SILDENAFIL
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 (G04B) — coverage varies; not interchangeable
- Darifenacin (Enablex): limited Use 290
- Solifenacin (Vesicare): limited Use 290
- Tolterodine l (Detrol LA): limited Use 290
- Trospium chloride (Trosec): limited Use 290, Not a benefit
Jamp-Sildenafil R · DIN 02469669 · 20mg · 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 criteria on record are for Brand(s): Revatio; DOSAGE FORM/ STRENGTH: 20 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
Sildenafil
Brand(s): Revatio
DOSAGE FORM/ STRENGTH: 20 mg tablet
Tadalafil
Brand(s): Adcirca
DOSAGE FORM/ STRENGTH: 20 mg tablet
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
414
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 414, record 245, corpus 2025-01-01; name match only, not an eligibility decision
Exceptional Access criteria on record are for Brand(s): Revatio; DOSAGE FORM/ STRENGTH: 20 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
Sildenafil
Brand(s): Revatio
DOSAGE FORM/ STRENGTH: 20 mg tablet
Tadalafil
Brand(s): Adcirca
DOSAGE FORM/ STRENGTH: 20 mg tablet
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
i) Sildenafil (Revatio, generics), Tadalafil (Adcirca, generics)
Initial Criteria:
For the treatment of patients with pulmonary arterial hypertension (PAH) [WHO Group 1
Pulmonary hypertension] who meet all the following criteria;
• 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 II (Note
that a PDE-5 inhibitor must be used as first line monotherapy for WHO-FC II
(unless contraindicated or demonstrated intolerance), III, or IV; OR
o Drug is being used as sequential dual therapy in combination with a funded ERA
(i.e. ambrisentan, bosentan, macitentan) 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 ERA (i.e.
ambrisentan, bosentan, macitentan) or a funded prostanoid (i.e. epoprostenol,
treprostinil) in a patient with advanced disease (i.e. WHO-functional class III or IV,
6MWD <380 metres; OR evidence of RV failure.)
1 Note: Left ventricular end-diastolic pressure ≤ 15 mmHg is also acceptable.
415
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 415, record 247, 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
Sildenafil
Brand(s): Revatio and generics, Viagra and generics
DOSAGE FORM/ STRENGTH: 20 mg (Revatio versions), 25 mg, 50 mg, 100 mg
(Viagra versions)
Effective date: September 9, 2022
For the treatment of severe Raynaud’s phenomenon (RP) and/or digital ulcers secondary
to scleroderma (systemic sclerosis) or scleroderma-like disease:
• After failure of at least one calcium channel blocker (CCB) OR without trial of a CCB
in a patient who has experienced an emergency situation such as threatened
ischemic digit(s) requiring hospitalization
• Must be prescribed by a specialist (i.e., rheumatologist, general internist, vascular
surgeon)
Duration of initial approval: 6 months
Renewals will be considered on a case-by-case basis for patients who demonstrate benefit
from treatment (e.g. positive response in the duration, frequency and or severity of RP
and/or improvement in the size or number of digital ulcers.)
Duration of renewals: 1 year
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 99, record 57, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
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 ↗)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
Jamp-Sildenafil R · DIN 02469669
Manufacturer: Jamp Pharma Corporation; listing date 2021-03-29
Health Canada: Marketed since 2021-02-08 · brand JAMP-SILDENAFIL R · ATC C02KX ANTIHYPERTENSIVES FOR PULMONARY ARTERIAL HYPERTENSION · form Tablet · route Oral · ingredients SILDENAFIL (SILDENAFIL CITRATE) 20 MG · company Jamp pharma corporation · schedule Prescription
Jamp-Sildenafil R: Formulary list price $7.2940/unit (unit not stated in source; not the patient's cost)
Ministry pays: $7.2940 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=95846 · Verify on the e-Formulary ↗ (DIN 02469669)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02469669).
DIN 02469669: Jamp-Sildenafil R
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000565; group id 957; item number 2271; lccId None; manufacturer id JPC
Source form: Tab; strength: 20mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $7.2940; ministry $7.2940
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02469669
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=95846
Interchangeable products
Apo-Sildenafil R · DIN 02418118 · $7.2940
PMS-Sildenafil R · DIN 02412179 · $7.2940
Revatio · DIN 02279401 · $7.2940
Teva-Sildenafil R · DIN 02319500 · $7.2940
Shortage status: resolved shortage (ended 2024-01-26); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02469669
Shortage record checked 2026-09-13T08:10:21.292534+00:00
PMS-Sildenafil R · DIN 02412179 · 20mg · 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 criteria on record are for Brand(s): Revatio; DOSAGE FORM/ STRENGTH: 20 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
Sildenafil
Brand(s): Revatio
DOSAGE FORM/ STRENGTH: 20 mg tablet
Tadalafil
Brand(s): Adcirca
DOSAGE FORM/ STRENGTH: 20 mg tablet
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
414
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 414, record 245, corpus 2025-01-01; name match only, not an eligibility decision
Exceptional Access criteria on record are for Brand(s): Revatio; DOSAGE FORM/ STRENGTH: 20 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
Sildenafil
Brand(s): Revatio
DOSAGE FORM/ STRENGTH: 20 mg tablet
Tadalafil
Brand(s): Adcirca
DOSAGE FORM/ STRENGTH: 20 mg tablet
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
i) Sildenafil (Revatio, generics), Tadalafil (Adcirca, generics)
Initial Criteria:
For the treatment of patients with pulmonary arterial hypertension (PAH) [WHO Group 1
Pulmonary hypertension] who meet all the following criteria;
• 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 II (Note
that a PDE-5 inhibitor must be used as first line monotherapy for WHO-FC II
(unless contraindicated or demonstrated intolerance), III, or IV; OR
o Drug is being used as sequential dual therapy in combination with a funded ERA
(i.e. ambrisentan, bosentan, macitentan) 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 ERA (i.e.
ambrisentan, bosentan, macitentan) or a funded prostanoid (i.e. epoprostenol,
treprostinil) in a patient with advanced disease (i.e. WHO-functional class III or IV,
6MWD <380 metres; OR evidence of RV failure.)
1 Note: Left ventricular end-diastolic pressure ≤ 15 mmHg is also acceptable.
415
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 415, record 247, 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
Sildenafil
Brand(s): Revatio and generics, Viagra and generics
DOSAGE FORM/ STRENGTH: 20 mg (Revatio versions), 25 mg, 50 mg, 100 mg
(Viagra versions)
Effective date: September 9, 2022
For the treatment of severe Raynaud’s phenomenon (RP) and/or digital ulcers secondary
to scleroderma (systemic sclerosis) or scleroderma-like disease:
• After failure of at least one calcium channel blocker (CCB) OR without trial of a CCB
in a patient who has experienced an emergency situation such as threatened
ischemic digit(s) requiring hospitalization
• Must be prescribed by a specialist (i.e., rheumatologist, general internist, vascular
surgeon)
Duration of initial approval: 6 months
Renewals will be considered on a case-by-case basis for patients who demonstrate benefit
from treatment (e.g. positive response in the duration, frequency and or severity of RP
and/or improvement in the size or number of digital ulcers.)
