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

Patient plan: look up a medication list

RIOCIGUAT

All strengths: Off-Formulary Interchangeable, not an ODB benefit; same patient cost rules

Shared coverage and patient cost rules
StatusOff-Formulary Interchangeable, not an ODB benefit
Patient paysPatient pays: program not supplied; amount cannot be determined.

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

  • Ambrisentan (Volibris): not a benefit
  • Bosentan (Tracleer): not a benefit

Adempas · DIN 02412764 · 0.5mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
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 ↗)
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 Riociguat Brand(s): Adempas DOSAGE FORM/ STRENGTH: 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg tablet For the treatment of chronic thromboembolic pulmonary hypertension (CTEPH) in patients who meet the following criteria; • the physician making the request is a clinician with experience in the diagnosis and treatment of CTEPH1; AND • the patient is diagnosed with inoperable CTEPH (World Health Organization [WHO] Group 4); OR persistent or recurrent CTEPH after surgical treatment in adult patients (18 years of age or older) with WHO Functional Class (FC) II or III pulmonary hypertension. 1 Request should come from a clinician from a Pulmonary Hypertension referral centre (See Pulmonary Arterial Hypertension referral clinics above). Duration of Approval: 1 Year Renewal of funding will be considered for patients who continue to respond to therapy with riociguat. When submitting a request for renewal of funding, the physician should submit clinical information to support that the patient is deriving benefit from the treatment compared to before they started the treatment. The physician should provide confirmation of improvement of any ONE or more reasonable clinical parameters which supports the response of the patient’s CTEPH to riociguat. Duration of Approval: 1 Year Requests for subsequent funding renewals (i.e. beyond the first two years of treatment) will be considered when a physician provides written confirmation that the patient continues to respond to therapy with riociguat. The physician should provide confirmation of improvement of any ONE or more reasonable clinical parameters which supports the response of the patient’s CTEPH to riociguat compared to baseline or that supports that the patient’s condition is stable while on riociguat. Duration of Approval: Subsequent Renewals - 5 Years 423 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 423, record 262, 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
Adempas · DIN 02412764 Manufacturer: Bayer Inc., Health Care Division; listing date 2024-06-28 Health Canada: Marketed since 2013-09-25 · brand ADEMPAS · ATC C02KX05 RIOCIGUAT · form Tablet · route Oral · ingredients RIOCIGUAT 0.5 MG · company Bayer inc · schedule Prescription
Check this DIN again · Health Canada product record

Ministry pays: $24.0460 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=89742 · Verify on the e-Formulary ↗ (DIN 02412764)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02412764). DIN 02412764: Adempas Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 241200098; group id 370; item number 0874; lccId None; manufacturer id BAH Source form: Tab; strength: 0.5mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $43.7200; ministry $24.0460 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02412764 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=89742
Interchangeable products
Sandoz Riociguat · DIN 02533545 · $24.0460
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=02412764
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Sandoz Riociguat · DIN 02533545 · 0.5mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
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 criteria on record are for Brand(s): Adempas; DOSAGE FORM/ STRENGTH: 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg tablet — 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 Riociguat Brand(s): Adempas DOSAGE FORM/ STRENGTH: 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg tablet For the treatment of chronic thromboembolic pulmonary hypertension (CTEPH) in patients who meet the following criteria; • the physician making the request is a clinician with experience in the diagnosis and treatment of CTEPH1; AND • the patient is diagnosed with inoperable CTEPH (World Health Organization [WHO] Group 4); OR persistent or recurrent CTEPH after surgical treatment in adult patients (18 years of age or older) with WHO Functional Class (FC) II or III pulmonary hypertension. 1 Request should come from a clinician from a Pulmonary Hypertension referral centre (See Pulmonary Arterial Hypertension referral clinics above). Duration of Approval: 1 Year Renewal of funding will be considered for patients who continue to respond to therapy with riociguat. When submitting a request for renewal of funding, the physician should submit clinical information to support that the patient is deriving benefit from the treatment compared to before they started the treatment. The physician should provide confirmation of improvement of any ONE or more reasonable clinical parameters which supports the response of the patient’s CTEPH to riociguat. Duration of Approval: 1 Year Requests for subsequent funding renewals (i.e. beyond the first two years of treatment) will be considered when a physician provides written confirmation that the patient continues to respond to therapy with riociguat. The physician should provide confirmation of improvement of any ONE or more reasonable clinical parameters which supports the response of the patient’s CTEPH to riociguat compared to baseline or that supports that the patient’s condition is stable while on riociguat. Duration of Approval: Subsequent Renewals - 5 Years 423 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 423, record 262, corpus 2025-01-01; name match only, not an eligibility decision
1 brand, same coverage
Sandoz Riociguat · DIN 02533545 Manufacturer: Sandoz Canada Inc.; listing date 2024-06-28 Health Canada: Marketed since 2024-04-29 · brand SANDOZ RIOCIGUAT · ATC C02KX05 RIOCIGUAT · form Tablet · route Oral · ingredients RIOCIGUAT 0.5 MG · company Sandoz canada incorporated · schedule Prescription
Check this DIN again · Health Canada product record

