Xolair (omalizumab) — Blue Cross Blue Shield of Oklahoma

Initial criteria

• The patient has epinephrine on hand for emergency treatment
• 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
• If patient has another FDA labeled indication for the requested agent, dose is within FDA labeled dosing
• If patient has a compendia-supported indication, dose is supported in compendia
• The prescriber is a specialist (e.g., allergist, immunologist, otolaryngologist, pulmonologist) or has consulted with such a specialist
• ONE of the following: (A) The patient will NOT use the agent with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR (B) The agent will be used with another immunomodulatory agent AND (1) prescribing information does NOT limit use with another agent AND (2) there is support for combination therapy (clinical trials, phase III studies, guidelines required)
• The patient does NOT have any FDA labeled contraindications to the requested agent
• For Ohio Fully Insured or HIM Shop plan members, approvals also require: (1) No FDA labeled contraindications AND (2) ONE of: (a) another FDA labeled indication and route; OR (b) compendia-supported indication and route; OR (c) submission of two peer-reviewed journal articles showing safety and effectiveness

Reauthorization criteria

• Patient previously approved through plan’s PA process
• Diagnosis-specific renewal criteria:
• Moderate to severe persistent asthma: clinical improvement or stabilization as shown by increase in FEV1 OR decrease in required inhaled corticosteroid OR fewer systemic steroid courses OR fewer hospitalizations/ER visits; patient currently treated within past 90 days and compliant with asthma control therapy (ICS, ICS/LABA, LTRA, LAMA, theophylline); dose based on pretreatment IgE and body weight and ≤375 mg every 2 weeks
• Chronic spontaneous urticaria (CSU): patient has had clinical benefit and dose within FDA labeled dosing and ≤300 mg every 4 weeks
• Chronic rhinosinusitis with nasal polyps (CRSwNP): patient has had clinical benefit; continues standard nasal polyp maintenance therapy (e.g., saline irrigation, intranasal corticosteroids); dose based on pretreatment IgE and body weight and ≤600 mg every 2 weeks
• IgE-mediated food allergy: patient avoids known food allergens, has epinephrine on hand, dose based on pretreatment IgE and body weight and ≤600 mg every 2 weeks
• Other indications: patient has had clinical benefit; dose within FDA labeling or compendia; prescriber specialist or has consulted with one; not used with immunomodulatory agents unless labeling allows and supportive evidence exists; no FDA labeled contraindications

Approval duration

BCBSIL: 12 months; other plans: 6 months for asthma, CSU, food allergy, CRSwNP; 12 months for other indications; renewals 12 months