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Reason for request
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 and requiring LDL-apheresis treatment,
- in adults with inadequately controlled (LDL-c ≥ 0.7 g/L) atherosclerotic cardiovascular disease established by a history of ACS (secondary prevention),
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 in the therapeutic strategy.
Role in the care pathway?
Role of the medicinal product in the care pathway
In the event of contraindication or known intolerance to statins and/or ezetimibe, PRALUENT (alirocumab) should be used:
- in adults with heterozygous familial hypercholesterolaemia, at very high cardiovascular risk, inadequately controlled and requiring LDL-apheresis treatment,
- in adults with inadequately controlled (LDL-c ≥ 0.7 g/L) atherosclerotic cardiovascular disease established by a history of ACS (secondary prevention),
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 treatment for patients with a contraindication or known intolerance to statins and/or ezetimibe is therefore defined as follows:
- the maximum tolerated dose of a statin, 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 treatment, including, in particular:
- patients who are not at very high cardiovascular risk,
- patients not receiving an optimised treatment where this is possible.
The Committee will pay particularly close attention to the real conditions of use of PRALUENT (alirocumab) at its next assessments.
Clinical Benefit
| Substantial |
The Committee deems that the clinical benefit of PRALUENT (alirocumab) is substantial in the event of contraindication or known intolerance to statins and/or ezetimibe:
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:
the Committee considers that PRALUENT (alirocumab) in combination with an optimised lipid-lowering therapy or in the event of known intolerance provides no clinical added value (CAV V) in the event of contraindication or known intolerance to statins and/or ezetimibe:
in combination with an optimised lipid-lowering therapy or alone in the event of contraindication or known intolerance to both statins and ezetimibe. |
