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Exceptional Access Program criteria on record (ministry list dated 2025-01-01, not exhaustive): Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. https://www.ontario.ca/page/sadie-special-authorization-digital-information-exchange Ambrisentan Brand(s): Volibris DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet Bosentan Brand(s): Tracleer, Generics (Co-, Mylan-. PMS-, Sandoz-) DOSAGE FORM/ STRENGTH: 62.5 mg, 125 mg tablet Macitentan Brand(s): Opsumit DOSAGE FORM/ STRENGTH: 10 mg tablet Updated April 20, 2021 All requests (initial, renewal, monotherapy, combination therapy) for a PAH drug must come from one of the following recognized PAH referral centres. o Pulmonary Hypertension Centre Hamilton Health Sciences – General Hospital o The Firestone Institute Pulmonary Hypertension Program St. Joseph's Healthcare Hamilton and McMaster University o Pulmonary Hypertension Clinic Hotel Dieu Hospital/Kingston General Hospital o Pulmonary Hypertension Program London Health Science Centre – Victoria Hospital o Ottawa Pulmonary Hypertension Clinic University of Ottawa Heart Institute and the Ottawa Hospital o University Health Network Pulmonary Hypertension Program Toronto General Hospital Requests from other physicians/centres must include a recent (less than or equal to 3 months old) consult note/recommendation from a recognized PAH referral centre that supports the request; Out-of-province referral centre consults (e.g., from Winnipeg for patients in Northern Ontario) will also be considered on a case-by-case basis Initial Criteria: For the treatment of patients with pulmonary arterial hypertension (PAH) [WHO Group 1 Pulmonary hypertension] who meet all the following criteria; 416  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 416, record 250, corpus 2025-01-01; name match only, not an eligibility decision 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 Ambrisentan Brand(s): Volibris DOSAGE FORM/ STRENGTH: 5 mg, 10 mg tablet Bosentan Brand(s): Tracleer, Generics (Co-, Mylan-. PMS-, Sandoz-) DOSAGE FORM/ STRENGTH: 62.5 mg, 125 mg tablet Macitentan Brand(s): Opsumit DOSAGE FORM/ STRENGTH: 10 mg tablet Updated: April 20, 2021 • PAH defined as a resting mean pulmonary artery pressure (mPAP) of ≥ 25 mmHg at rest AND normal pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg on right heart catheterization1; AND • The drug request meets one of the following circumstances of use: o Drug is being used as monotherapy in a patient with WHO-functional class III or IV; OR o Drug is being used as monotherapy in a patient with WHO-functional class II who has contraindication or has intolerance to a PDE-5 inhibitor; OR o Drug is being used as sequential dual therapy in combination with a funded PDE-5 (i.e. sildenafil, tadalafil) or a funded prostanoid (i.e. epoprostenol, treprostinil) in a patient who has had an inadequate response with monotherapy (i.e., failure to achieve WHO-FC I or II; or 6MWD >440 metres; or no/mild RV failure); OR o Drug is being used as up-front dual therapy in combination with a funded PDE-5 (i.e. sildenafil, tadalafil) or a funded prostanoid (i.e. epoprostenol, treprostinil) in a patient with advanced disease (i.e. WHO-functional class III or IV; OR 6MWD <380 metres; OR evidence of RV failure.) 1 Note: Left ventricular end-diastolic pressure ≤15 mmHg is also acceptable. 417  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 417, record 253, corpus 2025-01-01; name match only, not an eligibility decision

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

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

Co Bosentan · DIN 02386194 Manufacturer: Cobalt Pharmaceuticals Company; listing date 2012-07-27 Health Canada: Cancelled post market since 2018-04-25 · brand ACT BOSENTAN · ATC C02KX01 BOSENTAN · form Tablet · route Oral · ingredients BOSENTAN (BOSENTAN MONOHYDRATE) 62.5 MG · company Actavis pharma company · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02386194). DIN 02386194: Co Bosentan Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 241200096; group id 363; item number 0849; lccId None; manufacturer id COB Source form: Tab; strength: 62.5mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $32.0893; ministry $32.0893 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02386194 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=87177

Interchangeable products

Apo-Bosentan · DIN 02399202 · $32.0893 Nat-Bosentan · DIN 02467984 · $32.0893 PMS-Bosentan · DIN 02383012 · $32.0893 Sandoz Bosentan · DIN 02386275 · $32.0893 Taro-Bosentan · DIN 02483130 · $32.0893 Tracleer · DIN 02244981 · $32.0893

Shortage status: not checked (no credentials)

Health Canada lists this DIN as Cancelled post market since 2018-04-25 — choose a marketed DIN from the same-category list.