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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 Pioglitazone Brand(s): Actos , Generics DOSAGE FORM/ STRENGTH: 15 mg, 30 mg, 45 mg tablet For the treatment of type 2 diabetes in patients who require; • Dual combination therapy of diabetes AND demonstrate inadequate glycemic control (HbA1c of >7%) on maximal doses of metformin (2000 mg/day) OR • Dual combination therapy of diabetes AND demonstrate inadequate glycemic control (HbA1c of >7%) on maximal* doses of sulfonylurea and demonstrated intolerance / contraindication to metformin OR • Triple combination therapy of diabetes and who demonstrate inadequate glycemic control on maximal** doses of metformin and a sulfonylurea AND only if the physician has offered insulin as an alternative option first, and the patient has refused or is not able to take insulin. Note: Both the physician and patient must be aware that thiazolidinediones (TZDs), are not indicated for use in triple therapy. ***Those with one or more of the following contraindications/ precautions to therapy with pioglitazone/rosiglitazone will not be considered • Patients with type 1 diabetes • Patients who will be using this as monotherapy • Combination use with a nitrates • Combination use with insulin • Patients with any stage of heart failure (i.e. NYHA Class I, II, III, IV) • Patients at high risk for bone fracture (i.e. post-menopausal women with previously confirmed osteoporosis or osteopenia) • Patients with recent history (in the past 3 months) of an ischemic cardiovascular event (myocardial infarction, unstable angina) * Note: For the purpose of the EAP submission, maximal dose of sulfonylurea is considered to be glyburide 10 mg/day, gliclazide 160mg/day OR Diamicron MR 60mg/day, OR glimepiride (Amaryl ) 4 mg/day and aximal dose of metformin is considered to be 2000 mg/day. Duration of Approval: 5 years Renewals as well as requests for ongoing treatment in patients previously provided these drugs by other means will be considered for those patients who have NOT developed a contraindication/precautionary use*** in the intervening period AND have demonstrated a recent HbA1c level ≤7% while on treatment Duration of Approval: 5 years 34  EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 34, record 15, 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 Pioglitazone Brand(s): Generics DOSAGE FORM/ STRENGTH: 15 mg, 30 mg, 45 mg tablet For dual combination therapy of type 2 diabetes, in patients with: a) Inadequate glycemic control (HbA1c of >7%) on maximal doses of metformin (2000 mg/day); OR b) Inadequate glycemic control, on maximal doses of sulfonylurea (glyburide 10mg/day, gliclazide 160mg/day or gliclazide modified release (MR) 60 mg/day) or glimepiride 4 mg/day and demonstrated intolerance / contraindication to metformin For triple combination therapy of type 2 diabetes, in patients with: a) Inadequate glycemic control on maximal doses of metformin and a sulfonylurea AND only if: • physician has offered insulin as alternative option first, and patient has refused or is not able to take insulin, AND both physician and patient are aware that thiazolidinediones are not indicated for use in triple therapy. Standard Approval Duration: 5 years 471 Pioglitazone Brand(s): Generics DOSAGE FORM/ STRENGTH: 15mg, 30 mg, 45 mg tablet Renewals: EAP will renew pioglitazone only for patients who have achieved adequate glycemic control (HbA1c of ≤ 7% while on therapy and who have no known contraindications to pioglitazone. Standard Approval Duration: 5 years EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 471, record 310, 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 ↗)

Actos · DIN 02242574 Manufacturer: Takeda Canada Inc.; listing date 2006-10-23 Health Canada: Cancelled post market since 2018-03-30 · brand ACTOS · ATC A10BG03 PIOGLITAZONE · form Tablet · route Oral · ingredients PIOGLITAZONE (PIOGLITAZONE HYDROCHLORIDE) 45 MG · company Takeda canada inc · schedule Prescription

The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02242574). DIN 02242574: Actos Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 682002021; group id 751; item number 1842; lccId None; manufacturer id TAK Source form: Tab; strength: 45mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $5.2710; ministry $5.2710 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02242574 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=66346

Interchangeable products

Accel Pioglitazone · DIN 02303469 · $2.9500 Apo-Pioglitazone · DIN 02302977 · $3.3105 Auro-Pioglitazone · DIN 02384922 · $3.3105 Jamp-Pioglitazone · DIN 02365537 · $3.3105 Mint-Pioglitazone · DIN 02326493 · $3.3105 Pioglitazone Hydrochloride Tablets · DIN 02339595 · $3.3105 Sandoz Pioglitazone · DIN 02297922 · $3.3105 Teva-Pioglitazone · DIN 02274930 · $3.3105 Teva-Pioglitazone · DIN 02302896 · $3.3105

Shortage status: not checked (no credentials)

Health Canada lists this DIN as Cancelled post market since 2018-03-30 — choose a marketed DIN from the same-category list.