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TADALAFIL

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 (G04BE) — coverage varies; not interchangeable

  • Vardenafil (Staxyn): not a benefit

Apo-Tadalafil · DIN 02422085 · 2.5mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria
Exceptional Access criteria on record are for Brand(s): Adcirca; 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 246, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Adcirca; 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 248, 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 Tadalafil Brand(s): Adcirca and generics, Cialis and generics DOSAGE FORM/ STRENGTH: 20 mg (Adcirca versions) ; 2.5 mg, 5 mg, 10 mg, 20 mg (Cialis 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 99 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 99, record 58, 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-Tadalafil · DIN 02422085 Manufacturer: Apotex Inc.; listing date 2016-09-29 Health Canada: Marketed since 2016-07-12 · brand APO-TADALAFIL · ATC G04BE08 TADALAFIL · form Tablet · route Oral · ingredients TADALAFIL 2.5 MG · company Apotex inc · schedule Prescription
Check this DIN again · Health Canada product record

Apo-Tadalafil: Formulary list price $3.6470/unit (unit not stated in source; not the patient's cost)

Ministry pays: $3.6470 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=90680 · Verify on the e-Formulary ↗ (DIN 02422085)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02422085). DIN 02422085: Apo-Tadalafil Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 241200103; group id 371; item number 0879; lccId None; manufacturer id APX Source form: Tab; strength: 2.5mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $3.6470; ministry $3.6470 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02422085 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90680
Interchangeable products
Act Tadalafil · DIN 02428628 · $3.6471 Auro-Tadalafil · DIN 02435896 · $3.6470 Cialis · DIN 02296888 · not recorded Jamp-Tadalafil · DIN 02451824 · $3.6471 Mar-Tadalafil · DIN 02452286 · $3.6471 Mylan-Tadalafil · DIN 02410621 · $3.6471 PMS-Tadalafil · DIN 02409410 · $3.6471 PRZ-Tadalafil · DIN 02512262 · $3.6470 Ran-Tadalafil · DIN 02452081 · $3.6471 Tadalafil · DIN 02536676 · $3.8616 Teva-Tadalafil · DIN 02440148 · $3.8616
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=02422085
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Auro-Tadalafil · DIN 02435896 · 2.5mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria
Exceptional Access criteria on record are for Brand(s): Adcirca; 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 246, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Adcirca; 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 248, 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 Tadalafil Brand(s): Adcirca and generics, Cialis and generics DOSAGE FORM/ STRENGTH: 20 mg (Adcirca versions) ; 2.5 mg, 5 mg, 10 mg, 20 mg (Cialis 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 99 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 99, record 58, 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-Tadalafil · DIN 02435896 Manufacturer: Auro Pharma Inc.; listing date 2016-09-29 Health Canada: Marketed since 2016-07-14 · brand AURO-TADALAFIL · ATC G04BE08 TADALAFIL · form Tablet · route Oral · ingredients TADALAFIL 2.5 MG · company Auro pharma inc · schedule Prescription
Check this DIN again · Health Canada product record

Auro-Tadalafil: Formulary list price $3.6470/unit (unit not stated in source; not the patient's cost)

Ministry pays: $3.6470 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=92025 · Verify on the e-Formulary ↗ (DIN 02435896)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02435896). DIN 02435896: Auro-Tadalafil Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 241200103; group id 371; item number 0879; lccId None; manufacturer id AUR Source form: Tab; strength: 2.5mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $3.6470; ministry $3.6470 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02435896 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=92025
Interchangeable products
Act Tadalafil · DIN 02428628 · $3.6471 Apo-Tadalafil · DIN 02422085 · $3.6470 Cialis · DIN 02296888 · not recorded Jamp-Tadalafil · DIN 02451824 · $3.6471 Mar-Tadalafil · DIN 02452286 · $3.6471 Mylan-Tadalafil · DIN 02410621 · $3.6471 PMS-Tadalafil · DIN 02409410 · $3.6471 PRZ-Tadalafil · DIN 02512262 · $3.6470 Ran-Tadalafil · DIN 02452081 · $3.6471 Tadalafil · DIN 02536676 · $3.8616 Teva-Tadalafil · DIN 02440148 · $3.8616
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=02435896
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Cialis · DIN 02296888 · 2.5mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria
Exceptional Access criteria on record are for Brand(s): Adcirca; 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 246, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Adcirca; 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 248, 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 Tadalafil Brand(s): Adcirca and generics, Cialis and generics DOSAGE FORM/ STRENGTH: 20 mg (Adcirca versions) ; 2.5 mg, 5 mg, 10 mg, 20 mg (Cialis 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 99 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 99, record 58, 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
Cialis · DIN 02296888 Manufacturer: Eli Lilly Canada Inc.; listing date 2016-09-29 Health Canada: Marketed since 2008-01-18 · brand CIALIS · ATC G04BE08 TADALAFIL · form Tablet · route Oral · ingredients TADALAFIL 2.5 MG · company Eli lilly canada inc · schedule Prescription
Check this DIN again · Health Canada product record

