Xolair Prior Authorization Criteria – Medicare Part D

Prior Authorization Criteria for Approval

Initial Evaluation

Xolair will be approved when ALL of the following are met:

1. ONE of the following:
   1. The patient has a diagnosis of moderate to severe persistent asthma AND ALL of the following:
      1. The patient is at least 6 years of age
         AND
      2. ONE of the following:
         1. The patient is 6 to less than 12 years of age AND BOTH of the following:
            1. The patient’s pretreatment IgE level is 30 IU/mL to 1300 IU/mL
               AND
            2. The patient’s weight is 20 kg to 150 kg
               OR
         2. The patient is 12 years of age or over AND BOTH of the following:
            1. The patient’s pretreatment IgE level is 30 IU/mL to 700 IU/mL
               AND
            2. The patient’s weight is 30 kg to 150 kg
               AND
      3. Allergic asthma has been confirmed by positive skin test or in vitro reactivity test (RAST) to a perennial aeroallergen
         AND
      4. ONE of the following:
         1. The patient is currently being treated with AND will continue asthma control therapy (e.g., ICS, ICS/LABA, LTRA, LAMA, theophylline) in combination with the requested medication
            OR
         2. The patient has an intolerance, FDA labeled, contraindication, or hypersensitivity to an asthma control therapy
            OR
   2. The patient has a diagnosis of chronic idiopathic urticaria AND ALL of the following:
      1. The patient is at least 12 years of age
         AND
      2. The patient has had over 6 weeks of hives and itching
         AND
      3. ONE of the following:
         1. The patient has tried and had an inadequate response to maximum tolerable H1 antihistamine therapy
            OR
         2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to H1 antihistamine therapy
            OR
   3. The patient has a diagnosis of nasal polyps AND ALL of the following:
      1. The patient is at least 18 years of age
         AND
      2. ONE of the following:
         1. The patient has tried and had an inadequate response to an intranasal corticosteroid
            OR
         2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to an intranasal corticosteroid
            AND
      3. ONE of the following:
         1. The requested medication will be used in combination with an intranasal corticosteroid
            OR
         2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to an intranasal corticosteroid
            OR
   4. The patient has a diagnosis of IgE-mediated food allergy AND ALL of the following:
      1. The patient is using the requested medication for the reduction of allergic reactions (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods
         AND
      2. IgE-mediated food allergy has been confirmed by an allergy diagnostic test (e.g., skin prick test, serum specific IgE test, oral food challenge)
         AND
      3. The patient is 1 year of age or over
         AND
      4. The patient will avoid known food allergens while treated with the requested medication
         AND
      5. The requested medication will NOT be used for the emergency treatment of allergic reactions, including anaphylaxis
         AND
2. The patient will NOT be using the requested medication in combination with Dupixent or an injectable Interleukin 5 (IL-5) inhibitor (e.g., Cinqair, Fasenra, Nucala) for the requested indication
   AND
3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist, immunologist, otolaryngologist, pulmonologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
   AND
4. The requested dose is within FDA labeled dosing for the requested indication

Length of Approval: 6 months

Renewal Evaluation

Xolair will be approved when ALL of the following are met:

1. The patient has been previously approved for the requested medication through the plan’s Prior Authorization criteria
   AND
2. ONE of the following:
   1. The patient has a diagnosis of moderate to severe persistent asthma AND ALL of the following:
      1. The patient is at least 6 years of age
         AND
      2. The patient has had clinical benefit with the requested medication
         AND
      3. ONE of the following:
         1. The patient is currently being treated with and will continue asthma control therapy (e.g., ICS, ICS/LABA, LAMA, LRTA, theophylline) in combination with the requested medication
            OR
         2. The patient has an intolerance, FDA labeled contraindication, or hypersensitivity to asthma control therapy
            OR
   2. The patient has a diagnosis of chronic idiopathic urticaria AND BOTH of the following:
      1. The patient is at least 12 years of age
         AND
      2. The patient has had clinical benefit with the requested medication
         OR
   3. The patient has a diagnosis of nasal polyps AND BOTH of the following:
      1. The patient is at least 18 years of age
         AND
      2. The patient has had clinical benefit with the requested medication
         OR
   4. The patient has a diagnosis of IgE-mediated food allergy AND ALL of the following:
      1. The patient is using the requested agent for the reduction of allergic reactions
         (Type I), including anaphylaxis, that may occur with accidental exposure to one or more foods
         AND
      2. The patient is 1 year of age or over
         AND
      3. The patient has had clinical benefit with the requested medication
         AND
      4. The patient will avoid known food allergens while treated with the requested medication
         AND
      5. The requested medication will NOT be used for the emergency treatment of allergic reactions, including anaphylaxis
         AND
3. The patient will NOT be using the requested medication in combination with Dupixent or an injectable interleukin 5 (IL-5) inhibitor (e.g., Cinqair, Fasenra, Nucala) for the requested indication
   AND
4. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist, immunologist, otolaryngologist, pulmonologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
   AND
5. The requested dose is within FDA labeled dosing for the requested indication

Length of Approval: 12 months