ERLOTINIB
All products: not a benefit
Other products in the same Health Canada class (L01E, L01EB) — coverage varies; not interchangeable
- Afatinib (Giotrif): 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
Apo-Erlotinib · DIN 02461862 · 25mg · tablet
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗) Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Erlotinib
Brand(s): Tarceva and generics see formulary for a funded list of generics
DOSAGE FORM/ STRENGTH: 25 mg,100 mg, 150 mg tablet
For the treatment of clinically documented incurable progressive non-small cell
lung cancer (NSCLC) where:
• Erlotinib is used as monotherapy for the 2nd- or 3rd-line treatment after failure of prior
chemotherapy (any regimen) in patients 70 years of age or older.
• Erlotinib is used as monotherapy for the 2nd- or 3rd-line treatment of patients with
clinically documented incurable progressive non-small cell lung cancer (NSCLC)
despite prior chemotherapy including both docetaxel and a platinum-based treatment
(i.e. cisplatin or carboplatin).
• Erlotinib is used as monotherapy for the 3rd-line treatment of patients with clinically
documented incurable progressive non-small cell lung cancer (NSCLC) despite prior
chemotherapy including both a platinum-based therapy (i.e. cisplatin or carboplatin)
AND either pemetrexed or topotecan.
• Erlotinib is used as monotherapy for 2nd line treatment of NSCLC after 1st line
platinum-based therapy, where no other chemotherapy will be given and erlotinib is
used as the last treatment for the patient
Patients should be assessed for disease status at least every two months. Erlotinib should
be discontinued if there is evidence of disease progression.
Note that erlotinib is not indicated and therefore, is not considered for reimbursement as
1st line therapy in treatment of NSCLC.
Requests for 2nd-line and 3rd-line use of erlotinib in patients 70 years of age or older and
have not received treatment with either platinum-based combinations will be considered on
a case-by-case basis.
Approved dosage: 150 mg/day
Duration of Approval: 6 Months
Renewal will be considered for patients who respond to therapy with no evidence of
disease progression. Patients should be assessed for disease status at least every two
months. Erlotinib should be discontinued if there is evidence of disease progression.
Duration of Approval: 6 Months
311
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 311, record 184, 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 ↗)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
Apo-Erlotinib · DIN 02461862
Manufacturer: Apotex Inc.; listing date 2017-10-30
Health Canada: Marketed since 2017-08-22 · brand APO-ERLOTINIB · ATC L01EB02 ERLOTINIB · form Tablet · route Oral · ingredients ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 25 MG · company Apotex inc · schedule Prescription
Apo-Erlotinib: Formulary list price $11.8667/unit (unit not stated in source; not the patient's cost)
Ministry pays: $11.8667 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=94960 · Verify on the e-Formulary ↗ (DIN 02461862)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02461862).
DIN 02461862: Apo-Erlotinib
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 100000204; group id 157; item number 0268; lccId None; manufacturer id APX
Source form: Tab; strength: 25mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $11.8667; ministry $11.8667
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02461862
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=94960
Interchangeable products
Nat-Erlotinib · DIN 02483912 · $11.8667
Tarceva · DIN 02269007 · not recorded
Teva-Erlotinib · DIN 02377691 · $11.8666
Shortage status: resolved shortage (ended 2019-11-20); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02461862
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Teva-Erlotinib · DIN 02377691 · 25mg · tablet
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗) Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Erlotinib
Brand(s): Tarceva and generics see formulary for a funded list of generics
DOSAGE FORM/ STRENGTH: 25 mg,100 mg, 150 mg tablet
For the treatment of clinically documented incurable progressive non-small cell
lung cancer (NSCLC) where:
• Erlotinib is used as monotherapy for the 2nd- or 3rd-line treatment after failure of prior
chemotherapy (any regimen) in patients 70 years of age or older.
• Erlotinib is used as monotherapy for the 2nd- or 3rd-line treatment of patients with
clinically documented incurable progressive non-small cell lung cancer (NSCLC)
despite prior chemotherapy including both docetaxel and a platinum-based treatment
(i.e. cisplatin or carboplatin).
• Erlotinib is used as monotherapy for the 3rd-line treatment of patients with clinically
documented incurable progressive non-small cell lung cancer (NSCLC) despite prior
chemotherapy including both a platinum-based therapy (i.e. cisplatin or carboplatin)
AND either pemetrexed or topotecan.
• Erlotinib is used as monotherapy for 2nd line treatment of NSCLC after 1st line
platinum-based therapy, where no other chemotherapy will be given and erlotinib is
used as the last treatment for the patient
Patients should be assessed for disease status at least every two months. Erlotinib should
be discontinued if there is evidence of disease progression.
Note that erlotinib is not indicated and therefore, is not considered for reimbursement as
1st line therapy in treatment of NSCLC.
Requests for 2nd-line and 3rd-line use of erlotinib in patients 70 years of age or older and
have not received treatment with either platinum-based combinations will be considered on
a case-by-case basis.
Approved dosage: 150 mg/day
Duration of Approval: 6 Months
Renewal will be considered for patients who respond to therapy with no evidence of
disease progression. Patients should be assessed for disease status at least every two
months. Erlotinib should be discontinued if there is evidence of disease progression.
Duration of Approval: 6 Months
311
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 311, record 184, 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
Teva-Erlotinib · DIN 02377691
Manufacturer: Teva Canada Limited; listing date 2015-02-26
Health Canada: Marketed since 2014-12-08 · brand TEVA-ERLOTINIB · ATC L01EB02 ERLOTINIB · form Tablet · route Oral · ingredients ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 25 MG · company Teva canada limited · schedule Prescription
Teva-Erlotinib: Formulary list price $11.8666/unit (unit not stated in source; not the patient's cost)
Ministry pays: $11.8666 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=86351 · Verify on the e-Formulary ↗ (DIN 02377691)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02377691).