Sandoz Riociguat: Formulary list price $24.0460/unit (unit not stated in source; not the patient's cost)

Ministry pays: $24.0460 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=102253 · Verify on the e-Formulary ↗ (DIN 02533545)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02533545). DIN 02533545: Sandoz Riociguat Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 241200098; group id 370; item number 0874; lccId None; manufacturer id SDZ Source form: Tab; strength: 0.5mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $24.0460; ministry $24.0460 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02533545 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102253
Interchangeable products
Adempas · DIN 02412764 · $24.0460
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=02533545
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Adempas · DIN 02412772 · 1mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
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 ↗)
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 Riociguat Brand(s): Adempas DOSAGE FORM/ STRENGTH: 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg tablet For the treatment of chronic thromboembolic pulmonary hypertension (CTEPH) in patients who meet the following criteria; • the physician making the request is a clinician with experience in the diagnosis and treatment of CTEPH1; AND • the patient is diagnosed with inoperable CTEPH (World Health Organization [WHO] Group 4); OR persistent or recurrent CTEPH after surgical treatment in adult patients (18 years of age or older) with WHO Functional Class (FC) II or III pulmonary hypertension. 1 Request should come from a clinician from a Pulmonary Hypertension referral centre (See Pulmonary Arterial Hypertension referral clinics above). Duration of Approval: 1 Year Renewal of funding will be considered for patients who continue to respond to therapy with riociguat. When submitting a request for renewal of funding, the physician should submit clinical information to support that the patient is deriving benefit from the treatment compared to before they started the treatment. The physician should provide confirmation of improvement of any ONE or more reasonable clinical parameters which supports the response of the patient’s CTEPH to riociguat. Duration of Approval: 1 Year Requests for subsequent funding renewals (i.e. beyond the first two years of treatment) will be considered when a physician provides written confirmation that the patient continues to respond to therapy with riociguat. The physician should provide confirmation of improvement of any ONE or more reasonable clinical parameters which supports the response of the patient’s CTEPH to riociguat compared to baseline or that supports that the patient’s condition is stable while on riociguat. Duration of Approval: Subsequent Renewals - 5 Years 423 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 423, record 262, 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
Adempas · DIN 02412772 Manufacturer: Bayer Inc., Health Care Division; listing date 2024-06-28 Health Canada: Marketed since 2013-09-25 · brand ADEMPAS · ATC C02KX05 RIOCIGUAT · form Tablet · route Oral · ingredients RIOCIGUAT 1 MG · company Bayer inc · schedule Prescription
Check this DIN again · Health Canada product record