Cialis: Formulary list price not recorded/unit (unit not stated in source; not the patient's cost)

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=78223 · Verify on the e-Formulary ↗ (DIN 02296888)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02296888). DIN 02296888: Cialis Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 241200103; group id 371; item number 0879; lccId None; manufacturer id LIL Source form: Tab; strength: 2.5mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): not recorded; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02296888 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=78223
Interchangeable products
Act Tadalafil · DIN 02428628 · $3.6471 Apo-Tadalafil · DIN 02422085 · $3.6470 Auro-Tadalafil · DIN 02435896 · $3.6470 Jamp-Tadalafil · DIN 02451824 · $3.6471 Mar-Tadalafil · DIN 02452286 · $3.6471 Mylan-Tadalafil · DIN 02410621 · $3.6471 PMS-Tadalafil · DIN 02409410 · $3.6471 PRZ-Tadalafil · DIN 02512262 · $3.6470 Ran-Tadalafil · DIN 02452081 · $3.6471 Tadalafil · DIN 02536676 · $3.8616 Teva-Tadalafil · DIN 02440148 · $3.8616
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=02296888
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Mylan-Tadalafil · DIN 02410621 · 2.5mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria
Exceptional Access criteria on record are for Brand(s): Adcirca; 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 246, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Adcirca; 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 248, 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 Tadalafil Brand(s): Adcirca and generics, Cialis and generics DOSAGE FORM/ STRENGTH: 20 mg (Adcirca versions) ; 2.5 mg, 5 mg, 10 mg, 20 mg (Cialis 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 99 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 99, record 58, 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
Mylan-Tadalafil · DIN 02410621 Manufacturer: Mylan Pharmaceuticals ULC; listing date 2016-09-29 Health Canada: Marketed since 2016-07-12 · brand MYLAN-TADALAFIL · ATC G04BE08 TADALAFIL · form Tablet · route Oral · ingredients TADALAFIL 2.5 MG · company Mylan pharmaceuticals ulc · schedule Prescription
Check this DIN again · Health Canada product record

Mylan-Tadalafil: Formulary list price $3.6471/unit (unit not stated in source; not the patient's cost)

Ministry pays: $3.6471 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=89530 · Verify on the e-Formulary ↗ (DIN 02410621)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02410621). DIN 02410621: Mylan-Tadalafil Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 241200103; group id 371; item number 0879; lccId None; manufacturer id MYL Source form: Tab; strength: 2.5mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $3.6471; ministry $3.6471 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02410621 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=89530
Interchangeable products
Act Tadalafil · DIN 02428628 · $3.6471 Apo-Tadalafil · DIN 02422085 · $3.6470 Auro-Tadalafil · DIN 02435896 · $3.6470 Cialis · DIN 02296888 · not recorded Jamp-Tadalafil · DIN 02451824 · $3.6471 Mar-Tadalafil · DIN 02452286 · $3.6471 PMS-Tadalafil · DIN 02409410 · $3.6471 PRZ-Tadalafil · DIN 02512262 · $3.6470 Ran-Tadalafil · DIN 02452081 · $3.6471 Tadalafil · DIN 02536676 · $3.8616 Teva-Tadalafil · DIN 02440148 · $3.8616
Shortage status: resolved shortage (ended 2018-12-18); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02410621
Shortage record checked 2026-09-13T08:10:21.292534+00:00

