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EVOLOCUMAB

All injection strengths: Limited Use (codes 527, 737)

Other products in the same Health Canada class (C10A, C10AX) — coverage varies; not interchangeable

  • Alirocumab (Praluent): limited Use 555
  • Ezetimibe (Ezetrol): limited Use 380, 381
  • Inclisiran (Leqvio): limited Use 732
  • Atorvastatin (Lipitor): general benefit
  • Bezafibrate (Bezalip): general benefit
  • Cholestyramine resin (Questran Light 4g Pk): general benefit, Not a benefit

9 more in the class list below

Repatha · DIN 02446057 · 140mg/mL · injection, pre-filled syringe Autoinj

Limited Use — Reason for Use code 527, 737 requiredMarketed · checked 2026-09-19
StatusLimited Use — Reason for Use code 527, 737 required
Write on scriptLU code 527, 737 (patient must meet the criteria below)
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.
Ontario Limited Use criteria — code 527, 737
Reason for Use code 527 For the treatment of Heterozygous Familial Hypercholesterolemia (HeFH) in patients 18 years of age or older who meet the following criteria: - Definite or probable diagnosis of HeFH using the Simon Broome or Dutch Lipid Network criteria or genetic testing; AND - Unable to reach Low Density Lipoprotein Cholesterol (LDL-C) target (i.e., LDL-C less than 2.0 mmol/L for secondary prevention) or at least a 50% reduction in LDL-C from untreated baseline despite: A. Confirmed adherence to high dose statin (e.g., atorvastatin 80mg or rosuvastatin 40mg) in combination with ezetimibe for at least a total of 3 months; OR B. Confirmed adherence to ezetimibe for at least a total of 3 months and inability to tolerate high dose statin defined as: (i). Inability to tolerate at least 2 statins with at least one started at the lowest starting dose; AND (ii). For each statin (two statins in total), dose reduction is attempted for intolerable symptom (myopathy) or biomarker abnormality (creatine kinase (CK) greater than 5 times the upper limit of normal) resolution rather than discontinuation of statin altogether; AND (iii). For each statin (two statins in total), intolerable symptoms (myopathy) or abnormal biomarker (creatine kinase (CK) greater than 5 times the upper limit of normal) changes are reversible upon statin discontinuation but reproducible by re-challenge of statins where clinically appropriate; AND (iv). One of the following: I) Other known determinants of intolerable symptoms or abnormal biomarkers have been ruled out; OR II) Patient developed confirmed and documented rhabdomyolysis; OR III) Patient is statin contraindicated i.e. active liver disease, unexplained persistent elevations of serum transaminases exceeding 3 times the upper limit of normal Treatment with Repatha should be discontinued if the patient does not meet all of the following: 1. Patient is adherent to therapy. 2. Patient has achieved a reduction in LDL-C of at least 40% from baseline (4-8 weeks after initiation of Repatha). 3. Patient continues to have a significant reduction in LDL-C (with continuation of Repatha) of at least 40% from baseline since initiation of PCSK9 inhibitor. LDL-C should be checked periodically with continued treatment with PCSK9 inhibitors (e.g., every 6 months). Patients prescribed Repatha 140mg every two weeks are limited to 26 prefilled syringes (PFS) per year. Coverage limit: LU Authorization Period: 1 year Reason for Use code 737 To reduce elevated low-density lipoprotein cholesterol (LDL-C) in adult patients with atherosclerotic cardiovascular disease (ASCVD) when all of the following criteria apply: 1. Patient is aged 18 years or older; AND 2. Patient has experienced a recent acute coronary syndrome (ACS) event, defined as those who have been hospitalized for a heart attack or unstable angina in the past 52 weeks; AND 3. Patient is unable to meet cholesterol targets, defined as having an LDL-C level 1.8mmol/L or greater, OR a non-HDL-C level 2.6mmol/L or greater, OR an Apo-B level 0.7g/L or greater, despite taking maximally tolerated dose of statins*; AND *Maximally tolerated dose of statins includes one moderate-to-high intensity statin (i.e., at least atorvastatin 20mg daily or equivalent) for at least 4 weeks before treatment OR documented intolerance to at least 2 statins OR contraindication to statin therapy. 4. Patient has received an adequate trial (i.e., at least 4 weeks) of ezetimibe** if only modest reductions in cholesterol targets are required (i.e., those with an LDL-C level of 1.8mmol/L to less than or equal to 2.2mmol/L, OR a non-HDL-C level of 2.6mmol/L to less than or equal to 2.9mmol/L, OR an Apo-B level of 0.7g/L to less than or equal to 0.8g/L) despite taking a maximally tolerated statin dose; AND **For clarity, an adequate trial of ezetimibe is not required for patients with an LDL-C level greater than 2.2mmol/L, a non-HDL-C level greater than 2.9mmol/L, or an Apo-B level greater than 0.8g/L, despite taking a maximally tolerated statin dose. 5. Prescribed by a healthcare practitioner with expertise managing patients in the post-ACS setting; AND 6. Is not being used in combination with other proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors. Treatment with Repatha should be discontinued if the patient does not meet all of the following: 1. Patient is adherent to therapy. 2. Patient has achieved a reduction in cholesterol parameters (i.e., LDL-C, and/or non-HDL-C and/or Apo-B) from baseline deemed clinically appropriate by the treating prescriber. Approved dose: 140mg every 2 weeks. Patients prescribed Repatha 140mg every two weeks are limited to 26 prefilled syringes (PFS) per year. Coverage limit: LU Authorization Period: Indefinite
No interchangeable product listed in the Ontario extract
Repatha · DIN 02446057 Manufacturer: Amgen Canada Inc.; listing date 2018-04-30 Health Canada: Marketed since 2015-09-28 · brand REPATHA · ATC C10AX13 EVOLOCUMAB · form Solution · route Subcutaneous · ingredients EVOLOCUMAB 140 MG/ML · company Amgen canada inc · schedule Schedule d, Prescription
Check this DIN again · Health Canada product record