DIN 02377691: Teva-Erlotinib
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 100000204; group id 157; item number 0268; lccId None; manufacturer id TEV
Source form: Tab; strength: 25mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $11.8666; ministry $11.8666
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02377691
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=86351
Interchangeable products
Apo-Erlotinib · DIN 02461862 · $11.8667
Nat-Erlotinib · DIN 02483912 · $11.8667
Tarceva · DIN 02269007 · not recorded
Shortage status: resolved shortage (ended 2024-07-30); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02377691
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Apo-Erlotinib · DIN 02461870 · 100mg · tablet
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗) Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Erlotinib
Brand(s): Tarceva and generics see formulary for a funded list of generics
DOSAGE FORM/ STRENGTH: 25 mg,100 mg, 150 mg tablet
For the treatment of clinically documented incurable progressive non-small cell
lung cancer (NSCLC) where:
• Erlotinib is used as monotherapy for the 2nd- or 3rd-line treatment after failure of prior
chemotherapy (any regimen) in patients 70 years of age or older.
• Erlotinib is used as monotherapy for the 2nd- or 3rd-line treatment of patients with
clinically documented incurable progressive non-small cell lung cancer (NSCLC)
despite prior chemotherapy including both docetaxel and a platinum-based treatment
(i.e. cisplatin or carboplatin).
• Erlotinib is used as monotherapy for the 3rd-line treatment of patients with clinically
documented incurable progressive non-small cell lung cancer (NSCLC) despite prior
chemotherapy including both a platinum-based therapy (i.e. cisplatin or carboplatin)
AND either pemetrexed or topotecan.
• Erlotinib is used as monotherapy for 2nd line treatment of NSCLC after 1st line
platinum-based therapy, where no other chemotherapy will be given and erlotinib is
used as the last treatment for the patient
Patients should be assessed for disease status at least every two months. Erlotinib should
be discontinued if there is evidence of disease progression.
Note that erlotinib is not indicated and therefore, is not considered for reimbursement as
1st line therapy in treatment of NSCLC.
Requests for 2nd-line and 3rd-line use of erlotinib in patients 70 years of age or older and
have not received treatment with either platinum-based combinations will be considered on
a case-by-case basis.
Approved dosage: 150 mg/day
Duration of Approval: 6 Months
Renewal will be considered for patients who respond to therapy with no evidence of
disease progression. Patients should be assessed for disease status at least every two
months. Erlotinib should be discontinued if there is evidence of disease progression.
Duration of Approval: 6 Months
311
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 311, record 184, 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 ↗)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
Apo-Erlotinib · DIN 02461870
Manufacturer: Apotex Inc.; listing date 2017-10-30
Health Canada: Marketed since 2017-08-22 · brand APO-ERLOTINIB · ATC L01EB02 ERLOTINIB · form Tablet · route Oral · ingredients ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 100 MG · company Apotex inc · schedule Prescription
Apo-Erlotinib: Formulary list price $47.4667/unit (unit not stated in source; not the patient's cost)
Ministry pays: $47.4667 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=94961 · Verify on the e-Formulary ↗ (DIN 02461870)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02461870).
DIN 02461870: Apo-Erlotinib
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 100000183; group id 157; item number 0269; lccId None; manufacturer id APX
Source form: Tab; strength: 100mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $47.4667; ministry $47.4667
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02461870
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=94961
Interchangeable products
Nat-Erlotinib · DIN 02483920 · $47.4667
PMS-Erlotinib · DIN 02454386 · $47.4667
Tarceva · DIN 02269015 · not recorded
Teva-Erlotinib · DIN 02377705 · $47.4666
Shortage status: resolved shortage (ended 2019-11-20); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02461870
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Teva-Erlotinib · DIN 02377705 · 100mg · tablet
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗) Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Erlotinib
Brand(s): Tarceva and generics see formulary for a funded list of generics
DOSAGE FORM/ STRENGTH: 25 mg,100 mg, 150 mg tablet
For the treatment of clinically documented incurable progressive non-small cell
lung cancer (NSCLC) where:
• Erlotinib is used as monotherapy for the 2nd- or 3rd-line treatment after failure of prior
chemotherapy (any regimen) in patients 70 years of age or older.
• Erlotinib is used as monotherapy for the 2nd- or 3rd-line treatment of patients with
clinically documented incurable progressive non-small cell lung cancer (NSCLC)
despite prior chemotherapy including both docetaxel and a platinum-based treatment
(i.e. cisplatin or carboplatin).
• Erlotinib is used as monotherapy for the 3rd-line treatment of patients with clinically
documented incurable progressive non-small cell lung cancer (NSCLC) despite prior
chemotherapy including both a platinum-based therapy (i.e. cisplatin or carboplatin)
AND either pemetrexed or topotecan.
• Erlotinib is used as monotherapy for 2nd line treatment of NSCLC after 1st line
platinum-based therapy, where no other chemotherapy will be given and erlotinib is
used as the last treatment for the patient
Patients should be assessed for disease status at least every two months. Erlotinib should
be discontinued if there is evidence of disease progression.
Note that erlotinib is not indicated and therefore, is not considered for reimbursement as
1st line therapy in treatment of NSCLC.
Requests for 2nd-line and 3rd-line use of erlotinib in patients 70 years of age or older and
have not received treatment with either platinum-based combinations will be considered on
a case-by-case basis.
Approved dosage: 150 mg/day
Duration of Approval: 6 Months
Renewal will be considered for patients who respond to therapy with no evidence of
disease progression. Patients should be assessed for disease status at least every two
months. Erlotinib should be discontinued if there is evidence of disease progression.
Duration of Approval: 6 Months
311
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 311, record 184, 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
Teva-Erlotinib · DIN 02377705
Manufacturer: Teva Canada Limited; listing date 2015-02-26
Health Canada: Marketed since 2014-12-08 · brand TEVA-ERLOTINIB · ATC L01EB02 ERLOTINIB · form Tablet · route Oral · ingredients ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 100 MG · company Teva canada limited · schedule Prescription
Teva-Erlotinib: Formulary list price $47.4666/unit (unit not stated in source; not the patient's cost)
Ministry pays: $47.4666 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=86352 · Verify on the e-Formulary ↗ (DIN 02377705)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02377705).