PMS-Tadalafil · DIN 02409410 · 2.5mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria
Exceptional Access criteria on record are for Brand(s): Adcirca; 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 246, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Adcirca; 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 248, 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 Tadalafil Brand(s): Adcirca and generics, Cialis and generics DOSAGE FORM/ STRENGTH: 20 mg (Adcirca versions) ; 2.5 mg, 5 mg, 10 mg, 20 mg (Cialis 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 99 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 99, record 58, 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-Tadalafil · DIN 02409410 Manufacturer: Pharmascience Inc.; listing date 2016-09-29 Health Canada: Marketed since 2020-05-22 · brand PMS-TADALAFIL · ATC G04BE08 TADALAFIL · form Tablet · route Oral · ingredients TADALAFIL 2.5 MG · company Pharmascience inc · schedule Prescription
Check this DIN again · Health Canada product record

PMS-Tadalafil: Formulary list price $3.6471/unit (unit not stated in source; not the patient's cost)

Ministry pays: $3.6471 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=89412 · Verify on the e-Formulary ↗ (DIN 02409410)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02409410). DIN 02409410: PMS-Tadalafil Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 241200103; group id 371; item number 0879; lccId None; manufacturer id PMS Source form: Tab; strength: 2.5mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $3.6471; ministry $3.6471 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02409410 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=89412
Interchangeable products
Act Tadalafil · DIN 02428628 · $3.6471 Apo-Tadalafil · DIN 02422085 · $3.6470 Auro-Tadalafil · DIN 02435896 · $3.6470 Cialis · DIN 02296888 · not recorded Jamp-Tadalafil · DIN 02451824 · $3.6471 Mar-Tadalafil · DIN 02452286 · $3.6471 Mylan-Tadalafil · DIN 02410621 · $3.6471 PRZ-Tadalafil · DIN 02512262 · $3.6470 Ran-Tadalafil · DIN 02452081 · $3.6471 Tadalafil · DIN 02536676 · $3.8616 Teva-Tadalafil · DIN 02440148 · $3.8616
Shortage status: resolved shortage (ended 2023-07-21); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02409410
Shortage record checked 2026-09-13T08:10:21.292534+00:00

PRZ-Tadalafil · DIN 02512262 · 2.5mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria
Exceptional Access criteria on record are for Brand(s): Adcirca; 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 246, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Adcirca; 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 248, 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 Tadalafil Brand(s): Adcirca and generics, Cialis and generics DOSAGE FORM/ STRENGTH: 20 mg (Adcirca versions) ; 2.5 mg, 5 mg, 10 mg, 20 mg (Cialis 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 99 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 99, record 58, 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-Tadalafil · DIN 02512262 Manufacturer: Pharmaris Canada Inc.; listing date 2022-02-28 Health Canada: Marketed since 2021-09-27 · brand PRZ-TADALAFIL · ATC G04BE08 TADALAFIL · form Tablet · route Oral · ingredients TADALAFIL 2.5 MG · company Pharmaris canada inc · schedule Prescription
Check this DIN again · Health Canada product record

PRZ-Tadalafil: Formulary list price $3.6470/unit (unit not stated in source; not the patient's cost)

Ministry pays: $3.6470 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=100156 · Verify on the e-Formulary ↗ (DIN 02512262)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02512262). DIN 02512262: PRZ-Tadalafil Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 241200103; group id 371; item number 0879; lccId None; manufacturer id PRZ Source form: Tab; strength: 2.5mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $3.6470; ministry $3.6470 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02512262 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100156
Interchangeable products
Act Tadalafil · DIN 02428628 · $3.6471 Apo-Tadalafil · DIN 02422085 · $3.6470 Auro-Tadalafil · DIN 02435896 · $3.6470 Cialis · DIN 02296888 · not recorded Jamp-Tadalafil · DIN 02451824 · $3.6471 Mar-Tadalafil · DIN 02452286 · $3.6471 Mylan-Tadalafil · DIN 02410621 · $3.6471 PMS-Tadalafil · DIN 02409410 · $3.6471 Ran-Tadalafil · DIN 02452081 · $3.6471 Tadalafil · DIN 02536676 · $3.8616 Teva-Tadalafil · DIN 02440148 · $3.8616
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=02512262
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Tadalafil · DIN 02536676 · 2.5mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria
Exceptional Access criteria on record are for Brand(s): Adcirca; 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 246, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Adcirca; 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 248, 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 Tadalafil Brand(s): Adcirca and generics, Cialis and generics DOSAGE FORM/ STRENGTH: 20 mg (Adcirca versions) ; 2.5 mg, 5 mg, 10 mg, 20 mg (Cialis 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 99 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 99, record 58, 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
Tadalafil · DIN 02536676 Manufacturer: Sivem Pharmaceuticals ULC; listing date 2024-10-31 Health Canada: Marketed since 2024-08-29 · brand TADALAFIL · ATC G04BE08 TADALAFIL · form Tablet · route Oral · ingredients TADALAFIL 2.5 MG · company Sivem pharmaceuticals ulc · schedule Prescription
Check this DIN again · Health Canada product record

