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New HTA Decisions in England
October 2021
Drug name
LEQVIO® (inclisiran)
Decision date
Therapeutic area
Cardiovascular conditions
Therapeutic sub area
Lipid disorders
Recommended with restrictions
For treating primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia as an adjunct to diet in adults.
Decision Detail
1.1 It is recommended only if: • there is a history of any of the following cardiovascular events: o acute coronary syndrome (such as myocardial infarction or unstable angina needing hospitalisation) o coronary or other arterial revascularisation procedures o coronary heart disease o ischaemic stroke or o 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: o maximum tolerated statins with or without other lipid-lowering therapies or, o other lipid-lowering therapies when statins are not tolerated or are contraindicated, and o the company provides inclisiran according to the commercial arrangement (commercial access agreement). 1.2 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. 1.3 These recommendations are not intended to affect treatment with inclisiran that was started in the NHS before this guidance was published. People having treatment outside these recommendations may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Clinical trial evidence came from 3 randomised 18-month trials (ORION-9, ORION-10 and ORION-11) comparing inclisiran with placebo. Results from these trials show that inclisiran can lower LDL-C levels when statins or other lipid-lowering therapies have not reduced them enough. But, there is no data directly comparing inclisiran with ezetimibe, alirocumab or evolocumab. There is also no long-term evidence on whether inclisiran reduces cardiovascular events. This means the clinical evidence and the cost-effectiveness estimates are very uncertain. The committee was concerned that there was a lack of long-term data on cardiovascular outcomes from the clinical trials that compared inclisiran with placebo. However, it noted that ongoing clinical trials would provide more data on these outcomes. The cost-effectiveness results based on the committee's preferred modelling assumptions with a commercial arrangement for inclisiran, represent a cost-effective use of NHS resources for adults with a history of cardiovascular events and persistent LDL-C levels of at least 2.6 mmol/l despite having the maximum tolerated lipid-lowering therapy. The committee therefore concluded that inclisiran is recommended for this group. The cost-effectiveness results for both the primary prevention with elevated risk, and primary prevention with heterozygous familial hypercholesterolaemia were highly uncertain and the ICERs for these populations were likely above £20,000 per QALY gained. The committee considered that inclisiran had the potential to be cost effective in these populations. Based on the information it had heard about ORION-17, it considered that it was likely that the research needed would be commissioned and successfully report, and that its potential value to the NHS would likely represent good value in the context of limited research resources. It therefore recommended inclisiran only in the context of research in this group.