Drug lookup | Fillwise

Jamp Pirfenidone · DIN 02509938 · 267mg · capsule

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02

StatusOff-Formulary Interchangeable, not an ODB benefit

Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗)

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.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria

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

How long EAP takes

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 ↗)

1 brand, same coverage

Jamp Pirfenidone · DIN 02509938 Manufacturer: Jamp Pharma Corporation; listing date 2021-07-30 Health Canada: Marketed since 2021-06-04 · brand JAMP PIRFENIDONE · ATC L04AX05 PIRFENIDONE · form Capsule · route Oral · ingredients PIRFENIDONE 267 MG · company Jamp pharma corporation · schedule Prescription

Check this DIN again · Health Canada product record

Jamp Pirfenidone: Formulary list price $6.7120/unit (unit not stated in source; not the patient's cost)

Ministry pays: $6.7120 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=99919 · Verify on the e-Formulary ↗ (DIN 02509938)

Source record

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02509938). DIN 02509938: Jamp Pirfenidone Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 920000699; group id 948; item number 2254; lccId None; manufacturer id JPC Source form: Cap; strength: 267mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $6.7120; ministry $6.7120 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02509938 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99919

Interchangeable products

Esbriet · DIN 02393751 · not recorded Sandoz Pirfenidone Capsules · DIN 02488833 · $6.7120

Shortage status: resolved shortage (ended 2024-04-26); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02509938

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

Sandoz Pirfenidone Capsules · DIN 02488833 · 267mg · capsule

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02

StatusOff-Formulary Interchangeable, not an ODB benefit

Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗)

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.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria

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

How long EAP takes

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 ↗)

1 brand, same coverage

Sandoz Pirfenidone Capsules · DIN 02488833 Manufacturer: Sandoz Canada Inc.; listing date 2021-11-30 Health Canada: Marketed since 2021-10-25 · brand SANDOZ PIRFENIDONE CAPSULES · ATC L04AX05 PIRFENIDONE · form Capsule · route Oral · ingredients PIRFENIDONE 267 MG · company Sandoz canada incorporated · schedule Prescription

Check this DIN again · Health Canada product record

Sandoz Pirfenidone Capsules: Formulary list price $6.7120/unit (unit not stated in source; not the patient's cost)

Ministry pays: $6.7120 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=97891 · Verify on the e-Formulary ↗ (DIN 02488833)

Source record

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02488833). DIN 02488833: Sandoz Pirfenidone Capsules Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 920000699; group id 948; item number 2254; lccId None; manufacturer id SDZ Source form: Cap; strength: 267mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $6.7120; ministry $6.7120 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02488833 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=97891

Interchangeable products

Esbriet · DIN 02393751 · not recorded Jamp Pirfenidone · DIN 02509938 · $6.7120

Shortage status: resolved shortage (ended 2026-03-23); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02488833

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

Auro-Pirfenidone · DIN 02537753 · 267mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02

StatusOff-Formulary Interchangeable, not an ODB benefit

Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗)

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.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria

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

Brand vs generic price

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 ↗)

How long EAP takes

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 ↗)

1 brand, same coverage

Auro-Pirfenidone · DIN 02537753 Manufacturer: Auro Pharma Inc.; listing date 2024-03-28 Health Canada: Marketed since 2024-03-05 · brand AURO-PIRFENIDONE · ATC L04AX05 PIRFENIDONE · form Tablet · route Oral · ingredients PIRFENIDONE 267 MG · company Auro pharma inc · schedule Prescription

Check this DIN again · Health Canada product record

Auro-Pirfenidone: Formulary list price $6.7119/unit (unit not stated in source; not the patient's cost)

Ministry pays: $6.7119 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=102653 · Verify on the e-Formulary ↗ (DIN 02537753)

Source record

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02537753). DIN 02537753: Auro-Pirfenidone Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 480200003; group id 570; item number 1521; lccId None; manufacturer id AUR Source form: Tab; strength: 267mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $6.7119; ministry $6.7119 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02537753 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102653