Tadalafil: Formulary list price $3.8616/unit (unit not stated in source; not the patient's cost)

Ministry pays: $3.8616 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=102542 · Verify on the e-Formulary ↗ (DIN 02536676)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02536676). DIN 02536676: Tadalafil Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 241200103; group id 371; item number 0879; lccId None; manufacturer id SIV Source form: Tab; strength: 2.5mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $3.8616; ministry $3.8616 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02536676 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=102542
Interchangeable products
Act Tadalafil · DIN 02428628 · $3.6471 Apo-Tadalafil · DIN 02422085 · $3.6470 Auro-Tadalafil · DIN 02435896 · $3.6470 Cialis · DIN 02296888 · not recorded Jamp-Tadalafil · DIN 02451824 · $3.6471 Mar-Tadalafil · DIN 02452286 · $3.6471 Mylan-Tadalafil · DIN 02410621 · $3.6471 PMS-Tadalafil · DIN 02409410 · $3.6471 PRZ-Tadalafil · DIN 02512262 · $3.6470 Ran-Tadalafil · DIN 02452081 · $3.6471 Teva-Tadalafil · DIN 02440148 · $3.8616
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=02536676
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Teva-Tadalafil · DIN 02440148 · 2.5mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria
Exceptional Access criteria on record are for Brand(s): Adcirca; 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 246, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Adcirca; 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 248, 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 Tadalafil Brand(s): Adcirca and generics, Cialis and generics DOSAGE FORM/ STRENGTH: 20 mg (Adcirca versions) ; 2.5 mg, 5 mg, 10 mg, 20 mg (Cialis 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 99 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 99, record 58, 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-Tadalafil · DIN 02440148 Manufacturer: Teva Canada Limited; listing date 2016-10-27 Health Canada: Marketed since 2016-07-12 · brand TEVA-TADALAFIL · ATC G04BE08 TADALAFIL · form Tablet · route Oral · ingredients TADALAFIL 2.5 MG · company Teva canada limited · schedule Prescription
Check this DIN again · Health Canada product record

Teva-Tadalafil: Formulary list price $3.8616/unit (unit not stated in source; not the patient's cost)

Ministry pays: $3.8616 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=92452 · Verify on the e-Formulary ↗ (DIN 02440148)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02440148). DIN 02440148: Teva-Tadalafil Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 241200103; group id 371; item number 0879; lccId None; manufacturer id TEV Source form: Tab; strength: 2.5mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $3.8616; ministry $3.8616 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02440148 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=92452
Interchangeable products
Act Tadalafil · DIN 02428628 · $3.6471 Apo-Tadalafil · DIN 02422085 · $3.6470 Auro-Tadalafil · DIN 02435896 · $3.6470 Cialis · DIN 02296888 · not recorded Jamp-Tadalafil · DIN 02451824 · $3.6471 Mar-Tadalafil · DIN 02452286 · $3.6471 Mylan-Tadalafil · DIN 02410621 · $3.6471 PMS-Tadalafil · DIN 02409410 · $3.6471 PRZ-Tadalafil · DIN 02512262 · $3.6470 Ran-Tadalafil · DIN 02452081 · $3.6471 Tadalafil · DIN 02536676 · $3.8616
Shortage status: resolved shortage (ended 2024-09-10); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02440148
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Ach-Tadalafil · DIN 02515989 · 5mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria
Exceptional Access criteria on record are for Brand(s): Adcirca; 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 246, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Adcirca; 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 248, 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 Tadalafil Brand(s): Adcirca and generics, Cialis and generics DOSAGE FORM/ STRENGTH: 20 mg (Adcirca versions) ; 2.5 mg, 5 mg, 10 mg, 20 mg (Cialis 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 99 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 99, record 58, 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
Ach-Tadalafil · DIN 02515989 Manufacturer: Accord Healthcare Inc.; listing date 2023-05-31 Health Canada: Marketed since 2023-03-30 · brand ACH-TADALAFIL · ATC G04BE08 TADALAFIL · form Tablet · route Oral · ingredients TADALAFIL 5 MG · company Accord healthcare inc · schedule Prescription
Check this DIN again · Health Canada product record

