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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

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 ↗)

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 ↗)

Reddy-Dasatinib · DIN 02514745 Manufacturer: Dr. Reddy's Laboratories Inc.; listing date 2021-06-30 Health Canada: Marketed since 2021-09-16 · brand REDDY-DASATINIB · ATC L01EA02 DASATINIB · form Tablet · route Oral · ingredients DASATINIB (DASATINIB (S)-PROPYLENE GLYCOL) 50 MG · company Dr reddy's laboratories ltd · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02514745). DIN 02514745: Reddy-Dasatinib Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 100000193; group id 153; item number 0259; lccId None; manufacturer id DRR Source form: Tab; strength: 50mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $66.1782; ministry $66.1782 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02514745 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100415

Interchangeable products

Apo-Dasatinib · DIN 02470713 · $66.1782 Apo-Dasatinib Tablets · DIN 02562472 · $66.1782 Sprycel · DIN 02293137 · $66.1783 Taro-Dasatinib · DIN 02499304 · $66.1783 Teva-Dasatinib · DIN 02478315 · $66.1782

Shortage status: not checked (no credentials)