Xolair (omalizumab) — Blue Cross Blue Shield of Illinois

chronic rhinosinusitis with nasal polyps (CRSwNP)

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 dose is within FDA labeled dosing for that indication AND
If the patient has another indication supported in compendia, the requested dose is supported in compendia AND
The prescriber is a specialist in the area of the patient’s diagnosis (e.g., allergist, immunologist, otolaryngologist, pulmonologist) or has consulted with one AND
ONE of the following: (A) The patient will NOT use the requested agent with another immunomodulatory agent (e.g., TNF inhibitor, JAK inhibitor, IL-4 inhibitor) OR (B) The patient will use it in combination AND both of the following: (1) The prescribing information does not limit such use AND (2) There is support for combination therapy from submitted trials or guidelines AND
The patient has no FDA labeled contraindications to the requested agent
For Ohio fully insured or HIM Shop plan members: The above criteria AND one of the following: (1) another FDA labeled indication; OR (2) another indication supported in compendia; OR (3) two peer-reviewed journal articles supporting safe and effective use

Patient previously approved for the agent via prior authorization AND
ONE of the following:
A. Moderate to severe persistent asthma – patient shows improvement or stabilization in at least one measure (increase in FEV1, decreased inhaled corticosteroid dose, decreased systemic corticosteroid need, or reduced exacerbations/hospitalizations) AND is compliant with asthma control therapy in past 90 days AND dose ≤ 375 mg q2w
B. Chronic spontaneous urticaria (CSU/CIU) – patient has clinical benefit AND dose within FDA labeling and ≤ 300 mg q4w
C. Chronic rhinosinusitis with nasal polyps (CRSwNP) – patient has clinical benefit AND continues standard nasal polyp maintenance therapy AND dose is per FDA labeling and ≤ 600 mg q2w
D. IgE-mediated food allergy – patient avoids known food allergens AND has epinephrine on hand AND dose is per FDA labeling and ≤ 600 mg q2w
E. Other indications – patient has clinical benefit AND dose within FDA labeling or supportive compendia AND prescriber specialist involvement AND not used with contraindicated immunomodulatory(s) unless justified and supported AND patient has no FDA labeled contraindications

12 months (BCBSIL); other plans: 6 months for asthma, CSU, food allergy, CRSwNP; 12 months otherwise