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SACUBITRIL & VALSARTAN

All products: Limited Use (codes 497)

Entresto · DIN 02446928 · 24.3mg & 25.7mg · tablet

Limited Use — Reason for Use code 497 requiredMarketed · checked 2026-09-19
StatusLimited Use — Reason for Use code 497 required
Write on scriptLU code 497 (patient must meet the criteria below)
Patient paysPatient pays: program not supplied; amount cannot be determined.
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.
Ontario Limited Use criteria — code 497
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
1 brand, same coverage
Entresto · DIN 02446928 Manufacturer: Novartis Pharma Canada Inc.; listing date 2017-04-27 Health Canada: Marketed since 2016-08-04 · brand ENTRESTO · ATC C09DX04 VALSARTAN AND SACUBITRIL · form Tablet · route Oral · ingredients SACUBITRIL (SACUBITRIL VALSARTAN SODIUM HYDRATE COMPLEX) 24 MG, VALSARTAN (SACUBITRIL VALSARTAN SODIUM HYDRATE COMPLEX) 26 MG · company Novartis pharmaceuticals canada inc · schedule Prescription
Check this DIN again · Health Canada product record

Ministry pays: $1.8530 per source unit.

Source explanation: The formulary price is what ODB pays; the cash price at the counter is set by the pharmacy.

Formulary data: Ontario extract of Aug 26, 2026 · Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=93249 · Verify on the e-Formulary ↗ (DIN 02446928)

Source record
DIN 02446928: Entresto Raw flags: chronicUseMed=Y, sec12=Y, sec3=Y Item: 243208002; group id 375; item number 0893; lccId 00283; manufacturer id NOV Source form: Tab; strength: 24.3mg & 25.7mg 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): $3.7060; ministry $1.8530 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02446928 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=93249
Interchangeable products
PMS-Sacubitril-Valsartan · DIN 02564432 · $1.8530 Sandoz Sacubitril-Valsartan · DIN 02549018 · $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=02446928
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary class (24:32:08 Angiotensin II Receptor Antagonists) and how they are covered

Matched class: 24:32:08 Angiotensin II Receptor Antagonists

Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment. No displayed product is listed as a general benefit in this extract. Check its listing requirements below. 24:32:08 Angiotensin II Receptor Antagonists

AZILSARTAN MEDOXOMIL

· 4 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 40mg, 80mg · Tab Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 24:32:08
Full class listing Related classes: 24:06:24 PCSK9 Inhibitors, 24:08:16 Central Alpha-Agonists Same formulary class, not same indication: class membership alone does not establish equivalent uses.
What the Health Canada label says it is for
1. Indications ENTRESTO® (sacubitril/valsartan) is indicated for: • the treatment of heart failure with reduced ejection fraction (HFrEF) in patients with NYHA Class II or III, to reduce the incidence of cardiovascular death and heart failure hospitalisation (see 4 Dosage and Administration ). ENTRESTO should be administered in combination with other heart failure therapies, in place of an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARB) (see 2 Contraindications, 4 Dosage and Administration, 7 Warnings and Precautions and 14 Clinical Trials). ENTRESTO should be initiated, and up-titration conducted, by a physician experienced with the treatment of heart failure. 1.1. Pediatrics Pediatrics (< 18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of ENTRESTO in pediatric patients has not been established. 1.2. Geriatrics Geriatrics (> 65 years of age): No dosage adjustment is required in patients over 65 years. However, ENTRESTO has been studied in a limited number of patients above the age of 80 years (see 7.1.4 Geriatrics, and 14 Clinical Trials). Caution is required in these patients … https://pdf.hres.ca/dpd_pm/00083663.PDF PM date: 2026-02-26 Source product: ENTRESTO; DIN 02446928; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.