Status:

Red

Decision Date:

October 2021

Comments

RED: NICE TA733 

Inclisiran 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:

• there is a history of any of the following cardiovascular events:
• acute coronary syndrome (such as myocardial infarction or unstable angina needing hospitalisation)
• coronary or other arterial revascularisation procedures
• coronary heart disease
• ischaemic stroke or
• peripheral arterial disease, and
• low density lipoprotein cholesterol (LDL-C) concentrations are persistently 2.6 mmol/l or more, despite maximum tolerated lipid lowering therapy, that is:
• maximum tolerated statins with or without other lipid-lowering therapies or,
• other lipid-lowering therapies when statins are not tolerated or are contraindicated, 
• the company provides inclisiran according to the commercial arrangement

Inclisiran is recommended only in research for treating primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia in adults who have no history of cardiovascular events. This research is in the form of a clinical trial currently in development.

Red Drug Classifications

• 1: Requiring specialist assessment to enable patient selection, initiation and ongoing treating
• 8. NHS England commissioned – to be used in line with NHSE commissioning intentions

search again