REPATHA (evolocumab), anti-PCSK9

High clinical benefit in uncontrolled primary hypercholesterolaemia or mixed dyslipidaemia with established atherosclerotic cardiovascular disease, and in uncontrolled heterozygous familial hypercholesterolaemia, requiring apheresis, but no clinical benefit demonstrated in the therapeutic strategy

Insufficient clinical benefit to justify reimbursement in other populations

• REPATHA has MA in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, homozygous familial hypercholesterolaemia and established atherosclerotic cardiovascular disease.

• In primary hypercholesterolaemia or mixed dyslipidaemia, its efficacy in combination with a statin has been demonstrated in terms of reduction in LDL-c levels and reduction in the number of cardiovascular events compared to a statin alone. There are uncertainties as to the extent of the effect and the transposability of the results observed.

• In severe heterozygous familial hypercholesterolaemia requiring LDL-apheresis treatment, its efficacy in combination with a lipid-lowering therapy has been demonstrated on the reduction in LDL-c level and the reduction in the use of LDL-apheresis compared to LDL-apheresis combined with a lipid-lowering therapy.

• No benefit has been demonstrated on cardiovascular mortality, overall mortality and quality of life.