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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 Sunitinib Brand(s): Sutent and generics DOSAGE FORM/ STRENGTH: 12.5 mg, 25 mg, 50 mg capsule For the treatment of gastrointestinal stromal tumour (GIST) in patients with unresectable or metastatic/recurrent GIST where one of the following conditions is met: • Early progression (within 6 months) while on imatinib; OR • Progression following treatment with optimum (escalated) doses of imatinib (800mg per day); OR • Intolerance* to imatinib (where detailed description of intolerance is provided). *Definition of intolerance to imatinib – patient has experienced persistent grade 3 toxicity requiring discontinuation of therapy. Duration of Approval: 6 months Renewal will be considered for patients who are stable (no disease progression) and not experiencing intolerance to sunitinib therapy. Note: Approval will be granted at a dose of 50mg per day (4 weeks on, 2 weeks off). For the treatment of metastatic renal cell carcinoma (MRCC): • First-line therapy for patients with MSK Prognostic Score of Favourable Risk or an Intermediate Risk OR • Second-line therapy for patients where: o The disease is of clear cell histology AND o Documented failure to first-line cytokine-based therapy 368 Sunitinib Brand(s): Sutent DOSAGE FORM/ STRENGTH: 12.5 mg, 25 mg, 50 mg capsules Duration of Approval: 1 year Renewal will be considered for patients with documentation of radiography and/or scan results indicating no diseases progression. Duration of Approval: 1 year Note: The prescribed dosage should be 50 mg daily for four (4) weeks, followed by two (2) weeks off the Drug Product, in repeated six (6) week cycles. For the treatment of progressive, unresectable, well-differentiated or moderately differentiated, locally advanced or metastatic pancreatic neuroendocrine tumors (“pNET”) with good performance status (ECOG ≤ 2), until disease progression. Exclusion criteria: Sutent will not be approved for second-line sequential therapy after everolimus failure in the first-line setting. Dosing: 37.5 mg daily EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 368, record 213, 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 ↗)

Teva-Sunitinib · DIN 02526212 Manufacturer: Teva Canada Limited; listing date 2023-11-30 Health Canada: Marketed since 2023-09-11 · brand TEVA-SUNITINIB · ATC L01EX01 SUNITINIB · form Capsule · route Oral · ingredients SUNITINIB (SUNITINIB MALATE) 25 MG · company Teva canada limited · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02526212). DIN 02526212: Teva-Sunitinib Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 920000555; group id 962; item number 2283; lccId None; manufacturer id TEV Source form: Cap; strength: 25mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $110.7100; ministry $110.7100 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02526212 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=101532

Interchangeable products

Auro-Sunitinib · DIN 02532204 · $110.7100 Nat-Sunitinib · DIN 02552906 · $110.7100 Sandoz Sunitinib · DIN 02532867 · $110.7100 Sutent · DIN 02280809 · $110.7100 Taro-Sunitinib · DIN 02524066 · $110.7100

Shortage status: not checked (no credentials)