Limited Coverage Drugs – Icatibant

Generic Name:

icatibant

Strength:

30 mg/3 mL

Form:

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 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 by a physician experienced in the treatment of HAE.

1 year1

Practitioner Exemptions

  • No practitioner exemptions.

Special Notes

  1. PharmaCare coverage is limited to a maximum of 24 pre-filled syringes per year.
  2. Non-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.
  3. To 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.
  4. Prophylaxis of HAE attacks is not eligible for PharmaCare coverage.

Special Authority Request Form(s)