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"

Reference:

Last edited 10/2021 and last reviewed 10/2021

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