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Limited coverage criteria – omalizumab for chronic idiopathic urticaria

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 treatment of patients 12 years and older with moderate to severe chronic idiopathic urticaria (CIU)1 who meet the following criteria:

  • Patient has a documented Urticaria Activity Score over 7 days (UAS7) of at least 16 within 4 weeks prior to initiating omalizumab​

AND

  • Patient remains symptomatic with CIU despite a trial of at least TWO different second generation H1 antihistamines
    • Each second generation H1 antihistamine must be tried at 4 times the standard daily dose2 for a minimum of 4 weeks (i.e., in total, minimum of 8 consecutive weeks)

AND​

  • Special Authority request is submitted by an allergist or dermatologist

6 months

Renewal3

  • Special Authority request is submitted by an allergist or dermatologist

AND

  • Patient has demonstrated partial symptom control (i.e., a reduction in pre-omalizumab UAS7 of greater than or equal to 9.5 points)

OR

  • Patient has achieved complete symptom control (i.e., UAS7 of 0) for less than 12 consecutive weeks4

OR

  • Patient had complete symptom control (i.e., UAS7 of 0) for at least 12 consecutive weeks while on omalizumab, but experienced symptom relapse during the tapering period4
 6 months

Practitioner exemptions

  • None

Special notes

  • 1Chronic CIU is defined as greater than 6 weeks
  • 2Examples of H1 antihistamines with 4 times the standard daily dose include:
    • cetirizine 40 mg daily
    • desloratadine 20 mg daily
    • fexofenadine 480 mg daily
    • loratadine 40 mg daily
    • bilastine 80 mg daily
    • rupatadine 40 mg daily
  • 3A UAS7 within the past 4 weeks must be recorded. Additional UAS7 scores may be requested if patients have been on omalizumab therapy for longer than 6 months
  • 46-month renewal may be provided to assist the patient with tapering off omalizumab therapy
  • PharmaCare covers a maximum supply of 28 days per fill for omalizumab and coverage is limited to 300 mg every 4 weeks
  • 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 CIU

Special Authority requests