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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

Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)

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 ↗)

Sandoz Gefitinib · DIN 02487748 Manufacturer: Sandoz Canada Inc.; listing date 2019-08-30 Health Canada: Cancelled post market since 2026-07-31 · brand SANDOZ GEFITINIB · ATC L01EB01 GEFITINIB · form Tablet · route Oral · ingredients GEFITINIB 250 MG · company Sandoz canada incorporated · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02487748). DIN 02487748: Sandoz Gefitinib Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 100000178; group id 165; item number 0280; lccId None; manufacturer id SDZ 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): $62.3050; ministry $62.3050 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02487748 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=97788

Interchangeable products

Apo-Gefitinib · DIN 02468050 · $62.3050 Iressa · DIN 02248676 · $62.3050 Jamp-Gefitinib · DIN 02500663 · $62.3050 Nat-Gefitinib · DIN 02491796 · $62.3050

Shortage status: discontinued (2025-11-03, reported by SANDOZ CANADA INCORPORATED); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02487748

Shortage record checked 2026-09-13T08:10:21.292534+00:00

Health Canada lists this DIN as Cancelled post market since 2026-07-31 — choose a marketed DIN from the same-category list.