DIN 02377705: Teva-Erlotinib
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 100000183; group id 157; item number 0269; lccId None; manufacturer id TEV
Source form: Tab; strength: 100mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $47.4666; ministry $47.4666
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02377705
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=86352
Interchangeable products
Apo-Erlotinib · DIN 02461870 · $47.4667
Nat-Erlotinib · DIN 02483920 · $47.4667
PMS-Erlotinib · DIN 02454386 · $47.4667
Tarceva · DIN 02269015 · not recorded
Shortage status: resolved shortage (ended 2024-08-07); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02377705
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Apo-Erlotinib · DIN 02461889 · 150mg · tablet
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗) Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Erlotinib
Brand(s): Tarceva and generics see formulary for a funded list of generics
DOSAGE FORM/ STRENGTH: 25 mg,100 mg, 150 mg tablet
For the treatment of clinically documented incurable progressive non-small cell
lung cancer (NSCLC) where:
• Erlotinib is used as monotherapy for the 2nd- or 3rd-line treatment after failure of prior
chemotherapy (any regimen) in patients 70 years of age or older.
• Erlotinib is used as monotherapy for the 2nd- or 3rd-line treatment of patients with
clinically documented incurable progressive non-small cell lung cancer (NSCLC)
despite prior chemotherapy including both docetaxel and a platinum-based treatment
(i.e. cisplatin or carboplatin).
• Erlotinib is used as monotherapy for the 3rd-line treatment of patients with clinically
documented incurable progressive non-small cell lung cancer (NSCLC) despite prior
chemotherapy including both a platinum-based therapy (i.e. cisplatin or carboplatin)
AND either pemetrexed or topotecan.
• Erlotinib is used as monotherapy for 2nd line treatment of NSCLC after 1st line
platinum-based therapy, where no other chemotherapy will be given and erlotinib is
used as the last treatment for the patient
Patients should be assessed for disease status at least every two months. Erlotinib should
be discontinued if there is evidence of disease progression.
Note that erlotinib is not indicated and therefore, is not considered for reimbursement as
1st line therapy in treatment of NSCLC.
Requests for 2nd-line and 3rd-line use of erlotinib in patients 70 years of age or older and
have not received treatment with either platinum-based combinations will be considered on
a case-by-case basis.
Approved dosage: 150 mg/day
Duration of Approval: 6 Months
Renewal will be considered for patients who respond to therapy with no evidence of
disease progression. Patients should be assessed for disease status at least every two
months. Erlotinib should be discontinued if there is evidence of disease progression.
Duration of Approval: 6 Months
311
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 311, record 184, 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
Apo-Erlotinib · DIN 02461889
Manufacturer: Apotex Inc.; listing date 2017-10-30
Health Canada: Marketed since 2017-08-22 · brand APO-ERLOTINIB · ATC L01EB02 ERLOTINIB · form Tablet · route Oral · ingredients ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 150 MG · company Apotex inc · schedule Prescription
Apo-Erlotinib: Formulary list price $71.2000/unit (unit not stated in source; not the patient's cost)
Ministry pays: $71.2000 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=94962 · Verify on the e-Formulary ↗ (DIN 02461889)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02461889).
DIN 02461889: Apo-Erlotinib
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 100000184; group id 157; item number 0270; lccId None; manufacturer id APX
Source form: Tab; strength: 150mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $71.2000; ministry $71.2000
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02461889
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=94962
Interchangeable products
Nat-Erlotinib · DIN 02483939 · $71.2000
PMS-Erlotinib · DIN 02454394 · $71.2000
Tarceva · DIN 02269023 · not recorded
Teva-Erlotinib · DIN 02377713 · $71.2000
Shortage status: resolved shortage (ended 2019-11-20); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02461889
Shortage record checked 2026-09-13T08:10:21.292534+00:00
PMS-Erlotinib · DIN 02454394 · 150mg · tablet
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗) Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Erlotinib
Brand(s): Tarceva and generics see formulary for a funded list of generics
DOSAGE FORM/ STRENGTH: 25 mg,100 mg, 150 mg tablet
For the treatment of clinically documented incurable progressive non-small cell
lung cancer (NSCLC) where:
• Erlotinib is used as monotherapy for the 2nd- or 3rd-line treatment after failure of prior
chemotherapy (any regimen) in patients 70 years of age or older.
• Erlotinib is used as monotherapy for the 2nd- or 3rd-line treatment of patients with
clinically documented incurable progressive non-small cell lung cancer (NSCLC)
despite prior chemotherapy including both docetaxel and a platinum-based treatment
(i.e. cisplatin or carboplatin).
• Erlotinib is used as monotherapy for the 3rd-line treatment of patients with clinically
documented incurable progressive non-small cell lung cancer (NSCLC) despite prior
chemotherapy including both a platinum-based therapy (i.e. cisplatin or carboplatin)
AND either pemetrexed or topotecan.
• Erlotinib is used as monotherapy for 2nd line treatment of NSCLC after 1st line
platinum-based therapy, where no other chemotherapy will be given and erlotinib is
used as the last treatment for the patient
Patients should be assessed for disease status at least every two months. Erlotinib should
be discontinued if there is evidence of disease progression.
Note that erlotinib is not indicated and therefore, is not considered for reimbursement as
1st line therapy in treatment of NSCLC.
Requests for 2nd-line and 3rd-line use of erlotinib in patients 70 years of age or older and
have not received treatment with either platinum-based combinations will be considered on
a case-by-case basis.
Approved dosage: 150 mg/day
Duration of Approval: 6 Months
Renewal will be considered for patients who respond to therapy with no evidence of
disease progression. Patients should be assessed for disease status at least every two
months. Erlotinib should be discontinued if there is evidence of disease progression.
Duration of Approval: 6 Months
311
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 311, record 184, 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
PMS-Erlotinib · DIN 02454394
Manufacturer: Pharmascience Inc.; listing date 2016-09-29
Health Canada: Marketed since 2016-07-28 · brand PMS-ERLOTINIB · ATC L01EB02 ERLOTINIB · form Tablet · route Oral · ingredients ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 150 MG · company Pharmascience inc · schedule Prescription
PMS-Erlotinib: Formulary list price $71.2000/unit (unit not stated in source; not the patient's cost)
Ministry pays: $71.2000 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=94097 · Verify on the e-Formulary ↗ (DIN 02454394)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02454394).
