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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 Pirfenidone Brand(s): Esbriet and generics (see formulary for OFIs) DOSAGE FORM/ STRENGTH: 267 mg capsule, 267 mg tablet, 801 mg tablet Initial approval criteria: For the treatment of adult patients with a diagnosis of mild to moderate idiopathic pulmonary fibrosis (IPF): • Diagnosis confirmed by a respirologist and a high-resolution CT scan. • All other causes of restrictive lung disease (e.g. collagen vascular disorder or hypersensitivity pneumonitis) should be excluded. • Mild to moderate IPF is defined as forced vital capacity (FVC) greater than or equal to 50% of predicted. • Patient is under the care of a physician with experience in IPF. Initial approval period: 7 months (allow 4 weeks for repeat pulmonary function tests) Initial renewal criteria (at 6 months): Patients must NOT demonstrate progression of disease defined as an absolute decline in percent predicted FVC of ≥10% from initiation of therapy until renewal (initial 6 month treatment period). If a patient has experienced progression as defined above, then the results should be validated with a confirmatory pulmonary function test conducted 4 weeks later. Approval period: 6 months Second and subsequent renewals (at 12 months and thereafter): Patients must NOT demonstrate progression of disease defined as an absolute decline in percent predicted FVC of ≥10% within any 12 month period. If a patient has experienced progression as defined above, then the results should be validated with a confirmatory pulmonary function test conducted 4 weeks later. Approval period: 12 months Documentation/information required: • If high-resolution CT scan is not available, lung biopsy may be provided to support the diagnosis of IPF as applicable and available • Full pulmonary function test results. Exclusion Criteria: Combination use of Esbriet (pirfenidone) and Ofev (nintedanib) will not be funded. 437  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 437, record 267, 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 ↗)

Turnaround times The Exceptional Access Program receives between 250 and 500 requests a day. Requests are categorized in order of priority based on how quickly a drug is needed, the type of drug, and the condition for which the drug is being used. Turnaround times begin on the business day on which the EAP receives a complete request from a physician or nurse practitioner. You may have to wait longer if the request is missing information or supporting documents required by the EAP criteria, if a request requires external review, or if documents are sent by fax or mail instead of submitted via SADIE. EAP Weekly Progress Report Date: September 15, 2026 Processing categories and examples | Target | Current | Priority 1 — for drugs such as antibiotics, cancer medications, and initial requests for pain medications | 3 business days | 2 business day | Priority 2 — for antiviral drugs to treat HIV, drugs for multiple sclerosis, and pulmonary hypertension | 5 business days | 3 business days | Biologics — for biologic drugs to treat rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and Crohn’s disease | 10 business days | 4 business days | Chronic — for drugs used for chronic conditions such as migraines, chronic pain, Ménière's disease and symptoms of Parkinson’s disease. | 4 to 6 weeks | 11 business days | (ontario.ca, Updated September 15, 2026 ↗) For selected drugs, the Telephone Request Service is available to authorized prescribers or their delegates. In most cases, the funding decision is provided by the end of the call and processed within one business day. (ontario.ca, Updated September 15, 2026 ↗)

M-Pirfenidone · DIN 02550652 Manufacturer: Mantra Pharma Inc.; listing date 2025-03-31 Health Canada: Marketed since 2025-01-29 · brand M-PIRFENIDONE · ATC L04AX05 PIRFENIDONE · form Tablet · route Oral · ingredients PIRFENIDONE 801 MG · company Mantra pharma inc · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02550652). DIN 02550652: M-Pirfenidone Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 480200004; group id 570; item number 1522; lccId None; manufacturer id MAT Source form: Tab; strength: 801mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $20.1360; ministry $20.1360 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02550652 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103944

Interchangeable products

Auro-Pirfenidone · DIN 02537761 · $20.1361 Esbriet · DIN 02464500 · $20.1361 Jamp Pirfenidone · DIN 02514710 · $20.1360 PMS-Pirfenidone · DIN 02531534 · $20.1360 Sandoz Pirfenidone Tablets · DIN 02488515 · $20.1360

Shortage status: not checked (no credentials)