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Limited coverage criteria – icatibant

Last updated on March 18, 2025

 

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Generic name

icatibant

Strength & form

30 mg/3 mL pre-filled syringe

Special Authority criteria

Approval period

Initial

For the treatment of acute attacks of hereditary angioedema (HAE) in adult patients with lab confirmed c1-esterase inhibitor deficiency (type I or type II) who meet ALL of the following criteria:

  • For the treatment of acute laryngeal attacks OR for the treatment of non-laryngeal attacks of at least moderate severity2

AND

  • Patient is limited to a single dose for self-administration per attack3,4

AND

  • Drug is prescribed and a Special Authority request is submitted by a physician experienced in the treatment of HAE

1 year1

Renewal

  • Must provide details regarding the patient’s history of attacks, medication utilization, and medical follow-up received for each attack within the last year

AND

  • Patient is limited to a single dose for self-administration per attack3,4

AND

  • Drug is prescribed and a Special Authority request is submitted by a physician experienced in the treatment of HAE

1 year1

Practitioner exemptions

  • No practitioner exemptions

Special notes

  • 1PharmaCare coverage is limited to a maximum of 24 pre-filled syringes per year
  • 2Non-laryngeal attack of at least moderate severity is defined as cutaneous swellings of the face and/or neck or abdominal attacks. Cutaneous swellings of areas other than the face or neck are not eligible for PharmaCare coverage
  • 3To minimize drug wastage, patients are limited to a maximum of one pre-filled syringe of icatibant dispensed per prescription fill. Patients should not fill an additional dose of icatibant prior to the utilization of the patient’s existing pre-filled syringe of the drug
  • 4Prophylaxis of HAE attacks is not eligible for PharmaCare coverage

Special Authority request form(s)