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

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NILOTINIB

All products: not a benefit

Other products in the same Health Canada class (L01E, L01EA) — coverage varies; not interchangeable

  • Imatinib (Gleevec): general benefit
  • Bosutinib (Bosulif): not a benefit
  • Dasatinib (Sprycel): not a benefit
  • Afatinib (Giotrif): not a benefit
  • Erlotinib (Tarceva): not a benefit
  • Gefitinib (Iressa): not a benefit

2 more in the class list below

Tasigna · DIN 02315874 · 200mg · capsule

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-20
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 Nilotinib Brand(s): Tasigna DOSAGE FORM/ STRENGTH: 150 mg, 200 mg capsule For the treatment of patients with chronic phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML). Note: Ministry will only fund any TWO of the oral Tyrosine Kinase inhibitors (TKIs) * used for chronic phase CML per patient in a lifetime. (* TKIs: imatinib, nilotinib, or dasatinib) If the patient develops grade 3 or 4 toxicity on one of the above TKI’s within 3 months of initiating therapy, access to a 3rd oral TKI will be funded for that patient. Approved dose: 300 mg twice daily but not exceeding 800 mg/day Duration of Approval: 1 Year 333 Nilotinib Brand(s): Tasigna DOSAGE FORM/ STRENGTH: 150 mg, 200 mg capsule For the treatment of patients with accelerated phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) with documented intolerance1 or resistance2 to imatinib therapy. 1Intolerance to imatinib at any dose occurs where the Patient has experienced persistent grade 3 or grade 4 toxicity requiring discontinuation of imatinib therapy; or 2Imatinib resistance occurs where the Patient has primary or acquired resistance to imatinib at doses of at least 600mg/day or via a mutational analysis report. Exclusion Criteria – Patients with the following exclusion criteria will not be funded: blast phase CML; a. for Ph+ acute lymphocytic leukemia (ALL); b. combination treatment with any two or more oral TKIS’s (imatinib, nilotinib, or dasatinib) will not be funded c. For accelerated phase CML, nilotinib is not funded as a sequential third line therapy in patients who experience primary or acquired resistance (not including mutational resistance) to dasatinib. Approved dosage: Up to 800 mg/day but doses above 800 mg per day will not be considered Renewal Criteria: Renewals are considered for patients who experience hematologic and/or cytogenic response to therapy, is expected to continue to do benefit from therapy with Tasigna. Duration of Approval: 1 Year 334 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 333, record 198, 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
Tasigna · DIN 02315874 Manufacturer: Novartis Pharma Canada Inc.; listing date 2025-03-31 Health Canada: Marketed since 2008-09-30 · brand TASIGNA · ATC L01EA03 NILOTINIB · form Capsule · route Oral · ingredients NILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) 200 MG · company Novartis pharmaceuticals canada inc · schedule Prescription
Check this DIN again · Health Canada product record

Ministry pays: $23.0473 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=80138 · Verify on the e-Formulary ↗ (DIN 02315874)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02315874). DIN 02315874: Tasigna Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 100000201; group id 177; item number 0320; lccId None; manufacturer id NOV Source form: Cap; strength: 200mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $47.9567; ministry $23.0473 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02315874 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=80138
Interchangeable products
Apo-Nilotinib · DIN 02550903 · $23.0473 Reddy-Nilotinib · DIN 02556642 · $23.0473
Shortage status: not checked (no credentials)
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

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

AFATINIB

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

ERLOTINIB

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

GEFITINIB

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

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
1. Indications Tasigna® (nilotinib) 150 mg and 200 mg capsules are indicated for: • The treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP). Clinical effectiveness of Tasigna in adults with newly diagnosed Ph+ CML-CP is based on major molecular response rate at 12 months and complete cytogenetic response rate by 12 months. • The treatment of pediatric patients 2 years of age and older with newly diagnosed Ph+ CML-CP. Clinical effectiveness of Tasigna in pediatric patients with newly diagnosed Ph+ CML-CP is based on major molecular response by 12 cycles and complete cytogenetic response at 12 cycles. • The treatment of chronic phase (CP) and accelerated phase (AP) Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) in adult patients resistant to or intolerant of at least one prior therapy including imatinib. Clinical effectiveness of Tasigna in adults with imatinib-resistant or -intolerant Ph+ CML-CP was based on the unconfirmed major cytogenetic and complete hematologic response rates. Clinical effectiveness of Tasigna in i… https://pdf.hres.ca/dpd_pm/00085162.PDF PM date: 2026-06-26 Source product: TASIGNA; DIN 02315874; 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

Nilotinib (Tasigna)

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

Prepare answers: For the treatment of patients with chronic phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML).

Ministry criteria corpus 2025-01-01; page 333

Nilotinib Brand(s): Tasigna DOSAGE FORM/ STRENGTH: 150 mg, 200 mg capsule
For the treatment of patients with chronic phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML).
Note: Ministry will only fund any TWO of the oral Tyrosine Kinase inhibitors (TKIs) * used for chronic phase CML per patient in a lifetime. (* TKIs: imatinib, nilotinib, or dasatinib)
If the patient develops grade 3 or 4 toxicity on one of the above TKI’s within 3 months of initiating therapy, access to a 3rd oral TKI will be funded for that patient.
Approved dose: 300 mg twice daily but not exceeding 800 mg/day
Duration of Approval: 1 Year
333 Nilotinib Brand(s): Tasigna DOSAGE FORM/ STRENGTH: 150 mg, 200 mg capsule
For the treatment of patients with accelerated phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) with documented intolerance1 or resistance2 to imatinib therapy. 1Intolerance to imatinib at any dose occurs where the Patient has experienced persistent
grade 3 or grade 4 toxicity requiring discontinuation of imatinib therapy; or 2Imatinib resistance occurs where the Patient has primary or acquired resistance to
imatinib at doses of at least 600mg/day or via a mutational analysis report.
Exclusion Criteria – Patients with the following exclusion criteria will not be funded:
blast phase CML;
a. for Ph+ acute lymphocytic leukemia (ALL);
b. combination treatment with any two or more oral TKIS’s (imatinib, nilotinib, or dasatinib) will not be funded
c. For accelerated phase CML, nilotinib is not funded as a sequential third line therapy in patients who experience primary or acquired resistance (not including mutational resistance) to dasatinib.
Approved dosage: Up to 800 mg/day but doses above 800 mg per day will not be considered
Renewal Criteria:
Renewals are considered for patients who experience hematologic and/or cytogenic response to therapy, is expected to continue to do benefit from therapy with Tasigna.
Duration of Approval: 1 Year
334

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