Interchangeable products

Esbriet · DIN 02464489 · $6.7120 Jamp Pirfenidone · DIN 02514702 · $6.7120 M-Pirfenidone · DIN 02550644 · $6.7120 PMS-Pirfenidone · DIN 02531526 · $6.7120 Sandoz Pirfenidone Tablets · DIN 02488507 · $6.7120

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=02537753

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

Esbriet · DIN 02464489 · 267mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02

StatusOff-Formulary Interchangeable, not an ODB benefit

Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗)

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.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria

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

Brand vs generic price

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 ↗)

How long EAP takes

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 ↗)

1 brand, same coverage

Esbriet · DIN 02464489 Manufacturer: Hoffmann-La Roche Limited; listing date 2021-06-30 Health Canada: Marketed since 2017-07-26 · brand ESBRIET · ATC L04AX05 PIRFENIDONE · form Tablet · route Oral · ingredients PIRFENIDONE 267 MG · company Hoffmann-la roche limited · schedule Prescription

Check this DIN again · Health Canada product record

Ministry pays: $6.7120 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=95262 · Verify on the e-Formulary ↗ (DIN 02464489)

Source record

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02464489). DIN 02464489: Esbriet Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 480200003; group id 570; item number 1521; lccId None; manufacturer id HLR Source form: Tab; strength: 267mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $13.4240; ministry $6.7120 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02464489 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=95262

Interchangeable products

Auro-Pirfenidone · DIN 02537753 · $6.7119 Jamp Pirfenidone · DIN 02514702 · $6.7120 M-Pirfenidone · DIN 02550644 · $6.7120 PMS-Pirfenidone · DIN 02531526 · $6.7120 Sandoz Pirfenidone Tablets · DIN 02488507 · $6.7120

Shortage status: discontinued (2021-11-25, reported by HOFFMANN-LA ROCHE LIMITED); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02464489

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

Jamp Pirfenidone · DIN 02514702 · 267mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02

StatusOff-Formulary Interchangeable, not an ODB benefit

Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗)

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.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria

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

Brand vs generic price

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 ↗)

How long EAP takes

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 ↗)

1 brand, same coverage

Jamp Pirfenidone · DIN 02514702 Manufacturer: Jamp Pharma Corporation; listing date 2021-08-31 Health Canada: Marketed since 2021-10-08 · brand JAMP PIRFENIDONE · ATC L04AX05 PIRFENIDONE · form Tablet · route Oral · ingredients PIRFENIDONE 267 MG · company Jamp pharma corporation · schedule Prescription

Check this DIN again · Health Canada product record

Jamp Pirfenidone: Formulary list price $6.7120/unit (unit not stated in source; not the patient's cost)

Ministry pays: $6.7120 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=100410 · Verify on the e-Formulary ↗ (DIN 02514702)

Source record

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02514702). DIN 02514702: Jamp Pirfenidone Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 480200003; group id 570; item number 1521; lccId None; manufacturer id JPC Source form: Tab; strength: 267mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $6.7120; ministry $6.7120 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02514702 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100410

Interchangeable products

Auro-Pirfenidone · DIN 02537753 · $6.7119 Esbriet · DIN 02464489 · $6.7120 M-Pirfenidone · DIN 02550644 · $6.7120 PMS-Pirfenidone · DIN 02531526 · $6.7120 Sandoz Pirfenidone Tablets · DIN 02488507 · $6.7120

Shortage status: resolved shortage (ended 2022-07-13); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02514702

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

M-Pirfenidone · DIN 02550644 · 267mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02

StatusOff-Formulary Interchangeable, not an ODB benefit

Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗)

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.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria

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

Brand vs generic price

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 ↗)

How long EAP takes

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 ↗)

1 brand, same coverage

M-Pirfenidone · DIN 02550644 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 267 MG · company Mantra pharma inc · schedule Prescription

Check this DIN again · Health Canada product record

M-Pirfenidone: Formulary list price $6.7120/unit (unit not stated in source; not the patient's cost)

Ministry pays: $6.7120 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=103943 · Verify on the e-Formulary ↗ (DIN 02550644)

Source record

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02550644). DIN 02550644: M-Pirfenidone Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 480200003; group id 570; item number 1521; lccId None; manufacturer id MAT Source form: Tab; strength: 267mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $6.7120; ministry $6.7120 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02550644 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=103943