DIN 02454394: PMS-Erlotinib
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 100000184; group id 157; item number 0270; lccId None; manufacturer id PMS
Source form: Tab; strength: 150mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $71.2000; ministry $71.2000
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02454394
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=94097
Interchangeable products
Apo-Erlotinib · DIN 02461889 · $71.2000
Nat-Erlotinib · DIN 02483939 · $71.2000
Tarceva · DIN 02269023 · not recorded
Teva-Erlotinib · DIN 02377713 · $71.2000
Shortage status: discontinued (2021-11-15, reported by PHARMASCIENCE INC); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02454394
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Teva-Erlotinib · DIN 02377713 · 150mg · tablet
Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗) Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Erlotinib
Brand(s): Tarceva and generics see formulary for a funded list of generics
DOSAGE FORM/ STRENGTH: 25 mg,100 mg, 150 mg tablet
For the treatment of clinically documented incurable progressive non-small cell
lung cancer (NSCLC) where:
• Erlotinib is used as monotherapy for the 2nd- or 3rd-line treatment after failure of prior
chemotherapy (any regimen) in patients 70 years of age or older.
• Erlotinib is used as monotherapy for the 2nd- or 3rd-line treatment of patients with
clinically documented incurable progressive non-small cell lung cancer (NSCLC)
despite prior chemotherapy including both docetaxel and a platinum-based treatment
(i.e. cisplatin or carboplatin).
• Erlotinib is used as monotherapy for the 3rd-line treatment of patients with clinically
documented incurable progressive non-small cell lung cancer (NSCLC) despite prior
chemotherapy including both a platinum-based therapy (i.e. cisplatin or carboplatin)
AND either pemetrexed or topotecan.
• Erlotinib is used as monotherapy for 2nd line treatment of NSCLC after 1st line
platinum-based therapy, where no other chemotherapy will be given and erlotinib is
used as the last treatment for the patient
Patients should be assessed for disease status at least every two months. Erlotinib should
be discontinued if there is evidence of disease progression.
Note that erlotinib is not indicated and therefore, is not considered for reimbursement as
1st line therapy in treatment of NSCLC.
Requests for 2nd-line and 3rd-line use of erlotinib in patients 70 years of age or older and
have not received treatment with either platinum-based combinations will be considered on
a case-by-case basis.
Approved dosage: 150 mg/day
Duration of Approval: 6 Months
Renewal will be considered for patients who respond to therapy with no evidence of
disease progression. Patients should be assessed for disease status at least every two
months. Erlotinib should be discontinued if there is evidence of disease progression.
Duration of Approval: 6 Months
311
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 311, record 184, 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
Teva-Erlotinib · DIN 02377713
Manufacturer: Teva Canada Limited; listing date 2015-02-26
Health Canada: Marketed since 2014-12-08 · brand TEVA-ERLOTINIB · ATC L01EB02 ERLOTINIB · form Tablet · route Oral · ingredients ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 150 MG · company Teva canada limited · schedule Prescription
Teva-Erlotinib: Formulary list price $71.2000/unit (unit not stated in source; not the patient's cost)
Ministry pays: $71.2000 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=86353 · Verify on the e-Formulary ↗ (DIN 02377713)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02377713).
DIN 02377713: Teva-Erlotinib
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 100000184; group id 157; item number 0270; lccId None; manufacturer id TEV
Source form: Tab; strength: 150mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $71.2000; ministry $71.2000
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02377713
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=86353
Interchangeable products
Apo-Erlotinib · DIN 02461889 · $71.2000
Nat-Erlotinib · DIN 02483939 · $71.2000
PMS-Erlotinib · DIN 02454394 · $71.2000
Tarceva · DIN 02269023 · not recorded
Shortage status: resolved shortage (ended 2026-03-04); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02377713
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Nat-Erlotinib · DIN 02483912 · 25mg · tablet
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗) Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Erlotinib
Brand(s): Tarceva and generics see formulary for a funded list of generics
DOSAGE FORM/ STRENGTH: 25 mg,100 mg, 150 mg tablet
For the treatment of clinically documented incurable progressive non-small cell
lung cancer (NSCLC) where:
• Erlotinib is used as monotherapy for the 2nd- or 3rd-line treatment after failure of prior
chemotherapy (any regimen) in patients 70 years of age or older.
• Erlotinib is used as monotherapy for the 2nd- or 3rd-line treatment of patients with
clinically documented incurable progressive non-small cell lung cancer (NSCLC)
despite prior chemotherapy including both docetaxel and a platinum-based treatment
(i.e. cisplatin or carboplatin).
• Erlotinib is used as monotherapy for the 3rd-line treatment of patients with clinically
documented incurable progressive non-small cell lung cancer (NSCLC) despite prior
chemotherapy including both a platinum-based therapy (i.e. cisplatin or carboplatin)
AND either pemetrexed or topotecan.
• Erlotinib is used as monotherapy for 2nd line treatment of NSCLC after 1st line
platinum-based therapy, where no other chemotherapy will be given and erlotinib is
used as the last treatment for the patient
Patients should be assessed for disease status at least every two months. Erlotinib should
be discontinued if there is evidence of disease progression.
Note that erlotinib is not indicated and therefore, is not considered for reimbursement as
1st line therapy in treatment of NSCLC.
Requests for 2nd-line and 3rd-line use of erlotinib in patients 70 years of age or older and
have not received treatment with either platinum-based combinations will be considered on
a case-by-case basis.
Approved dosage: 150 mg/day
Duration of Approval: 6 Months
Renewal will be considered for patients who respond to therapy with no evidence of
disease progression. Patients should be assessed for disease status at least every two
months. Erlotinib should be discontinued if there is evidence of disease progression.
Duration of Approval: 6 Months
311
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 311, record 184, 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 ↗)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
Nat-Erlotinib · DIN 02483912
Manufacturer: Natco Pharma (Canada) Inc.; listing date 2019-03-28
Health Canada: Dormant since 2021-05-01 · brand NAT-ERLOTINIB · ATC L01EB02 ERLOTINIB · form Tablet · route Oral · ingredients ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 25 MG · company Natco pharma (canada) inc · schedule Prescription
Nat-Erlotinib: Formulary list price $11.8667/unit (unit not stated in source; not the patient's cost)
Ministry pays: $11.8667 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=97427 · Verify on the e-Formulary ↗ (DIN 02483912)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02483912).
