bempedoic acid (Nilemdo)

following a resubmission:

bempedoic acid (Nilemdo®) is accepted for restricted  use within NHSScotland.

Indication under review: in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:

• In combination with a statin, or a 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 contra-indicated.

SMC restriction: for use in combination with ezetimibe in patients who are:

• statin intolerant or for whom a statin is contra-indicated
  and
• where ezetimibe alone does not appropriately control LDL-C
  and
• where proprotein convertase subtilisin/ kexin type 9 (PCSK9) inhibitors are not appropriate

In two phase III studies in patients intolerant to statins, the percentage reduction in LDL-C to 12-weeks was significantly larger with bempedoic acid compared with placebo.

This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS/ list price that is equivalent or lower.