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Ontario coverage, price, criteria word for word, Health Canada status and shortages for one product

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BOSENTAN MONOHYDRATE

All products: not a benefit

Other products in the same Health Canada class (C02KX) — coverage varies; not interchangeable

  • Ambrisentan (Volibris): not a benefit
  • Riociguat (Adempas): not a benefit

Tracleer · DIN 02244982 · 125mg · 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 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
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
Tracleer · DIN 02244982 Manufacturer: Janssen Inc.; listing date 2012-07-27 Health Canada: Marketed since 2019-10-18 · brand TRACLEER · ATC C02KX01 BOSENTAN · form Tablet · route Oral · ingredients BOSENTAN (BOSENTAN MONOHYDRATE) 125 MG · company Janssen inc · schedule Prescription
Check this DIN again · Health Canada product record

Ministry pays: $32.0893 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=68980 · Verify on the e-Formulary ↗ (DIN 02244982)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02244982). DIN 02244982: Tracleer Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 241200097; group id 363; item number 0850; lccId None; manufacturer id JAN Source form: Tab; strength: 125mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $88.8725; ministry $32.0893 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02244982 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=68980
Interchangeable products
Apo-Bosentan · DIN 02399210 · $32.0893 Co Bosentan · DIN 02386208 · $32.0893 Nat-Bosentan · DIN 02467992 · $32.0893 PMS-Bosentan · DIN 02383020 · $32.0893 Sandoz Bosentan · DIN 02386283 · $32.0893 Taro-Bosentan · DIN 02483149 · $32.0893
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=02244982
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary class (24:12 Vasodilating Drugs) and how they are covered

Matched class: 24:12 Vasodilating Drugs

Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment. Some products covered without a code (check the product listing): ISOSORBIDE DINITRATE, NITROGLYCERIN 24:12 Vasodilating Drugs

AMBRISENTAN

· 7 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 5mg, 10mg · Tab

RIOCIGUAT

· 10 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 0.5mg, 1.5mg, 1mg, 2.5mg, 2mg · Tab

ISOSORBIDE DINITRATE

· 6 products · General benefit (3), Listed, not a benefit (3) · strengths: 5mg, 10mg, 30mg · SL Tab, Tab

NITROGLYCERIN

· 20 products · General benefit (13), Temporary benefit (2), Listed, not a benefit (1), Off-Formulary Interchangeable, not an ODB benefit (4) · strengths: 0.4mg/Hr/20 Sq Cm, 0.6mg/Hr/30 Sq Cm, 0.4mg/Hr/14 Sq Cm, 0.6mg/Hr/21 Sq Cm, 0.3mg, 0.6mg, 0.4mg/Metered Dose, 0.2mg/Hr, 0.4mg/Hr, 0.6mg/Hr, 0.8mg/Hr · Patch, SL Tab, Sp-180 Dose Pk, Sp-75 Dose Pk, Spray-200 Dose Pk, Transdermal Patch

DIPYRIDAMOLE & ACETYLSALICYLIC ACID

· 2 products · Listed, not a benefit (1), Limited Use, codes 349 (1) · strengths: 200mg/25mg · Cap

NIMODIPINE

· 1 products · Limited Use, codes 42, 43 · strengths: 30mg · Tab

VERICIGUAT

· 3 products · Limited Use, codes 685 · strengths: 2.5mg, 5mg, 10mg · Tab

BETAHISTINE DIHYDROCHLORIDE

· 24 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 8mg, 16mg, 24mg · Tab

DIPYRIDAMOLE

· 6 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 25mg, 50mg, 75mg · Tab

ISOSORBIDE-5-MONONITRATE

· 3 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 60mg · ER Tab

TADALAFIL

· 73 products · Off-Formulary Interchangeable, not an ODB benefit (72), Off-Formulary Interchangeable, not an ODB benefit; DIN status E (meaning unconfirmed); confirm discontinuation/availability with Health Canada (1) · strengths: 2.5mg, 5mg, 10mg, 20mg · Tab

VARDENAFIL HCL

· 16 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 10mg, 5mg, 20mg · Orally Disintergrating Tab, Tab Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 24:12
Full class listing Related classes: 24:04 Cardiac Drugs, 24:06 Antilipemic Drugs, 24:08 Hypotensive Drugs (For Diuretics See 40:28), 24:32 Renin-Angiotensin Aldosterone Inhibitors Same formulary class, not same indication: class membership alone does not establish equivalent uses.
What the Health Canada label says it is for
1 Indications TRACLEER® (bosentan monohydrate) is indicated for the treatment of: • pulmonary arterial hypertension in patients with WHO functional class III or IV primary pulmonary hypertension, or • pulmonary hypertension secondary to scleroderma or congenital heart disease or human immunodeficiency virus in patients who did not respond adequately to conventional therapy. As well, a prolongation of time to clinical worsening was shown in patients with WHO functional class II. 1.1 Pediatrics Pediatrics (<18 years of age): There is only limited experience with TRACLEER in patients under the age of 18 years (see 7.1.3 Pediatrics). Based on the data submitted and reviewed by Health Canada, the safety and efficacy of TRACLEER in pediatric patients has not been established; therefore, Health Canada has not authorized an indication for pediatric use. 1.2 Geriatrics Geriatrics (> 65 years of age): Data available to Health Canada are insufficient to establish differences in the safety and efficacy associated with the use of TRACLEER in geriatric patients. https://pdf.hres.ca/dpd_pm/00081800.PDF PM date: 2025-09-12 Source product: TRACLEER; DIN 02244981; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.

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

Bosentan (Tracleer, Generics (Co-, Mylan-. PMS-, Sandoz-))

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 patients with pulmonary arterial hypertension (PAH) [WHO Group 1 Pulmonary hypertension] who meet all the following criteria;

Ministry criteria corpus 2025-01-01; page 416

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

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

Bosentan (Tracleer, Generics (Co-, Mylan-. PMS-, Sandoz-))

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: See the ministry wording below; no separate indication heading is held.

Ministry criteria corpus 2025-01-01; page 417

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

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