Ministry pays: $24.0460 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=89743 · Verify on the e-Formulary ↗ (DIN 02412772)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02412772). DIN 02412772: Adempas Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 241200099; group id 370; item number 0876; lccId None; manufacturer id BAH Source form: Tab; strength: 1mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $43.7200; ministry $24.0460 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02412772 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=89743
Interchangeable products
Sandoz Riociguat · DIN 02533561 · $24.0460
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=02412772
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Sandoz Riociguat · DIN 02533561 · 1mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
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 criteria on record are for Brand(s): Adempas; DOSAGE FORM/ STRENGTH: 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg tablet — 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 Riociguat Brand(s): Adempas DOSAGE FORM/ STRENGTH: 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg tablet For the treatment of chronic thromboembolic pulmonary hypertension (CTEPH) in patients who meet the following criteria; • the physician making the request is a clinician with experience in the diagnosis and treatment of CTEPH1; AND • the patient is diagnosed with inoperable CTEPH (World Health Organization [WHO] Group 4); OR persistent or recurrent CTEPH after surgical treatment in adult patients (18 years of age or older) with WHO Functional Class (FC) II or III pulmonary hypertension. 1 Request should come from a clinician from a Pulmonary Hypertension referral centre (See Pulmonary Arterial Hypertension referral clinics above). Duration of Approval: 1 Year Renewal of funding will be considered for patients who continue to respond to therapy with riociguat. When submitting a request for renewal of funding, the physician should submit clinical information to support that the patient is deriving benefit from the treatment compared to before they started the treatment. The physician should provide confirmation of improvement of any ONE or more reasonable clinical parameters which supports the response of the patient’s CTEPH to riociguat. Duration of Approval: 1 Year Requests for subsequent funding renewals (i.e. beyond the first two years of treatment) will be considered when a physician provides written confirmation that the patient continues to respond to therapy with riociguat. The physician should provide confirmation of improvement of any ONE or more reasonable clinical parameters which supports the response of the patient’s CTEPH to riociguat compared to baseline or that supports that the patient’s condition is stable while on riociguat. Duration of Approval: Subsequent Renewals - 5 Years 423 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 423, record 262, corpus 2025-01-01; name match only, not an eligibility decision
1 brand, same coverage
Sandoz Riociguat · DIN 02533561 Manufacturer: Sandoz Canada Inc.; listing date 2024-06-28 Health Canada: Marketed since 2024-04-29 · brand SANDOZ RIOCIGUAT · ATC C02KX05 RIOCIGUAT · form Tablet · route Oral · ingredients RIOCIGUAT 1 MG · company Sandoz canada incorporated · schedule Prescription
Check this DIN again · Health Canada product record

Sandoz Riociguat: Formulary list price $24.0460/unit (unit not stated in source; not the patient's cost)

Ministry pays: $24.0460 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=102255 · Verify on the e-Formulary ↗ (DIN 02533561)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02533561). DIN 02533561: Sandoz Riociguat Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 241200099; group id 370; item number 0876; lccId None; manufacturer id SDZ Source form: Tab; strength: 1mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $24.0460; ministry $24.0460 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02533561 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102255
Interchangeable products
Adempas · DIN 02412772 · $24.0460
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=02533561
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Adempas · DIN 02412799 · 1.5mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
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 ↗)
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 Riociguat Brand(s): Adempas DOSAGE FORM/ STRENGTH: 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg tablet For the treatment of chronic thromboembolic pulmonary hypertension (CTEPH) in patients who meet the following criteria; • the physician making the request is a clinician with experience in the diagnosis and treatment of CTEPH1; AND • the patient is diagnosed with inoperable CTEPH (World Health Organization [WHO] Group 4); OR persistent or recurrent CTEPH after surgical treatment in adult patients (18 years of age or older) with WHO Functional Class (FC) II or III pulmonary hypertension. 1 Request should come from a clinician from a Pulmonary Hypertension referral centre (See Pulmonary Arterial Hypertension referral clinics above). Duration of Approval: 1 Year Renewal of funding will be considered for patients who continue to respond to therapy with riociguat. When submitting a request for renewal of funding, the physician should submit clinical information to support that the patient is deriving benefit from the treatment compared to before they started the treatment. The physician should provide confirmation of improvement of any ONE or more reasonable clinical parameters which supports the response of the patient’s CTEPH to riociguat. Duration of Approval: 1 Year Requests for subsequent funding renewals (i.e. beyond the first two years of treatment) will be considered when a physician provides written confirmation that the patient continues to respond to therapy with riociguat. The physician should provide confirmation of improvement of any ONE or more reasonable clinical parameters which supports the response of the patient’s CTEPH to riociguat compared to baseline or that supports that the patient’s condition is stable while on riociguat. Duration of Approval: Subsequent Renewals - 5 Years 423 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 423, record 262, 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
Adempas · DIN 02412799 Manufacturer: Bayer Inc., Health Care Division; listing date 2024-06-28 Health Canada: Marketed since 2013-09-25 · brand ADEMPAS · ATC C02KX05 RIOCIGUAT · form Tablet · route Oral · ingredients RIOCIGUAT 1.5 MG · company Bayer inc · schedule Prescription
Check this DIN again · Health Canada product record

