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ICATIBANT

All injection strengths: not a benefit

Firazyr · DIN 02425696 · 30mg/3mL · injection, pre-filled syringe 3mL Pk

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-19

StatusOff-Formulary Interchangeable, not an ODB benefit

Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗)

Patient paysPatient pays: program not supplied; amount cannot be determined.

Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria

Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Icatibant Brand(s): Firazyr DOSAGE FORM/ STRENGTH: 30 mg/3 mL prefilled syringe Effective date: November 5, 2015 For the treatment of acute attacks of type I or type II hereditary angioedema (HAE) in adults with lab confirmed c1-esterase inhibitor deficiency if the following conditions are met: a. Treatment of acute non-laryngeal attacks of at least moderate severity; OR b. Treatment of acute laryngeal attacks; AND c. Must be prescribed by physicians (e.g. immunologists, allergists or hematologists) with experience in the treatment of HAE. Notes: • Documentation of diagnosis (e.g. patient and family history, symptoms, lab test results) must be provided. • For acute non-laryngeal attacks, documentation of severity (frequency, location, and degree of swelling) must be provided Doses for acute treatment are limited to a single dose for self-administration per attack. Duration of Approval: Lifetime EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 81, record 49, corpus 2025-01-01; name match only, not an eligibility decision

How long EAP takes

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

1 brand, same coverage

Firazyr · DIN 02425696 Manufacturer: Takeda Canada Inc.; listing date 2024-08-30 Health Canada: Marketed since 2021-07-21 · brand FIRAZYR · ATC B06AC02 ICATIBANT · form Solution · route Subcutaneous · ingredients ICATIBANT (ICATIBANT ACETATE) 10 MG/ML · company Takeda canada inc · schedule Prescription

Check this DIN again · Health Canada product record

Ministry pays: $1485.0000 per source unit.

Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.

Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=91034 · Verify on the e-Formulary ↗ (DIN 02425696)

Source record

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02425696). DIN 02425696: Firazyr Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 920000709; group id 923; item number 2198; lccId None; manufacturer id TAK Source form: Inj Sol-Pref Syr 3mL Pk; strength: 30mg/3mL Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $2700.0000; ministry $1485.0000 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02425696 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=91034

Interchangeable products

Icatibant Injection · DIN 02547562 · $1485.0000

Shortage status: not checked (no credentials)

Other drugs in the same formulary class (92:00 UNCLASSIFIED THERAPEUTIC AGENTS) and how they are covered

Matched class: 92:00 UNCLASSIFIED THERAPEUTIC AGENTS

Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment. Covered without a code on the Ontario formulary: ALENDRONATE & CHOLECALCIFEROL, AZATHIOPRINE, CYCLOSPORINE, GLUCAGON RDNA ORIGIN, LANREOTIDE ACETATE, LEFLUNOMIDE, LEVODOPA & BENSERAZIDE, MYCOPHENOLATE SODIUM Some products covered without a code (check the product listing): ALENDRONATE, ALLOPURINOL, AMANTADINE HCL, BROMOCRIPTINE, CLOPIDOGREL BISULFATE, LEVODOPA & CARBIDOPA, MYCOPHENOLATE MOFETIL, OCTREOTIDE, RISEDRONATE SODIUM, ROPINIROLE, SELEGILINE HCL, TAMSULOSIN HCL 92:00 UNCLASSIFIED THERAPEUTIC AGENTS

ALENDRONATE

· 28 products · Off-Formulary Interchangeable, not an ODB benefit (4), Listed, not a benefit (1), General benefit (23) · strengths: 5mg, 10mg, 70mg · Tab

ALENDRONATE & CHOLECALCIFEROL

· 6 products · General benefit · strengths: 70mg & 70mcg, 70mg & 140mcg · Tab

ALLOPURINOL

· 10 products · General benefit (6), Listed, not a benefit (4) · strengths: 100mg, 200mg, 300mg · Tab

AMANTADINE HCL

· 5 products · Listed, not a benefit (2), General benefit (3) · strengths: 100mg, 10mg/mL · Cap, O/L

