evolocumab (Repatha)

in the absence of a submission from the holder of the marketing authorisation:

evolocumab (Repatha®) is not recommended for use within NHSScotland.

Indication under review: In adults with established atherosclerotic cardiovascular disease (myocardial infarction, stroke or peripheral arterial disease) to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:

• in combination with the maximum tolerated dose of a statin with or without other lipid-lowering therapies or,
• alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.

The holder of the marketing authorisation has not made a submission to SMC regarding this product in this setting. As a result we cannot recommend its use within NHSScotland in adults with established atherosclerotic cardiovascular disease outwith the restriction specified in SMC advice (1148/16). Note that SMC advice (1148/16) remains valid.