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

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BOSUTINIB

All products: not a benefit

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

  • Imatinib (Gleevec): general benefit
  • Dasatinib (Sprycel): 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

Reddy-Bosutinib · DIN 02560046 · 500mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-20
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): Bosulif; DOSAGE FORM/ STRENGTH: 100 mg, 500 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 Bosutinib Brand(s): Bosulif DOSAGE FORM/ STRENGTH: 100 mg, 500 mg tablet (Last Update: September 3, 2020) For the treatment of patients with Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in patients meeting the following criteria; 1. 18 years of age or older; AND 2. Diagnosis of (Ph+) chronic phase, accelerated phase, or blast phase CML; AND 3. Bosutinib is used in one of the following clinical situations: i) As second line therapy after experiencing disease progression on imatinib, dasatinib, or nilotinib1 in first line: OR ii) as third line therapy after experiencing disease progression to imatinib, dasatinib, nilotinib1, or ponatinib in second line; OR iii) In patients who have not progressed on one or more prior TKIs but who have documented mutational drug resistance to imatinib, dasatinib, and/or nilotinib1 which make them clinically inappropriate treatment choices; OR iv) In patients who have not progressed on one or more TKIs but have experienced unacceptable intolerance or toxicity to one prior TKI (i.e. imatinib, dasatinib, or nilotinib1) Exclusion Criteria: 1. Bosutinib will not be funded in combination with another oral TKI (e.g. imatinib, nilotinib, dasatinib, or ponatinib) 2. Bosutinib will not be funded as 4th line treatment for CML or beyond. 1Note that nilotinib is not funded in blast phase CML, therefore, considerations will only be applied for imatinib and dasatinib in patients with blast phase CML Renewal criteria: Renewal of funding will be considered upon confirmation from the patient’s clinician that the patient has experienced hematologic and/or cytogenic response and is expected to continue to do so Recommended Dosing: 500mg per day Approval period for initials & renewals: 1 year 279 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 279, record 171, corpus 2025-01-01; name match only, not an eligibility decision
1 brand, same coverage
Reddy-Bosutinib · DIN 02560046 Manufacturer: Dr. Reddy's Laboratories Inc.; listing date 2025-10-31 Health Canada: Marketed since 2025-09-08 · brand REDDY-BOSUTINIB · ATC L01EA04 BOSUTINIB · form Tablet · route Oral · ingredients BOSUTINIB (BOSUTINIB DIHYDRATE) 500 MG · company Dr reddy's laboratories ltd · schedule Prescription
Check this DIN again · Health Canada product record

Reddy-Bosutinib: Formulary list price $83.7322/unit (unit not stated in source; not the patient's cost)

Ministry pays: $83.7322 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=106313 · Verify on the e-Formulary ↗ (DIN 02560046)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02560046). DIN 02560046: Reddy-Bosutinib Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 100000252; group id 146; item number 0246; lccId None; manufacturer id DRR Source form: Tab; strength: 500mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $83.7322; ministry $83.7322 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02560046 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106313
Interchangeable products
Bosulif · DIN 02419157 · $83.7322
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

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

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 BOSULIF (bosutinib) is indicated for: • the treatment of adult patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML). Market authorization in patients with newly-diagnosed chronic phase Ph+ CML is based on major molecular response (MMR) rates in a Phase 3 clinical trial with a minimum of 12 months of follow-up (see 14 Clinical Trials). • the treatment of chronic, accelerated, or blast phase Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in adult patients with resistance or intolerance to prior TKI therapy. Market authorization in patients with resistance or intolerance to prior TKI therapy, is based on cytogenetic and hematologic response rates observed in a single-arm, Phase 1/ 2 study. Overall survival benefit has not been demonstrated (see 14 Clinical Trials). BOSULIF should only be prescribed by a qualified healthcare professional who is experienced in the use of antineoplastic therapy and in the treatment of chronic myeloid leukemia. 1.1. Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has n… https://pdf.hres.ca/dpd_pm/00084898.PDF PM date: 2026-06-02 Source product: BOSULIF; DIN 02419149; 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

Bosutinib (Bosulif)

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 Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in patients meeting the following criteria;

Ministry criteria corpus 2025-01-01; page 279

Bosutinib Brand(s): Bosulif DOSAGE FORM/ STRENGTH: 100 mg, 500 mg tablet (Last Update: September 3, 2020)
For the treatment of patients with Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML) in patients meeting the following criteria;
1. 18 years of age or older; AND
2. Diagnosis of (Ph+) chronic phase, accelerated phase, or blast phase CML; AND
3. Bosutinib is used in one of the following clinical situations:
i) As second line therapy after experiencing disease progression on imatinib, dasatinib, or nilotinib1 in first line: OR
ii) as third line therapy after experiencing disease progression to imatinib, dasatinib, nilotinib1, or ponatinib in second line; OR
iii) In patients who have not progressed on one or more prior TKIs but who have documented mutational drug resistance to imatinib, dasatinib, and/or nilotinib1 which make them clinically inappropriate treatment choices; OR
iv) In patients who have not progressed on one or more TKIs but have experienced unacceptable intolerance or toxicity to one prior TKI (i.e. imatinib, dasatinib, or nilotinib1)
Exclusion Criteria:
1. Bosutinib will not be funded in combination with another oral TKI (e.g. imatinib, nilotinib, dasatinib, or ponatinib)
2. Bosutinib will not be funded as 4th line treatment for CML or beyond. 1Note that nilotinib is not funded in blast phase CML, therefore, considerations will only be
applied for imatinib and dasatinib in patients with blast phase CML
Renewal criteria:
Renewal of funding will be considered upon confirmation from the patient’s clinician that the patient has experienced hematologic and/or cytogenic response and is expected to continue to do so
Recommended Dosing: 500mg per day
Approval period for initials & renewals: 1 year
279

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

Other review policies

For Reddy-Bosutinib: 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