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Limited coverage drugs – evolocumab

Publication date: December 18, 2018

Generic name

evolocumab

Strength

140 mg/mL, 120 mg/mL

Form

solution for subcutaneous injection in 1 mL prefilled autoinjector of 140 mg/mL, or 3.5 mL automated mini-doser with prefilled cartridge of 120 mg/mL

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:

  1. 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

  1. 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

  1. Definite or probable diagnosis of HeFH is determined using the Simon Broome or Dutch Lipid Network criteria or genetic testing
  2. Target 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
  1. Inability 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
  2. Patients prescribed evolocumab 140 mg every 2 weeks are limited to 26 of 140 mg prefilled autoinjectors per year
  3. Patients prescribed evolocumab 420 mg monthly are limited to 12 prefilled cartridges per year

Special Authority request form(s)