Duration of renewals: 1 year
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 99, record 57, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
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 ↗)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
PMS-Sildenafil R · DIN 02412179
Manufacturer: Pharmascience Inc.; listing date 2015-01-28
Health Canada: Marketed since 2014-11-14 · brand PMS-SILDENAFIL R · ATC C02KX ANTIHYPERTENSIVES FOR PULMONARY ARTERIAL HYPERTENSION · form Tablet · route Oral · ingredients SILDENAFIL (SILDENAFIL CITRATE) 20 MG · company Pharmascience inc · schedule Prescription
PMS-Sildenafil R: Formulary list price $7.2940/unit (unit not stated in source; not the patient's cost)
Ministry pays: $7.2940 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=89674 · Verify on the e-Formulary ↗ (DIN 02412179)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02412179).
DIN 02412179: PMS-Sildenafil R
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000565; group id 957; item number 2271; lccId None; manufacturer id PMS
Source form: Tab; strength: 20mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $7.2940; ministry $7.2940
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02412179
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=89674
Interchangeable products
Apo-Sildenafil R · DIN 02418118 · $7.2940
Jamp-Sildenafil R · DIN 02469669 · $7.2940
Revatio · DIN 02279401 · $7.2940
Teva-Sildenafil R · DIN 02319500 · $7.2940
Shortage status: resolved shortage (ended 2025-11-30); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02412179
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Revatio · DIN 02279401 · 20mg · 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
Sildenafil
Brand(s): Revatio and generics, Viagra and generics
DOSAGE FORM/ STRENGTH: 20 mg (Revatio versions), 25 mg, 50 mg, 100 mg
(Viagra versions)
Effective date: September 9, 2022
For the treatment of severe Raynaud’s phenomenon (RP) and/or digital ulcers secondary
to scleroderma (systemic sclerosis) or scleroderma-like disease:
• After failure of at least one calcium channel blocker (CCB) OR without trial of a CCB
in a patient who has experienced an emergency situation such as threatened
ischemic digit(s) requiring hospitalization
• Must be prescribed by a specialist (i.e., rheumatologist, general internist, vascular
surgeon)
Duration of initial approval: 6 months
Renewals will be considered on a case-by-case basis for patients who demonstrate benefit
from treatment (e.g. positive response in the duration, frequency and or severity of RP
and/or improvement in the size or number of digital ulcers.)
Duration of renewals: 1 year
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 99, record 57, 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
Sildenafil
Brand(s): Revatio
DOSAGE FORM/ STRENGTH: 20 mg tablet
Tadalafil
Brand(s): Adcirca
DOSAGE FORM/ STRENGTH: 20 mg tablet
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
414
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 414, record 245, 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
Sildenafil
Brand(s): Revatio
DOSAGE FORM/ STRENGTH: 20 mg tablet
Tadalafil
Brand(s): Adcirca
DOSAGE FORM/ STRENGTH: 20 mg tablet
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
i) Sildenafil (Revatio, generics), Tadalafil (Adcirca, generics)
Initial Criteria:
For the treatment of patients with pulmonary arterial hypertension (PAH) [WHO Group 1
Pulmonary hypertension] who meet all the following criteria;
• 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 II (Note
that a PDE-5 inhibitor must be used as first line monotherapy for WHO-FC II
(unless contraindicated or demonstrated intolerance), III, or IV; OR
o Drug is being used as sequential dual therapy in combination with a funded ERA
(i.e. ambrisentan, bosentan, macitentan) 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 ERA (i.e.
ambrisentan, bosentan, macitentan) or a funded prostanoid (i.e. epoprostenol,
treprostinil) in a patient with advanced disease (i.e. WHO-functional class III or IV,
6MWD <380 metres; OR evidence of RV failure.)
1 Note: Left ventricular end-diastolic pressure ≤ 15 mmHg is also acceptable.
415
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 415, record 247, 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
Revatio · DIN 02279401
Manufacturer: Upjohn Canada ULC; listing date 2010-09-09
Health Canada: Marketed since 2023-09-11 · brand REVATIO · ATC C02KX ANTIHYPERTENSIVES FOR PULMONARY ARTERIAL HYPERTENSION · form Tablet · route Oral · ingredients SILDENAFIL (SILDENAFIL CITRATE) 20 MG · company Bgp pharma ulc · schedule Prescription
Ministry pays: $7.2940 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=76500 · Verify on the e-Formulary ↗ (DIN 02279401)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02279401).
DIN 02279401: Revatio
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000565; group id 957; item number 2271; lccId None; manufacturer id UJC
Source form: Tab; strength: 20mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $13.5314; ministry $7.2940
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02279401
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=76500
Interchangeable products
Apo-Sildenafil R · DIN 02418118 · $7.2940
Jamp-Sildenafil R · DIN 02469669 · $7.2940
PMS-Sildenafil R · DIN 02412179 · $7.2940
Teva-Sildenafil R · DIN 02319500 · $7.2940
Shortage status: resolved shortage (ended 2026-02-25); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02279401
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Teva-Sildenafil R · DIN 02319500 · 20mg · 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 criteria on record are for Brand(s): Revatio; DOSAGE FORM/ STRENGTH: 20 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
Sildenafil
Brand(s): Revatio
DOSAGE FORM/ STRENGTH: 20 mg tablet
Tadalafil
Brand(s): Adcirca
DOSAGE FORM/ STRENGTH: 20 mg tablet
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
414
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 414, record 245, corpus 2025-01-01; name match only, not an eligibility decision
Exceptional Access criteria on record are for Brand(s): Revatio; DOSAGE FORM/ STRENGTH: 20 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
Sildenafil
Brand(s): Revatio
DOSAGE FORM/ STRENGTH: 20 mg tablet
Tadalafil
Brand(s): Adcirca
DOSAGE FORM/ STRENGTH: 20 mg tablet
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
i) Sildenafil (Revatio, generics), Tadalafil (Adcirca, generics)
Initial Criteria:
For the treatment of patients with pulmonary arterial hypertension (PAH) [WHO Group 1
Pulmonary hypertension] who meet all the following criteria;
• 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 II (Note
that a PDE-5 inhibitor must be used as first line monotherapy for WHO-FC II
(unless contraindicated or demonstrated intolerance), III, or IV; OR
o Drug is being used as sequential dual therapy in combination with a funded ERA
(i.e. ambrisentan, bosentan, macitentan) 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 ERA (i.e.
ambrisentan, bosentan, macitentan) or a funded prostanoid (i.e. epoprostenol,
treprostinil) in a patient with advanced disease (i.e. WHO-functional class III or IV,
6MWD <380 metres; OR evidence of RV failure.)