Ministry pays: $24.0460 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=89745 · Verify on the e-Formulary ↗ (DIN 02412799)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02412799). DIN 02412799: Adempas Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 241200100; group id 370; item number 0875; lccId None; manufacturer id BAH Source form: Tab; strength: 1.5mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $43.7200; ministry $24.0460 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02412799 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=89745
Interchangeable products
Sandoz Riociguat · DIN 02533588 · $24.0460
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=02412799
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Sandoz Riociguat · DIN 02533588 · 1.5mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
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 criteria on record are for Brand(s): Adempas; DOSAGE FORM/ STRENGTH: 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg tablet — 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 Riociguat Brand(s): Adempas DOSAGE FORM/ STRENGTH: 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg tablet For the treatment of chronic thromboembolic pulmonary hypertension (CTEPH) in patients who meet the following criteria; • the physician making the request is a clinician with experience in the diagnosis and treatment of CTEPH1; AND • the patient is diagnosed with inoperable CTEPH (World Health Organization [WHO] Group 4); OR persistent or recurrent CTEPH after surgical treatment in adult patients (18 years of age or older) with WHO Functional Class (FC) II or III pulmonary hypertension. 1 Request should come from a clinician from a Pulmonary Hypertension referral centre (See Pulmonary Arterial Hypertension referral clinics above). Duration of Approval: 1 Year Renewal of funding will be considered for patients who continue to respond to therapy with riociguat. When submitting a request for renewal of funding, the physician should submit clinical information to support that the patient is deriving benefit from the treatment compared to before they started the treatment. The physician should provide confirmation of improvement of any ONE or more reasonable clinical parameters which supports the response of the patient’s CTEPH to riociguat. Duration of Approval: 1 Year Requests for subsequent funding renewals (i.e. beyond the first two years of treatment) will be considered when a physician provides written confirmation that the patient continues to respond to therapy with riociguat. The physician should provide confirmation of improvement of any ONE or more reasonable clinical parameters which supports the response of the patient’s CTEPH to riociguat compared to baseline or that supports that the patient’s condition is stable while on riociguat. Duration of Approval: Subsequent Renewals - 5 Years 423 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 423, record 262, corpus 2025-01-01; name match only, not an eligibility decision
1 brand, same coverage
Sandoz Riociguat · DIN 02533588 Manufacturer: Sandoz Canada Inc.; listing date 2024-06-28 Health Canada: Marketed since 2024-04-29 · brand SANDOZ RIOCIGUAT · ATC C02KX05 RIOCIGUAT · form Tablet · route Oral · ingredients RIOCIGUAT 1.5 MG · company Sandoz canada incorporated · schedule Prescription
Check this DIN again · Health Canada product record

