2 Information about bempedoic acid
Marketing authorisation indication
Bempedoic acid
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:
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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,
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alone or in combination with other lipid-lowering therapies in patients who are statin intolerant, or for whom a statin is contraindicated'.
Bempedoic acid–ezetimibe
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:
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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,
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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,
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in patients already being treated with the combination of bempedoic acid and ezetimibe as separate tablets with or without statin'.
Price
2.5 Bempedoic acid and bempedoic acid–ezetimibe costs £55.44 per 28‑pack, excluding VAT.
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.