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Limited coverage criteria – evolocumab

Last updated on August 12, 2026

 

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Generic name

evolocumab

Strength & form

140 mg/mL solution for subcutaneous injection

Special Authority criteria

Approval period

Acute coronary syndrome

For the reduction of elevated low-density lipoprotein cholesterol (LDL-C) in adult patients with primary hyperlipidemia (atherosclerotic cardiovascular disease [ASCVD]) when ALL of the following criteria are met:

  • Special Authority request is submitted within 52 weeks of the initial hospitalization for the acute coronary syndrome (ACS) event1

AND

  • Special Authority request is submitted by a cardiologist or internal medicine specialist with expertise in the post ACS setting

AND

  • Patient has elevated LDL-C levels, defined as an LDL-C ≥ 1.8 mmol/L, or non-high-density lipoprotein cholesterol (non-HDL-C) ≥ 2.4 mmol/L, or apolipoprotein B (ApoB) ≥ 0.7 g/L, despite receiving maximally tolerated dose of high-intensity HMG-CoA reductase inhibitors (statins) therapy (i.e., at least atorvastatin 40 mg daily or equivalent) for a minimum of 4 weeks (unless contraindicated or patient has intolerance2)
    • If LDL-C is ≤ 2.2 mmol/L, or non-HDL-C is ≤ 2.9 mmol/L, or ApoB is ≤ 0.8 g/L, patients must have demonstrated an adequate trial of ezetimibe3 before initiation of evolocumab
    • Evolocumab can be initiated with or without ezetimibe if LDL-C is > 2.2 mmol/L, or non-HDL-C is > 2.9 mmol/L, or ApoB is > 0.8 g/L
 Indefinite

Heterozygous familial hypercholesterolemia 

For the treatment of heterozygous familial hypercholesterolemia (HeFH)4 as an adjunct to maximally tolerated statins therapy in adult patients when ALL the following criteria are met:

  • The patient is unable to reach LDL-C levels or non-HDL-C or ApoB with the following target:
    • For primary prevention, a ≥ 50% reduction in LDL-C from untreated baseline, or
    • For secondary prevention, an LDL-C < 1.8 mmol/L or non-HDL-C < 2.4 mmol/L or ApoB < 0.7 g/L

AND

  • The patient has confirmed adherence to treatment with BOTH:
    • A high dose statin (i.e., atorvastatin 80 mg or rosuvastatin 40 mg) for a minimum of 3 months (unless the patient has intolerance to high dose statin therapy or is contraindicated2), and
    • Adjunctive ezetimibe for a minimum of 3 months

Indefinite

Practitioner exemptions

  • None

Special notes

  • 1Defined as those who have been hospitalized for a myocardial infarction or unstable angina in the past 52 weeks
  • 2PharmaCare will consider coverage of evolocumab for patients with a contraindication to treatment with statins, or intolerance to at least 2 statins. For patients experiencing intolerance, a dose reduction and a re-challenge of each statin must be attempted to resolve intolerable symptoms or biomarker abnormality (creatine kinase > 5 times the upper limit of normal) before discontinuing a treatment, or the patient must have confirmed rhabdomyolysis
  • 3Defined as a trial with ezetimibe for at least 4 weeks
  • 4Definite or probable diagnosis of HeFH is determined using the Simon Boome or Dutch Lipid Network criteria or genetic testing
  • Patients prescribed evolocumab 140 mg every 2 weeks are limited to 26 140 mg pre-filled auto-injectors per year
  • Evolocumab will not be covered by PharmaCare for use in combination with other PCSK9 inhibitors

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