Repatha: Formulary list price $291.6650/unit (unit not stated in source; not the patient's cost)

Ministry pays: $291.6650 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=93132 · Verify on the e-Formulary ↗ (DIN 02446057)

Source record
DIN 02446057: Repatha Raw flags: sec12=Y, sec3=Y Item: 240600075; group id 301; item number 0655; lccId 00302; manufacturer id AMG Source form: Inj Sol-Pref Syr Autoinj; strength: 140mg/mL Recorded listing: Limited Use: paid only with a Reason for Use code and the criteria below Source prices (unrounded): $291.6650; ministry $291.6650 Source: ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26 DIN=02446057 Health Canada DPD extract of Sep 2, 2026 (Open Government Licence – Canada) · https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=93132
Shortage status: not checked (no credentials)
Other drugs in the same formulary class (24:06 Antilipemic Drugs) and how they are covered

Matched class: 24:06 Antilipemic Drugs

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: AMLODIPINE BESYLATE & ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, BEZAFIBRATE, ROSUVASTATIN CALCIUM Some products covered without a code (check the product listing): CHOLESTYRAMINE RESIN, COLESEVELAM HYDROCHLORIDE, FENOFIBRATE, FLUVASTATIN SODIUM, GEMFIBROZIL, LOVASTATIN, PRAVASTATIN SODIUM, SIMVASTATIN 24:00 CARDIOVASCULAR DRUGS

INCLISIRAN

· 1 products · Limited Use, codes 732 · strengths: 284mg/1.5mL · Inj Sol-1.5mL Pref Syr Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 24:00 24:06 Antilipemic Drugs

EZETIMIBE

· 20 products · Limited Use, codes 380, 381 · strengths: 10mg · Tab

ATORVASTATIN CALCIUM

· 99 products · General benefit · strengths: 10mg, 20mg, 40mg, 80mg · Tab

BEZAFIBRATE

· 2 products · General benefit · strengths: 400mg · SR Tab

CHOLESTYRAMINE RESIN

· 4 products · Listed, not a benefit (1), General benefit (3) · strengths: · Oral Pd-Pouch Pk

COLESEVELAM HYDROCHLORIDE

· 3 products · General benefit (2), Temporary benefit (1) · strengths: 625mg · Tab

FENOFIBRATE

· 16 products · Listed, not a benefit (2), General benefit (9), Off-Formulary Interchangeable, not an ODB benefit (5) · strengths: 100mg, 67mg, 200mg, 160mg, 48mg, 145mg · Cap, Tab

FLUVASTATIN SODIUM

· 5 products · Listed, not a benefit (2), General benefit (3) · strengths: 20mg, 40mg, 80mg · Cap, ER Tab

GEMFIBROZIL

· 6 products · Listed, not a benefit (1), General benefit (2), Off-Formulary Interchangeable, not an ODB benefit (3) · strengths: 300mg, 600mg · Cap, Tab

LOVASTATIN

· 4 products · Listed, not a benefit (2), General benefit (2) · strengths: 20mg, 40mg · Tab

PRAVASTATIN SODIUM

· 57 products · Listed, not a benefit (3), General benefit (54) · strengths: 10mg, 20mg, 40mg · Tab

ROSUVASTATIN CALCIUM

· 80 products · General benefit · strengths: 5mg, 10mg, 20mg, 40mg · Tab Source: formulary-ed43-front-matter.txt Part V; ODB odb-formulary-ed43-extract-2026-08-26.xml extract_date=2026-08-26; class 24:06 and 4 more
Full class listing Related classes: 24:04 Cardiac Drugs, 24:08 Hypotensive Drugs (For Diuretics See 40:28), 24:12 Vasodilating Drugs, 24:32 Renin-Angiotensin Aldosterone Inhibitors Same formulary class, not same indication: class membership alone does not establish equivalent uses.
What the Health Canada label says it is for
1 INDICATIONS Prevention of Cardiovascular Events Repatha® (evolocumab injection) is indicated as an adjunct to diet and standard of care therapy (including moderate- to high-intensity statin therapy alone or in combination with other lipid - lowering therapy), to reduce the risk of myocardial infarction, stroke, and coronary revascularization in adult patients with atherosclerotic cardiovascular disease (ASCVD) by further lowering low-density lipoprotein cholesterol (LDL-C) levels (see 14 CLINICAL TRIALS). Primary Hyperlipidemia (including Heterozygous Familial Hypercholesterolemia [HeFH] and ASCVD) REPATHA is indicated for the reduction of elevated LDL-C in adult patients with primary hyperlipidemia (including heterozygous familial hypercholesterolemia and ASCVD): • as an adjunct to diet and statin therapy, with or without other lipid -lowering therapies, in patients who require additional lowering of LDL-C • as an adjunct to diet, alone or in combination with non-statin lipid-lowering therapies, in patients for whom a statin is contraindicated Pediatric Patients with Heterozygous Familial Hypercholesterolemia REPATHA is indicated as an adjunct to diet and other LDL-C-… https://pdf.hres.ca/dpd_pm/00080599.PDF PM date: May 16, 2025 Source product: REPATHA; DIN 02446057; fetched 2026-09-10 Product monograph posted by Health Canada; excerpt for lookup only.