DIN 02483912: Nat-Erlotinib
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 100000204; group id 157; item number 0268; lccId None; manufacturer id NAT
Source form: Tab; strength: 25mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $11.8667; ministry $11.8667
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02483912
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=97427
Interchangeable products
Apo-Erlotinib · DIN 02461862 · $11.8667
Tarceva · DIN 02269007 · not recorded
Teva-Erlotinib · DIN 02377691 · $11.8666
Shortage status: active shortage (reported 2020-12-01, estimated to end 2027-06-30, last updated 2026-04-13); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02483912
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Health Canada lists this DIN as Dormant since 2021-05-01 — choose a marketed DIN from the same-category list.
Nat-Erlotinib · DIN 02483920 · 100mg · tablet
Off-Formulary Interchangeable, not an ODB benefitDormant since 2021-10-01 · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗) Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Erlotinib
Brand(s): Tarceva and generics see formulary for a funded list of generics
DOSAGE FORM/ STRENGTH: 25 mg,100 mg, 150 mg tablet
For the treatment of clinically documented incurable progressive non-small cell
lung cancer (NSCLC) where:
• Erlotinib is used as monotherapy for the 2nd- or 3rd-line treatment after failure of prior
chemotherapy (any regimen) in patients 70 years of age or older.
• Erlotinib is used as monotherapy for the 2nd- or 3rd-line treatment of patients with
clinically documented incurable progressive non-small cell lung cancer (NSCLC)
despite prior chemotherapy including both docetaxel and a platinum-based treatment
(i.e. cisplatin or carboplatin).
• Erlotinib is used as monotherapy for the 3rd-line treatment of patients with clinically
documented incurable progressive non-small cell lung cancer (NSCLC) despite prior
chemotherapy including both a platinum-based therapy (i.e. cisplatin or carboplatin)
AND either pemetrexed or topotecan.
• Erlotinib is used as monotherapy for 2nd line treatment of NSCLC after 1st line
platinum-based therapy, where no other chemotherapy will be given and erlotinib is
used as the last treatment for the patient
Patients should be assessed for disease status at least every two months. Erlotinib should
be discontinued if there is evidence of disease progression.
Note that erlotinib is not indicated and therefore, is not considered for reimbursement as
1st line therapy in treatment of NSCLC.
Requests for 2nd-line and 3rd-line use of erlotinib in patients 70 years of age or older and
have not received treatment with either platinum-based combinations will be considered on
a case-by-case basis.
Approved dosage: 150 mg/day
Duration of Approval: 6 Months
Renewal will be considered for patients who respond to therapy with no evidence of
disease progression. Patients should be assessed for disease status at least every two
months. Erlotinib should be discontinued if there is evidence of disease progression.
Duration of Approval: 6 Months
311
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 311, record 184, 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 ↗)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
Nat-Erlotinib · DIN 02483920
Manufacturer: Natco Pharma (Canada) Inc.; listing date 2019-03-28
Health Canada: Dormant since 2021-10-01 · brand NAT-ERLOTINIB · ATC L01EB02 ERLOTINIB · form Tablet · route Oral · ingredients ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 100 MG · company Natco pharma (canada) inc · schedule Prescription
Nat-Erlotinib: Formulary list price $47.4667/unit (unit not stated in source; not the patient's cost)
Ministry pays: $47.4667 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=97428 · Verify on the e-Formulary ↗ (DIN 02483920)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02483920).
DIN 02483920: Nat-Erlotinib
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 100000183; group id 157; item number 0269; lccId None; manufacturer id NAT
Source form: Tab; strength: 100mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $47.4667; ministry $47.4667
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02483920
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=97428
Interchangeable products
Apo-Erlotinib · DIN 02461870 · $47.4667
PMS-Erlotinib · DIN 02454386 · $47.4667
Tarceva · DIN 02269015 · not recorded
Teva-Erlotinib · DIN 02377705 · $47.4666
Shortage status: active shortage (reported 2020-12-01, estimated to end 2027-06-30, last updated 2026-04-13); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02483920
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Health Canada lists this DIN as Dormant since 2021-10-01 — choose a marketed DIN from the same-category list.
PMS-Erlotinib · DIN 02454386 · 100mg · tablet
Off-Formulary Interchangeable, not an ODB benefitDormant since 2025-07-31 · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗) Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Erlotinib
Brand(s): Tarceva and generics see formulary for a funded list of generics
DOSAGE FORM/ STRENGTH: 25 mg,100 mg, 150 mg tablet
For the treatment of clinically documented incurable progressive non-small cell
lung cancer (NSCLC) where:
• Erlotinib is used as monotherapy for the 2nd- or 3rd-line treatment after failure of prior
chemotherapy (any regimen) in patients 70 years of age or older.
• Erlotinib is used as monotherapy for the 2nd- or 3rd-line treatment of patients with
clinically documented incurable progressive non-small cell lung cancer (NSCLC)
despite prior chemotherapy including both docetaxel and a platinum-based treatment
(i.e. cisplatin or carboplatin).
• Erlotinib is used as monotherapy for the 3rd-line treatment of patients with clinically
documented incurable progressive non-small cell lung cancer (NSCLC) despite prior
chemotherapy including both a platinum-based therapy (i.e. cisplatin or carboplatin)
AND either pemetrexed or topotecan.
• Erlotinib is used as monotherapy for 2nd line treatment of NSCLC after 1st line
platinum-based therapy, where no other chemotherapy will be given and erlotinib is
used as the last treatment for the patient
Patients should be assessed for disease status at least every two months. Erlotinib should
be discontinued if there is evidence of disease progression.
Note that erlotinib is not indicated and therefore, is not considered for reimbursement as
1st line therapy in treatment of NSCLC.
Requests for 2nd-line and 3rd-line use of erlotinib in patients 70 years of age or older and
have not received treatment with either platinum-based combinations will be considered on
a case-by-case basis.