Ach-Tadalafil: Formulary list price $3.6470/unit (unit not stated in source; not the patient's cost)

Ministry pays: $3.6470 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=100534 · Verify on the e-Formulary ↗ (DIN 02515989)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02515989). DIN 02515989: Ach-Tadalafil Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 241200104; group id 371; item number 0880; lccId None; manufacturer id ACH Source form: Tab; strength: 5mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $3.6470; ministry $3.6470 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02515989 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100534
Interchangeable products
Act Tadalafil · DIN 02428636 · $3.6471 Apo-Tadalafil · DIN 02422093 · $3.6470 Auro-Tadalafil · DIN 02435926 · $3.6471 Bio-Tadalafil · DIN 02508702 · $3.6471 Cialis · DIN 02296896 · not recorded Jamp-Tadalafil · DIN 02451832 · $3.6471 M-Tadalafil · DIN 02512114 · $3.6470 Mar-Tadalafil · DIN 02452278 · $3.6471 Mint-Tadalafil · DIN 02451670 · $3.6472 Mylan-Tadalafil · DIN 02410648 · $3.6471 NRA-Tadalafil · DIN 02520931 · $3.6471 PMS-Tadalafil · DIN 02409429 · $3.6471 PRZ-Tadalafil · DIN 02512270 · $3.6471 Priva-Tadalafil · DIN 02452480 · $3.6471 Ran-Tadalafil · DIN 02452073 · $3.6471 Riva-Tadalafil · DIN 02454726 · $3.6471 Tadalafil · DIN 02457016 · $3.6471 Tadalafil · DIN 02536684 · $3.8616 Teva-Tadalafil · DIN 02440156 · $3.8616
Shortage status: resolved shortage (ended 2023-09-15); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02515989
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Apo-Tadalafil · DIN 02422093 · 5mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria
Exceptional Access criteria on record are for Brand(s): Adcirca; 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 246, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Adcirca; 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 248, 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 Tadalafil Brand(s): Adcirca and generics, Cialis and generics DOSAGE FORM/ STRENGTH: 20 mg (Adcirca versions) ; 2.5 mg, 5 mg, 10 mg, 20 mg (Cialis 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 99 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 99, record 58, 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-Tadalafil · DIN 02422093 Manufacturer: Apotex Inc.; listing date 2016-09-29 Health Canada: Marketed since 2016-07-12 · brand APO-TADALAFIL · ATC G04BE08 TADALAFIL · form Tablet · route Oral · ingredients TADALAFIL 5 MG · company Apotex inc · schedule Prescription
Check this DIN again · Health Canada product record

Apo-Tadalafil: Formulary list price $3.6470/unit (unit not stated in source; not the patient's cost)

