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REPATHA (evolocumab)

Opinions on drugs - Posted on Feb 07 2022

Reason for request

Réévaluation SMR

Key points

Favourable opinion for reimbursement in the event of contraindication or known intolerance to statins and/or ezetimibe:

  • in adults with heterozygous familial hypercholesterolaemia, at very high cardiovascular risk, inadequately controlled with optimised therapy and requiring LDL-apheresis therapy
  • in adults with  atherosclerotic cardiovascular disease established by a history of myocardial infarction, non-haemorrhagic stroke and/or symptomatic peripheral arterial disease (secondary prevention), and inadequately controlled (LDL-c ≥ 0.7 g/L)

in combination with an optimised lipid-lowering therapy or alone in the event of contraindication or known intolerance to both statins and ezetimibe.

What therapeutic improvement?

No clinical added value.

Role in the care pathway?

Role of REPATHA (evolocumab) in the care pathway:

REPATHA (evolocumab) should be used in the event of contraindication or known intolerance to statins and/or ezetimibe:

  • in adults with heterozygous familial hypercholesterolaemia, at very high cardiovascular risk, inadequately controlled with optimised therapy and requiring LDL-apheresis therapy
  • in adults with atherosclerotic cardiovascular disease established by a history of myocardial infarction, non-haemorrhagic stroke and/or symptomatic peripheral arterial disease (secondary prevention), and inadequately controlled (LDL-c ≥ 0.7 g/L)

in combination with an optimised lipid-lowering therapy or alone in the event of contraindication or known intolerance to both statins and ezetimibe.

As a reminder, optimised lipid-lowering therapy for patients with a contraindication or known intolerance to statins and/or ezetimibe is therefore defined as follows:

  • statin at maximum tolerated dose, alone in the event of contraindication or intolerance to ezetimibe;
  • ezetimibe in the event of contraindication or known intolerance to statins.

Special recommendations

The Committee warns that there is a risk of misuse in populations not eligible for therapy, including, in particular:

  •  patients who are not at very high cardiovascular risk,
  • patients not receiving an optimised therapy where this is possible.

The Committee will pay particularly close attention to the real conditions of use of REPATHA (evolocumab) at its next assessments.

 

 


Clinical Benefit

Substantial

The Committee deems that the clinical benefit of REPATHA (evolocumab) is substantial in the event of contraindication or known intolerance to statins and/or ezetimibe:

  • in adults with heterozygous familial hypercholesterolaemia, at very high cardiovascular risk, inadequately controlled with optimised therapy and requiring LDL-apheresis therapy
  • in adults with atherosclerotic cardiovascular disease established by a history of myocardial infarction, non-haemorrhagic stroke and/or symptomatic peripheral arterial disease (secondary prevention), and inadequately controlled (LDL-c ≥ 0.7 g/L)

in combination with an optimised lipid-lowering therapy or alone in the event of contraindication or known intolerance to both statins and ezetimibe.


Clinical Added Value

no clinical added value

Considering:

  • demonstration of the efficacy of REPATHA (evolocumab), in terms of the reduction in laboratory parameters (reductions in LDL-c levels) in adults intolerant or contraindicated to statins (GAUSS, GAUSS 2 and GAUSS 3 studies) and/or ezetimibe,
  • But in view of the absence of data demonstrating a benefit in terms of morbidity and mortality in patients with a contraindication or intolerance to statins and/or ezetimibe,

the Committee considers that REPATHA (evolocumab) provides no clinical added value (CAV V) in the event of contraindication or known intolerance to statins and/or ezetimibe:

  • in adults with heterozygous familial hypercholesterolaemia, at very high cardiovascular risk, inadequately controlled with optimised therapy and requiring LDL-apheresis therapy
  • in adults with atherosclerotic cardiovascular disease established by a history of myocardial infarction, non-haemorrhagic stroke and/or symptomatic peripheral arterial disease (secondary prevention), and inadequately controlled (LDL-c ≥ 0.7 g/L)

in combination with an optimised lipid-lowering therapy or alone in the event of contraindication or known intolerance to both statins and ezetimibe.


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