Approved dosage: 150 mg/day
Duration of Approval: 6 Months
Renewal will be considered for patients who respond to therapy with no evidence of
disease progression. Patients should be assessed for disease status at least every two
months. Erlotinib should be discontinued if there is evidence of disease progression.
Duration of Approval: 6 Months
311
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 311, record 184, 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 ↗)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
PMS-Erlotinib · DIN 02454386
Manufacturer: Pharmascience Inc.; listing date 2016-09-29
Health Canada: Dormant since 2025-07-31 · brand PMS-ERLOTINIB · ATC L01EB02 ERLOTINIB · form Tablet · route Oral · ingredients ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 100 MG · company Pharmascience inc · schedule Prescription
PMS-Erlotinib: Formulary list price $47.4667/unit (unit not stated in source; not the patient's cost)
Ministry pays: $47.4667 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=94096 · Verify on the e-Formulary ↗ (DIN 02454386)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02454386).
DIN 02454386: PMS-Erlotinib
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 100000183; group id 157; item number 0269; lccId None; manufacturer id PMS
Source form: Tab; strength: 100mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $47.4667; ministry $47.4667
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02454386
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=94096
Interchangeable products
Apo-Erlotinib · DIN 02461870 · $47.4667
Nat-Erlotinib · DIN 02483920 · $47.4667
Tarceva · DIN 02269015 · not recorded
Teva-Erlotinib · DIN 02377705 · $47.4666
Shortage status: discontinued (2021-11-15, reported by PHARMASCIENCE INC); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02454386
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Health Canada lists this DIN as Dormant since 2025-07-31 — choose a marketed DIN from the same-category list.
Nat-Erlotinib · DIN 02483939 · 150mg · tablet
Off-Formulary Interchangeable, not an ODB benefitDormant since 2021-12-01 · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗) Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Erlotinib
Brand(s): Tarceva and generics see formulary for a funded list of generics
DOSAGE FORM/ STRENGTH: 25 mg,100 mg, 150 mg tablet
For the treatment of clinically documented incurable progressive non-small cell
lung cancer (NSCLC) where:
• Erlotinib is used as monotherapy for the 2nd- or 3rd-line treatment after failure of prior
chemotherapy (any regimen) in patients 70 years of age or older.
• Erlotinib is used as monotherapy for the 2nd- or 3rd-line treatment of patients with
clinically documented incurable progressive non-small cell lung cancer (NSCLC)
despite prior chemotherapy including both docetaxel and a platinum-based treatment
(i.e. cisplatin or carboplatin).
• Erlotinib is used as monotherapy for the 3rd-line treatment of patients with clinically
documented incurable progressive non-small cell lung cancer (NSCLC) despite prior
chemotherapy including both a platinum-based therapy (i.e. cisplatin or carboplatin)
AND either pemetrexed or topotecan.
• Erlotinib is used as monotherapy for 2nd line treatment of NSCLC after 1st line
platinum-based therapy, where no other chemotherapy will be given and erlotinib is
used as the last treatment for the patient
Patients should be assessed for disease status at least every two months. Erlotinib should
be discontinued if there is evidence of disease progression.
Note that erlotinib is not indicated and therefore, is not considered for reimbursement as
1st line therapy in treatment of NSCLC.
Requests for 2nd-line and 3rd-line use of erlotinib in patients 70 years of age or older and
have not received treatment with either platinum-based combinations will be considered on
a case-by-case basis.
Approved dosage: 150 mg/day
Duration of Approval: 6 Months
Renewal will be considered for patients who respond to therapy with no evidence of
disease progression. Patients should be assessed for disease status at least every two
months. Erlotinib should be discontinued if there is evidence of disease progression.
Duration of Approval: 6 Months
311
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 311, record 184, 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
Nat-Erlotinib · DIN 02483939
Manufacturer: Natco Pharma (Canada) Inc.; listing date 2019-03-28
Health Canada: Dormant since 2021-12-01 · brand NAT-ERLOTINIB · ATC L01EB02 ERLOTINIB · form Tablet · route Oral · ingredients ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 150 MG · company Natco pharma (canada) inc · schedule Prescription
Nat-Erlotinib: Formulary list price $71.2000/unit (unit not stated in source; not the patient's cost)
Ministry pays: $71.2000 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=97429 · Verify on the e-Formulary ↗ (DIN 02483939)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02483939).
DIN 02483939: Nat-Erlotinib
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 100000184; group id 157; item number 0270; lccId None; manufacturer id NAT
Source form: Tab; strength: 150mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $71.2000; ministry $71.2000
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02483939
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=97429
Interchangeable products
Apo-Erlotinib · DIN 02461889 · $71.2000
PMS-Erlotinib · DIN 02454394 · $71.2000
Tarceva · DIN 02269023 · not recorded
Teva-Erlotinib · DIN 02377713 · $71.2000
Shortage status: active shortage (reported 2020-12-01, estimated to end 2027-06-30, last updated 2026-04-13); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02483939
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Health Canada lists this DIN as Dormant since 2021-12-01 — choose a marketed DIN from the same-category list.
Tarceva · DIN 02269007 · 25mg · tablet
Off-Formulary Interchangeable, not an ODB benefit; Health Canada lists this DIN as Cancelled post market since 2024-10-01 — choose a marketed DIN from the same-category list.Discontinued 2024-10-01 · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit; Health Canada lists this DIN as Cancelled post market since 2024-10-01 — choose a marketed DIN from the same-category list.
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 ↗); Health Canada lists this DIN as Cancelled post market since 2024-10-01 — choose a marketed DIN from the same-category list. Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Erlotinib
Brand(s): Tarceva and generics see formulary for a funded list of generics
DOSAGE FORM/ STRENGTH: 25 mg,100 mg, 150 mg tablet
For the treatment of clinically documented incurable progressive non-small cell
lung cancer (NSCLC) where:
• Erlotinib is used as monotherapy for the 2nd- or 3rd-line treatment after failure of prior
chemotherapy (any regimen) in patients 70 years of age or older.