Sandoz Riociguat: Formulary list price $24.0460/unit (unit not stated in source; not the patient's cost)

Ministry pays: $24.0460 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=102256 · Verify on the e-Formulary ↗ (DIN 02533588)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02533588). DIN 02533588: Sandoz Riociguat Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 241200100; group id 370; item number 0875; lccId None; manufacturer id SDZ Source form: Tab; strength: 1.5mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $24.0460; ministry $24.0460 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02533588 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102256
Interchangeable products
Adempas · DIN 02412799 · $24.0460
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=02533588
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Adempas · DIN 02412802 · 2mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
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 ↗)
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 Riociguat Brand(s): Adempas DOSAGE FORM/ STRENGTH: 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg tablet For the treatment of chronic thromboembolic pulmonary hypertension (CTEPH) in patients who meet the following criteria; • the physician making the request is a clinician with experience in the diagnosis and treatment of CTEPH1; AND • the patient is diagnosed with inoperable CTEPH (World Health Organization [WHO] Group 4); OR persistent or recurrent CTEPH after surgical treatment in adult patients (18 years of age or older) with WHO Functional Class (FC) II or III pulmonary hypertension. 1 Request should come from a clinician from a Pulmonary Hypertension referral centre (See Pulmonary Arterial Hypertension referral clinics above). Duration of Approval: 1 Year Renewal of funding will be considered for patients who continue to respond to therapy with riociguat. When submitting a request for renewal of funding, the physician should submit clinical information to support that the patient is deriving benefit from the treatment compared to before they started the treatment. The physician should provide confirmation of improvement of any ONE or more reasonable clinical parameters which supports the response of the patient’s CTEPH to riociguat. Duration of Approval: 1 Year Requests for subsequent funding renewals (i.e. beyond the first two years of treatment) will be considered when a physician provides written confirmation that the patient continues to respond to therapy with riociguat. The physician should provide confirmation of improvement of any ONE or more reasonable clinical parameters which supports the response of the patient’s CTEPH to riociguat compared to baseline or that supports that the patient’s condition is stable while on riociguat. Duration of Approval: Subsequent Renewals - 5 Years 423 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 423, record 262, 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
Adempas · DIN 02412802 Manufacturer: Bayer Inc., Health Care Division; listing date 2024-06-28 Health Canada: Marketed since 2013-09-25 · brand ADEMPAS · ATC C02KX05 RIOCIGUAT · form Tablet · route Oral · ingredients RIOCIGUAT 2 MG · company Bayer inc · schedule Prescription
Check this DIN again · Health Canada product record

Ministry pays: $24.0460 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=89746 · Verify on the e-Formulary ↗ (DIN 02412802)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02412802). DIN 02412802: Adempas Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 241200101; group id 370; item number 0878; lccId None; manufacturer id BAH Source form: Tab; strength: 2mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $43.7200; ministry $24.0460 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02412802 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=89746
Interchangeable products
Sandoz Riociguat · DIN 02533596 · $24.0460
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=02412802
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Sandoz Riociguat · DIN 02533596 · 2mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
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 criteria on record are for Brand(s): Adempas; DOSAGE FORM/ STRENGTH: 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg tablet — 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 Riociguat Brand(s): Adempas DOSAGE FORM/ STRENGTH: 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg tablet For the treatment of chronic thromboembolic pulmonary hypertension (CTEPH) in patients who meet the following criteria; • the physician making the request is a clinician with experience in the diagnosis and treatment of CTEPH1; AND • the patient is diagnosed with inoperable CTEPH (World Health Organization [WHO] Group 4); OR persistent or recurrent CTEPH after surgical treatment in adult patients (18 years of age or older) with WHO Functional Class (FC) II or III pulmonary hypertension. 1 Request should come from a clinician from a Pulmonary Hypertension referral centre (See Pulmonary Arterial Hypertension referral clinics above). Duration of Approval: 1 Year Renewal of funding will be considered for patients who continue to respond to therapy with riociguat. When submitting a request for renewal of funding, the physician should submit clinical information to support that the patient is deriving benefit from the treatment compared to before they started the treatment. The physician should provide confirmation of improvement of any ONE or more reasonable clinical parameters which supports the response of the patient’s CTEPH to riociguat. Duration of Approval: 1 Year Requests for subsequent funding renewals (i.e. beyond the first two years of treatment) will be considered when a physician provides written confirmation that the patient continues to respond to therapy with riociguat. The physician should provide confirmation of improvement of any ONE or more reasonable clinical parameters which supports the response of the patient’s CTEPH to riociguat compared to baseline or that supports that the patient’s condition is stable while on riociguat. Duration of Approval: Subsequent Renewals - 5 Years 423 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 423, record 262, corpus 2025-01-01; name match only, not an eligibility decision
1 brand, same coverage
Sandoz Riociguat · DIN 02533596 Manufacturer: Sandoz Canada Inc.; listing date 2024-06-28 Health Canada: Marketed since 2024-04-29 · brand SANDOZ RIOCIGUAT · ATC C02KX05 RIOCIGUAT · form Tablet · route Oral · ingredients RIOCIGUAT 2 MG · company Sandoz canada incorporated · schedule Prescription
Check this DIN again · Health Canada product record

