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

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REPAGLINIDE

All products: not a benefit

Other products in the same Health Canada class (A10B) — coverage varies; not interchangeable

  • Canagliflozin (Invokana): general benefit
  • Dapagliflozin (Forxiga): general benefit
  • Dapagliflozin + metformin (Xigduo): general benefit
  • Empagliflozin (Jardiance): general benefit
  • Empagliflozin + metformin (Synjardy): general benefit
  • Gliclazide (Diamicron MR): general benefit, Not a benefit

12 more in the class list below

Sandoz Repaglinide · DIN 02357488 · 2mg · tablet

Off-Formulary Interchangeable, not an ODB benefitMarketed · checked 2026-09-02
StatusOff-Formulary Interchangeable, not an ODB benefit
Write on scriptnot a benefit; no Exceptional Access criteria on record; see alternatives
Patient paysPatient pays: program not supplied; amount cannot be determined.
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): GlucoNorm; DOSAGE FORM/ STRENGTH: 0.5 mg, 1 mg, 2 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 Repaglinide Brand(s): GlucoNorm DOSAGE FORM/ STRENGTH: 0.5 mg, 1 mg, 2 mg tablet For the treatment of type 2 diabetes in patients with: • Inadequate glycemic control (HbA1c >7%) using maximal* doses of a sulfonylurea AND metformin (2000mg/day) OR • Inadequate glycemic control and demonstrated intolerance or contraindication to metformin and who are on maximal* doses of a sulfonylurea OR • Inadequate glycemic control and demonstrated intolerance or contraindication to a sulfonylurea (glyburide, gliclazide or glimepiride) and are on maximal** doses of metformin OR • Demonstrated intolerance or contraindication to both a sulfonylurea (glyburide, gliclazide or glimepiride) AND metformin OR • Adequate glycemic control (HbA1c ≤ 7%) who develops intolerance or contraindication to sulfonylurea (glyburide, gliclazide or glimepiride) or metformin OR • HbA1c ≤ 7% but with greater than 50% of fasting blood glucose (FBG >7mmol/L) or post-prandial plasma glucose (PPG >10mmol/L) levels not within target range and using maximally tolerated doses of a sulfonylurea and metformin. * Note: For the purpose of the EAP submission, maximal dose of sulfonylurea is considered to be glyburide 10mg/day, gliclazide 160 mg/day or Diamicron MR 60 mg/day, OR glimepiride (Amaryl ) 4 mg/day. **Note: For the purpose of the EAP submission, maximal dose of metformin is considered to be 2000 mg/day Duration of Approval: 5 years 35 EAP source: eap-frequently-requested-drugs-2025-01-01.txt, page 35, record 16, corpus 2025-01-01; name match only, not an eligibility decision
1 brand, same coverage
Sandoz Repaglinide · DIN 02357488 Manufacturer: Sandoz Canada Inc.; listing date 2011-08-04 Health Canada: Marketed since 2011-02-17 · brand SANDOZ REPAGLINIDE · ATC A10BX02 REPAGLINIDE · form Tablet · route Oral · ingredients REPAGLINIDE 2 MG · company Sandoz canada incorporated · schedule Prescription
Check this DIN again · Health Canada product record

Sandoz Repaglinide: Formulary list price $0.2440/unit (unit not stated in source; not the patient's cost)

Ministry pays: $0.2440 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=84261 · Verify on the e-Formulary ↗ (DIN 02357488)

Source record
The source extract's flag for this DIN is unclear — confirm on the e-Formulary before prescribing (DIN 02357488). DIN 02357488: Sandoz Repaglinide Raw flags: sec3=Y, sec3b=Y, sec3bEAP=Y Item: 682002015; group id 752; item number 1845; lccId None; manufacturer id SDZ Source form: Tab; strength: 2mg Recorded listing: Off-Formulary Interchangeable, not an ODB benefit; may be reimbursed through the Exceptional Access Program when approved (likely, unconfirmed) Source prices (unrounded): $0.2440; ministry $0.2440 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02357488 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=84261
Interchangeable products
Apo-Repaglinide · DIN 02355698 · $0.2441 Auro-Repaglinide · DIN 02424274 · $0.2441 Co Repaglinide · DIN 02321491 · $0.2441 GlucoNorm · DIN 02239926 · not recorded Jamp Repaglinide · DIN 02354942 · $0.2441
Shortage status: resolved shortage (ended 2024-10-15); reports as of 2026-09-13T08:10:21.292534+00:00 (Health Product Shortages Canada) Source: https://healthproductshortages.ca/search?term=02357488
Shortage record checked 2026-09-13T08:10:21.292534+00:00
Other drugs in the same formulary class (68:20:02 Oral Anti-Diabetic Agents) and how they are covered

Matched class: 68:20:02 Oral Anti-Diabetic Agents

Drug-class inventory only. Lists recorded Ontario formulary products, not every Canadian medication; does not recommend treatment. Covered without a code on the Ontario formulary: CANAGLIFLOZIN, DAPAGLIFLOZIN, DAPAGLIFLOZIN & METFORMIN, EMPAGLIFLOZIN, EMPAGLIFLOZIN & METFORMIN, LINAGLIPTIN, LINAGLIPTIN & METFORMIN, SAXAGLIPTIN, SAXAGLIPTIN & METFORMIN, SITAGLIPTIN, SITAGLIPTIN & METFORMIN Some products covered without a code (check the product listing): GLICLAZIDE, GLYBURIDE, METFORMIN HCL 68:20:02 Oral Anti-Diabetic Agents

