Oralair — United Healthcare

Initial criteria

• Diagnosis of moderate to severe grass pollen-induced allergic rhinitis defined by symptoms severe enough to interfere with quality of life (e.g., sleep disturbances; impairment of daily, sport, or leisure activities; impairment of school or work performance)
• Diagnosis confirmed by one of the following: Positive skin test to any of the five grass species contained in Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue grass mixed pollens) or cross-reactive grass pollens (e.g., Cocksfoot, Meadow Fescue, or Redtop) OR in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue grass mixed pollens) or cross-reactive grass pollens (e.g., Cocksfoot, Meadow Fescue, or Redtop)
• Treatment is started or will be started at least 4 months before the beginning of the grass pollen season
• History of failure, contraindication, or intolerance to two of the following: oral antihistamine [e.g., cetirizine (Zyrtec)] AND/OR intranasal antihistamine [e.g., azelastine (Astelin)] AND/OR intranasal corticosteroid [e.g., fluticasone (Flonase)] AND/OR leukotriene inhibitor [e.g., montelukast (Singulair)]
• Not received in combination with similar cross-reactive grass pollen immunotherapy (e.g., Grastek)
• Patient does not have unstable and/or uncontrolled asthma
• Prescribed by or in consultation with a specialist in allergy and immunology

Reauthorization criteria

• Documentation of positive clinical response to Oralair therapy

Approval duration

12 months