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

Patient plan: look up a medication list

DASATINIB

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
  • Nilotinib (Tasigna): 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

Taro-Dasatinib · DIN 02499347 · 140mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
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 criteria on record are for Brand(s): Sprycel and generics (see formulary for list of funded generics); DOSAGE FORM/ STRENGTH: 20 mg, 50 mg, 70 mg, 100 mg tablet — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Dasatinib Brand(s): Sprycel and generics (see formulary for list of funded generics) DOSAGE FORM/ STRENGTH: 20 mg, 50 mg, 70 mg, 100 mg tablet For the treatment of Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) in the chronic phase.1 Dosing recommendation: 100 mg per day. Renewals will be considered for patients who have experienced hematologic and/or cytogenic response and is expected to continue to do so. Duration of Approval: 1 Year Exclusion criteria: Combination treatment with any two or more of the oral tyrosine-kinase inhibitors (TKI) ( i.e. imatinib, nilotinib or dasatinib) will not be funded. 1Note: Funding is only considered for any two oral TKIs* per patient in a lifetime for chronic phase CML (*TKIs: imatinib, nilotinib, or dasatinib). If a patient develops grade 3 or grade 4 toxicity on one of the listed TKI’s within 3 months of initiating therapy, funding for a third oral TKI will be allowed. For the treatment of patients with accelerated phase or blast phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) with documented resistance1 or intolerance2 (as defined below) to imatinib therapy Dosing recommendation: 140 mg per day. Definitions of resistance and intolerance: 1Imatinib resistance is defined as primary or acquired resistance to imatinib at doses of at least 600 mg/day or through a mutational analysis report. 2Intolerance to imatinib (at any dose) is defined as persistent grade 3 or grade 4 toxicity requiring discontinuation of therapy. Renewals will be considered for patients who have experienced hematologic and/or cytogenic response and are expected to continue to do so. Duration of Approval: 1 Year 296 Dasatinib Brand(s): Sprycel and generics (see formulary for list of funded generics) DOSAGE FORM/ STRENGTH: 20 mg, 50 mg, 70 mg, 100 mg tablet Exclusion criteria: • Combination treatment with any 2 or more of the oral TKIs (i.e. imatinib, nilotinib or dasatinib) will not be funded. • Dasatinib is not funded as a sequential third line therapy in patients who experience primary or acquired resistance (not including mutational resistance) to nilotinib. For the treatment of Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in patients meeting the following criteria: i) An adult patient with Philadelphia chromosome positive acute lymphoblastic leukemia (Ph +ALL); AND ii) Patient’s disease is resistant1 to imatinib-containing chemotherapy (patient must have tried 600 mg/day); O iii) Patient has experienced intolerance2 to imatinib therapy. 1Imatinib resistance is defined as primary or acquired resistance to imatinib at doses of at least 600 mg/day or through a mutational analysis report. 2Intolerance to imatinib (at any dose) is defined as the patient has experienced persistent grade 3 or grade 4 toxicity requiring discontinuation of therapy. Renewals will be considered after confirmation from the patient’s physician that the patient has benefited or continues to benefit from therapy with Sprycel and is expected to continue to do so. Duration of Approval: 1 Year Reimbursement of dasatinib for children with acute lymphoblastic leukemia will be considered on a case-by-case basis. 297 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 296, record 179, corpus 2025-01-01; name match only, not an eligibility decision
1 brand, same coverage
Taro-Dasatinib · DIN 02499347 Manufacturer: Taro Pharmaceuticals Inc.; listing date 2021-03-29 Health Canada: Marketed since 2021-03-04 · brand TARO-DASATINIB · ATC L01EA02 DASATINIB · form Tablet · route Oral · ingredients DASATINIB 140 MG · company Taro pharmaceuticals inc · schedule Prescription
Check this DIN again · Health Canada product record

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=98908 · Verify on the e-Formulary ↗ (DIN 02499347)

Source record
DIN 02499347: Taro-Dasatinib Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 100000322; group id 153; item number 0263; lccId None; manufacturer id TAR Source form: Tab; strength: 140mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): $141.8806; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02499347 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=98908
Interchangeable products
Reddy-Dasatinib · DIN 02514796 · not recorded Sprycel · DIN 02360829 · not recorded
Shortage status: resolved shortage (ended 2026-03-13); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02499347
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary class (10:00 ANTINEOPLASTIC AGENTS) and how they are covered

Matched class: 10:00 ANTINEOPLASTIC AGENTS

Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment. Covered without a code on the Ontario formulary: ABIRATERONE ACETATE, ALTRETAMINE, ANASTROZOLE, BUSERELIN ACETATE, BUSULFAN, CAPECITABINE, CHLORAMBUCIL, CYPROTERONE ACETATE, DAUNORUBICIN, DEGARELIX ACETATE, ETOPOSIDE, EXEMESTANE, FLUOROURACIL & SALICYLIC ACID, FULVESTRANT, GOSERELIN ACETATE, HYDROXYUREA, IMATINIB MESYLATE, LETROZOLE, LEUPROLIDE ACETATE, MELPHALAN, MERCAPTOPURINE, MITOTANE, PROCARBAZINE HCL, TEMOZOLOMIDE, THIOGUANINE, TRIPTORELIN PAMOATE Some products covered without a code (check the product listing): BICALUTAMIDE, CYCLOPHOSPHAMIDE, FLUTAMIDE, LOMUSTINE (CCNU), MEGESTROL ACETATE, METHOTREXATE, TAMOXIFEN CITRATE, VINCRISTINE SULFATE 10:00 ANTINEOPLASTIC AGENTS

