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Ontario coverage, price, criteria word for word, Health Canada status and shortages for one product

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GEFITINIB

All products: not a benefit

Other products in the same Health Canada class (L01E, L01EB) — coverage varies; not interchangeable

  • Afatinib (Giotrif): not a benefit
  • Erlotinib (Tarceva): not a benefit
  • Imatinib (Gleevec): general benefit
  • Bosutinib (Bosulif): not a benefit
  • Dasatinib (Sprycel): not a benefit
  • Nilotinib (Tasigna): not a benefit

2 more in the class list below

Iressa · DIN 02248676 · 250mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
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 Gefitinib Brand(s): Iressa and generics (see formulary for funded OFIs) DOSAGE FORM/ STRENGTH: 250 mg tablet For the first line, monotherapy treatment of locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) in patients who have activating mutations of epidermal growth factor receptor-tyrosine kinase (EGFR-TK). (i.e. Patients who are EGFR Positive) The patient is to be assessed for disease status at least every two months and treatment will be discontinued if there is evidence of disease progression. Dose Reimbursed: 250 mg orally once daily. Duration of Approval: 6 months Iressa will not be granted funding in the following circumstances; Patients with EGFR wild-type mutation (i.e. negative for mutation); Patients with EGFR unknown mutation; 2nd or 3rd line or maintenance NSCLC; or Patients with unknown EGFR status who start their first chemotherapy while waiting for EGFR testing, then are found/confirmed to be EGFR positive, should continue with the current therapy and will not be eligible for gefitinib (Iressa) in this setting. Patients who receive gefitinib (Iressa) first line are not eligible for erlotinib in the second- or third-line in the setting of maintenance therapy of NSCLC. Requests for gefitinib for patients who have initiated another EGFR TKI therapy (i.e. Afatanib [Giotrif]) in the first line setting and who have not had disease progression will be considered on a case-by-case basis. Renewal will be considered for patients until there is any evidence of disease progression, at which point, treatment with gefitinib (Iressa) must be discontinued. Patients must have their disease status assessed at least every two months. Dose Reimbursed: 250 mg orally once daily. Duration of Approval: 6 months 317 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 317, record 187, 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 ↗)
Savings card: innoviCares lists Iressa (Ontario list dated 2026-09-10) — pays part of the brand-versus-generic difference after other coverage; free sign-up. (innovicares.ca ↗)
1 brand, same coverage
Iressa · DIN 02248676 Manufacturer: AstraZeneca; listing date 2017-10-30 Health Canada: Marketed since 2003-12-17 · brand IRESSA · ATC L01EB01 GEFITINIB · form Tablet · route Oral · ingredients GEFITINIB 250 MG · company Astrazeneca canada inc · schedule Prescription
Check this DIN again · Health Canada product record

Ministry pays: $62.3050 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=73040 · Verify on the e-Formulary ↗ (DIN 02248676)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02248676). DIN 02248676: Iressa Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 100000178; group id 165; item number 0280; lccId None; manufacturer id AZC Source form: Tab; strength: 250mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $74.1063; ministry $62.3050 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02248676 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=73040
Interchangeable products
Apo-Gefitinib · DIN 02468050 · $62.3050 Jamp-Gefitinib · DIN 02500663 · $62.3050 Nat-Gefitinib · DIN 02491796 · $62.3050 Sandoz Gefitinib · DIN 02487748 · $62.3050
Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02248676
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary class (10:00 ANTINEOPLASTIC AGENTS) and how they are covered

Matched class: 10:00 ANTINEOPLASTIC 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: ABIRATERONE ACETATE, ALTRETAMINE, ANASTROZOLE, BUSERELIN ACETATE, BUSULFAN, CAPECITABINE, CHLORAMBUCIL, CYPROTERONE ACETATE, DAUNORUBICIN, DEGARELIX ACETATE, ETOPOSIDE, EXEMESTANE, FLUOROURACIL & SALICYLIC ACID, FULVESTRANT, GOSERELIN ACETATE, HYDROXYUREA, IMATINIB MESYLATE, LETROZOLE, LEUPROLIDE ACETATE, MELPHALAN, MERCAPTOPURINE, MITOTANE, PROCARBAZINE HCL, TEMOZOLOMIDE, THIOGUANINE, TRIPTORELIN PAMOATE Some products covered without a code (check the product listing): BICALUTAMIDE, CYCLOPHOSPHAMIDE, FLUTAMIDE, LOMUSTINE (CCNU), MEGESTROL ACETATE, METHOTREXATE, TAMOXIFEN CITRATE, VINCRISTINE SULFATE 10:00 ANTINEOPLASTIC AGENTS

