Xolair (omalizumab) — Blue Cross Blue Shield of New Mexico

Initial criteria

• The patient has epinephrine on hand for emergency treatment AND
• The requested dose is based on the patient’s pretreatment serum IgE level and body weight as defined in FDA labeling AND does NOT exceed 600 mg every 2 weeks AND
• If the patient has another FDA labeled indication for the requested agent, the requested quantity (dose) is within FDA labeled dosing for the requested indication AND
• If the patient has another indication that is supported in compendia for the requested agent, the requested quantity (dose) is supported in compendia for the requested indication AND
• 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
• ONE of the following: (A) The patient will NOT be using the requested agent in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR (B) The patient will be using the requested agent in combination with another immunomodulatory agent AND (1) The prescribing information for the requested agent does NOT limit the use with another immunomodulatory agent AND (2) There is support for the use of combination therapy (submitted copy of clinical trials, phase III studies, or guidelines required) AND
• The patient does NOT have any FDA labeled contraindications to the requested agent
• Alternate coverage: The member resides in Ohio AND the plan is Fully Insured or HIM Shop (SG) AND BOTH of the following – (A) The patient does NOT have any FDA labeled contraindications to the requested agent AND (B) ONE of the following: (1) The patient has another FDA labeled indication, (2) Compendia supported indication, or (3) Two peer-reviewed journal articles supporting proposed use.

Reauthorization criteria

• The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND
• For moderate to severe persistent asthma: Improvements or stabilization since baseline as shown by increased FEV1, reduced inhaled corticosteroid dose, reduced systemic corticosteroid use due to exacerbations, or reduced hospitalizations/ER visits AND currently compliant with asthma control therapy AND requested dose not exceeding 375 mg every 2 weeks.
• For CSU/CIU: Clinical benefit achieved AND requested dose within FDA labeled dosing and does not exceed 300 mg every 4 weeks.
• For CRSwNP: Clinical benefit achieved AND continuation of standard nasal polyp maintenance therapy (nasal saline irrigation, intranasal corticosteroids, e.g., fluticasone, mometasone, Sinuva) AND requested dose not exceeding 600 mg every 2 weeks.
• For IgE-mediated food allergy: Patient will avoid known food allergens, has epinephrine on hand for emergency treatment, and requested dose within FDA labeled dosing and ≤600 mg every 2 weeks.
• For other indications: Clinical benefit achieved, dose within FDA labeled or compendia supported dosing, prescriber is or has consulted a specialist, no use with other immunomodulatory agents unless justified, and no FDA labeled contraindications.

Approval duration

6–12 months