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Reason for Use code 347 Initial Trial: For patients with mild to moderate Alzheimer's Disease (Mini-Mental State Exam [MMSE] 10-26). Patients will be reimbursed for a period of up to 3 months after which continued treatment must be reassessed. Network note: Maximum duration 3 months. Coverage limit: LU Authorization Period: 1 year Reason for Use code 348 Continuation: Further reimbursement will be made available to those patients whose disease has not progressed/deteriorated while on this drug. Patients must continue to have a MMSE score of 10-26. Coverage limit: LU Authorization Period: 1 year

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 ↗)

PMS-Donepezil · DIN 02322358 Manufacturer: Pharmascience Inc.; listing date 2014-02-27 Health Canada: Marketed since 2013-12-27 · brand PMS-DONEPEZIL · ATC N06DA02 DONEPEZIL · form Tablet · route Oral · ingredients DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE MONOHYDRATE) 10 MG · company Pharmascience inc · schedule Prescription

DIN 02322358: PMS-Donepezil Raw flags: sec12=Y, sec3=Y Item: 120400018; group id 193; item number 0355; lccId 00026; manufacturer id PMS Source form: Tab; strength: 10mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $0.4586; ministry $0.4586 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02322358 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=80780

Interchangeable products

AG-Donepezil · DIN 02432692 · $0.4586 Ach-Donepezil · DIN 02402653 · $0.4586 Apo-Donepezil · DIN 02362279 · $0.4586 Aricept · DIN 02232044 · $0.4586 Auro-Donepezil · DIN 02400588 · $0.4586 Bio-Donepezil · DIN 02412861 · $0.4586 Co Donepezil · DIN 02397609 · $0.4586 Donepezil · DIN 02420600 · $0.4586 Donepezil · DIN 02426854 · $0.4586 Donepezil · DIN 02475286 · $0.4586 Jamp-Donepezil · DIN 02404427 · $0.4586 Jamp-Donepezil Tablets · DIN 02416956 · $0.4586 M-Donepezil · DIN 02467461 · $0.4586 Mar-Donepezil · DIN 02402106 · $0.4586 Mint-Donepezil · DIN 02408619 · $0.4586 NRA-Donepezil · DIN 02535394 · $0.4586 Ran-Donepezil · DIN 02381516 · $0.4586 Sandoz Donepezil · DIN 02328682 · $0.4586 Septa-Donepezil · DIN 02428490 · $0.4586 Teva-Donepezil · DIN 02340615 · $0.4586

Shortage status: no shortage or discontinuation reported (checked 2026-09-13T08:10:21.292534+00:00); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02322358

Shortage record checked 2026-09-13T08:10:21.292534+00:00