1 Note: Left ventricular end-diastolic pressure ≤ 15 mmHg is also acceptable.
415
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 415, record 247, 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
Sildenafil
Brand(s): Revatio and generics, Viagra and generics
DOSAGE FORM/ STRENGTH: 20 mg (Revatio versions), 25 mg, 50 mg, 100 mg
(Viagra versions)
Effective date: September 9, 2022
For the treatment of severe Raynaud’s phenomenon (RP) and/or digital ulcers secondary
to scleroderma (systemic sclerosis) or scleroderma-like disease:
• After failure of at least one calcium channel blocker (CCB) OR without trial of a CCB
in a patient who has experienced an emergency situation such as threatened
ischemic digit(s) requiring hospitalization
• Must be prescribed by a specialist (i.e., rheumatologist, general internist, vascular
surgeon)
Duration of initial approval: 6 months
Renewals will be considered on a case-by-case basis for patients who demonstrate benefit
from treatment (e.g. positive response in the duration, frequency and or severity of RP
and/or improvement in the size or number of digital ulcers.)
Duration of renewals: 1 year
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 99, record 57, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
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 ↗)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
Teva-Sildenafil R · DIN 02319500
Manufacturer: Teva Canada Limited; listing date 2010-09-09
Health Canada: Marketed since 2017-11-21 · brand TEVA-SILDENAFIL R · ATC C02KX ANTIHYPERTENSIVES FOR PULMONARY ARTERIAL HYPERTENSION · form Tablet · route Oral · ingredients SILDENAFIL (SILDENAFIL CITRATE) 20 MG · company Teva canada limited · schedule Prescription
Teva-Sildenafil R: Formulary list price $7.2940/unit (unit not stated in source; not the patient's cost)
Ministry pays: $7.2940 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=80498 · Verify on the e-Formulary ↗ (DIN 02319500)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02319500).
DIN 02319500: Teva-Sildenafil R
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000565; group id 957; item number 2271; lccId None; manufacturer id TEV
Source form: Tab; strength: 20mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $7.2940; ministry $7.2940
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02319500
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=80498
Interchangeable products
Apo-Sildenafil R · DIN 02418118 · $7.2940
Jamp-Sildenafil R · DIN 02469669 · $7.2940
PMS-Sildenafil R · DIN 02412179 · $7.2940
Revatio · DIN 02279401 · $7.2940
Shortage status: resolved shortage (ended 2026-01-14); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02319500
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Accel-Sildenafil · DIN 02479796 · 25mg · 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 criteria on record are for Brand(s): Revatio; DOSAGE FORM/ STRENGTH: 20 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
Sildenafil
Brand(s): Revatio
DOSAGE FORM/ STRENGTH: 20 mg tablet
Tadalafil
Brand(s): Adcirca
DOSAGE FORM/ STRENGTH: 20 mg tablet
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
414
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 414, record 245, corpus 2025-01-01; name match only, not an eligibility decision
Exceptional Access criteria on record are for Brand(s): Revatio; DOSAGE FORM/ STRENGTH: 20 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
Sildenafil
Brand(s): Revatio
DOSAGE FORM/ STRENGTH: 20 mg tablet
Tadalafil
Brand(s): Adcirca
DOSAGE FORM/ STRENGTH: 20 mg tablet
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
i) Sildenafil (Revatio, generics), Tadalafil (Adcirca, generics)
Initial Criteria:
For the treatment of patients with pulmonary arterial hypertension (PAH) [WHO Group 1
Pulmonary hypertension] who meet all the following criteria;
• 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 II (Note
that a PDE-5 inhibitor must be used as first line monotherapy for WHO-FC II
(unless contraindicated or demonstrated intolerance), III, or IV; OR
o Drug is being used as sequential dual therapy in combination with a funded ERA
(i.e. ambrisentan, bosentan, macitentan) 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 ERA (i.e.
ambrisentan, bosentan, macitentan) or a funded prostanoid (i.e. epoprostenol,
treprostinil) in a patient with advanced disease (i.e. WHO-functional class III or IV,
6MWD <380 metres; OR evidence of RV failure.)
1 Note: Left ventricular end-diastolic pressure ≤ 15 mmHg is also acceptable.
415
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 415, record 247, 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
Sildenafil
Brand(s): Revatio and generics, Viagra and generics
DOSAGE FORM/ STRENGTH: 20 mg (Revatio versions), 25 mg, 50 mg, 100 mg
(Viagra versions)
Effective date: September 9, 2022
For the treatment of severe Raynaud’s phenomenon (RP) and/or digital ulcers secondary
to scleroderma (systemic sclerosis) or scleroderma-like disease:
• After failure of at least one calcium channel blocker (CCB) OR without trial of a CCB
in a patient who has experienced an emergency situation such as threatened
ischemic digit(s) requiring hospitalization
• Must be prescribed by a specialist (i.e., rheumatologist, general internist, vascular
surgeon)
Duration of initial approval: 6 months
Renewals will be considered on a case-by-case basis for patients who demonstrate benefit
from treatment (e.g. positive response in the duration, frequency and or severity of RP
and/or improvement in the size or number of digital ulcers.)
Duration of renewals: 1 year
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 99, record 57, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
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 ↗)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
Accel-Sildenafil · DIN 02479796
Manufacturer: Accel Pharma Inc.; listing date 2019-11-29
Health Canada: Marketed since 2019-08-15 · brand ACCEL-SILDENAFIL · ATC G04BE03 SILDENAFIL · form Tablet · route Oral · ingredients SILDENAFIL (SILDENAFIL CITRATE) 25 MG · company Accel pharma inc · schedule Prescription
Accel-Sildenafil: Formulary list price $3.1850/unit (unit not stated in source; not the patient's cost)
Ministry pays: $3.1850 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=97038 · Verify on the e-Formulary ↗ (DIN 02479796)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02479796).
