Prior Authorization and Quantity Limit Criteria for Approval

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

1. The patient has a diagnosis of allergic rhinitis, with or without conjunctivitis
   AND
2. The patient’s diagnosis is confirmed with ONE of the following:
   1. Positive skin test to ONE of the pollen extracts included in the requested medication
      OR
   2. IgE specific antibodies to ONE of the extracts included in the requested medication: Sweet vernal, orchard, perennial rye, Timothy, or Kentucky blue grass
      AND
3. The patient is within the FDA labeled age for the requested medication (between the ages of 5 and 65)
   AND
4. ONE of the following:
   1. The patient has tried and had an inadequate response to at least TWO standard allergy medications*, one of which was an intranasal corticosteroid
      OR
   2. The patient has an intolerance or hypersensitivity to TWO standard allergy medications, one of which was an intranasal corticosteroid
      OR
   3. The patient has an FDA labeled contraindication to TWO standard allergy medications, one of which was an intranasal corticosteroid
      AND
5. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist, immunologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis
   AND
6. The patient will NOT be using the requested medication in combination with a subcutaneous injectable immunotherapy medication
   AND
7. The requested medication will be started, or has already been started, 3 to 4 months before the expected onset of the applicable pollen season
   AND
8. The first dose is given in the clinic/hospital under direct supervision from the provider for a period of at least 30 minutes
   AND
9. The patient has been prescribed epinephrine auto-injector for at home emergency use
   AND
10. The patient does NOT have any FDA labeled contraindications to the requested medication
    AND
11. ONE of the following:
    1. The requested quantity (dose) does NOT exceed the program quantity limit
       OR
    2. BOTH of the following:
       1. The requested quantity (dose) is greater than the program quantity limit
          AND
       2. The prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of approval: 12 months

*Standard allergy medications: oral antihistamines, oral corticosteroids, intranasal corticosteroids, intranasal antihistamines, or leukotriene inhibitors