Sandoz Riociguat: Formulary list price $24.0460/unit (unit not stated in source; not the patient's cost)

Ministry pays: $24.0460 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=102258 · Verify on the e-Formulary ↗ (DIN 02533596)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02533596). DIN 02533596: Sandoz Riociguat Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 241200101; group id 370; item number 0878; lccId None; manufacturer id SDZ Source form: Tab; strength: 2mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $24.0460; ministry $24.0460 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02533596 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102258
Interchangeable products
Adempas · DIN 02412802 · $24.0460
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=02533596
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Adempas · DIN 02412810 · 2.5mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
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 ↗)
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 Riociguat Brand(s): Adempas DOSAGE FORM/ STRENGTH: 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg tablet For the treatment of chronic thromboembolic pulmonary hypertension (CTEPH) in patients who meet the following criteria; • the physician making the request is a clinician with experience in the diagnosis and treatment of CTEPH1; AND • the patient is diagnosed with inoperable CTEPH (World Health Organization [WHO] Group 4); OR persistent or recurrent CTEPH after surgical treatment in adult patients (18 years of age or older) with WHO Functional Class (FC) II or III pulmonary hypertension. 1 Request should come from a clinician from a Pulmonary Hypertension referral centre (See Pulmonary Arterial Hypertension referral clinics above). Duration of Approval: 1 Year Renewal of funding will be considered for patients who continue to respond to therapy with riociguat. When submitting a request for renewal of funding, the physician should submit clinical information to support that the patient is deriving benefit from the treatment compared to before they started the treatment. The physician should provide confirmation of improvement of any ONE or more reasonable clinical parameters which supports the response of the patient’s CTEPH to riociguat. Duration of Approval: 1 Year Requests for subsequent funding renewals (i.e. beyond the first two years of treatment) will be considered when a physician provides written confirmation that the patient continues to respond to therapy with riociguat. The physician should provide confirmation of improvement of any ONE or more reasonable clinical parameters which supports the response of the patient’s CTEPH to riociguat compared to baseline or that supports that the patient’s condition is stable while on riociguat. Duration of Approval: Subsequent Renewals - 5 Years 423 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 423, record 262, 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
Adempas · DIN 02412810 Manufacturer: Bayer Inc., Health Care Division; listing date 2024-06-28 Health Canada: Marketed since 2013-09-25 · brand ADEMPAS · ATC C02KX05 RIOCIGUAT · form Tablet · route Oral · ingredients RIOCIGUAT 2.5 MG · company Bayer inc · schedule Prescription
Check this DIN again · Health Canada product record