Interchangeable products

Auro-Pirfenidone · DIN 02537753 · $6.7119 Esbriet · DIN 02464489 · $6.7120 Jamp Pirfenidone · DIN 02514702 · $6.7120 PMS-Pirfenidone · DIN 02531526 · $6.7120 Sandoz Pirfenidone Tablets · DIN 02488507 · $6.7120

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=02550644

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

Sandoz Pirfenidone Tablets · DIN 02488507 · 267mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02

StatusOff-Formulary Interchangeable, not an ODB benefit

Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗)

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.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria

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

Brand vs generic price

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 ↗)

How long EAP takes

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 ↗)

1 brand, same coverage

Sandoz Pirfenidone Tablets · DIN 02488507 Manufacturer: Sandoz Canada Inc.; listing date 2021-06-30 Health Canada: Marketed since 2021-05-04 · brand SANDOZ PIRFENIDONE TABLETS · ATC L04AX05 PIRFENIDONE · form Tablet · route Oral · ingredients PIRFENIDONE 267 MG · company Sandoz canada incorporated · schedule Prescription

Check this DIN again · Health Canada product record

Sandoz Pirfenidone Tablets: Formulary list price $6.7120/unit (unit not stated in source; not the patient's cost)

Ministry pays: $6.7120 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=97860 · Verify on the e-Formulary ↗ (DIN 02488507)

Source record

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02488507). DIN 02488507: Sandoz Pirfenidone Tablets Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 480200003; group id 570; item number 1521; lccId None; manufacturer id SDZ Source form: Tab; strength: 267mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $6.7120; ministry $6.7120 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02488507 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=97860

Interchangeable products

Auro-Pirfenidone · DIN 02537753 · $6.7119 Esbriet · DIN 02464489 · $6.7120 Jamp Pirfenidone · DIN 02514702 · $6.7120 M-Pirfenidone · DIN 02550644 · $6.7120 PMS-Pirfenidone · DIN 02531526 · $6.7120

Shortage status: resolved shortage (ended 2026-01-30); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02488507

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

Auro-Pirfenidone · DIN 02537761 · 801mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02

StatusOff-Formulary Interchangeable, not an ODB benefit

Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗)

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.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria

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

Brand vs generic price

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 ↗)

How long EAP takes

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 ↗)

1 brand, same coverage

Auro-Pirfenidone · DIN 02537761 Manufacturer: Auro Pharma Inc.; listing date 2024-03-28 Health Canada: Marketed since 2024-03-05 · brand AURO-PIRFENIDONE · ATC L04AX05 PIRFENIDONE · form Tablet · route Oral · ingredients PIRFENIDONE 801 MG · company Auro pharma inc · schedule Prescription

Check this DIN again · Health Canada product record

Auro-Pirfenidone: Formulary list price $20.1361/unit (unit not stated in source; not the patient's cost)

Ministry pays: $20.1361 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=102654 · Verify on the e-Formulary ↗ (DIN 02537761)

Source record

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02537761). DIN 02537761: Auro-Pirfenidone Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 480200004; group id 570; item number 1522; lccId None; manufacturer id AUR 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): $20.1361; ministry $20.1361 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02537761 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102654

Interchangeable products

Esbriet · DIN 02464500 · $20.1361 Jamp Pirfenidone · DIN 02514710 · $20.1360 M-Pirfenidone · DIN 02550652 · $20.1360 PMS-Pirfenidone · DIN 02531534 · $20.1360 Sandoz Pirfenidone Tablets · DIN 02488515 · $20.1360

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=02537761

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

Esbriet · DIN 02464500 · 801mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02

StatusOff-Formulary Interchangeable, not an ODB benefit

Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗)

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.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria

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

Brand vs generic price

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 ↗)

How long EAP takes

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 ↗)

1 brand, same coverage

Esbriet · DIN 02464500 Manufacturer: Hoffmann-La Roche Limited; listing date 2021-06-30 Health Canada: Marketed since 2017-07-26 · brand ESBRIET · ATC L04AX05 PIRFENIDONE · form Tablet · route Oral · ingredients PIRFENIDONE 801 MG · company Hoffmann-la roche limited · schedule Prescription

