Archived: evolocumab (Repatha)
following a full submission
evolocumab (Repatha®) is not recommended for 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.
• In adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia in combination with other lipid-lowering therapies.
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. Addition of evolocumab to standard care also significantly reduced LDL-C versus standard care alone in patients with homozygous familial hypercholesterolaemia.
The submitting company did not present a sufficiently robust clinical and economic analysis to gain acceptance by SMC.
|Drug Name:||evolocumab (Repatha)|
|SMC Drug ID:||1148/16|
|Indication:||In adults with primary hypercholesterolaemia (heterozygous familial hypercholesterolaemia and non-familial) or mixed dyslipidaemia, as an adjunct to diet:|
|Sub Category:||2.12 Lipid-regulating drugs|
|Submission Type:||Full submission|
|Date Advice Published:||13 June 2016|
|evolocumab (Repatha)||Resubmission||13 February 2017|