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

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AFATINIB

All strengths: Off-Formulary Interchangeable, not an ODB benefit; same patient cost rules

Shared coverage and patient cost rules
StatusOff-Formulary Interchangeable, not an ODB benefit
Patient paysPatient pays: program not supplied; amount cannot be determined.

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

  • Erlotinib (Tarceva): not a benefit
  • Gefitinib (Iressa): 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

Giotrif · DIN 02415666 · 20mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
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 ↗)
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 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
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
Giotrif · DIN 02415666 Manufacturer: Boehringer-Ingelheim (Canada) Ltd./Ltee; listing date 2024-12-30 Health Canada: Marketed since 2014-01-17 · brand GIOTRIF · ATC L01EB03 AFATINIB · form Tablet · route Oral · ingredients AFATINIB (AFATINIB DIMALEATE) 20 MG · company Boehringer ingelheim (canada) ltd ltee · schedule Prescription
Check this DIN again · Health Canada product record

Ministry pays: $38.7392 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=90026 · Verify on the e-Formulary ↗ (DIN 02415666)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02415666). DIN 02415666: Giotrif Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 100000232; group id 142; item number 0239; lccId None; manufacturer id BOE Source form: Tab; strength: 20mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $80.8334; ministry $38.7392 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02415666 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90026
Interchangeable products
Mar-Afatinib · DIN 02517019 · $38.7392 Sandoz AFAtinib · DIN 02512777 · $38.7392
Shortage status: anticipated shortage (last updated 2026-06-26); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02415666
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Mar-Afatinib · DIN 02517019 · 20mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
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 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
Brand vs generic price
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 ↗)
1 brand, same coverage
Mar-Afatinib · DIN 02517019 Manufacturer: Marcan Pharmaceuticals Inc.; listing date 2025-03-31 Health Canada: Marketed since 2025-01-31 · brand MAR-AFATINIB · ATC L01EB03 AFATINIB · form Tablet · route Oral · ingredients AFATINIB (AFATINIB DIMALEATE) 20 MG · company Marcan pharmaceuticals inc · schedule Prescription
Check this DIN again · Health Canada product record

Mar-Afatinib: Formulary list price $38.7392/unit (unit not stated in source; not the patient's cost)

Ministry pays: $38.7392 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=100635 · Verify on the e-Formulary ↗ (DIN 02517019)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02517019). DIN 02517019: Mar-Afatinib Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 100000232; group id 142; item number 0239; lccId None; manufacturer id MAR Source form: Tab; strength: 20mg 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=02517019 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100635
Interchangeable products
Giotrif · DIN 02415666 · $38.7392 Sandoz AFAtinib · DIN 02512777 · $38.7392
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=02517019
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Sandoz AFAtinib · DIN 02512777 · 20mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
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 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
Brand vs generic price
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 ↗)
1 brand, same coverage
Sandoz AFAtinib · DIN 02512777 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) 20 MG · company Sandoz canada incorporated · schedule Prescription
Check this DIN again · Health Canada product record

Sandoz AFAtinib: Formulary list price $38.7392/unit (unit not stated in source; not the patient's cost)

Ministry pays: $38.7392 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=100203 · Verify on the e-Formulary ↗ (DIN 02512777)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02512777). DIN 02512777: Sandoz AFAtinib Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 100000232; group id 142; item number 0239; lccId None; manufacturer id SDZ Source form: Tab; strength: 20mg 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=02512777 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100203
Interchangeable products
Giotrif · DIN 02415666 · $38.7392 Mar-Afatinib · DIN 02517019 · $38.7392
Shortage status: active shortage (reported 2026-08-03, estimated to end 2026-11-06, last updated 2026-09-02); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02512777
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Giotrif · DIN 02415674 · 30mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
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 ↗)
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 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
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
Giotrif · DIN 02415674 Manufacturer: Boehringer-Ingelheim (Canada) Ltd./Ltee; listing date 2024-12-30 Health Canada: Marketed since 2014-01-17 · brand GIOTRIF · ATC L01EB03 AFATINIB · form Tablet · route Oral · ingredients AFATINIB (AFATINIB DIMALEATE) 30 MG · company Boehringer ingelheim (canada) ltd ltee · schedule Prescription
Check this DIN again · Health Canada product record