Ministry pays: $3.6470 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=90681 · Verify on the e-Formulary ↗ (DIN 02422093)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02422093). DIN 02422093: Apo-Tadalafil Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 241200104; group id 371; item number 0880; lccId None; manufacturer id APX Source form: Tab; strength: 5mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $3.6470; ministry $3.6470 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02422093 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=90681
Interchangeable products
Ach-Tadalafil · DIN 02515989 · $3.6470 Act Tadalafil · DIN 02428636 · $3.6471 Auro-Tadalafil · DIN 02435926 · $3.6471 Bio-Tadalafil · DIN 02508702 · $3.6471 Cialis · DIN 02296896 · not recorded Jamp-Tadalafil · DIN 02451832 · $3.6471 M-Tadalafil · DIN 02512114 · $3.6470 Mar-Tadalafil · DIN 02452278 · $3.6471 Mint-Tadalafil · DIN 02451670 · $3.6472 Mylan-Tadalafil · DIN 02410648 · $3.6471 NRA-Tadalafil · DIN 02520931 · $3.6471 PMS-Tadalafil · DIN 02409429 · $3.6471 PRZ-Tadalafil · DIN 02512270 · $3.6471 Priva-Tadalafil · DIN 02452480 · $3.6471 Ran-Tadalafil · DIN 02452073 · $3.6471 Riva-Tadalafil · DIN 02454726 · $3.6471 Tadalafil · DIN 02457016 · $3.6471 Tadalafil · DIN 02536684 · $3.8616 Teva-Tadalafil · DIN 02440156 · $3.8616
Shortage status: active shortage (reported 2026-09-08, estimated to end 2026-10-30, last updated 2026-09-11); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02422093
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Auro-Tadalafil · DIN 02435926 · 5mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria
Exceptional Access criteria on record are for Brand(s): Adcirca; 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 246, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Adcirca; 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 248, 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 Tadalafil Brand(s): Adcirca and generics, Cialis and generics DOSAGE FORM/ STRENGTH: 20 mg (Adcirca versions) ; 2.5 mg, 5 mg, 10 mg, 20 mg (Cialis 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 99 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 99, record 58, 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-Tadalafil · DIN 02435926 Manufacturer: Auro Pharma Inc.; listing date 2016-09-29 Health Canada: Marketed since 2016-07-14 · brand AURO-TADALAFIL · ATC G04BE08 TADALAFIL · form Tablet · route Oral · ingredients TADALAFIL 5 MG · company Auro pharma inc · schedule Prescription
Check this DIN again · Health Canada product record

Auro-Tadalafil: Formulary list price $3.6471/unit (unit not stated in source; not the patient's cost)

Ministry pays: $3.6471 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=92026 · Verify on the e-Formulary ↗ (DIN 02435926)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02435926). DIN 02435926: Auro-Tadalafil Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 241200104; group id 371; item number 0880; lccId None; manufacturer id AUR Source form: Tab; strength: 5mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $3.6471; ministry $3.6471 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02435926 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=92026
Interchangeable products
Ach-Tadalafil · DIN 02515989 · $3.6470 Act Tadalafil · DIN 02428636 · $3.6471 Apo-Tadalafil · DIN 02422093 · $3.6470 Bio-Tadalafil · DIN 02508702 · $3.6471 Cialis · DIN 02296896 · not recorded Jamp-Tadalafil · DIN 02451832 · $3.6471 M-Tadalafil · DIN 02512114 · $3.6470 Mar-Tadalafil · DIN 02452278 · $3.6471 Mint-Tadalafil · DIN 02451670 · $3.6472 Mylan-Tadalafil · DIN 02410648 · $3.6471 NRA-Tadalafil · DIN 02520931 · $3.6471 PMS-Tadalafil · DIN 02409429 · $3.6471 PRZ-Tadalafil · DIN 02512270 · $3.6471 Priva-Tadalafil · DIN 02452480 · $3.6471 Ran-Tadalafil · DIN 02452073 · $3.6471 Riva-Tadalafil · DIN 02454726 · $3.6471 Tadalafil · DIN 02457016 · $3.6471 Tadalafil · DIN 02536684 · $3.8616 Teva-Tadalafil · DIN 02440156 · $3.8616
Shortage status: resolved shortage (ended 2024-07-15); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02435926
Shortage record checked 2026-09-13T08:10:21.292534+00:00

Cialis · DIN 02296896 · 5mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
Write on scriptExceptional Access application required. For a drug to be considered for funding, the EAP reimbursement criteria must always be met and the request approved prior to the initiation of treatment with the drug being requested, unless otherwise specified within the criteria. (ontario.ca, Aug 31, 2026 ↗) Submit through SADIE: "The SADIE portal is available to authorized prescribers and their delegates and designates, enabling the creation, submission and tracking of web-based electronic requests directly to the Exceptional Access Program." (ontario.ca, Aug 31, 2026 ↗)
Private plan unknown: ask. If yes, check its coverage and payer coordination; if no, see the public routes below.

