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

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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

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 2026-09-20
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
Check this DIN again · Health Canada product record

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: not checked (no credentials)
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

AFATINIB

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

GEFITINIB

· 5 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 250mg · Tab

IMATINIB MESYLATE

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

BOSUTINIB

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

DASATINIB

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

NILOTINIB

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

PALBOCICLIB

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

PAZOPANIB

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

ABIRATERONE ACETATE

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

ALTRETAMINE

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

ANASTROZOLE

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

BICALUTAMIDE

· 9 products · Listed, not a benefit (1), General benefit (8) · strengths: 50mg · Tab Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 10:00 and 34 more
Full class listing Related classes: Same formulary class, not same indication: class membership alone does not establish equivalent uses.
What the Health Canada label says it is for
INDICATIONS AND CLINICAL USE TEVA-ERLOTINIB (erlotinib) is indicated as monotherapy for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen, and whose EGFR expression status is positive or unknown. [see CLINICAL TRIALS - Relation of Results to EGFR Protein Expression Status (as Determined by Immunohistochemistry)] TEVA-ERLOTINIB is also indicated as monotherapy for maintenance treatment in patients with locally advanced or metastatic non-small cell lung cancer with EGFR activating mutations after 4 cycles of standard platinum-based first-line chemotherapy. The efficacy of erlotinib as maintenance treatment has not been demonstrated in patients with metastatic NSCLC whose tumors do not harbour an activating mutation [see CLINICAL TRIALS]. TEVA-ERLOTINIB is also indicated as monotherapy for the first-line treatment of patients with locally advanced (stage III b, not amenable to curative therapy) or metastatic (stage IV) non- small cell lung cancer (NSCLC) with EGFR activating mutations. … https://pdf.hres.ca/dpd_pm/00049276.PDF PM date: January 16, 2019 Source product: TEVA-ERLOTINIB; DIN 02377691; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.

Prepare an Exceptional Access request

SADIE has its own form for many drugs; this checklist prepares the answers; the ministry decides. Open SADIE

Use this text in SADIE’s free-text fields or read from it on a Telephone Request Service call. Review marks do not indicate eligibility. Evidence stays in this page until you copy it; nothing entered here is sent or saved. Do not enter patient identifiers.

EAP Telephone Request Service: The TRS can be accessed by calling toll-free at 1-866-811-9893 or 416-327-8109 (Toronto area) between 8:30 a.m. and 5:00 p.m. Monday through Friday (except holidays) and selecting the TRS option. Source; updated September 15, 2026

EAP fax: In Ontario: 1-866-811-9908 or 416-327-7526 (Toronto area). Outside Ontario: 1-833-905-4260. Source; updated September 15, 2026

Posted turnaround and Telephone Request Service scope
Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days |
For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day.
Source; updated September 15, 2026

Erlotinib (Tarceva and generics see formulary for a funded list of generics)

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Prepare answers: For the treatment of clinically documented incurable progressive non-small cell lung cancer (NSCLC) where:

Ministry criteria corpus 2025-01-01; page 311

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

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