Xolair (omalizumab) — Blue Cross Blue Shield of Montana

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, the requested quantity (dose) is within FDA labeled dosing AND
• If the patient has another compendia-supported indication, the requested quantity (dose) is supported in compendia AND
• The prescriber is a specialist in or has consulted with a specialist in the area of the patient's diagnosis (e.g., allergist, immunologist, otolaryngologist, pulmonologist) AND
• One of the following: • 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 • The patient will be using the requested agent with another immunomodulatory agent AND the prescribing information does not limit such use AND there is support for combination therapy (clinical trials, phase III studies, or guidelines required) AND
• The patient does not have any FDA-labeled contraindications to the requested agent

Reauthorization criteria

• The patient was previously approved for the requested agent through the plan’s Prior Authorization process AND
• One of the following: A. Moderate to severe persistent asthma: • Documented improvements or stabilization since baseline by ≥1 of: – Increase in percent predicted FEV1 OR – Decrease in dose of inhaled corticosteroid required OR – Decrease in need for systemic corticosteroids due to exacerbations OR – Decrease in hospitalizations, ER, or urgent care visits due to exacerbations AND • Patient is currently on and compliant with asthma control therapy within past 90 days (ICS, ICS/LABA, LTRA, LAMA, theophylline) AND • Dose within FDA labeling and ≤375 mg every 2 weeks OR B. Chronic spontaneous urticaria (CSU/CIU): • Clinical benefit with the requested agent AND • Dose within FDA labeled dosing and ≤300 mg every 4 weeks OR C. Chronic rhinosinusitis with nasal polyps (CRSwNP): • Clinical benefit with the requested agent AND • Continued use of standard nasal polyp maintenance therapy (nasal saline irrigation, intranasal corticosteroids) AND • Dose within FDA labeling and ≤600 mg every 2 weeks OR D. IgE-mediated food allergy: • Patient avoids known food allergens while treated AND • Patient has epinephrine on hand for emergency use AND • Dose within FDA labeling and ≤600 mg every 2 weeks OR E. Other indications: • Clinical benefit with the requested agent AND • Requested quantity within FDA labeling or supported in compendia AND • Prescriber is or consulted with appropriate specialist AND • Meets combination therapy criteria as in initial approval AND • No FDA-labeled contraindications

Approval duration

6 or 12 months (6 months for certain indications; 12 months for others)