• Erlotinib is used as monotherapy for the 2nd- or 3rd-line treatment of patients with
clinically documented incurable progressive non-small cell lung cancer (NSCLC)
despite prior chemotherapy including both docetaxel and a platinum-based treatment
(i.e. cisplatin or carboplatin).
• Erlotinib is used as monotherapy for the 3rd-line treatment of patients with clinically
documented incurable progressive non-small cell lung cancer (NSCLC) despite prior
chemotherapy including both a platinum-based therapy (i.e. cisplatin or carboplatin)
AND either pemetrexed or topotecan.
• Erlotinib is used as monotherapy for 2nd line treatment of NSCLC after 1st line
platinum-based therapy, where no other chemotherapy will be given and erlotinib is
used as the last treatment for the patient
Patients should be assessed for disease status at least every two months. Erlotinib should
be discontinued if there is evidence of disease progression.
Note that erlotinib is not indicated and therefore, is not considered for reimbursement as
1st line therapy in treatment of NSCLC.
Requests for 2nd-line and 3rd-line use of erlotinib in patients 70 years of age or older and
have not received treatment with either platinum-based combinations will be considered on
a case-by-case basis.
Approved dosage: 150 mg/day
Duration of Approval: 6 Months
Renewal will be considered for patients who respond to therapy with no evidence of
disease progression. Patients should be assessed for disease status at least every two
months. Erlotinib should be discontinued if there is evidence of disease progression.
Duration of Approval: 6 Months
311
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 311, record 184, 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 ↗)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
Tarceva · DIN 02269007
Manufacturer: Hoffmann-La Roche Limited; listing date 2015-02-26
Health Canada: Cancelled post market since 2024-10-01 · brand TARCEVA · ATC L01EB02 ERLOTINIB · form Tablet · route Oral · ingredients ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 25 MG · company Hoffmann-la roche limited · schedule Prescription
Tarceva: Formulary list price not recorded/unit (unit not stated in source; not the patient's cost)
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=75441 · Verify on the e-Formulary ↗ (DIN 02269007)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02269007).
DIN 02269007: Tarceva
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 100000204; group id 157; item number 0268; lccId None; manufacturer id HLR
Source form: Tab; strength: 25mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): not recorded; ministry not recorded
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02269007
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=75441
Interchangeable products
Apo-Erlotinib · DIN 02461862 · $11.8667
Nat-Erlotinib · DIN 02483912 · $11.8667
Teva-Erlotinib · DIN 02377691 · $11.8666
Shortage status: discontinued (2024-10-01, reported by HOFFMANN-LA ROCHE LIMITED); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02269007
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Health Canada lists this DIN as Cancelled post market since 2024-10-01 — choose a marketed DIN from the same-category list.
Tarceva · DIN 02269015 · 100mg · tablet
Off-Formulary Interchangeable, not an ODB benefit; Health Canada lists this DIN as Cancelled post market since 2024-10-01 — choose a marketed DIN from the same-category list.Discontinued 2024-10-01 · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit; Health Canada lists this DIN as Cancelled post market since 2024-10-01 — choose a marketed DIN from the same-category list.
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 ↗); Health Canada lists this DIN as Cancelled post market since 2024-10-01 — choose a marketed DIN from the same-category list. Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Erlotinib
Brand(s): Tarceva and generics see formulary for a funded list of generics
DOSAGE FORM/ STRENGTH: 25 mg,100 mg, 150 mg tablet
For the treatment of clinically documented incurable progressive non-small cell
lung cancer (NSCLC) where:
• Erlotinib is used as monotherapy for the 2nd- or 3rd-line treatment after failure of prior
chemotherapy (any regimen) in patients 70 years of age or older.
• Erlotinib is used as monotherapy for the 2nd- or 3rd-line treatment of patients with
clinically documented incurable progressive non-small cell lung cancer (NSCLC)
despite prior chemotherapy including both docetaxel and a platinum-based treatment
(i.e. cisplatin or carboplatin).
• Erlotinib is used as monotherapy for the 3rd-line treatment of patients with clinically
documented incurable progressive non-small cell lung cancer (NSCLC) despite prior
chemotherapy including both a platinum-based therapy (i.e. cisplatin or carboplatin)
AND either pemetrexed or topotecan.
• Erlotinib is used as monotherapy for 2nd line treatment of NSCLC after 1st line
platinum-based therapy, where no other chemotherapy will be given and erlotinib is
used as the last treatment for the patient
Patients should be assessed for disease status at least every two months. Erlotinib should
be discontinued if there is evidence of disease progression.
Note that erlotinib is not indicated and therefore, is not considered for reimbursement as
1st line therapy in treatment of NSCLC.
Requests for 2nd-line and 3rd-line use of erlotinib in patients 70 years of age or older and
have not received treatment with either platinum-based combinations will be considered on
a case-by-case basis.
Approved dosage: 150 mg/day
Duration of Approval: 6 Months
Renewal will be considered for patients who respond to therapy with no evidence of
disease progression. Patients should be assessed for disease status at least every two
months. Erlotinib should be discontinued if there is evidence of disease progression.
Duration of Approval: 6 Months
311
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 311, record 184, 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 ↗)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
Tarceva · DIN 02269015
Manufacturer: Hoffmann-La Roche Limited; listing date 2015-02-26
Health Canada: Cancelled post market since 2024-10-01 · brand TARCEVA · ATC L01EB02 ERLOTINIB · form Tablet · route Oral · ingredients ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 100 MG · company Hoffmann-la roche limited · schedule Prescription
Tarceva: Formulary list price not recorded/unit (unit not stated in source; not the patient's cost)
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=75442 · Verify on the e-Formulary ↗ (DIN 02269015)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02269015).
DIN 02269015: Tarceva
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 100000183; group id 157; item number 0269; lccId None; manufacturer id HLR
Source form: Tab; strength: 100mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): not recorded; ministry not recorded
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02269015
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=75442
Interchangeable products
Apo-Erlotinib · DIN 02461870 · $47.4667
Nat-Erlotinib · DIN 02483920 · $47.4667
PMS-Erlotinib · DIN 02454386 · $47.4667
Teva-Erlotinib · DIN 02377705 · $47.4666
Shortage status: discontinued (2024-10-01, reported by HOFFMANN-LA ROCHE LIMITED); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02269015
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Health Canada lists this DIN as Cancelled post market since 2024-10-01 — choose a marketed DIN from the same-category list.
