2 Information about inclisiran

Marketing authorisation indication

2.1 Inclisiran (Leqvio, Novartis) 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'.

Dosage in the marketing authorisation

2.2 The dosage schedule for inclisiran is available in the summary of product characteristics.


2.3 Inclisiran costs £1,987.36 per 284-mg dose pack (company submission). The company has a commercial arrangement. This makes inclisiran 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.

  • National Institute for Health and Care Excellence (NICE)