DIN 02479796: Accel-Sildenafil
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000550; group id 957; item number 2272; lccId None; manufacturer id ACC
Source form: Tab; strength: 25mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $3.1850; ministry $3.1850
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02479796
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=97038
Interchangeable products
Apo-Sildenafil · DIN 02248201 · $8.2894
Auro-Sildenafil · DIN 02414368 · $8.2894
Co Sildenafil · DIN 02372053 · $8.2894
Jamp-Sildenafil · DIN 02405660 · $8.2894
Mint-Sildenafil · DIN 02393069 · $8.2894
PRZ-Sildenafil · DIN 02505150 · $8.2894
Sildenafil · DIN 02317559 · $8.2894
Sildenafil · DIN 02400693 · $8.2894
Sildenafil · DIN 02540770 · $8.2894
Teva-Sildenafil · DIN 02308738 · $8.2894
Viagra · DIN 02239766 · not recorded
Shortage status: resolved shortage (ended 2023-06-16); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02479796
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Apo-Sildenafil · DIN 02248201 · 25mg · 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 criteria on record are for Brand(s): Revatio; DOSAGE FORM/ STRENGTH: 20 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
Sildenafil
Brand(s): Revatio
DOSAGE FORM/ STRENGTH: 20 mg tablet
Tadalafil
Brand(s): Adcirca
DOSAGE FORM/ STRENGTH: 20 mg tablet
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
414
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 414, record 245, corpus 2025-01-01; name match only, not an eligibility decision
Exceptional Access criteria on record are for Brand(s): Revatio; DOSAGE FORM/ STRENGTH: 20 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
Sildenafil
Brand(s): Revatio
DOSAGE FORM/ STRENGTH: 20 mg tablet
Tadalafil
Brand(s): Adcirca
DOSAGE FORM/ STRENGTH: 20 mg tablet
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
i) Sildenafil (Revatio, generics), Tadalafil (Adcirca, generics)
Initial Criteria:
For the treatment of patients with pulmonary arterial hypertension (PAH) [WHO Group 1
Pulmonary hypertension] who meet all the following criteria;
• 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 II (Note
that a PDE-5 inhibitor must be used as first line monotherapy for WHO-FC II
(unless contraindicated or demonstrated intolerance), III, or IV; OR
o Drug is being used as sequential dual therapy in combination with a funded ERA
(i.e. ambrisentan, bosentan, macitentan) 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 ERA (i.e.
ambrisentan, bosentan, macitentan) or a funded prostanoid (i.e. epoprostenol,
treprostinil) in a patient with advanced disease (i.e. WHO-functional class III or IV,
6MWD <380 metres; OR evidence of RV failure.)
1 Note: Left ventricular end-diastolic pressure ≤ 15 mmHg is also acceptable.
415
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 415, record 247, 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
Sildenafil
Brand(s): Revatio and generics, Viagra and generics
DOSAGE FORM/ STRENGTH: 20 mg (Revatio versions), 25 mg, 50 mg, 100 mg
(Viagra versions)
Effective date: September 9, 2022
For the treatment of severe Raynaud’s phenomenon (RP) and/or digital ulcers secondary
to scleroderma (systemic sclerosis) or scleroderma-like disease:
• After failure of at least one calcium channel blocker (CCB) OR without trial of a CCB
in a patient who has experienced an emergency situation such as threatened
ischemic digit(s) requiring hospitalization
• Must be prescribed by a specialist (i.e., rheumatologist, general internist, vascular
surgeon)
Duration of initial approval: 6 months
Renewals will be considered on a case-by-case basis for patients who demonstrate benefit
from treatment (e.g. positive response in the duration, frequency and or severity of RP
and/or improvement in the size or number of digital ulcers.)
Duration of renewals: 1 year
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 99, record 57, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
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 ↗)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
Apo-Sildenafil · DIN 02248201
Manufacturer: Apotex Inc.; listing date 2013-01-29
Health Canada: Marketed since 2012-11-14 · brand APO-SILDENAFIL · ATC G04BE03 SILDENAFIL · form Tablet · route Oral · ingredients SILDENAFIL (SILDENAFIL CITRATE) 25 MG · company Apotex inc · schedule Prescription
Apo-Sildenafil: Formulary list price $8.2894/unit (unit not stated in source; not the patient's cost)
Ministry pays: $8.2894 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=72537 · Verify on the e-Formulary ↗ (DIN 02248201)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02248201).
DIN 02248201: Apo-Sildenafil
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000550; group id 957; item number 2272; lccId None; manufacturer id APX
Source form: Tab; strength: 25mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $8.2894; ministry $8.2894
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02248201
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=72537
Interchangeable products
Accel-Sildenafil · DIN 02479796 · $3.1850
Auro-Sildenafil · DIN 02414368 · $8.2894
Co Sildenafil · DIN 02372053 · $8.2894
Jamp-Sildenafil · DIN 02405660 · $8.2894
Mint-Sildenafil · DIN 02393069 · $8.2894
PRZ-Sildenafil · DIN 02505150 · $8.2894
Sildenafil · DIN 02317559 · $8.2894
Sildenafil · DIN 02400693 · $8.2894
Sildenafil · DIN 02540770 · $8.2894
Teva-Sildenafil · DIN 02308738 · $8.2894
Viagra · DIN 02239766 · not recorded
Shortage status: resolved shortage (ended 2021-07-16); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02248201
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Auro-Sildenafil · DIN 02414368 · 25mg · 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 criteria on record are for Brand(s): Revatio; DOSAGE FORM/ STRENGTH: 20 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
Sildenafil
Brand(s): Revatio
DOSAGE FORM/ STRENGTH: 20 mg tablet
Tadalafil
Brand(s): Adcirca
DOSAGE FORM/ STRENGTH: 20 mg tablet
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
414
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 414, record 245, corpus 2025-01-01; name match only, not an eligibility decision
Exceptional Access criteria on record are for Brand(s): Revatio; DOSAGE FORM/ STRENGTH: 20 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
Sildenafil
Brand(s): Revatio
DOSAGE FORM/ STRENGTH: 20 mg tablet
Tadalafil
Brand(s): Adcirca
DOSAGE FORM/ STRENGTH: 20 mg tablet
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
i) Sildenafil (Revatio, generics), Tadalafil (Adcirca, generics)
Initial Criteria:
For the treatment of patients with pulmonary arterial hypertension (PAH) [WHO Group 1
Pulmonary hypertension] who meet all the following criteria;
• 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 II (Note
that a PDE-5 inhibitor must be used as first line monotherapy for WHO-FC II
(unless contraindicated or demonstrated intolerance), III, or IV; OR
o Drug is being used as sequential dual therapy in combination with a funded ERA
(i.e. ambrisentan, bosentan, macitentan) 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 ERA (i.e.
ambrisentan, bosentan, macitentan) or a funded prostanoid (i.e. epoprostenol,
treprostinil) in a patient with advanced disease (i.e. WHO-functional class III or IV,
6MWD <380 metres; OR evidence of RV failure.)