Tarceva · DIN 02269023 · 150mg · tablet
Off-Formulary Interchangeable, not an ODB benefit; Health Canada lists this DIN as Cancelled post market since 2024-10-01 — choose a marketed DIN from the same-category list.Discontinued 2024-10-01 · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit; Health Canada lists this DIN as Cancelled post market since 2024-10-01 — choose a marketed DIN from the same-category list.
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 ↗); Health Canada lists this DIN as Cancelled post market since 2024-10-01 — choose a marketed DIN from the same-category list. Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE
Coverage criteria
Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive):
Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange
Erlotinib
Brand(s): Tarceva and generics see formulary for a funded list of generics
DOSAGE FORM/ STRENGTH: 25 mg,100 mg, 150 mg tablet
For the treatment of clinically documented incurable progressive non-small cell
lung cancer (NSCLC) where:
• Erlotinib is used as monotherapy for the 2nd- or 3rd-line treatment after failure of prior
chemotherapy (any regimen) in patients 70 years of age or older.
• Erlotinib is used as monotherapy for the 2nd- or 3rd-line treatment of patients with
clinically documented incurable progressive non-small cell lung cancer (NSCLC)
despite prior chemotherapy including both docetaxel and a platinum-based treatment
(i.e. cisplatin or carboplatin).
• Erlotinib is used as monotherapy for the 3rd-line treatment of patients with clinically
documented incurable progressive non-small cell lung cancer (NSCLC) despite prior
chemotherapy including both a platinum-based therapy (i.e. cisplatin or carboplatin)
AND either pemetrexed or topotecan.
• Erlotinib is used as monotherapy for 2nd line treatment of NSCLC after 1st line
platinum-based therapy, where no other chemotherapy will be given and erlotinib is
used as the last treatment for the patient
Patients should be assessed for disease status at least every two months. Erlotinib should
be discontinued if there is evidence of disease progression.
Note that erlotinib is not indicated and therefore, is not considered for reimbursement as
1st line therapy in treatment of NSCLC.
Requests for 2nd-line and 3rd-line use of erlotinib in patients 70 years of age or older and
have not received treatment with either platinum-based combinations will be considered on
a case-by-case basis.
Approved dosage: 150 mg/day
Duration of Approval: 6 Months
Renewal will be considered for patients who respond to therapy with no evidence of
disease progression. Patients should be assessed for disease status at least every two
months. Erlotinib should be discontinued if there is evidence of disease progression.
Duration of Approval: 6 Months
311
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 311, record 184, 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
Tarceva · DIN 02269023
Manufacturer: Hoffmann-La Roche Limited; listing date 2015-02-26
Health Canada: Cancelled post market since 2024-10-01 · brand TARCEVA · ATC L01EB02 ERLOTINIB · form Tablet · route Oral · ingredients ERLOTINIB (ERLOTINIB HYDROCHLORIDE) 150 MG · company Hoffmann-la roche limited · schedule Prescription
Tarceva: Formulary list price not recorded/unit (unit not stated in source; not the patient's cost)
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=75443 · Verify on the e-Formulary ↗ (DIN 02269023)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02269023).
DIN 02269023: Tarceva
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 100000184; group id 157; item number 0270; lccId None; manufacturer id HLR
Source form: Tab; strength: 150mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): not recorded; ministry not recorded
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02269023
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=75443
Interchangeable products
Apo-Erlotinib · DIN 02461889 · $71.2000
Nat-Erlotinib · DIN 02483939 · $71.2000
PMS-Erlotinib · DIN 02454394 · $71.2000
Teva-Erlotinib · DIN 02377713 · $71.2000
Shortage status: discontinued (2024-10-01, reported by HOFFMANN-LA ROCHE LIMITED); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02269023
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Health Canada lists this DIN as Cancelled post market since 2024-10-01 — choose a marketed DIN from the same-category list.
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
· 9 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 20mg, 30mg, 40mg · Tab
· 5 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 250mg · Tab
· 20 products · General benefit · strengths: 100mg, 400mg · Tab
· 4 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 100mg, 500mg · Tab
· 33 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 20mg, 50mg, 70mg, 80mg, 100mg, 140mg · Tab
· 6 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 150mg, 200mg · Cap
· 9 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 75mg, 100mg, 125mg · Tab
· 3 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 200mg · Tab
· 18 products · General benefit · strengths: 250mg, 500mg · Tab
· 1 products · General benefit · strengths: 50mg · Cap
· 17 products · General benefit · strengths: 1mg · Tab
· 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
Availability
PMS-Erlotinib · DIN 02454394
Shortage status: discontinued (2021-11-15, reported by PHARMASCIENCE INC); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02454394
Check this DIN againNat-Erlotinib · DIN 02483912
Shortage status: active shortage (reported 2020-12-01, estimated to end 2027-06-30, last updated 2026-04-13); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02483912
Check this DIN againNat-Erlotinib · DIN 02483920
Shortage status: active shortage (reported 2020-12-01, estimated to end 2027-06-30, last updated 2026-04-13); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02483920
Check this DIN againPMS-Erlotinib · DIN 02454386
Shortage status: discontinued (2021-11-15, reported by PHARMASCIENCE INC); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02454386
Check this DIN againNat-Erlotinib · DIN 02483939
Shortage status: active shortage (reported 2020-12-01, estimated to end 2027-06-30, last updated 2026-04-13); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02483939
Check this DIN againTarceva · DIN 02269007
Shortage status: discontinued (2024-10-01, reported by HOFFMANN-LA ROCHE LIMITED); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02269007
Check this DIN againTarceva · DIN 02269015
Shortage status: discontinued (2024-10-01, reported by HOFFMANN-LA ROCHE LIMITED); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02269015
Check this DIN againTarceva · DIN 02269023
Shortage status: discontinued (2024-10-01, reported by HOFFMANN-LA ROCHE LIMITED); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02269023
Check this DIN again