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Reason for Use code 497 For the treatment of heart failure (HF) with reduced ejection fraction in patients with New York Heart Association (NYHA) class II or III HF to reduce the incidence of cardiovascular (CV) death and HF hospitalization, if all of the following clinical criteria are met: - Reduced left ventricular ejection fraction (LVEF) (Less than 40%); - Patient has NYHA class II to III symptoms despite at least four weeks of treatment with a stable dose of an angiotensin-converting enzyme inhibitor (ACEI) or an angiotensin II receptor antagonist (ARB); and - In combination with a beta blocker and other recommended therapies, including an aldosterone antagonist (if tolerable). 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 ↗)

PMS-Sacubitril-Valsartan · DIN 02564440 Manufacturer: Pharmascience Inc.; listing date 2026-03-31 Health Canada: Marketed since 2026-01-22 · brand PMS-SACUBITRIL-VALSARTAN · ATC C09DX04 VALSARTAN AND SACUBITRIL · form Tablet · route Oral · ingredients VALSARTAN (SACUBITRIL VALSARTAN SODIUM COMPLEX) 51 MG, SACUBITRIL (SACUBITRIL VALSARTAN SODIUM COMPLEX) 49 MG · company Pharmascience inc · schedule Prescription

DIN 02564440: PMS-Sacubitril-Valsartan Raw flags: chronicUseMed=Y, sec12=Y, sec3=Y Item: 243208003; group id 375; item number 0894; lccId 00283; manufacturer id PMS Source form: Tab; strength: 48.6mg & 51.4mg 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): $1.8530; ministry $1.8530 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02564440 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=106714

Interchangeable products

Entresto · DIN 02446936 · $1.8530 Sandoz Sacubitril-Valsartan · DIN 02549026 · $1.8530

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=02564440

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