1 Note: Left ventricular end-diastolic pressure ≤ 15 mmHg is also acceptable.
415
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 415, record 247, 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
Sildenafil
Brand(s): Revatio and generics, Viagra and generics
DOSAGE FORM/ STRENGTH: 20 mg (Revatio versions), 25 mg, 50 mg, 100 mg
(Viagra versions)
Effective date: September 9, 2022
For the treatment of severe Raynaud’s phenomenon (RP) and/or digital ulcers secondary
to scleroderma (systemic sclerosis) or scleroderma-like disease:
• After failure of at least one calcium channel blocker (CCB) OR without trial of a CCB
in a patient who has experienced an emergency situation such as threatened
ischemic digit(s) requiring hospitalization
• Must be prescribed by a specialist (i.e., rheumatologist, general internist, vascular
surgeon)
Duration of initial approval: 6 months
Renewals will be considered on a case-by-case basis for patients who demonstrate benefit
from treatment (e.g. positive response in the duration, frequency and or severity of RP
and/or improvement in the size or number of digital ulcers.)
Duration of renewals: 1 year
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 99, record 57, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
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 ↗)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
Auro-Sildenafil · DIN 02414368
Manufacturer: Auro Pharma Inc.; listing date 2016-02-25
Health Canada: Marketed since 2019-05-17 · brand AURO-SILDENAFIL · ATC G04BE03 SILDENAFIL · form Tablet · route Oral · ingredients SILDENAFIL (SILDENAFIL CITRATE) 25 MG · company Auro pharma inc · schedule Prescription
Auro-Sildenafil: Formulary list price $8.2894/unit (unit not stated in source; not the patient's cost)
Ministry pays: $8.2894 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=89902 · Verify on the e-Formulary ↗ (DIN 02414368)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02414368).
DIN 02414368: Auro-Sildenafil
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000550; group id 957; item number 2272; lccId None; manufacturer id AUR
Source form: Tab; strength: 25mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $8.2894; ministry $8.2894
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02414368
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=89902
Interchangeable products
Accel-Sildenafil · DIN 02479796 · $3.1850
Apo-Sildenafil · DIN 02248201 · $8.2894
Co Sildenafil · DIN 02372053 · $8.2894
Jamp-Sildenafil · DIN 02405660 · $8.2894
Mint-Sildenafil · DIN 02393069 · $8.2894
PRZ-Sildenafil · DIN 02505150 · $8.2894
Sildenafil · DIN 02317559 · $8.2894
Sildenafil · DIN 02400693 · $8.2894
Sildenafil · DIN 02540770 · $8.2894
Teva-Sildenafil · DIN 02308738 · $8.2894
Viagra · DIN 02239766 · not recorded
Shortage status: resolved shortage (ended 2024-05-30); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada)
Source: https://healthproductshortages.ca/search?term=02414368
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Mint-Sildenafil · DIN 02393069 · 25mg · 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 criteria on record are for Brand(s): Revatio; DOSAGE FORM/ STRENGTH: 20 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
Sildenafil
Brand(s): Revatio
DOSAGE FORM/ STRENGTH: 20 mg tablet
Tadalafil
Brand(s): Adcirca
DOSAGE FORM/ STRENGTH: 20 mg tablet
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
414
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 414, record 245, corpus 2025-01-01; name match only, not an eligibility decision
Exceptional Access criteria on record are for Brand(s): Revatio; DOSAGE FORM/ STRENGTH: 20 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
Sildenafil
Brand(s): Revatio
DOSAGE FORM/ STRENGTH: 20 mg tablet
Tadalafil
Brand(s): Adcirca
DOSAGE FORM/ STRENGTH: 20 mg tablet
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
i) Sildenafil (Revatio, generics), Tadalafil (Adcirca, generics)
Initial Criteria:
For the treatment of patients with pulmonary arterial hypertension (PAH) [WHO Group 1
Pulmonary hypertension] who meet all the following criteria;
• 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 II (Note
that a PDE-5 inhibitor must be used as first line monotherapy for WHO-FC II
(unless contraindicated or demonstrated intolerance), III, or IV; OR
o Drug is being used as sequential dual therapy in combination with a funded ERA
(i.e. ambrisentan, bosentan, macitentan) 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 ERA (i.e.
ambrisentan, bosentan, macitentan) or a funded prostanoid (i.e. epoprostenol,
treprostinil) in a patient with advanced disease (i.e. WHO-functional class III or IV,
6MWD <380 metres; OR evidence of RV failure.)
1 Note: Left ventricular end-diastolic pressure ≤ 15 mmHg is also acceptable.
415
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 415, record 247, 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
Sildenafil
Brand(s): Revatio and generics, Viagra and generics
DOSAGE FORM/ STRENGTH: 20 mg (Revatio versions), 25 mg, 50 mg, 100 mg
(Viagra versions)
Effective date: September 9, 2022
For the treatment of severe Raynaud’s phenomenon (RP) and/or digital ulcers secondary
to scleroderma (systemic sclerosis) or scleroderma-like disease:
• After failure of at least one calcium channel blocker (CCB) OR without trial of a CCB
in a patient who has experienced an emergency situation such as threatened
ischemic digit(s) requiring hospitalization
• Must be prescribed by a specialist (i.e., rheumatologist, general internist, vascular
surgeon)
Duration of initial approval: 6 months
Renewals will be considered on a case-by-case basis for patients who demonstrate benefit
from treatment (e.g. positive response in the duration, frequency and or severity of RP
and/or improvement in the size or number of digital ulcers.)
Duration of renewals: 1 year
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 99, record 57, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
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 ↗)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
Mint-Sildenafil · DIN 02393069
Manufacturer: Mint Pharmaceuticals Inc.; listing date 2013-08-29
Health Canada: Marketed since 2025-11-07 · brand MINT-SILDENAFIL · ATC G04BE03 SILDENAFIL · form Tablet · route Oral · ingredients SILDENAFIL (SILDENAFIL CITRATE) 25 MG · company Mint pharmaceuticals inc · schedule Prescription
Ministry pays: $8.2894 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=87831 · Verify on the e-Formulary ↗ (DIN 02393069)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02393069).
