evolocumab (Repatha)

following a resubmission:

evolocumab (Repatha®) is accepted for restricted use within NHS Scotland.

Indication under review: in adults with primary hypercholesterolaemia (heterozygous familial hypercholesterolaemia and non-familial) or mixed dyslipidaemia, as an adjunct to diet: 
• in combination with a statin or statin with other lipid lowering therapies in patients unable to reach low density lipoprotein-cholesterol (LDL-C) goals with the maximum tolerated dose of a statin or, 
• alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated. 

SMC restriction: for specialist use only, when administered at a dose of 140mg every two weeks, in patients at high cardiovascular risk as follows:
• patients with heterozygous familial hypercholesterolaemia (HeFH) and LDL-C ≥5.0mmol/L for primary prevention of cardiovascular events or,
• patients with HeFH and LDL-C ≥3.5mmol/L for secondary prevention of cardiovascular events or,
• patients at high risk due to previous cardiovascular events and LDL-C ≥4.0mmol/L or
• patients with recurrent/polyvascular disease and LDL-C ≥3.5mmol/L

In phase III clinical studies, treatment with evolocumab added to optimised background lipid-lowering therapy significantly improved mean percentage change in LDL-C from baseline to week 12, versus placebo and another lipid-lowering treatment, in patients with heterozygous familial and non-familial hypercholesterolaemia and mixed dyslipidaemia.

SMC advice takes account of the benefits of a Patient Access Scheme (PAS) that improves the cost effectiveness of evolocumab and is contingent upon the continuing availability of the PAS in NHS Scotland or a list price that is equivalent or lower.

SMC cannot recommend the use of evolocumab in adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies as the company’s submission related only to its use in primary hypercholesterolaemia (heterozygous familial hypercholesterolaemia and non-familial)  and mixed dyslipidaemia.