Ministry pays: $38.7392 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=90027 · Verify on the e-Formulary ↗ (DIN 02415674)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02415674). DIN 02415674: Giotrif Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 100000233; group id 142; item number 0240; lccId None; manufacturer id BOE 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): $80.8334; ministry $38.7392 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02415674 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90027
Interchangeable products
Mar-Afatinib · DIN 02517027 · $38.7392 Sandoz AFAtinib · DIN 02512785 · $38.7392
Shortage status: anticipated shortage (last updated 2026-06-26); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02415674
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Mar-Afatinib · DIN 02517027 · 30mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
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 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
Brand vs generic price
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 ↗)
1 brand, same coverage
Mar-Afatinib · DIN 02517027 Manufacturer: Marcan Pharmaceuticals Inc.; listing date 2025-03-31 Health Canada: Marketed since 2025-01-31 · brand MAR-AFATINIB · ATC L01EB03 AFATINIB · form Tablet · route Oral · ingredients AFATINIB (AFATINIB DIMALEATE) 30 MG · company Marcan pharmaceuticals inc · schedule Prescription
Check this DIN again · Health Canada product record

Mar-Afatinib: Formulary list price $38.7392/unit (unit not stated in source; not the patient's cost)

Ministry pays: $38.7392 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=100636 · Verify on the e-Formulary ↗ (DIN 02517027)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02517027). DIN 02517027: Mar-Afatinib Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 100000233; group id 142; item number 0240; lccId None; manufacturer id MAR 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=02517027 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100636
Interchangeable products
Giotrif · DIN 02415674 · $38.7392 Sandoz AFAtinib · DIN 02512785 · $38.7392
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=02517027
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Sandoz AFAtinib · DIN 02512785 · 30mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
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 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
Brand vs generic price
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 ↗)
1 brand, same coverage
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
Check this DIN again · Health Canada product record

Sandoz AFAtinib: Formulary list price $38.7392/unit (unit not stated in source; not the patient's cost)

Ministry pays: $38.7392 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=100204 · Verify on the e-Formulary ↗ (DIN 02512785)

Source record
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: 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=02512785
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Giotrif · DIN 02415682 · 40mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
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 ↗)
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 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
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
Giotrif · DIN 02415682 Manufacturer: Boehringer-Ingelheim (Canada) Ltd./Ltee; listing date 2024-12-30 Health Canada: Marketed since 2014-01-17 · brand GIOTRIF · ATC L01EB03 AFATINIB · form Tablet · route Oral · ingredients AFATINIB (AFATINIB DIMALEATE) 40 MG · company Boehringer ingelheim (canada) ltd ltee · schedule Prescription
Check this DIN again · Health Canada product record

Ministry pays: $38.7392 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=90028 · Verify on the e-Formulary ↗ (DIN 02415682)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02415682). DIN 02415682: Giotrif Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 100000234; group id 142; item number 0241; lccId None; manufacturer id BOE Source form: Tab; strength: 40mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $80.8334; ministry $38.7392 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02415682 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90028
Interchangeable products
Mar-Afatinib · DIN 02517035 · $38.7392 Sandoz AFAtinib · DIN 02512793 · $38.7392
Shortage status: anticipated shortage (last updated 2026-06-26); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02415682
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Mar-Afatinib · DIN 02517035 · 40mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
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 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
Brand vs generic price
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 ↗)
1 brand, same coverage
Mar-Afatinib · DIN 02517035 Manufacturer: Marcan Pharmaceuticals Inc.; listing date 2025-03-31 Health Canada: Marketed since 2025-01-31 · brand MAR-AFATINIB · ATC L01EB03 AFATINIB · form Tablet · route Oral · ingredients AFATINIB (AFATINIB DIMALEATE) 40 MG · company Marcan pharmaceuticals inc · schedule Prescription
Check this DIN again · Health Canada product record

Mar-Afatinib: Formulary list price $38.7392/unit (unit not stated in source; not the patient's cost)