DIN 02393069: Mint-Sildenafil
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000550; group id 957; item number 2272; lccId None; manufacturer id MIN
Source form: Tab; strength: 25mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $8.2900; ministry $8.2894
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02393069
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=87831
Interchangeable products
Accel-Sildenafil · DIN 02479796 · $3.1850
Apo-Sildenafil · DIN 02248201 · $8.2894
Auro-Sildenafil · DIN 02414368 · $8.2894
Co Sildenafil · DIN 02372053 · $8.2894
Jamp-Sildenafil · DIN 02405660 · $8.2894
PRZ-Sildenafil · DIN 02505150 · $8.2894
Sildenafil · DIN 02317559 · $8.2894
Sildenafil · DIN 02400693 · $8.2894
Sildenafil · DIN 02540770 · $8.2894
Teva-Sildenafil · DIN 02308738 · $8.2894
Viagra · DIN 02239766 · not recorded
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=02393069
Shortage record checked 2026-09-13T08:10:21.292534+00:00
PRZ-Sildenafil · DIN 02505150 · 25mg · 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 criteria on record are for Brand(s): Revatio; DOSAGE FORM/ STRENGTH: 20 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
Sildenafil
Brand(s): Revatio
DOSAGE FORM/ STRENGTH: 20 mg tablet
Tadalafil
Brand(s): Adcirca
DOSAGE FORM/ STRENGTH: 20 mg tablet
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
414
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 414, record 245, corpus 2025-01-01; name match only, not an eligibility decision
Exceptional Access criteria on record are for Brand(s): Revatio; DOSAGE FORM/ STRENGTH: 20 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
Sildenafil
Brand(s): Revatio
DOSAGE FORM/ STRENGTH: 20 mg tablet
Tadalafil
Brand(s): Adcirca
DOSAGE FORM/ STRENGTH: 20 mg tablet
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
i) Sildenafil (Revatio, generics), Tadalafil (Adcirca, generics)
Initial Criteria:
For the treatment of patients with pulmonary arterial hypertension (PAH) [WHO Group 1
Pulmonary hypertension] who meet all the following criteria;
• 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 II (Note
that a PDE-5 inhibitor must be used as first line monotherapy for WHO-FC II
(unless contraindicated or demonstrated intolerance), III, or IV; OR
o Drug is being used as sequential dual therapy in combination with a funded ERA
(i.e. ambrisentan, bosentan, macitentan) 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 ERA (i.e.
ambrisentan, bosentan, macitentan) or a funded prostanoid (i.e. epoprostenol,
treprostinil) in a patient with advanced disease (i.e. WHO-functional class III or IV,
6MWD <380 metres; OR evidence of RV failure.)
1 Note: Left ventricular end-diastolic pressure ≤ 15 mmHg is also acceptable.
415
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 415, record 247, 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
Sildenafil
Brand(s): Revatio and generics, Viagra and generics
DOSAGE FORM/ STRENGTH: 20 mg (Revatio versions), 25 mg, 50 mg, 100 mg
(Viagra versions)
Effective date: September 9, 2022
For the treatment of severe Raynaud’s phenomenon (RP) and/or digital ulcers secondary
to scleroderma (systemic sclerosis) or scleroderma-like disease:
• After failure of at least one calcium channel blocker (CCB) OR without trial of a CCB
in a patient who has experienced an emergency situation such as threatened
ischemic digit(s) requiring hospitalization
• Must be prescribed by a specialist (i.e., rheumatologist, general internist, vascular
surgeon)
Duration of initial approval: 6 months
Renewals will be considered on a case-by-case basis for patients who demonstrate benefit
from treatment (e.g. positive response in the duration, frequency and or severity of RP
and/or improvement in the size or number of digital ulcers.)
Duration of renewals: 1 year
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 99, record 57, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
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 ↗)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
PRZ-Sildenafil · DIN 02505150
Manufacturer: Pharmaris Canada Inc.; listing date 2022-01-31
Health Canada: Marketed since 2021-08-20 · brand PRZ-SILDENAFIL · ATC G04BE03 SILDENAFIL · form Tablet · route Oral · ingredients SILDENAFIL (SILDENAFIL CITRATE) 25 MG · company Pharmaris canada inc · schedule Prescription
PRZ-Sildenafil: Formulary list price $8.2894/unit (unit not stated in source; not the patient's cost)
Ministry pays: $8.2894 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=99450 · Verify on the e-Formulary ↗ (DIN 02505150)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02505150).
DIN 02505150: PRZ-Sildenafil
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000550; group id 957; item number 2272; lccId None; manufacturer id PRZ
Source form: Tab; strength: 25mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $8.2894; ministry $8.2894
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02505150
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=99450
Interchangeable products
Accel-Sildenafil · DIN 02479796 · $3.1850
Apo-Sildenafil · DIN 02248201 · $8.2894
Auro-Sildenafil · DIN 02414368 · $8.2894
Co Sildenafil · DIN 02372053 · $8.2894
Jamp-Sildenafil · DIN 02405660 · $8.2894
Mint-Sildenafil · DIN 02393069 · $8.2894
Sildenafil · DIN 02317559 · $8.2894
Sildenafil · DIN 02400693 · $8.2894
Sildenafil · DIN 02540770 · $8.2894
Teva-Sildenafil · DIN 02308738 · $8.2894
Viagra · DIN 02239766 · not recorded
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=02505150
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Sildenafil · DIN 02317559 · 25mg · 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 criteria on record are for Brand(s): Revatio; DOSAGE FORM/ STRENGTH: 20 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
Sildenafil
Brand(s): Revatio
DOSAGE FORM/ STRENGTH: 20 mg tablet
Tadalafil
Brand(s): Adcirca
DOSAGE FORM/ STRENGTH: 20 mg tablet
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
414
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 414, record 245, corpus 2025-01-01; name match only, not an eligibility decision
Exceptional Access criteria on record are for Brand(s): Revatio; DOSAGE FORM/ STRENGTH: 20 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
Sildenafil
Brand(s): Revatio
DOSAGE FORM/ STRENGTH: 20 mg tablet
Tadalafil
Brand(s): Adcirca
DOSAGE FORM/ STRENGTH: 20 mg tablet
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
i) Sildenafil (Revatio, generics), Tadalafil (Adcirca, generics)
Initial Criteria:
For the treatment of patients with pulmonary arterial hypertension (PAH) [WHO Group 1
Pulmonary hypertension] who meet all the following criteria;
• 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 II (Note
that a PDE-5 inhibitor must be used as first line monotherapy for WHO-FC II
(unless contraindicated or demonstrated intolerance), III, or IV; OR
o Drug is being used as sequential dual therapy in combination with a funded ERA
(i.e. ambrisentan, bosentan, macitentan) 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 ERA (i.e.
ambrisentan, bosentan, macitentan) or a funded prostanoid (i.e. epoprostenol,
treprostinil) in a patient with advanced disease (i.e. WHO-functional class III or IV,
6MWD <380 metres; OR evidence of RV failure.)