Ministry pays: $24.0460 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=89747 · Verify on the e-Formulary ↗ (DIN 02412810)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02412810). DIN 02412810: Adempas Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 241200102; group id 370; item number 0877; lccId None; manufacturer id BAH Source form: Tab; strength: 2.5mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $43.7200; ministry $24.0460 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02412810 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=89747
Interchangeable products
Sandoz Riociguat · DIN 02533618 · $24.0460
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=02412810
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Sandoz Riociguat · DIN 02533618 · 2.5mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
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 criteria on record are for Brand(s): Adempas; DOSAGE FORM/ STRENGTH: 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg tablet — 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 Riociguat Brand(s): Adempas DOSAGE FORM/ STRENGTH: 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg tablet For the treatment of chronic thromboembolic pulmonary hypertension (CTEPH) in patients who meet the following criteria; • the physician making the request is a clinician with experience in the diagnosis and treatment of CTEPH1; AND • the patient is diagnosed with inoperable CTEPH (World Health Organization [WHO] Group 4); OR persistent or recurrent CTEPH after surgical treatment in adult patients (18 years of age or older) with WHO Functional Class (FC) II or III pulmonary hypertension. 1 Request should come from a clinician from a Pulmonary Hypertension referral centre (See Pulmonary Arterial Hypertension referral clinics above). Duration of Approval: 1 Year Renewal of funding will be considered for patients who continue to respond to therapy with riociguat. When submitting a request for renewal of funding, the physician should submit clinical information to support that the patient is deriving benefit from the treatment compared to before they started the treatment. The physician should provide confirmation of improvement of any ONE or more reasonable clinical parameters which supports the response of the patient’s CTEPH to riociguat. Duration of Approval: 1 Year Requests for subsequent funding renewals (i.e. beyond the first two years of treatment) will be considered when a physician provides written confirmation that the patient continues to respond to therapy with riociguat. The physician should provide confirmation of improvement of any ONE or more reasonable clinical parameters which supports the response of the patient’s CTEPH to riociguat compared to baseline or that supports that the patient’s condition is stable while on riociguat. Duration of Approval: Subsequent Renewals - 5 Years 423 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 423, record 262, corpus 2025-01-01; name match only, not an eligibility decision
1 brand, same coverage
Sandoz Riociguat · DIN 02533618 Manufacturer: Sandoz Canada Inc.; listing date 2024-06-28 Health Canada: Marketed since 2024-04-29 · brand SANDOZ RIOCIGUAT · ATC C02KX05 RIOCIGUAT · form Tablet · route Oral · ingredients RIOCIGUAT 2.5 MG · company Sandoz canada incorporated · schedule Prescription
Check this DIN again · Health Canada product record

Sandoz Riociguat: Formulary list price $24.0460/unit (unit not stated in source; not the patient's cost)

Ministry pays: $24.0460 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=102257 · Verify on the e-Formulary ↗ (DIN 02533618)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02533618). DIN 02533618: Sandoz Riociguat Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 241200102; group id 370; item number 0877; lccId None; manufacturer id SDZ Source form: Tab; strength: 2.5mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $24.0460; ministry $24.0460 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02533618 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102257
Interchangeable products
Adempas · DIN 02412810 · $24.0460
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=02533618
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

BOSENTAN MONOHYDRATE

· 14 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 62.5mg, 125mg · 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 Pulmonary Hypertension ADEMPAS (riociguat) is indicated for the treatment of:  inoperable chronic thromboembolic pulmonary hypertension (CTEPH, WHO Group 4)  persistent or recurrent CTEPH after surgical treatment  pulmonary arterial hypertension (PAH, WHO Group 1), as monotherapy or in combination with endothelin receptor antagonists in adult patients (≥18 years of age) with WHO Functional Class II or III pulmonary hypertension. ADEMPAS should only be used by clinicians experienced in the diagnosis and treatment of CTEPH or PAH. 1.1 Pediatrics Pediatrics (<18 years of age): Safety and effectiveness in pediatric patients have not been established (see 7.1.3 Pediatrics). Therefore, Health Canada has not authorized an indication for pediatric use. 1.2 Geriatrics Geriatrics (≥ 65 years of age): Evidence from clinical studies and experience suggests that use in the geriatric population (up to 80 years of age) is associated with increases in some adverse events (see 7.1.4 Geriatrics). https://pdf.hres.ca/dpd_pm/00067772.PDF PM date: September 19, 2013 Source product: ADEMPAS; DIN 02412764; 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

