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Limited coverage criteria – evolocumab

Publication date: December 18, 2018

 

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Generic name

evolocumab

Strength & form

140 mg/mL prefilled syringe or autoinjector for subcutaneous injection

420 mg/3.5 mL automated mini-doser with prefilled cartridge

Special Authority criteria

Approval period

Initial

For the treatment of heterozygous familial hypercholesterolemia (HeFH)1 as an adjunct to maximally tolerated HMG-CoA reductase inhibitors (statins) therapy in adult patients who are unable to reach target low-density lipoprotein cholesterol (LDL-C) levels2, when:

The patient has confirmed adherence to treatment with atorvastatin 80 mg or rosuvastatin 40 mg for a minimum of 6 months

OR

The patient is unable to tolerate at least 2 HMG-CoA reductase inhibitors (statins)3

OR

The patient has confirmed rhabdomyolysis

OR

Treatment with HMG-CoA reductase inhibitors (statins) is contraindicated

AND

The patient has confirmed adherence to treatment with ezetimibe for a minimum of 3 months

12 weeks

Renewal

Approval will be granted if the following criteria are met:

The patient is adherent to therapy

AND

The patient has achieved a reduction in LDL-C of at least 40% from baseline within 4–8 weeks after initiation of evolocumab

AND

The patient maintains a significant reduction in LDL-C (with continuation of evolocumab) of at least 40% from baseline since initiation of evolocumab

1 year4,5

Practitioner exemptions

  • None

Special notes

  • 1Definite or probable diagnosis of HeFH is determined using the Simon Broome or Dutch Lipid Network criteria or genetic testing
  • 2Target LDL-C levels are:
    • For primary prevention, a ≥ 50% reduction in LDL-C from untreated baseline
    • For secondary prevention, an LDL-C ≤ 1.8 mmol/L
  • 3Inability to tolerate at least two HMG-CoA reductase inhibitors (statins): Dose reduction and re-challenge of each HMG-CoA reductase inhibitors (statin) must be attempted to resolve intolerable symptoms or biomarker abnormality (creatine kinase > 5 times the upper limit of normal) before discontinuing a treatment
  • 4Patients prescribed evolocumab 140 mg every 2 weeks are limited to 26 of 140 mg prefilled autoinjectors per year
  • 5Patients prescribed evolocumab 420 mg monthly are limited to 12 prefilled cartridges per year

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