Check this DIN again · Health Canada product record

Ministry pays: $20.1361 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=95264 · Verify on the e-Formulary ↗ (DIN 02464500)

Source record

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02464500). DIN 02464500: Esbriet Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 480200004; group id 570; item number 1522; lccId None; manufacturer id HLR 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): $40.2720; ministry $20.1361 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02464500 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=95264

Interchangeable products

Auro-Pirfenidone · DIN 02537761 · $20.1361 Jamp Pirfenidone · DIN 02514710 · $20.1360 M-Pirfenidone · DIN 02550652 · $20.1360 PMS-Pirfenidone · DIN 02531534 · $20.1360 Sandoz Pirfenidone Tablets · DIN 02488515 · $20.1360

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=02464500

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

Jamp Pirfenidone · DIN 02514710 · 801mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02

StatusOff-Formulary Interchangeable, not an ODB benefit

Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗)

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.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria

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

Brand vs generic price

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 ↗)

How long EAP takes

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 ↗)

1 brand, same coverage

Jamp Pirfenidone · DIN 02514710 Manufacturer: Jamp Pharma Corporation; listing date 2021-08-31 Health Canada: Marketed since 2021-10-07 · brand JAMP PIRFENIDONE · ATC L04AX05 PIRFENIDONE · form Tablet · route Oral · ingredients PIRFENIDONE 801 MG · company Jamp pharma corporation · schedule Prescription

Check this DIN again · Health Canada product record

Jamp Pirfenidone: Formulary list price $20.1360/unit (unit not stated in source; not the patient's cost)

Ministry pays: $20.1360 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=100411 · Verify on the e-Formulary ↗ (DIN 02514710)

Source record

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02514710). DIN 02514710: Jamp Pirfenidone Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 480200004; group id 570; item number 1522; lccId None; manufacturer id JPC 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=02514710 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100411

Interchangeable products

Auro-Pirfenidone · DIN 02537761 · $20.1361 Esbriet · DIN 02464500 · $20.1361 M-Pirfenidone · DIN 02550652 · $20.1360 PMS-Pirfenidone · DIN 02531534 · $20.1360 Sandoz Pirfenidone Tablets · DIN 02488515 · $20.1360

Shortage status: resolved shortage (ended 2022-04-05); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02514710

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

M-Pirfenidone · DIN 02550652 · 801mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02

StatusOff-Formulary Interchangeable, not an ODB benefit

Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗)

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.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria

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

Brand vs generic price

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 ↗)

How long EAP takes

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 ↗)

1 brand, same coverage

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

Check this DIN again · Health Canada product record

M-Pirfenidone: Formulary list price $20.1360/unit (unit not stated in source; not the patient's cost)

Ministry pays: $20.1360 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=103944 · Verify on the e-Formulary ↗ (DIN 02550652)

Source record

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: 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=02550652

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

Sandoz Pirfenidone Tablets · DIN 02488515 · 801mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02

StatusOff-Formulary Interchangeable, not an ODB benefit

Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗)

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.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria

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

Brand vs generic price

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 ↗)

How long EAP takes

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 ↗)

1 brand, same coverage

Sandoz Pirfenidone Tablets · DIN 02488515 Manufacturer: Sandoz Canada Inc.; listing date 2021-06-30 Health Canada: Marketed since 2021-05-04 · brand SANDOZ PIRFENIDONE TABLETS · ATC L04AX05 PIRFENIDONE · form Tablet · route Oral · ingredients PIRFENIDONE 801 MG · company Sandoz canada incorporated · schedule Prescription

Check this DIN again · Health Canada product record

Sandoz Pirfenidone Tablets: Formulary list price $20.1360/unit (unit not stated in source; not the patient's cost)

Ministry pays: $20.1360 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=97861 · Verify on the e-Formulary ↗ (DIN 02488515)

Source record

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02488515). DIN 02488515: Sandoz Pirfenidone Tablets Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 480200004; group id 570; item number 1522; lccId None; manufacturer id SDZ 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=02488515 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=97861