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Coverage criteria
Exceptional Access criteria on record are for Brand(s): Adcirca; 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 246, corpus 2025-01-01; name match only, not an eligibility decision Exceptional Access criteria on record are for Brand(s): Adcirca; 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 248, 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 Tadalafil Brand(s): Adcirca and generics, Cialis and generics DOSAGE FORM/ STRENGTH: 20 mg (Adcirca versions) ; 2.5 mg, 5 mg, 10 mg, 20 mg (Cialis 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 99 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 99, record 58, 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
Cialis · DIN 02296896 Manufacturer: Eli Lilly Canada Inc.; listing date 2016-09-29 Health Canada: Marketed since 2008-01-18 · brand CIALIS · ATC G04BE08 TADALAFIL · form Tablet · route Oral · ingredients TADALAFIL 5 MG · company Eli lilly canada inc · schedule Prescription
Check this DIN again · Health Canada product record

Cialis: Formulary list price not recorded/unit (unit not stated in source; not the patient's cost)

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=78224 · Verify on the e-Formulary ↗ (DIN 02296896)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02296896). DIN 02296896: Cialis Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 241200104; group id 371; item number 0880; lccId None; manufacturer id LIL Source form: Tab; strength: 5mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): not recorded; ministry not recorded Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02296896 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=78224
Interchangeable products
Ach-Tadalafil · DIN 02515989 · $3.6470 Act Tadalafil · DIN 02428636 · $3.6471 Apo-Tadalafil · DIN 02422093 · $3.6470 Auro-Tadalafil · DIN 02435926 · $3.6471 Bio-Tadalafil · DIN 02508702 · $3.6471 Jamp-Tadalafil · DIN 02451832 · $3.6471 M-Tadalafil · DIN 02512114 · $3.6470 Mar-Tadalafil · DIN 02452278 · $3.6471 Mint-Tadalafil · DIN 02451670 · $3.6472 Mylan-Tadalafil · DIN 02410648 · $3.6471 NRA-Tadalafil · DIN 02520931 · $3.6471 PMS-Tadalafil · DIN 02409429 · $3.6471 PRZ-Tadalafil · DIN 02512270 · $3.6471 Priva-Tadalafil · DIN 02452480 · $3.6471 Ran-Tadalafil · DIN 02452073 · $3.6471 Riva-Tadalafil · DIN 02454726 · $3.6471 Tadalafil · DIN 02457016 · $3.6471 Tadalafil · DIN 02536684 · $3.8616 Teva-Tadalafil · DIN 02440156 · $3.8616
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=02296896
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary class (24:12 Vasodilating Drugs) and how they are covered

Matched class: 24:12 Vasodilating Drugs

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

VARDENAFIL HCL

· 16 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 10mg, 5mg, 20mg · Orally Disintergrating Tab, Tab

