bempedoic (Nilemdo)

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

bempedoic acid (Nilemdo®) is not recommended for use within NHSScotland.

Indication under review: in adults with established or at high risk for atherosclerotic cardiovascular disease to reduce cardiovascular risk by lowering LDL-C levels, as an adjunct to correction of other risk factors:

• in patients on a maximum tolerated dose of a statin with or without ezetimibe or,
• alone or in combination with ezetimibe 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 indication.

As a result, we cannot recommend its use within NHSScotland.

Bempedoic acid (Nilemdo®) has previously been accepted for restricted use in adults with primary hypercholesterolaemia or mixed dyslipidaemia (SMC2363). This advice remains valid.