Riociguat (Adempas)

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 chronic thromboembolic pulmonary hypertension (CTEPH) in patients who meet the following criteria;

Ministry criteria corpus 2025-01-01; page 423

Riociguat Brand(s): Adempas DOSAGE FORM/ STRENGTH: 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg tablet
For the treatment of chronic thromboembolic pulmonary hypertension (CTEPH) in patients who meet the following criteria;
• the physician making the request is a clinician with experience in the diagnosis and treatment of CTEPH1; AND
• the patient is diagnosed with inoperable CTEPH (World Health Organization [WHO] Group 4); OR persistent or recurrent CTEPH after surgical treatment in adult patients (18 years of age or older) with WHO Functional Class (FC) II or III pulmonary hypertension. 1 Request should come from a clinician from a Pulmonary Hypertension referral centre
(See Pulmonary Arterial Hypertension referral clinics above). Duration of Approval: 1 Year Renewal of funding will be considered for patients who continue to respond to therapy with riociguat. When submitting a request for renewal of funding, the physician should submit clinical information to support that the patient is deriving benefit from the treatment compared to before they started the treatment. The physician should provide confirmation of improvement of any ONE or more reasonable clinical parameters which supports the response of the patient’s CTEPH to riociguat.
Duration of Approval: 1 Year
Requests for subsequent funding renewals (i.e. beyond the first two years of treatment) will be considered when a physician provides written confirmation that the patient continues to respond to therapy with riociguat. The physician should provide confirmation of improvement of any ONE or more reasonable clinical parameters which supports the response of the patient’s CTEPH to riociguat compared to baseline or that supports that the patient’s condition is stable while on riociguat.
Duration of Approval: Subsequent Renewals - 5 Years
423

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

Other review policies

For Sandoz Riociguat: no applicable EAP criteria are held and no ODB benefit is established. These policies do not establish coverage.

For rare, immediately life-, limb- or organ-threatening circumstances, the Compassionate Review Policy may consider an unfunded drug or indication, subject to its criteria and without bypassing the drug review process. Compassionate Review Policy

Compassionate Review Policy: source quote
Where there are rare clinical circumstances in immediately life, limb, or organ-threatening conditions, the Executive Officer will also consider requests for drugs or indications in situations where there has not been a decision by the Executive Officer to provide funding of the drug or indication as part of the Ontario Drug Benefit program (and the EAP), and the drug or indication requested would not circumvent the established review process for new drugs or indications as part of the drug submission process for listing within the Ontario Drug Benefit program. Requests must meet the criteria for the Compassionate Review Policy.

Ontario source; updated September 15, 2026

For cancer drugs, Case-by-Case Review considers rare, immediately life-threatening circumstances when no satisfactory funded treatment exists; its criteria and application process apply. Case-by-Case Review (cancer drugs)

Case-by-Case Review (cancer drugs): source quote
Note: Requests for cancer drugs are considered under the Case-by-Case Review Program (CBCRP) which is administered by Ontario Health (Cancer Care Ontario) on behalf of the Ministry of Health. The CBCRP considers funding requests for drugs (both oral therapies and injectable drugs) for the treatment of cancer in patients who have a rare clinical circumstance that is immediately life-threatening (death is likely within a matter of months) and who require treatment with an unfunded drug, because there is no other satisfactory and funded treatment. Please refer to the Ontario Health website for information on the application process, FAQs, eligibility criteria and program policies.

Ontario source; updated September 15, 2026