CANAGLIFLOZIN

· 8 products · General benefit · strengths: 100mg, 300mg · Tab

DAPAGLIFLOZIN

· 22 products · General benefit · strengths: 5mg, 10mg · Tab

DAPAGLIFLOZIN & METFORMIN

· 6 products · General benefit · strengths: 5mg & 1000mg, 5mg & 850mg · Tab

EMPAGLIFLOZIN

· 2 products · General benefit · strengths: 10mg, 25mg · Tab

EMPAGLIFLOZIN & METFORMIN

· 6 products · General benefit · strengths: 5mg & 1000mg, 5mg & 500mg, 5mg & 850mg, 12.5mg & 1000mg, 12.5mg & 500mg, 12.5mg & 850mg · Tab

GLICLAZIDE

· 19 products · General benefit (18), Listed, not a benefit (1) · strengths: 60mg, 30mg, 80mg · ER Tab, SR Tab, Tab

GLYBURIDE

· 8 products · General benefit (6), Listed, not a benefit (2) · strengths: 2.5mg, 5mg · Tab

LINAGLIPTIN

· 1 products · General benefit · strengths: 5mg · Tab

LINAGLIPTIN & METFORMIN

· 3 products · General benefit · strengths: 2.5mg & 1000mg, 2.5mg & 500mg, 2.5mg & 850mg · Tab

METFORMIN HCL

· 53 products · Off-Formulary Interchangeable, not an ODB benefit (33), General benefit (19), Off-Formulary Interchangeable, not an ODB benefit; DIN status E (meaning unconfirmed); confirm discontinuation/availability with Health Canada (1) · strengths: 500mg, 1000mg, 850mg · ER Tab, Tab

SAXAGLIPTIN

· 6 products · General benefit · strengths: 2.5mg, 5mg · Tab

SAXAGLIPTIN & METFORMIN

· 3 products · General benefit · strengths: 2.5mg & 1000mg, 2.5mg & 500mg, 2.5mg & 850mg · Tab Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 68:20:02 and 6 more
Full class listing Related classes: 68:20:06 Incretin Mimetics, 68:20:10 Insulins (Rapid Acting), 68:20:12 Insulins (Intermediate Acting), 68:20:14 Insulins (Long Acting), 68:20:16 Insulins (Pre-Mixed) Same formulary class, not same indication: class membership alone does not establish equivalent uses.
What the Health Canada label says it is for
INDICATIONS AND CLINICAL USE JAMP REPAGLINIDE (repaglinide) is indicated:  As an adjunct to diet and exercise to lower the blood glucose in patients with type 2 diabetes mellitus whose hyperglycemia cannot be controlled satisfactorily by diet and exercise alone.  In combination therapy with metformin to lower blood glucose in patients whose hyperglycemia cannot be controlled by diet and exercise plus metformin monotherapy.  In combination with rosiglitazone in patients who show intolerance to metformin or for whom metformin is contraindicated, when diet and exercise plus rosiglitazone or repaglinide monotherapy do not result in adequate glycemic control. Geriatrics (> 65 years of age): Special care and monitoring is recommended in elderly patients between 65 and 75 years of age with renal, hepatic or other medical problems (see WARNINGS AND PRECAUTIONS and ACTION AND CLINICAL PHARMACOLOGY – Special Populations and Conditions). JAMP REPAGLINIDE is not recommended for use in elderly patients above 75 years of age due to lack of data on safety and/or efficacy (see WARNINGS AND PRECAUTIONS – Special Populations). Pediatrics (< 18 years of age): Safety and effectiveness o… https://pdf.hres.ca/dpd_pm/00046202.PDF PM date: June 27, 2018 Source product: JAMP REPAGLINIDE; DIN 02354926; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.

Prepare an Exceptional Access request

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

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

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

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

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

Repaglinide (GlucoNorm)

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 type 2 diabetes in patients with:

Ministry criteria corpus 2025-01-01; page 35

Repaglinide Brand(s): GlucoNorm DOSAGE FORM/ STRENGTH: 0.5 mg, 1 mg, 2 mg tablet
For the treatment of type 2 diabetes in patients with:
• Inadequate glycemic control (HbA1c >7%) using maximal* doses of a sulfonylurea AND metformin (2000mg/day) OR
• Inadequate glycemic control and demonstrated intolerance or contraindication to metformin and who are on maximal* doses of a sulfonylurea OR
• Inadequate glycemic control and demonstrated intolerance or contraindication to a sulfonylurea (glyburide, gliclazide or glimepiride) and are on maximal** doses of metformin OR
• Demonstrated intolerance or contraindication to both a sulfonylurea (glyburide, gliclazide or glimepiride) AND metformin OR
• Adequate glycemic control (HbA1c ≤ 7%) who develops intolerance or contraindication to sulfonylurea (glyburide, gliclazide or glimepiride) or metformin OR
• HbA1c ≤ 7% but with greater than 50% of fasting blood glucose (FBG >7mmol/L) or post-prandial plasma glucose (PPG >10mmol/L) levels not within target range and using maximally tolerated doses of a sulfonylurea and metformin.
* Note: For the purpose of the EAP submission, maximal dose of sulfonylurea is considered to be glyburide 10mg/day, gliclazide 160 mg/day or Diamicron MR 60 mg/day, OR glimepiride
(Amaryl ) 4 mg/day.
**Note: For the purpose of the EAP submission, maximal dose of metformin is considered to be 2000 mg/day
Duration of Approval: 5 years
35

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

Other review policies

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

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

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

Ontario source; updated September 15, 2026

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

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

Ontario source; updated September 15, 2026