Advice

following a full submission:

bempedoic acid (Nilemdo®) is not recommended for 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 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.

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

The submitting company did not present sufficiently robust clinical and economic analyses to gain acceptance by SMC.

Medicine details

Medicine name:
bempedoic acid (Nilemdo)
SMC ID:
SMC2292
Indication:

In adults with primary hypercholesterolaemia (heterozygous familial 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 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
Pharmaceutical company
Daiichi Sankyo UK Ltd
Submission type
Full
Status
Not recommended
Date advice published
07 December 2020