bempedoic acid/ezetimibe (Nustendi)

following an abbreviated submission:

bempedoic acid / ezetimibe (Nustendi®) 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 in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin in addition to ezetimibe
  
  
• alone in patients who are either statin-intolerant or for whom a statin is contraindicated, and are unable to reach LDL-C goals with ezetimibe alone
  
  
• in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin.

SMC restriction: for use in patients who are:

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

SMC has previously accepted bempedoic acid for restricted use in combination with ezetimibe for this indication. Nustendi® (bempedoic acid / ezetimibe) provides a single tablet alternative to bempedoic acid plus ezetimibe.

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.