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Reason for Use code 384 For use in combination with an alpha blocker for the treatment of men with symptomatic* Benign Prostatic Hyperplasia. Coverage limit: LU Authorization Period: Indefinite Reason for Use code 385 For monotherapy, as a second line agent in patients with symptomatic* Benign Prostatic Hyperplasia following treatment failure or intolerance to an alpha blocker. Coverage limit: * Symptomatic is defined as having moderate (about half the time) to severe (almost always) symptoms related to the prostate in at least 4 of the following domains: 1. feeling of incomplete emptying of the bladder after voiding 2. needing to urinate again less than 2 hours after previous void 3. stopping and starting urine several times while voiding 4. difficulty postponing urination 5. weak urinary stream 6. pushing or straining to begin voiding 7. the need to get up to void at least 3 times in the night. Coverage limit: LU Authorization Period: Indefinite

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 ↗)

Mint-Dutasteride · DIN 02428873 Manufacturer: Mint Pharmaceuticals Inc.; listing date 2014-11-27 Health Canada: Marketed since 2014-09-19 · brand MINT-DUTASTERIDE · ATC G04CB02 DUTASTERIDE · form Capsule · route Oral · ingredients DUTASTERIDE 0.5 MG · company Mint pharmaceuticals inc · schedule Prescription

DIN 02428873: Mint-Dutasteride Raw flags: chronicUseMed=Y, sec12=Y, sec3=Y Item: 920000524; group id 911; item number 2184; lccId 00166; manufacturer id MIN Source form: Cap; strength: 0.5mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below; chronic-use medication (100-day supply rule, dispensing-fee limit) Source prices (unrounded): $0.2565; ministry $0.2565 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02428873 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=91334

Interchangeable products

Apo-Dutasteride · DIN 02404206 · $0.2565 Auro-Dutasteride · DIN 02469308 · $0.2565 Avodart · DIN 02247813 · $0.2565 Dutasteride · DIN 02429012 · $0.2565 Dutasteride · DIN 02443058 · $0.2565 Jamp Dutasteride · DIN 02484870 · $0.2565 Jamp Dutasteride Capsules · DIN 02546167 · $0.2565 Med-Dutasteride · DIN 02416298 · $0.2565 Priva-Dutasteride · DIN 02490587 · $0.2565 Sandoz Dutasteride · DIN 02424444 · $0.2565 Teva-Dutasteride · DIN 02408287 · $0.2565

Shortage status: not checked (no credentials)