1 Note: Left ventricular end-diastolic pressure ≤ 15 mmHg is also acceptable.
415
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 415, record 247, 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
Sildenafil
Brand(s): Revatio and generics, Viagra and generics
DOSAGE FORM/ STRENGTH: 20 mg (Revatio versions), 25 mg, 50 mg, 100 mg
(Viagra versions)
Effective date: September 9, 2022
For the treatment of severe Raynaud’s phenomenon (RP) and/or digital ulcers secondary
to scleroderma (systemic sclerosis) or scleroderma-like disease:
• After failure of at least one calcium channel blocker (CCB) OR without trial of a CCB
in a patient who has experienced an emergency situation such as threatened
ischemic digit(s) requiring hospitalization
• Must be prescribed by a specialist (i.e., rheumatologist, general internist, vascular
surgeon)
Duration of initial approval: 6 months
Renewals will be considered on a case-by-case basis for patients who demonstrate benefit
from treatment (e.g. positive response in the duration, frequency and or severity of RP
and/or improvement in the size or number of digital ulcers.)
Duration of renewals: 1 year
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 99, record 57, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
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 ↗)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
Sildenafil · DIN 02317559
Manufacturer: Pharmascience Inc.; listing date 2013-09-27
Health Canada: Marketed since 2013-08-05 · brand SILDENAFIL · ATC G04BE03 SILDENAFIL · form Tablet · route Oral · ingredients SILDENAFIL (SILDENAFIL CITRATE) 25 MG · company Pharmascience inc · schedule Prescription
Sildenafil: Formulary list price $8.2894/unit (unit not stated in source; not the patient's cost)
Ministry pays: $8.2894 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=80308 · Verify on the e-Formulary ↗ (DIN 02317559)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02317559).
DIN 02317559: Sildenafil
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000550; group id 957; item number 2272; lccId None; manufacturer id PMS
Source form: Tab; strength: 25mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $8.2894; ministry $8.2894
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02317559
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=80308
Interchangeable products
Accel-Sildenafil · DIN 02479796 · $3.1850
Apo-Sildenafil · DIN 02248201 · $8.2894
Auro-Sildenafil · DIN 02414368 · $8.2894
Co Sildenafil · DIN 02372053 · $8.2894
Jamp-Sildenafil · DIN 02405660 · $8.2894
Mint-Sildenafil · DIN 02393069 · $8.2894
PRZ-Sildenafil · DIN 02505150 · $8.2894
Sildenafil · DIN 02400693 · $8.2894
Sildenafil · DIN 02540770 · $8.2894
Teva-Sildenafil · DIN 02308738 · $8.2894
Viagra · DIN 02239766 · not recorded
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=02317559
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Sildenafil · DIN 02400693 · 25mg · 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 criteria on record are for Brand(s): Revatio; DOSAGE FORM/ STRENGTH: 20 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
Sildenafil
Brand(s): Revatio
DOSAGE FORM/ STRENGTH: 20 mg tablet
Tadalafil
Brand(s): Adcirca
DOSAGE FORM/ STRENGTH: 20 mg tablet
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
414
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 414, record 245, corpus 2025-01-01; name match only, not an eligibility decision
Exceptional Access criteria on record are for Brand(s): Revatio; DOSAGE FORM/ STRENGTH: 20 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
Sildenafil
Brand(s): Revatio
DOSAGE FORM/ STRENGTH: 20 mg tablet
Tadalafil
Brand(s): Adcirca
DOSAGE FORM/ STRENGTH: 20 mg tablet
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
i) Sildenafil (Revatio, generics), Tadalafil (Adcirca, generics)
Initial Criteria:
For the treatment of patients with pulmonary arterial hypertension (PAH) [WHO Group 1
Pulmonary hypertension] who meet all the following criteria;
• 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 II (Note
that a PDE-5 inhibitor must be used as first line monotherapy for WHO-FC II
(unless contraindicated or demonstrated intolerance), III, or IV; OR
o Drug is being used as sequential dual therapy in combination with a funded ERA
(i.e. ambrisentan, bosentan, macitentan) 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 ERA (i.e.
ambrisentan, bosentan, macitentan) or a funded prostanoid (i.e. epoprostenol,
treprostinil) in a patient with advanced disease (i.e. WHO-functional class III or IV,
6MWD <380 metres; OR evidence of RV failure.)
1 Note: Left ventricular end-diastolic pressure ≤ 15 mmHg is also acceptable.
415
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 415, record 247, 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
Sildenafil
Brand(s): Revatio and generics, Viagra and generics
DOSAGE FORM/ STRENGTH: 20 mg (Revatio versions), 25 mg, 50 mg, 100 mg
(Viagra versions)
Effective date: September 9, 2022
For the treatment of severe Raynaud’s phenomenon (RP) and/or digital ulcers secondary
to scleroderma (systemic sclerosis) or scleroderma-like disease:
• After failure of at least one calcium channel blocker (CCB) OR without trial of a CCB
in a patient who has experienced an emergency situation such as threatened
ischemic digit(s) requiring hospitalization
• Must be prescribed by a specialist (i.e., rheumatologist, general internist, vascular
surgeon)
Duration of initial approval: 6 months
Renewals will be considered on a case-by-case basis for patients who demonstrate benefit
from treatment (e.g. positive response in the duration, frequency and or severity of RP
and/or improvement in the size or number of digital ulcers.)
Duration of renewals: 1 year
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 99, record 57, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
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 ↗)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
Sildenafil · DIN 02400693
Manufacturer: Sivem Pharmaceuticals ULC; listing date 2024-06-28
Health Canada: Marketed since 2024-04-29 · brand SILDENAFIL · ATC G04BE03 SILDENAFIL · form Tablet · route Oral · ingredients SILDENAFIL (SILDENAFIL CITRATE) 25 MG · company Sivem pharmaceuticals ulc · schedule Prescription
Ministry pays: $8.2894 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=88547 · Verify on the e-Formulary ↗ (DIN 02400693)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02400693).
