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CARDIOVASCULAR DRUGS › ANTILIPEMIC DRUGS

EVOLOCUMAB (Repatha)

140mg/mLInj Sol-Pref Syr Autoinj
LU527
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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…

LU Authorization Period: 1 year
Complete Ontario criteria

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.

LU737
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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…

LU Authorization Period: Indefinite
Complete Ontario criteria

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.

Clinical verification required

Quick summaries support scanning only. Confirm eligibility against the complete Ontario criteria and current Ontario e-Formulary before billing.

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