AFATINIB

· 9 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 20mg, 30mg, 40mg · Tab

ERLOTINIB

· 14 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 25mg, 100mg, 150mg · Tab

IMATINIB MESYLATE

· 20 products · General benefit · strengths: 100mg, 400mg · Tab

BOSUTINIB

· 4 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 100mg, 500mg · Tab

DASATINIB

· 33 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 20mg, 50mg, 70mg, 80mg, 100mg, 140mg · Tab

NILOTINIB

· 6 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 150mg, 200mg · Cap

PALBOCICLIB

· 9 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 75mg, 100mg, 125mg · Tab

PAZOPANIB

· 3 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 200mg · Tab

ABIRATERONE ACETATE

· 18 products · General benefit · strengths: 250mg, 500mg · Tab

ALTRETAMINE

· 1 products · General benefit · strengths: 50mg · Cap

ANASTROZOLE

· 17 products · General benefit · strengths: 1mg · Tab

BICALUTAMIDE

· 9 products · Listed, not a benefit (1), General benefit (8) · strengths: 50mg · Tab Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 10:00 and 34 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 IRESSA (gefitinib) is indicated for:  the first line treatment of patients with locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) who have activating mutations of the EGFR-TK (see 7 WARNINGS AND PRECAUTIONS – Monitoring and Laboratory Tests). This indication was based on progression-free survival (PFS). After 78% of trial patients had died, no statistically significant difference in overall survival (OS) was demonstrated with first line IRESSA compared to the first line chemotherapy doublet in patients with EGFR mutation positive tumours in the IPASS study (see 14 CLINICAL TRIALS). 1.1 Pediatrics Pediatrics (≤ 16 years of age): IRESSA is not indicated for use in pediatric patients, as safety and effectiveness have not been established (see 7 WARNINGS AND PRECAUTIONS – 7.1 Special Populations). 1.2 Geriatrics Geriatrics (≥ 65 years of age): No differences in safety or efficacy were observed between younger and older patients (see 7 WARNINGS AND PRECAUTIONS – 7.1 Special Populations). https://pdf.hres.ca/dpd_pm/00060650.PDF PM date: December 17, 2003 Source product: IRESSA; DIN 02248676; 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

Gefitinib (Iressa and generics (see formulary for funded OFIs))

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: See the ministry wording below; no separate indication heading is held.

Ministry criteria corpus 2025-01-01; page 317

Gefitinib Brand(s): Iressa and generics (see formulary for funded OFIs) DOSAGE FORM/ STRENGTH: 250 mg tablet
For the first line, monotherapy treatment of locally advanced (not amenable to curative therapy) or metastatic non-small cell lung cancer (NSCLC) in patients who have activating mutations of epidermal growth factor receptor-tyrosine kinase (EGFR-TK). (i.e. Patients who are EGFR Positive)
The patient is to be assessed for disease status at least every two months and treatment will be discontinued if there is evidence of disease progression.
Dose Reimbursed: 250 mg orally once daily.
Duration of Approval: 6 months
Iressa will not be granted funding in the following circumstances;
Patients with EGFR wild-type mutation (i.e. negative for mutation);
Patients with EGFR unknown mutation;
2nd or 3rd line or maintenance NSCLC; or
Patients with unknown EGFR status who start their first chemotherapy while waiting for EGFR testing, then are found/confirmed to be EGFR positive, should continue with the current therapy and will not be eligible for gefitinib (Iressa) in this setting.
Patients who receive gefitinib (Iressa) first line are not eligible for erlotinib in the second- or third-line in the setting of maintenance therapy of NSCLC.
Requests for gefitinib for patients who have initiated another EGFR TKI therapy (i.e. Afatanib [Giotrif]) in the first line setting and who have not had disease progression will be considered on a case-by-case basis.
Renewal will be considered for patients until there is any evidence of disease progression, at which point, treatment with gefitinib (Iressa) must be discontinued. Patients must have their disease status assessed at least every two months.
Dose Reimbursed: 250 mg orally once daily.
Duration of Approval: 6 months
317

Prepared from the ministry's published criteria; eligibility is decided by the Exceptional Access Program.