IMATINIB MESYLATE

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

BOSUTINIB

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

NILOTINIB

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

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 SPRYCEL (dasatinib) is indicated for the treatment of adults with:  Newly diagnosed Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase. Clinical effectiveness of SPRYCEL treatment in patients with newly diagnosed Ph+ CML in chronic phase is based on confirmed complete cytogenetic response rate (cCCyR) within 12 months. As of the 60 month cut-off date, overall survival, prevention of progression to advanced stage CML, or time-in cCCyR benefits have not been demonstrated (see 14 CLINICAL TRIALS).  Ph+ chronic, accelerated, or blast phase chronic myeloid leukemia (CML) with resistance or intolerance to prior therapy including imatinib mesylate. Clinical effectiveness of SPRYCEL in CML is based on the rates of hematologic and cytogenetic responses in clinical trials with a minimum of 24 months of follow-up (see 14 CLINICAL TRIALS).  Ph+ acute lymphoblastic leukemia (ALL) with resistance or intolerance to prior therapy. Clinical effectiveness in Ph+ ALL is based on the rates of hematologic and cytogenetic responses in clinical trials with a minimu… https://pdf.hres.ca/dpd_pm/00080799.PDF PM date: Mar 22, 2007 Source product: SPRYCEL; DIN 02293129; 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

Dasatinib (Sprycel and generics (see formulary for list of funded 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 Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) in the chronic phase.1

Ministry criteria corpus 2025-01-01; page 296

Dasatinib Brand(s): Sprycel and generics (see formulary for list of funded generics) DOSAGE FORM/ STRENGTH: 20 mg, 50 mg, 70 mg, 100 mg tablet
For the treatment of Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) in the chronic phase.1
Dosing recommendation: 100 mg per day.
Renewals will be considered for patients who have experienced hematologic and/or cytogenic response and is expected to continue to do so.
Duration of Approval: 1 Year
Exclusion criteria:
Combination treatment with any two or more of the oral tyrosine-kinase inhibitors (TKI) ( i.e. imatinib, nilotinib or dasatinib) will not be funded. 1Note: Funding is only considered for any two oral TKIs* per patient in a lifetime for chronic
phase CML (*TKIs: imatinib, nilotinib, or dasatinib). If a patient develops grade 3 or grade 4 toxicity on one of the listed TKI’s within 3 months of initiating therapy, funding for a third oral TKI will be allowed.
For the treatment of patients with accelerated phase or blast phase Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML) with documented resistance1 or intolerance2 (as defined below) to imatinib therapy
Dosing recommendation: 140 mg per day.
Definitions of resistance and intolerance: 1Imatinib resistance is defined as primary or acquired resistance to imatinib at doses of at
least 600 mg/day or through a mutational analysis report. 2Intolerance to imatinib (at any dose) is defined as persistent grade 3 or grade 4 toxicity
requiring discontinuation of therapy.
Renewals will be considered for patients who have experienced hematologic and/or cytogenic response and are expected to continue to do so.
Duration of Approval: 1 Year
296 Dasatinib Brand(s): Sprycel and generics (see formulary for list of funded generics) DOSAGE FORM/ STRENGTH: 20 mg, 50 mg, 70 mg, 100 mg tablet
Exclusion criteria:
• Combination treatment with any 2 or more of the oral TKIs (i.e. imatinib, nilotinib or dasatinib) will not be funded.
• Dasatinib is not funded as a sequential third line therapy in patients who experience primary or acquired resistance (not including mutational resistance) to nilotinib.
For the treatment of Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in patients meeting the following criteria:
i) An adult patient with Philadelphia chromosome positive acute lymphoblastic leukemia (Ph +ALL); AND
ii) Patient’s disease is resistant1 to imatinib-containing chemotherapy (patient must have tried 600 mg/day); O
iii) Patient has experienced intolerance2 to imatinib therapy. 1Imatinib resistance is defined as primary or acquired resistance to imatinib at doses of at
least 600 mg/day or through a mutational analysis report. 2Intolerance to imatinib (at any dose) is defined as the patient has experienced persistent
grade 3 or grade 4 toxicity requiring discontinuation of therapy.
Renewals will be considered after confirmation from the patient’s physician that the patient has benefited or continues to benefit from therapy with Sprycel and is expected to continue to do so.
Duration of Approval: 1 Year
Reimbursement of dasatinib for children with acute lymphoblastic leukemia will be considered on a case-by-case basis.
297

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

Other review policies

For Taro-Dasatinib: no applicable EAP criteria are held and no ODB benefit is established. These policies do not establish coverage.

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

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

Ontario source; updated September 15, 2026

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

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

Ontario source; updated September 15, 2026