DIN 02400693: Sildenafil
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000550; group id 957; item number 2272; lccId None; manufacturer id SIV
Source form: Tab; strength: 25mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $8.2900; ministry $8.2894
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02400693
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=88547
Interchangeable products
Accel-Sildenafil · DIN 02479796 · $3.1850
Apo-Sildenafil · DIN 02248201 · $8.2894
Auro-Sildenafil · DIN 02414368 · $8.2894
Co Sildenafil · DIN 02372053 · $8.2894
Jamp-Sildenafil · DIN 02405660 · $8.2894
Mint-Sildenafil · DIN 02393069 · $8.2894
PRZ-Sildenafil · DIN 02505150 · $8.2894
Sildenafil · DIN 02317559 · $8.2894
Sildenafil · DIN 02540770 · $8.2894
Teva-Sildenafil · DIN 02308738 · $8.2894
Viagra · DIN 02239766 · not recorded
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=02400693
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Sildenafil · DIN 02540770 · 25mg · 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 criteria on record are for Brand(s): Revatio; DOSAGE FORM/ STRENGTH: 20 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
Sildenafil
Brand(s): Revatio
DOSAGE FORM/ STRENGTH: 20 mg tablet
Tadalafil
Brand(s): Adcirca
DOSAGE FORM/ STRENGTH: 20 mg tablet
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
414
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 414, record 245, corpus 2025-01-01; name match only, not an eligibility decision
Exceptional Access criteria on record are for Brand(s): Revatio; DOSAGE FORM/ STRENGTH: 20 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
Sildenafil
Brand(s): Revatio
DOSAGE FORM/ STRENGTH: 20 mg tablet
Tadalafil
Brand(s): Adcirca
DOSAGE FORM/ STRENGTH: 20 mg tablet
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
i) Sildenafil (Revatio, generics), Tadalafil (Adcirca, generics)
Initial Criteria:
For the treatment of patients with pulmonary arterial hypertension (PAH) [WHO Group 1
Pulmonary hypertension] who meet all the following criteria;
• 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 II (Note
that a PDE-5 inhibitor must be used as first line monotherapy for WHO-FC II
(unless contraindicated or demonstrated intolerance), III, or IV; OR
o Drug is being used as sequential dual therapy in combination with a funded ERA
(i.e. ambrisentan, bosentan, macitentan) 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 ERA (i.e.
ambrisentan, bosentan, macitentan) or a funded prostanoid (i.e. epoprostenol,
treprostinil) in a patient with advanced disease (i.e. WHO-functional class III or IV,
6MWD <380 metres; OR evidence of RV failure.)
1 Note: Left ventricular end-diastolic pressure ≤ 15 mmHg is also acceptable.
415
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 415, record 247, 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
Sildenafil
Brand(s): Revatio and generics, Viagra and generics
DOSAGE FORM/ STRENGTH: 20 mg (Revatio versions), 25 mg, 50 mg, 100 mg
(Viagra versions)
Effective date: September 9, 2022
For the treatment of severe Raynaud’s phenomenon (RP) and/or digital ulcers secondary
to scleroderma (systemic sclerosis) or scleroderma-like disease:
• After failure of at least one calcium channel blocker (CCB) OR without trial of a CCB
in a patient who has experienced an emergency situation such as threatened
ischemic digit(s) requiring hospitalization
• Must be prescribed by a specialist (i.e., rheumatologist, general internist, vascular
surgeon)
Duration of initial approval: 6 months
Renewals will be considered on a case-by-case basis for patients who demonstrate benefit
from treatment (e.g. positive response in the duration, frequency and or severity of RP
and/or improvement in the size or number of digital ulcers.)
Duration of renewals: 1 year
EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 99, record 57, corpus 2025-01-01; name match only, not an eligibility decision
Brand vs generic price
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 ↗)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
Sildenafil · DIN 02540770
Manufacturer: Sanis Health Inc.; listing date 2024-07-31
Health Canada: Marketed since 2024-07-11 · brand SILDENAFIL · ATC G04BE03 SILDENAFIL · form Tablet · route Oral · ingredients SILDENAFIL (SILDENAFIL CITRATE) 25 MG · company Sanis health inc · schedule Prescription
Sildenafil: Formulary list price $8.2894/unit (unit not stated in source; not the patient's cost)
Ministry pays: $8.2894 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=102945 · Verify on the e-Formulary ↗ (DIN 02540770)
Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02540770).
DIN 02540770: Sildenafil
Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y
Item: 920000550; group id 957; item number 2272; lccId None; manufacturer id SAI
Source form: Tab; strength: 25mg
Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed)
Source prices (unrounded): $8.2894; ministry $8.2894
Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02540770
Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102945
Interchangeable products
Accel-Sildenafil · DIN 02479796 · $3.1850
Apo-Sildenafil · DIN 02248201 · $8.2894
Auro-Sildenafil · DIN 02414368 · $8.2894
Co Sildenafil · DIN 02372053 · $8.2894
Jamp-Sildenafil · DIN 02405660 · $8.2894
Mint-Sildenafil · DIN 02393069 · $8.2894
PRZ-Sildenafil · DIN 02505150 · $8.2894
Sildenafil · DIN 02317559 · $8.2894
Sildenafil · DIN 02400693 · $8.2894
Teva-Sildenafil · DIN 02308738 · $8.2894
Viagra · DIN 02239766 · not recorded
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=02540770
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary class (92:00 UNCLASSIFIED THERAPEUTIC AGENTS) and how they are covered
Matched class: 92:00 UNCLASSIFIED THERAPEUTIC AGENTS
Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment.
Covered without a code on the Ontario formulary: ALENDRONATE & CHOLECALCIFEROL, AZATHIOPRINE, CYCLOSPORINE, GLUCAGON RDNA ORIGIN, LANREOTIDE ACETATE, LEFLUNOMIDE, LEVODOPA & BENSERAZIDE, MYCOPHENOLATE SODIUM
Some products covered without a code (check the product listing): ALENDRONATE, ALLOPURINOL, AMANTADINE HCL, BROMOCRIPTINE, CLOPIDOGREL BISULFATE, LEVODOPA & CARBIDOPA, MYCOPHENOLATE MOFETIL, OCTREOTIDE, RISEDRONATE SODIUM, ROPINIROLE, SELEGILINE HCL, TAMSULOSIN HCL
92:00 UNCLASSIFIED THERAPEUTIC AGENTS
· 6 products ·
Limited Use, codes 290 · strengths: 7.5mg, 15mg · ER Tab
· 30 products ·
Limited Use, codes 290 · strengths: 5mg, 10mg · Tab
· 12 products ·
Limited Use, codes 290 · strengths: 2mg, 4mg, 1mg · SR Cap, Tab
· 3 products · Listed, not a benefit (1),
Limited Use, codes 290 (2) · strengths: 20mg · Tab
· 28 products · Off-Formulary Interchangeable, not an ODB benefit (4), Listed, not a benefit (1), General benefit (23) · strengths: 5mg, 10mg, 70mg · Tab
· 6 products · General benefit · strengths: 70mg & 70mcg, 70mg & 140mcg · Tab
· 10 products · General benefit (6), Listed, not a benefit (4) · strengths: 100mg, 200mg, 300mg · Tab
· 5 products · Listed, not a benefit (2), General benefit (3) · strengths: 100mg, 10mg/mL · Cap, O/L
· 3 products · General benefit · strengths: 50mg · Tab
· 4 products · Listed, not a benefit (2), General benefit (2) · strengths: 5mg, 2.5mg · Cap, Tab
· 19 products · General benefit (16), Off-Formulary Interchangeable, not an ODB benefit (3) · strengths: 75mg, 300mg · Tab
· 8 products · General benefit · strengths: 10mg, 25mg, 50mg, 100mg, 100mg/mL · Cap, O/L
Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 92:00
and 75 more