REPATHA (evolocumab) - Hypercholesterolaemia

Summary of opinion

Approval of retention of reimbursement for the following indications:

Homozygous familial hypercholesterolaemia

In adults and children aged 10 years and over with homozygous familial hypercholesterolaemia (HoFH) in combination with other lipid-lowering therapies

 Heterozygous familial hypercholesterolaemia 

In patients with heterozygous familial hypercholesterolaemia (HeFH):

• Adults, at a very high cardiovascular risk, insufficiently controlled with optimised lipid-lowering treatment and requiring LDL apheresis treatment:
  • In combination with optimised lipid-lowering treatment;
  • Or as monotherapy in cases of contraindication or established intolerance both to statins and ezetimibe.
• Children and adolescents aged 10 years and over insufficiently controlled (LDL-C > 130 g/L) with the maximum tolerated dose of a lipid-lowering treatment, as an adjunct to diet:
  • In combination with optimised lipid-lowering treatment;
  • Or as monotherapy in cases of contraindication or established intolerance both to statins and ezetimibe.
    • Established atherosclerotic cardiovascular disease

    In adults with established atherosclerotic cardiovascular disease with a history of symptomatic myocardial infarction (MI), non-haemorrhagic stroke (NHS) and/or peripheral arterial disease (PAD) (secondary prevention), whose disease is uncontrolled (LDL-C ≥ 0.7 g/L) despite optimised lipid-lowering treatment:

    • In combination with optimised lipid-lowering treatment;
    Or as monotherapy in cases of contraindication or established intolerance both to statins and ezetimibe.
    • Established atherosclerotic cardiovascular disease

    In adults with established atherosclerotic cardiovascular disease with a history of symptomatic myocardial infarction (MI), non-haemorrhagic stroke (NHS) and/or peripheral arterial disease (PAD) (secondary prevention), whose disease is uncontrolled (LDL-C ≥ 0.7 g/L) despite optimised lipid-lowering treatment:

    • In combination with optimised lipid-lowering treatment;
    Or as monotherapy in cases of contraindication or established intolerance both to statins and ezetimibe.

Established atherosclerotic cardiovascular disease

 In adults with established atherosclerotic cardiovascular disease with a history of symptomatic myocardial infarction (MI), non-haemorrhagic stroke (NHS) and/or peripheral arterial disease (PAD) (secondary prevention), whose disease is uncontrolled (LDL-C ≥ 0.7 g/L) despite optimised lipid-lowering treatment:

• In combination with optimised lipid-lowering treatment;

Or as monotherapy in cases of contraindication or established intolerance both to statins and ezetimibe.