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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

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

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

M-Tadalafil · DIN 02512130 Manufacturer: Mantra Pharma Inc.; listing date 2021-11-30 Health Canada: Marketed since 2021-09-27 · brand M-TADALAFIL · ATC G04BE08 TADALAFIL · form Tablet · route Oral · ingredients TADALAFIL 20 MG · company Mantra pharma inc · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02512130). DIN 02512130: M-Tadalafil Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 241200106; group id 371; item number 0883; lccId None; manufacturer id MAT Source form: Tab; strength: 20mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $12.3575; ministry $12.3575 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02512130 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100135

Interchangeable products

AG-Tadalafil · DIN 02481421 · $12.3569 Ach-Tadalafil · DIN 02516004 · $12.3575 Act Tadalafil · DIN 02428652 · $12.3569 Apo-Tadalafil · DIN 02422115 · $12.3575 Auro-Tadalafil · DIN 02435942 · $12.3575 Bio-Tadalafil · DIN 02508729 · $12.3575 Cialis · DIN 02248089 · not recorded Jamp-Tadalafil · DIN 02451859 · $12.3569 Mar-Tadalafil · DIN 02452243 · $12.3575 Mint-Tadalafil · DIN 02451697 · $12.3576 Mylan-Tadalafil · DIN 02410664 · $12.3569 NRA-Tadalafil · DIN 02520966 · $12.3575 PMS-Tadalafil · DIN 02409445 · $12.3569 PRZ-Tadalafil · DIN 02512297 · $12.3575 Priva-Tadalafil · DIN 02452502 · $12.3575 Ran-Tadalafil · DIN 02452111 · $12.3569 Riva-Tadalafil · DIN 02454742 · $12.3569 Tadalafil · DIN 02457032 · $12.3569 Tadalafil · DIN 02536706 · $13.0838 Teva-Tadalafil · DIN 02440172 · $13.0838

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=02512130

Shortage record checked 2026-09-13T08:10:21.292534+00:00