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Exceptional Access criteria on record are for Brand(s): Tasigna; DOSAGE FORM/ STRENGTH: 150 mg, 200 mg capsule — 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 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

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 ↗)

Reddy-Nilotinib · DIN 02556634 Manufacturer: Dr. Reddy's Laboratories Inc.; listing date 2025-07-31 Health Canada: Marketed since 2025-04-24 · brand REDDY-NILOTINIB · ATC L01EA03 NILOTINIB · form Capsule · route Oral · ingredients NILOTINIB (NILOTINIB HYDROCHLORIDE MONOHYDRATE) 150 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 02556634). DIN 02556634: Reddy-Nilotinib Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 100000209; group id 177; item number 0319; lccId None; manufacturer id DRR Source form: Cap; 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): $16.5570; ministry $16.5570 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02556634 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106003

Interchangeable products

Apo-Nilotinib · DIN 02550881 · $16.5570 Tasigna · DIN 02368250 · $16.5570

Shortage status: not checked (no credentials)