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PIRFENIDONE

All products: not a benefit

Other products in the same Health Canada class (L04A, L04AX) — coverage varies; not interchangeable

  • Azathioprine (Imuran): general benefit
  • Lenalidomide (Revlimid): limited Use 630, 631, 632, 659, 741
  • Cyclosporine (Neoral): general benefit
  • Leflunomide (Arava): general benefit
  • Mycophenolate mofetil (CellCept): general benefit, Limited Use 556
  • Mycophenolate (Myfortic): general benefit

15 more in the class list below

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

Matched class: 92:00 UNCLASSIFIED THERAPEUTIC AGENTS

Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment. Covered without a code on the Ontario formulary: ALENDRONATE & CHOLECALCIFEROL, AZATHIOPRINE, CYCLOSPORINE, GLUCAGON RDNA ORIGIN, LANREOTIDE ACETATE, LEFLUNOMIDE, LEVODOPA & BENSERAZIDE, MYCOPHENOLATE SODIUM Some products covered without a code (check the product listing): ALENDRONATE, ALLOPURINOL, AMANTADINE HCL, BROMOCRIPTINE, CLOPIDOGREL BISULFATE, LEVODOPA & CARBIDOPA, MYCOPHENOLATE MOFETIL, OCTREOTIDE, RISEDRONATE SODIUM, ROPINIROLE, SELEGILINE HCL, TAMSULOSIN HCL 92:00 UNCLASSIFIED THERAPEUTIC AGENTS

AZATHIOPRINE

· 3 products · General benefit · strengths: 50mg · Tab

LENALIDOMIDE

· 42 products · Limited Use, codes 630, 631, 632, 659, 741 · strengths: 2.5mg, 15mg, 20mg, 25mg, 5mg, 10mg · Cap

CYCLOSPORINE

· 8 products · General benefit · strengths: 10mg, 25mg, 50mg, 100mg, 100mg/mL · Cap, O/L

LEFLUNOMIDE

· 16 products · General benefit · strengths: 10mg, 20mg · Tab

MYCOPHENOLATE MOFETIL

· 16 products · General benefit (14), Limited Use, codes 556 (2) · strengths: 250mg, 200mg/mL, 500mg · Cap, Pd for Oral Susp-175mL Pk, Tab

MYCOPHENOLATE SODIUM

· 8 products · General benefit · strengths: 180mg, 360mg · Ent Tab

SIROLIMUS

· 2 products · Limited Use, codes 392 · strengths: 1mg/mL, 1mg · O/L, Tab

TACROLIMUS

· 20 products · Limited Use, codes 173 (10), Limited Use, codes 410 (8), Limited Use, codes 383 (2) · strengths: 5mg/mL, 0.5mg, 1mg, 5mg, 3mg, 0.03%, 0.1% · Amp, Cap, ER Cap, Oint

TERIFLUNOMIDE

· 10 products · Listed, not a benefit (1), Limited Use, codes 647 (9) · strengths: 14mg · Tab

USTEKINUMAB

· 14 products · Limited Use, codes 669, 670, 671, 672 (5), Limited Use, codes 668, 669, 671, 672 (2), Limited Use, codes 669, 671, 672, 733 (3), Limited Use, codes 669, 671, 672, 742 (2), Limited Use, codes 671, 672 (2) · strengths: 45mg/0.5mL, 90mg/1.0mL, 90mg/mL, 130mg/26mL, 5mg/mL · Inj Sol-0.5mL Pref Autoinj (Preservative-Free), Inj Sol-0.5mL Pref Syr Pk, Inj Sol-0.5mL Pref Syr Pk (Preservative-Free), Inj Sol-0.5mL Vial Pk, Inj Sol-1.0mL Pref Syr Pk (Preservative-Free), Inj Sol-1mL Pref Autoinj (Preservative-Free), Inj Sol-1mL Pref Syr Pk, Inj Sol-26mL Vial Pk, Inj Sol-26mL Vial Pk (Preservative-Free), Inj Sol-Vial Pk (Preservative-Free)

FINGOLIMOD

· 10 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 0.5mg · Cap

ALENDRONATE

· 28 products · Off-Formulary Interchangeable, not an ODB benefit (4), Listed, not a benefit (1), General benefit (23) · strengths: 5mg, 10mg, 70mg · Tab Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 92:00 and 75 more
Full class listing Related classes: Same formulary class, not same indication: class membership alone does not establish equivalent uses.
Other drugs whose Health Canada label lists a similar indication: pulmonary fibrosis
From Health Canada product monographs; label wording only, not a treatment recommendation. Matching is lexical and uses one held product label per generic; formulations and qualifying criteria may differ. No displayed matched alternative is a general benefit. NINTEDANIB · Off-Formulary Interchangeable, not an ODB benefit • The treatment of Idiopathic Pulmonary Fibrosis (IPF) PM: https://pdf.hres.ca/dpd_pm/00077134.PDF; date JUN 25, 2015; DIN 02443066; fetched 2026-09-10 Product monograph Coverage source: ON formulary extract 2026-08-26
What the Health Canada label says it is for
1 INDICATIONS ESBRIET® (pirfenidone) is indicated for treatment of idiopathic pulmonary fibrosis (IPF) in adults. 1.1. Pediatrics Pediatrics (<18 years of age): The safety and effectiveness of ESBRIET in pediatric patients have not been established. 1.2. Geriatrics No dose adjustment is necessary in patients 65 years and older (see 10 CLINICAL PHARMACOLOGY). https://pdf.hres.ca/dpd_pm/00073373.PDF PM date: November 9, 2023 Source product: ESBRIET; DIN 02464489; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.

Availability

Esbriet · DIN 02393751 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

Check this DIN again

Prepare an Exceptional Access request

SADIE has its own form for many drugs; this checklist prepares the answers; the ministry decides. Open SADIE

Use this text in SADIE’s free-text fields or read from it on a Telephone Request Service call. Review marks do not indicate eligibility. Evidence stays in this page until you copy it; nothing entered here is sent or saved. Do not enter patient identifiers.

EAP Telephone Request Service: The TRS can be accessed by calling toll-free at 1-866-811-9893 or 416-327-8109 (Toronto area) between 8:30 a.m. and 5:00 p.m. Monday through Friday (except holidays) and selecting the TRS option. Source; updated September 15, 2026

EAP fax: In Ontario: 1-866-811-9908 or 416-327-7526 (Toronto area). Outside Ontario: 1-833-905-4260. Source; updated September 15, 2026

Posted turnaround and Telephone Request Service scope
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 |
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.
Source; updated September 15, 2026

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

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

Prepare answers: For the treatment of adult patients with a diagnosis of mild to moderate idiopathic pulmonary fibrosis (IPF):

Ministry criteria corpus 2025-01-01; page 437

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

Prepared from the ministry's published criteria; eligibility is decided by the Exceptional Access Program.