Xolair (omalizumab) pre-filled syringe for self-administration — Point32Health

Initial criteria

• Diagnosis of IgE-mediated food allergy evidenced by 1 of the following: positive skin prick test (≥ 4 mm wheal), positive food specific IgE (≥ 6 kUA/L), or positive oral food challenge (dose-limiting symptoms at ≤ 300 mg food protein)
• Clinical history of IgE-mediated food allergy OR provider attestation of history of severe allergic response including anaphylaxis after food exposure
• Patient age ≥ 1 year
• Prescribed by or in consultation with an allergist or immunologist
• Use in conjunction with food allergen avoidance
• Baseline serum total IgE level ≥ 30 IU/mL and dosing according to serum total IgE level and body weight

Reauthorization criteria

• Diagnosis of IgE-mediated food allergy
• Prescribed by or in consultation with an allergist or immunologist
• Patient age ≥ 1 year
• Use in conjunction with food allergen avoidance
• Dose continues to be based on body weight and pre-treatment total IgE serum levels
• Therapeutic response to therapy documented

Approval duration

initial 5 months; reauth 12 months