ISOSORBIDE DINITRATE

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

NITROGLYCERIN

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

DIPYRIDAMOLE & ACETYLSALICYLIC ACID

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

NIMODIPINE

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

VERICIGUAT

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

AMBRISENTAN

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

BETAHISTINE DIHYDROCHLORIDE

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

BOSENTAN MONOHYDRATE

· 14 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 62.5mg, 125mg · Tab

DIPYRIDAMOLE

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

ISOSORBIDE-5-MONONITRATE

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

RIOCIGUAT

· 10 products · Off-Formulary Interchangeable, not an ODB benefit · strengths: 0.5mg, 1.5mg, 1mg, 2.5mg, 2mg · Tab Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 24:12
Full class listing Related classes: 24:04 Cardiac Drugs, 24:06 Antilipemic Drugs, 24:08 Hypotensive Drugs (For Diuretics See 40:28), 24:32 Renin-Angiotensin Aldosterone Inhibitors Same formulary class, not same indication: class membership alone does not establish equivalent uses.
Other drugs whose Health Canada label lists a similar indication: erectile dysfunction, the signs and symptoms of benign prostatic hyperplasia
From Health Canada product monographs; label wording only, not a treatment recommendation. Matching is lexical and uses one held product label per generic; formulations and qualifying criteria may differ. No displayed matched alternative is a general benefit. ALFUZOSIN HYDROCHLORIDE · Limited Use, codes 351, 352 INDICATIONS AND CLINICAL USE XATRAL (alfuzosin hydrochloride) is indicated for:  Benign Prostatic Hyperplasia XATRAL is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH).  Acute Urinary Retention XATRAL is indicated as adjunctive therapy with urethral catheterization for Acute Urinary Retention related to BPH and management following catheter removal. PM: https://pdf.hres.ca/dpd_pm/00049054.PDF; date January 2, 2019; DIN 02245565; fetched 2026-09-10 Product monograph SILODOSIN · Listed, not a benefit (2), Limited Use, codes 351, 352 (8) INDICATIONS AND CLINICAL USE Sandoz Silodosin (silodosin) is indicated for:  The treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). PM: https://pdf.hres.ca/dpd_pm/00060987.PDF; date May 14, 2021; DIN 02475421; fetched 2026-09-10 Product monograph VARDENAFIL HCL · Off-Formulary Interchangeable, not an ODB benefit INDICATIONS AND CLINICAL USE MYLAN-VARDENAFIL (vardenafil tablets) is indicated for:  Treatment of erectile dysfunction (difficulties or the inability to achieve or maintain penile erection sufficient for satisfactory sexual performance). PM: https://pdf.hres.ca/dpd_pm/00057041.PDF; date June 22, 2020; DIN 02464209; fetched 2026-09-10 Product monograph Coverage source: ON formulary extract 2026-08-26
What the Health Canada label says it is for
INDICATIONS AND CLINICAL USE CIALIS (tadalafil) is indicated for the treatment of erectile dysfunction (ED) in men. CIALIS is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). CIALIS is indicated for the treatment of ED and the signs and symptoms of benign prostatic hyperplasia (ED/BPH). Geriatrics (> 65 years of age): No dose adjustment is warranted based on age alone. However, a greater sensitivity to medications in some older individuals should be considered. (See WARNINGS AND PRECAUTIONS, Use in the Elderly, and DOSAGE AND ADMINISTRATION). Pediatrics (< 18 years of age): CIALIS has not been evaluated in individuals less than 18 years old. CIALIS is not indicated for use in pediatric patients. https://pdf.hres.ca/dpd_pm/00037181.PDF PM date: not printed or not captured Source product: CIALIS; DIN 02248088; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.

Availability

Apo-Tadalafil · DIN 02422093 Shortage status: active shortage (reported 2026-09-08, estimated to end 2026-10-30, last updated 2026-09-11); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02422093

Check this DIN again

Prepare an Exceptional Access request

SADIE has its own form for many drugs; this checklist prepares the answers; the ministry decides. Open SADIE

Use this text in SADIE’s free-text fields or read from it on a Telephone Request Service call. Review marks do not indicate eligibility. Evidence stays in this page until you copy it; nothing entered here is sent or saved. Do not enter patient identifiers.

EAP Telephone Request Service: The TRS can be accessed by calling toll-free at 1-866-811-9893 or 416-327-8109 (Toronto area) between 8:30 a.m. and 5:00 p.m. Monday through Friday (except holidays) and selecting the TRS option. Source; updated September 15, 2026

EAP fax: In Ontario: 1-866-811-9908 or 416-327-7526 (Toronto area). Outside Ontario: 1-833-905-4260. Source; updated September 15, 2026

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

Tadalafil (Adcirca and generics, Cialis and generics)

Ministry criteria list dated January 1, 2025; the program's current criteria may differ; SADIE shows the current version. Current criteria in SADIE

Prepare answers: For the treatment of severe Raynaud’s phenomenon (RP) and/or digital ulcers secondary to scleroderma (systemic sclerosis) or scleroderma-like disease:

Ministry criteria corpus 2025-01-01; page 99

Tadalafil Brand(s): Adcirca and generics, Cialis and generics DOSAGE FORM/ STRENGTH: 20 mg (Adcirca versions) ; 2.5 mg, 5 mg, 10 mg, 20 mg (Cialis 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
99

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