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Limited coverage criteria – omalizumab for chronic rhinosinusitis with nasal polyps

Last updated on March 4, 2026

 

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Generic name

omalizumab

Brand name

 Omlyclo™

Strength & form

75 mg/0.5 mL, 150 mg/1 mL pre-filled syringe

Special Authority criteria

Approval period

Initial

For the add-on maintenance treatment of patients aged 18 years and older with severe chronic rhinosinusitis with nasal polyps (CRSwNP) who meet the following criteria:

  • Special Authority request is submitted by an otolaryngologist

AND

  • Patient has refractory symptoms despite 3 consecutive months of maximal intranasal corticosteroid use immediately preceding omalizumab initiation

AND

  • Patient has endoscopically- or computed tomography-documented bilateral nasal polyps

AND

  • Patient has undergone at least 1 prior surgical intervention for nasal polyps or has a specific contraindication to surgery

AND

  • Patient has a documented endoscopic nasal polyp score (NPS) of at least 5 after nasal surgery and prior2 to initiation of omalizumab

AND

  • Documentation of the patient's IgE (immunoglobulin E), weight, and SNOT-22 (Sino-Nasal Outcome Test 22) score prior to initiation of omalizumab is required1,2

1 year

Renewal

  • Special Authority request is submitted by an otolaryngologist, allergist, or respirologist

AND

  • Patient attains and maintains a clinically meaningful response on the SNOT-22 or endoscopic NPS, defined as:
    • A decrease in the SNOT-22 score by at least 8.9 points compared to baseline, or
    • A decrease in the endoscopic NPS by at least 1 point compared to baseline

OR

  • Maintenance treatment with oral corticosteroids has had a reduction in oral corticosteroid dose in 12 months since initiation of treatment
 1 year

Practitioner exemptions

  • None

Special notes

  • 1As per the omalizumab monograph, the appropriate dose and frequency for CRSwNP is determined by baseline IgE (30-1500 IU/mL) and the patient's weight (30-150 kg). PharmaCare will provide coverage of omalizumab in accordance with the product monograph, using the patient's baseline IgE and weight, up to a maximum dose of 600 mg every 2 weeks. Dose increases upon renewal are only permitted if there has been an increase in the patient's body weight
  • 2Baseline IgE and NPS must be collected within 12 months prior to initiating omalizumab. SNOT-22 must be collected within 28 days prior to initiating omalizumab
  • PharmaCare covers a maximum supply of 28 days per fill for omalizumab
  • Coverage of omalizumab will not be provided for use in combination with other biologics for the treatment of chronic rhinosinusitis with nasal polyps, asthma, or chronic idiopathic urticaria

Special Authority requests