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Reason for Use code 458 For persons suffering from New York Heart Association (NYHA) class II chronic heart failure with left ventricular systolic dysfunction (with ejection fraction less than or equal to 35 percent), as a complement to standard therapy. Note: Patients must be on optimal therapy with an angiotensin-converting-enzyme (ACE) inhibitor, an angiotensin-receptor blocker (ARB), or both and a beta-blocker (unless contraindicated) at the recommended dose or maximal tolerated dose. Coverage limit: LU Authorization Period: Indefinite Exceptional Access criteria on record are for Brand(s): Inspra; DOSAGE FORM/ STRENGTH: 25 mg, 50 mg tablets — not this product; no criteria on record for this product in this block. 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 Eplerenone Brand(s): Inspra DOSAGE FORM/ STRENGTH: 25 mg, 50 mg tablets For the treatment of patients who have heart failure and left ventricular systolic dysfunction due to acute myocardial infarction. Patients must have: • An ejection fraction ≤ 40% AND • Prior trial of spironolactone but experienced severe symptomatic (painful) gynecomastia Duration of Approval: Lifetime EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 95, record 54, 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 ↗)

Mint-Eplerenone · DIN 02471442 Manufacturer: Mint Pharmaceuticals Inc.; listing date 2018-06-29 Health Canada: Marketed since 2018-04-09 · brand MINT-EPLERENONE · ATC C03DA04 EPLERENONE · form Tablet · route Oral · ingredients EPLERENONE 25 MG · company Mint pharmaceuticals inc · schedule Prescription

DIN 02471442: Mint-Eplerenone Raw flags: sec12=Y, sec3=Y Item: 240800289; group id 324; item number 0721; lccId 00251; manufacturer id MIN Source form: Tab; strength: 25mg Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $1.3730; ministry $1.3730 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02471442 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=96055

Interchangeable products

Inspra · DIN 02323052 · $1.3730 Jamp Eplerenone · DIN 02543389 · $1.3730

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=02471442

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