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Exceptional Access criteria on record are for Brand(s): Giotrif; DOSAGE FORM/ STRENGTH: 20 mg, 30 mg, 40 mg tablet — not this product; no criteria on record for this product in this block. 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 Afatinib Brand(s): Giotrif DOSAGE FORM/ STRENGTH: 20 mg, 30 mg, 40 mg tablet Initial requests: For the treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) who meet the following criteria; • Afatanib is being used as first line therapy; AND • Afatanib is being used as monotherapy; AND • Patient’s cancer is EGFR positive Dose: 40 mg orally once daily Exclusion Criteria: • Patients with EGFR wild-type, negative, or unknown mutation. • Afatinib will not be considered for funding in patients who have progressed on a prior EGFR TKI targeted therapy. • Not funded for 2nd or 3rd line or maintenance NSCLC. Notes: • Patients should be assessed for disease status at least every two months. Afatinib may be continued until evidence of disease progression or development of unacceptable toxicity requiring discontinuation of afatinib. • Patients who receive afatinib 1st line are NOT eligible for erlotinib in the 2nd or 3rd line or maintenance NSCLC setting. • Requests for afatinib for patients who have initiated another EGFR TKI therapy (i.e. Iressa [gefitinib]) in the first line setting and who have not had disease progression will be considered on a case-by- case basis. Renewal requests will be considered based on the following; Afatinib 40 mg once daily may be continued until evidence of disease progression or development of unacceptable toxicity at which point the drug should be discontinued. Patients should have their disease status assessed at least every two months. Exclusion Criteria: • Patients with EGFR wild-type, negative, or unknown mutation. • Afatinib will not be considered for funding in patients who have progressed on a prior EGFR TKI targeted therapy. Not funded for 2nd or 3rd line or maintenance NSCLC. 266  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 266, record 163, 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 ↗)

Sandoz AFAtinib · DIN 02512785 Manufacturer: Sandoz Canada Inc.; listing date 2024-12-30 Health Canada: Marketed since 2024-10-28 · brand SANDOZ AFATINIB · ATC L01EB03 AFATINIB · form Tablet · route Oral · ingredients AFATINIB (AFATINIB DIMALEATE) 30 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 02512785). DIN 02512785: Sandoz AFAtinib Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 100000233; group id 142; item number 0240; lccId None; manufacturer id SDZ Source form: Tab; strength: 30mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $38.7392; ministry $38.7392 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02512785 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100204

Interchangeable products

Giotrif · DIN 02415674 · $38.7392 Mar-Afatinib · DIN 02517027 · $38.7392

Shortage status: not checked (no credentials)