Interchangeable products

Auro-Pirfenidone · DIN 02537761 · $20.1361 Esbriet · DIN 02464500 · $20.1361 Jamp Pirfenidone · DIN 02514710 · $20.1360 M-Pirfenidone · DIN 02550652 · $20.1360 PMS-Pirfenidone · DIN 02531534 · $20.1360

Shortage status: active shortage (reported 2026-07-06, estimated to end 2026-09-19, last updated 2026-07-07); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02488515

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

PMS-Pirfenidone · DIN 02531526 · 267mg · tablet

Off-Formulary Interchangeable, not an ODB benefitDormant since 2026-07-31 · checked 2026-09-02 · What does dormant mean?

StatusOff-Formulary Interchangeable, not an ODB benefit

Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗)

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.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria

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

Brand vs generic price

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 ↗)

How long EAP takes

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 ↗)

1 brand, same coverage

PMS-Pirfenidone · DIN 02531526 Manufacturer: Pharmascience Inc.; listing date 2022-12-21 Health Canada: Dormant since 2026-07-31 · brand PMS-PIRFENIDONE · ATC L04AX05 PIRFENIDONE · form Tablet · route Oral · ingredients PIRFENIDONE 267 MG · company Pharmascience inc · schedule Prescription

Check this DIN again · Health Canada product record

PMS-Pirfenidone: Formulary list price $6.7120/unit (unit not stated in source; not the patient's cost)

Ministry pays: $6.7120 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=102064 · Verify on the e-Formulary ↗ (DIN 02531526)

Source record

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02531526). DIN 02531526: PMS-Pirfenidone Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 480200003; group id 570; item number 1521; lccId None; manufacturer id PMS Source form: Tab; strength: 267mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $6.7120; ministry $6.7120 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02531526 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102064

Interchangeable products

Auro-Pirfenidone · DIN 02537753 · $6.7119 Esbriet · DIN 02464489 · $6.7120 Jamp Pirfenidone · DIN 02514702 · $6.7120 M-Pirfenidone · DIN 02550644 · $6.7120 Sandoz Pirfenidone Tablets · DIN 02488507 · $6.7120

Shortage status: active shortage (reported 2024-05-23, last updated 2025-08-27); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02531526

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

Health Canada lists this DIN as Dormant since 2026-07-31 — choose a marketed DIN from the same-category list.

PMS-Pirfenidone · DIN 02531534 · 801mg · tablet

Off-Formulary Interchangeable, not an ODB benefitDormant since 2026-07-31 · checked 2026-09-02

StatusOff-Formulary Interchangeable, not an ODB benefit

Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗)

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.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria

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

Brand vs generic price

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 ↗)

How long EAP takes

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 ↗)

1 brand, same coverage

PMS-Pirfenidone · DIN 02531534 Manufacturer: Pharmascience Inc.; listing date 2022-12-21 Health Canada: Dormant since 2026-07-31 · brand PMS-PIRFENIDONE · ATC L04AX05 PIRFENIDONE · form Tablet · route Oral · ingredients PIRFENIDONE 801 MG · company Pharmascience inc · schedule Prescription

Check this DIN again · Health Canada product record

PMS-Pirfenidone: Formulary list price $20.1360/unit (unit not stated in source; not the patient's cost)

Ministry pays: $20.1360 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=102065 · Verify on the e-Formulary ↗ (DIN 02531534)

Source record

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02531534). DIN 02531534: PMS-Pirfenidone Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 480200004; group id 570; item number 1522; lccId None; manufacturer id PMS 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=02531534 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102065

Interchangeable products

Auro-Pirfenidone · DIN 02537761 · $20.1361 Esbriet · DIN 02464500 · $20.1361 Jamp Pirfenidone · DIN 02514710 · $20.1360 M-Pirfenidone · DIN 02550652 · $20.1360 Sandoz Pirfenidone Tablets · DIN 02488515 · $20.1360

Shortage status: active shortage (reported 2024-05-23, last updated 2025-08-27); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02531534

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

Health Canada lists this DIN as Dormant since 2026-07-31 — choose a marketed DIN from the same-category list.

