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Exceptional Access criteria on record are for Brand(s): Ofev; DOSAGE FORM/ STRENGTH: 100 mg,150 mg capsules — not this product; no criteria on record for this product in this block. Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Nintedanib Brand(s): Ofev DOSAGE FORM/ STRENGTH: 100 mg,150 mg capsules Updated: April 29, 2022 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. Initial Renewal Duration: 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. Second Renewal Duration: 12 Months Exclusion Criteria: Combination use of Ofev (nintedanib) and Esbriet (pirfenidone) will not be funded. 435 Nintedanib Brand(s): Ofev DOSAGE FORM/ STRENGTH: 100 mg, 150 mg capsules Initiation Criteria For the treatment of chronic fibrosing interstitial lung disease with a progressive phenotype (PF-ILD) in patients meeting all of the following criteria: • Has a confirmed diagnosis by a specialist in interstitial lung diseases. Provide a copy of the consultation note. • Has a forced vital capacity (FVC) greater than or equal to 45% of predicted. • Requests must come from or in consultation with a specialist with experience in managing interstitial lung diseases. Initial requests should contain the following information: • Pulmonary function test results. • A high-resolution computed tomography (HRCT) scan, if available. • A consultation note from a specialist in interstitial lung diseases. Exclusion Criteria: • Nintedanib will not be funded as combination therapy with pirfenidone. Renewal Criteria: Renewals will be considered in patients who have not experienced an absolute decline in percent predicted forced vital capacity of greater than or equal to 10% over the preceding year of treatment with nintedanib. Duration of approval of initials and renewal: 12 months Approved Dosage: up to 150 mg orally every 12 hours 436  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 435, record 266, corpus 2025-01-01; name match only, not an eligibility decision

Lowest DBP recovery rule under medically necessary no-substitution claims: 6.2 Medically Necessary "No Substitution" Claims The Side Effect Reporting Form will not have to be renewed. However, the pharmacy must maintain a copy of the prescription that contains a direction that there be no substitution and the required Health Canada Side Effect Reporting Form (completed and signed by the prescriber). The prescriber must write “No Substitution” or “No Sub” on renewal or subsequent new written prescriptions, and indicate “No Substitution” on subsequent new oral prescriptions. The dispenser will be reimbursed the DBP plus a mark-up and the lesser of the posted usual and customary fee or the ODB dispensing fee minus the applicable ODB co-payment amount. Where a completed Side Effect Reporting Form is not available at the pharmacy during an inspection, the difference between the cost of the higher-cost product and the lowest DBP listed for the interchangeable category will be recovered. (ontario.ca, Revision #17; 2026-08-03 ↗) 6.2 Medically Necessary "No Substitution" Claims The Ministry will provide reimbursement of a higher-cost interchangeable product in medically necessary circumstances where a patient has experienced a significant adverse reaction with two (2) lower-cost interchangeable drug products, where available. When a prescriber identifies a patient for which it is medically necessary that a higher cost interchangeable product be provided, the prescriber must: • Complete, sign and forward to the pharmacist a copy of the Health Canada side effect reporting form for each lower-cost interchangeable drug product trialed (Side Effect Reporting Form[s]); and • Write “No Substitution” or “No Sub” on a written prescription or indicate “No Substitution” to the pharmacist in the case of a verbal prescription. The prescriber should keep a copy of the completed form in the patient’s record for future use and reference. In the case of a written prescription, when the pharmacist or dispensing physician receives a prescription with the written notation “No Substitution” or “No Sub”, reimbursement will be provided for the higher-cost interchangeable product only if the prescription is accompanied by a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed. This form must be completely filled out noting the details of the adverse reaction and signed by the prescriber. In the case of a verbal prescription, the prescriber must satisfy the operator of the pharmacy or dispensing physician that a completed Health Canada Side Effect Reporting Form for each of the lower-cost interchangeable drug products trialed has been completed and signed by the prescriber. A written record of this verbal prescription and the completed Health Canada Side Effect Reporting Form must be received by the pharmacy prior to claim submission. Upon receipt, the pharmacist must: • Fax, submit online or mail the completed and signed form to Health Canada’s Canada Vigilance Program; and • Retain his or her copy of the completed and signed Side Effect Reporting Form. (ontario.ca, Revision #17; 2026-08-03 ↗)

Jamp Nintedanib · DIN 02540762 Manufacturer: Jamp Pharma Corporation; listing date 2026-01-30 Health Canada: Marketed since 2025-12-22 · brand JAMP NINTEDANIB · ATC L01EX09 NINTEDANIB · form Capsule · route Oral · ingredients NINTEDANIB (NINTEDANIB ESILATE) 150 MG · company Jamp pharma corporation · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02540762). DIN 02540762: Jamp Nintedanib Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 480200002; group id 569; item number 1520; lccId None; manufacturer id JPC Source form: Cap; strength: 150mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $28.4168; ministry $28.4168 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02540762 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102944

Interchangeable products

Auro-Nintedanib · DIN 02526905 · $28.4168 Ofev · DIN 02443074 · $28.4168

Shortage status: not checked (no credentials)