NICE guidance - Inclisiran for treating primary hypercholesterolaemia or mixed dyslipidaemia

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NICE state (1):

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
    • schaemic 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, and
  • the company provides inclisiran according to the commercial arrangement

Note that there have been concerns raised concerning the NICE technology appraisal for inclisiran (2):

  • the Orion-9, Orion-10 and Orion-11 trials that the appraisal was based on had primary outcomes based on the change from baseline in participants' serum concentrations of LDL cholesterol - however LDL cholesterol is a surrogate outcome for cardiovascular disease, and doubts remain over whether improvements in surrogate endpoints are an accurate reflection of patient benefit
    • secondary outcomes included an exploratory cardiovascular endpoint -a composite of death, cardiac arrest, non-fatal myocardial infarction, and stroke - however the overall number of events was too low to draw conclusions
  • the study authors concluded that "NICE should reconsider its decision until patient relevant outcomes are available, and these, and all cost data, should be released for independent analysis"


Last edited 10/2021 and last reviewed 10/2021