continue to 8

      8.  Is the requested dose above the suggested dosing parameters? (See Table 1 and Table 2)

            If yes, do not approve and forward to physician reviewer.

            If no, approve for 12 months for the requested quantity of vials per month

Chronic Idiopathic Urticaria

I. Xolair (omalizumab) may be considered medically necessary for patients diagnosed with chronic idiopathic urticaria when ALL of the following criteria are met:

            a. Patient’s symptoms remain uncontrolled or inadequately controlled despite four weeks of treatment with a second-generation antihistamine (e.g., cetirizine, fexofenadine, desloratadine) used in combination with an H2-antihistamine (e.g., ranitidine, famotidine)      

           b. Omalizumab is prescribed by a board certified (or board eligible) allergist, dermatologist, or immunologist

           c. Omalizumab is not used in combination with benralizumab (Fasenra), mepolizumab (Nucala), or reslizumab (Cinqair)

   d. Omalizumab vials will only be approved after failure or intolerance to self-administered auto-injector or prefilled syringe

           e. Omalizumab dose does not exceed 300 mg every 4 weeks; maximum 2 vials or 60 HCPCS units every 28 days

           f. Patient is 12 years of age or older 

  Duration of approval: 12 months 

II. Continuation of omalizumab (Xolair) may be considered medically necessary for patients diagnosed with chronic idiopathic urticaria when ALL of the following criteria are met:

       a. Authorization/reauthorization has been previously approved by BCBSNE or another health plan in the past two years, OR the patient has previously met all indication-specific initiation criteria

       b. Prescriber indicates that patient has had reduction in CIU symptoms while on Xolair

       c. Omalizumab is not used in combination with benralizumab (Fasenra), mepolizumab (Nucala), or reslizumab (Cinqair)

    d. Omalizumab vials will only be approved after failure or intolerance to self-administered auto-injector or prefilled syringe

      e. Dose does not exceed 300 mg every 4 weeks; maximum 2 vials or 60 HCPCS units every 28 days

Duration of approval:  12 months

Chronic rhinosinusitis with nasal polyps

Xolair (omalizumab) may be considered medically necessary when ALL of the following criteria:

    A.  Diagnosis of chronic rhinosinusitis with nasal polyposis AND

    B.  ONE of the following:

1. The patient has tried and had an inadequate response to Xhance for minimum of 3 months [documentation required (e.g. drug, dates of use, outcome)]

OR

2. The patient has a documented intolerance, FDA labeled contraindication, or hypersensitivity to Xhance.

OR

3. The patient has had an inadequate response to sinonasal surgery or not a candidate for sinonasal surgery.

AND

   C. Patient will NOT be using the requested agent in combination with another biologic agent (Dupixent or Nucala)

    D. Xolair vials will only be approved after trial and failure or intolerance to self-administered auto-injector or prefilled syringe

Initial duration of approval: 12 months.

Renewal criteria:

A. The member has been previously approved for the requested agent through the plan's prior authorization criteria AND

B. The patient has had documented improvement in condition while on Xolair therapy AND

C. The patient will continue standard nasal polyp maintenance therapy (e.g., nasal saline irrigation, intranasal corticosteroids) in combination with Xolair AND

D. Xolair vials will only be approved after trial and failure or intolerance to self-administered auto-injector or prefilled syringe

E. Requested dose is within FDA approved dosage limits.

Duration of approval: 12 months.

IgE-Mediated Food Allergy

Xolair (omalizumab) may be considered medically necessary when ALL of the following criteria:

    A.  The patient has a diagnosis of IgE-mediated food allergy AND ALL of the following:

1. The patient has an IgE-mediated food allergy confirmed by an allergy diagnostic test (e.g., skin prick test, serum specific IgE test, oral food challenge) AND

2. The patient will avoid known food allergens while treated with the requested agent AND

3. The requested agent will not be used for the emergency treatment of allergic reactions, including anaphylaxis AND

4. Xolair vials will only be approved after trial and failure or intolerance to self-administered auto-injector or prefilled syringe

5. The requested dose is within FDA approved dosage limits.

Initial duration of approval: 12 months

Renewal criteria:

A. The member has been previously approved for the requested agent through the plan's prior authorization criteria AND

B. Requested dose is within FDA approved dosage limits.

C. Xolair vials will only be approved after trial and failure or intolerance to self-administered auto-injector or prefilled syringe

Duration of approval: 12 months.

**Note – This policy follows the stepwise therapy recommendation of the American Academy of Allergy, Asthma and Immunology (AAAAI) for the treatment of chronic idiopathic urticaria.

FORMS 

To request preauthorization complete the form at:

https://www.nebraskablue.com/~/media/pdf/Provider/Pharmacy/Xolair%208031%20072611.pdf

Table 1 – Xolair (omalizumab) Doses (mg) and Administration for patients age 12 years and older¹

Table 2 – Xolair (omalizumab) Doses (mg) and Administration for patients 6 to <12 years of age

Dosing for CIU is 150mg every 4 weeks or 300mg every 4 weeks. 

Failure to antihistamine therapy will follow the approach presented by AAAAI urticaria guidelines.