AZATHIOPRINE

· 3 products · General benefit · strengths: 50mg · Tab

BROMOCRIPTINE

· 4 products · Listed, not a benefit (2), General benefit (2) · strengths: 5mg, 2.5mg · Cap, Tab

CLOPIDOGREL BISULFATE

· 19 products · General benefit (16), Off-Formulary Interchangeable, not an ODB benefit (3) · strengths: 75mg, 300mg · Tab

CYCLOSPORINE

· 8 products · General benefit · strengths: 10mg, 25mg, 50mg, 100mg, 100mg/mL · Cap, O/L

GLUCAGON RDNA ORIGIN

· 2 products · General benefit · strengths: 1mg/Vial · Inj Pd-Syr Pk, Inj Pd-Vial Pk

LANREOTIDE ACETATE

· 6 products · General benefit · strengths: 60mg/Syr, 90mg/Syr, 120mg/Syr · ER Pref Syr Pk

LEFLUNOMIDE

· 16 products · General benefit · strengths: 10mg, 20mg · Tab

LEVODOPA & BENSERAZIDE

· 3 products · General benefit · strengths: 50mg & 12.5mg, 100mg & 25mg, 200mg & 50mg · Cap Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 92:00 and 75 more

Full class listing Related classes: Same formulary class, not same indication: class membership alone does not establish equivalent uses.

What the Health Canada label says it is for

1 INDICATIONS FIRAZYR (icatibant injection) is indicated for: • the treatment of acute attacks of hereditary angioedema (HAE) in adults, adolescents and children aged 2 years and older with C1-esterase inhibitor deficiency. FIRAZYR is supplied through a controlled distribution program that is accessed by patients and pharmacies. Patients or a caregiver should be trained in subcutaneous injection techniques under the guidance of a healthcare professional before they can administer FIRAZYR (see 4.4 Administration). 1.1 Pediatrics ≥ 2 years to <18 years of age and weighing ≥12 kg: Based on the data submitted and reviewed by Health Canada, the safety and efficacy of FIRAZYR in pediatric patients aged 2 years and older who weigh ≥12 kg have been established. Therefore, Health Canada has authorized an indication for pediatric use. < 2 years of age and in patients weighing < 12 kg: Studies in children aged less than 2 years or children weighing less than 12 kg have not been performed. No dosage regimen can be recommended in children aged less than two years or weighing less than 12 kg as the safety and efficacy have not been established (see 7.1.3 Pediatrics). 1.2 Geri… https://pdf.hres.ca/dpd_pm/00077521.PDF PM date: OCT 24, 2024 Source product: FIRAZYR; DIN 02425696; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.

Prepare an Exceptional Access request

SADIE has its own form for many drugs; this checklist prepares the answers; the ministry decides. Open SADIE

Use this text in SADIE’s free-text fields or read from it on a Telephone Request Service call. Review marks do not indicate eligibility. Evidence stays in this page until you copy it; nothing entered here is sent or saved. Do not enter patient identifiers.

EAP Telephone Request Service: The TRS can be accessed by calling toll-free at 1-866-811-9893 or 416-327-8109 (Toronto area) between 8:30 a.m. and 5:00 p.m. Monday through Friday (except holidays) and selecting the TRS option. Source; updated September 15, 2026

EAP fax: In Ontario: 1-866-811-9908 or 416-327-7526 (Toronto area). Outside Ontario: 1-833-905-4260. Source; updated September 15, 2026

Posted turnaround and Telephone Request Service scope

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days |

For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day.

Source; updated September 15, 2026

Icatibant (Firazyr)

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Prepare answers: For the treatment of acute attacks of type I or type II hereditary angioedema (HAE) in adults with lab confirmed c1-esterase inhibitor deficiency if the following conditions are met:

Ministry criteria corpus 2025-01-01; page 81

Icatibant Brand(s): Firazyr DOSAGE FORM/ STRENGTH: 30 mg/3 mL prefilled syringe Effective date: November 5, 2015

For the treatment of acute attacks of type I or type II hereditary angioedema (HAE) in adults with lab confirmed c1-esterase inhibitor deficiency if the following conditions are met: