Information intended for UK healthcare professionals only.
The production of this Guidelines card has been commissioned and funded by Daiichi Sankyo UK. See bottom of page for full disclaimer.
1.1 Bempedoic acid with ezetimibe is recommended as an option for treating primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia as an adjunct to diet in adults. It is recommended only if:
- statins are contraindicated or not tolerated,
- ezetimibe alone does not control low-density lipoprotein cholesterol well enough, and
- the company provides bempedoic acid and bempedoic acid with ezetimibe according to the commercial arrangement.
Bempedoic acid with ezetimibe can be used as separate tablets or a fixed-dose combination.
1.2 This recommendation is not intended to affect treatment with bempedoic acid with ezetimibe that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
2 Information about bempedoic acid1
Marketing authorisation indication
2.1 Bempedoic acid (Nilemdo, Daiichi Sankyo) is ‘indicated 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 contraindicated.
2.2 Bempedoic acid–ezetimibe (Nustendi, Daiichi Sankyo) is ‘indicated 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’.
Dosage in the marketing authorisation
2.3 The dosage schedule for bempedoic acid is available in the summary of product characteristics
2.4 The dosage schedule for bempedoic acid–ezetimibe is available in the summary of product characteristics
2.6 The company has a commercial arrangement (commercial access agreement). This makes bempedoic acid and bempedoic acid–ezetimibe available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company’s responsibility to let relevant NHS organisations know details of the discount.
- NICE. Bempedoic acid with ezetimibe for treating primary hypercholesterolaemia or mixed dyslipidaemia. NICE Technology Appraisal Guidance 694. NICE, April 2021. www.nice.org.uk/guidance/ta694
- AWMSG. bempedoic acid (Nilemdo®). Available at: https://awmsg.nhs.wales/medicines-appraisals-and-guidance/ medicines-appraisals/bempedoic-acid-nilemdo/ (accessed May 2021)
- AWMSG. bempedoic acid/ezetimibe (Nustendi®). Available at: https://awmsg.nhs.wales/medicines-appraisals-and-guidance/medicines-appraisals/bempedoic-acid-ezetimibe-nustendi/ (accessed May 2021)
When NICE recommends a treatment, the NHS must make sure it is available to those people it could help, normally within 3 months of the guidance being issued.
Date of preparation: May 2021