Esbriet · DIN 02393751 · 267mg · capsule

Off-Formulary Interchangeable, not an ODB benefit; Health Canada lists this DIN as Cancelled post market since 2023-07-01 — choose a marketed DIN from the same-category list.Discontinued 2023-07-01 · checked 2026-09-02

StatusOff-Formulary Interchangeable, not an ODB benefit; Health Canada lists this DIN as Cancelled post market since 2023-07-01 — choose a marketed DIN from the same-category list.

Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗); Health Canada lists this DIN as Cancelled post market since 2023-07-01 — choose a marketed DIN from the same-category list.

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.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria

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

How long EAP takes

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 ↗)

1 brand, same coverage

Esbriet · DIN 02393751 Manufacturer: InterMune Canada, Inc.; listing date 2021-07-30 Health Canada: Cancelled post market since 2023-07-01 · brand ESBRIET · ATC L04AX05 PIRFENIDONE · form Capsule · route Oral · ingredients PIRFENIDONE 267 MG · company Hoffmann-la roche limited · schedule Prescription

Check this DIN again · Health Canada product record

Esbriet: Formulary list price not recorded/unit (unit not stated in source; not the patient's cost)

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=87895 · Verify on the e-Formulary ↗ (DIN 02393751)

Source record

DIN 02393751: Esbriet Raw flags: notABenefit=Y, sec3=Y, sec3b=Y Item: 920000699; group id 948; item number 2254; lccId None; manufacturer id INT Source form: Cap; strength: 267mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit Source prices (unrounded): not recorded; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02393751 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=87895

Interchangeable products

Jamp Pirfenidone · DIN 02509938 · $6.7120 Sandoz Pirfenidone Capsules · DIN 02488833 · $6.7120

Shortage status: discontinued (2023-03-20, reported by HOFFMANN-LA ROCHE LIMITED); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02393751

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

Health Canada lists this DIN as Cancelled post market since 2023-07-01 — choose a marketed DIN from the same-category list.

Look up one drug

PIRFENIDONE

Jamp Pirfenidone · DIN 02509938 · 267mg · capsule

Sandoz Pirfenidone Capsules · DIN 02488833 · 267mg · capsule

Auro-Pirfenidone · DIN 02537753 · 267mg · tablet

Esbriet · DIN 02464489 · 267mg · tablet

Jamp Pirfenidone · DIN 02514702 · 267mg · tablet

M-Pirfenidone · DIN 02550644 · 267mg · tablet

Sandoz Pirfenidone Tablets · DIN 02488507 · 267mg · tablet

Auro-Pirfenidone · DIN 02537761 · 801mg · tablet

Esbriet · DIN 02464500 · 801mg · tablet

Jamp Pirfenidone · DIN 02514710 · 801mg · tablet

M-Pirfenidone · DIN 02550652 · 801mg · tablet

Sandoz Pirfenidone Tablets · DIN 02488515 · 801mg · tablet

PMS-Pirfenidone · DIN 02531526 · 267mg · tablet

PMS-Pirfenidone · DIN 02531534 · 801mg · tablet

Esbriet · DIN 02393751 · 267mg · capsule

Other drugs in the same formulary class (48:00 COUGH PREPARATIONS) and how they are covered

Matched class: 48:00 COUGH PREPARATIONS

NINTEDANIB

DEXTROMETHORPHAN HBR

HYDROCODONE BITARTRATE

GUAIFENESIN

Other drugs in the same formulary class (92:00 UNCLASSIFIED THERAPEUTIC AGENTS) and how they are covered

Matched class: 92:00 UNCLASSIFIED THERAPEUTIC AGENTS

AZATHIOPRINE

LENALIDOMIDE

CYCLOSPORINE

LEFLUNOMIDE

MYCOPHENOLATE MOFETIL

MYCOPHENOLATE SODIUM

SIROLIMUS

TACROLIMUS

TERIFLUNOMIDE

USTEKINUMAB

FINGOLIMOD

ALENDRONATE

Availability

Prepare an Exceptional Access request

Pirfenidone (Esbriet and generics (see formulary for OFIs))