Ministry pays: $38.7392 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=100637 · Verify on the e-Formulary ↗ (DIN 02517035)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02517035). DIN 02517035: Mar-Afatinib Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 100000234; group id 142; item number 0241; lccId None; manufacturer id MAR Source form: Tab; strength: 40mg 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=02517035 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100637
Interchangeable products
Giotrif · DIN 02415682 · $38.7392 Sandoz AFAtinib · DIN 02512793 · $38.7392
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=02517035
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Sandoz AFAtinib · DIN 02512793 · 40mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
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 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
Brand vs generic price
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 ↗)
1 brand, same coverage
Sandoz AFAtinib · DIN 02512793 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) 40 MG · company Sandoz canada incorporated · schedule Prescription
Check this DIN again · Health Canada product record

Sandoz AFAtinib: Formulary list price $38.7392/unit (unit not stated in source; not the patient's cost)

Ministry pays: $38.7392 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=100205 · Verify on the e-Formulary ↗ (DIN 02512793)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02512793). DIN 02512793: Sandoz AFAtinib Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 100000234; group id 142; item number 0241; lccId None; manufacturer id SDZ Source form: Tab; strength: 40mg 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=02512793 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100205
Interchangeable products
Giotrif · DIN 02415682 · $38.7392 Mar-Afatinib · DIN 02517035 · $38.7392
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=02512793
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

ERLOTINIB

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

GEFITINIB

· 5 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 250mg · 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
INDICATIONS AND CLINICAL USE GIOTRIF (afatinib) is indicated as monotherapy for the treatment of Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor naïve patients with metastatic (including cytologically proven pleural effusion) adenocarcinoma of the lung with activating EGFR mutation(s).  A validated test is required to identify EGFR mutation status.  Clinical efficacy was based on progression-free survival and objective response rate. There was no difference in overall survival (OS) between the two arms; however, the subgroup analysis of OS demonstrated an OS benefit in patients harbouring Del 19 but no OS benefit was demonstrated in patients with the L858R point mutation.  Safety and efficacy of GIOTRIF have not been established in patients with EGFR mutations other than Del 19 and exon 21 L858R point mutation (see CLINICAL TRIALS). GIOTRIF (afatinib) is indicated as monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) of squamous histology progressing after platinum-based chemotherapy (see CLINICAL TRIALS). Close monitoring and pr… https://pdf.hres.ca/dpd_pm/00051644.PDF PM date: June 6, 2019 Source product: GIOTRIF; DIN 02415666; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.

Availability

Sandoz AFAtinib · DIN 02512777 Shortage status: active shortage (reported 2026-08-03, estimated to end 2026-11-06, last updated 2026-09-02); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02512777

Check this DIN again

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

Afatinib (Giotrif)

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 patients with advanced or metastatic non-small cell lung cancer (NSCLC) who meet the following criteria;

Ministry criteria corpus 2025-01-01; page 266

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

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

Other review policies

For Mar-Afatinib, Sandoz AFAtinib: no applicable EAP criteria are held and no ODB benefit is established. These policies do not establish coverage.

For rare, immediately life-, limb- or organ-threatening circumstances, the Compassionate Review Policy may consider an unfunded drug or indication, subject to its criteria and without bypassing the drug review process. Compassionate Review Policy

Compassionate Review Policy: source quote
Where there are rare clinical circumstances in immediately life, limb, or organ-threatening conditions, the Executive Officer will also consider requests for drugs or indications in situations where there has not been a decision by the Executive Officer to provide funding of the drug or indication as part of the Ontario Drug Benefit program (and the EAP), and the drug or indication requested would not circumvent the established review process for new drugs or indications as part of the drug submission process for listing within the Ontario Drug Benefit program. Requests must meet the criteria for the Compassionate Review Policy.

Ontario source; updated September 15, 2026

For cancer drugs, Case-by-Case Review considers rare, immediately life-threatening circumstances when no satisfactory funded treatment exists; its criteria and application process apply. Case-by-Case Review (cancer drugs)

Case-by-Case Review (cancer drugs): source quote
Note: Requests for cancer drugs are considered under the Case-by-Case Review Program (CBCRP) which is administered by Ontario Health (Cancer Care Ontario) on behalf of the Ministry of Health. The CBCRP considers funding requests for drugs (both oral therapies and injectable drugs) for the treatment of cancer in patients who have a rare clinical circumstance that is immediately life-threatening (death is likely within a matter of months) and who require treatment with an unfunded drug, because there is no other satisfactory and funded treatment. Please refer to the Ontario Health website for information on the application process, FAQs, eligibility criteria and program policies.

Ontario source; updated September 15, 2026