Prescribing information (external link)
LEQVIO® (inclisiran) is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:1
in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach low-density lipoprotein cholesterol (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
For full safety information, please refer to the LEQVIO® Summary of Product Characteristics (SmPC).
LEQVIO® guidelines and sequencing
Guidelines
LEQVIO® is recommended by NICE2
LEQVIO® 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:2
There is a history of any of the following cardiovascular (CV) events:
- Acute coronary syndrome (such as myocardial infarction [MI] or unstable angina needing hospitalisation)
- Coronary or other arterial revascularisation procedures
- Coronary heart disease (CHD)
- Ischaemic stroke or
- Peripheral arterial disease (PAD), and
LDL-C concentrations are persistently 2.6 mmol/L or more, despite maximum tolerated lipid-lowering therapy (LLT), that is:
- Maximum tolerated statins with or without other lipid-lowering therapies, or
- Other LLTs when statins are not tolerated or are contraindicated
The effect of LEQVIO® on CV morbidity and mortality has not yet been determined.1
Thresholds and targets in secondary cardiovascular disease (CVD) prevention
ESC/EAS guidelines recommend that LDL-C should be <1.4 mmol/L with a ≥50% reduction from baseline for secondary prevention in patients at very high risk.3
To assess your patients’ LDL-C, monitor their levels at 6–8 weeks from initiation of therapy and at follow-up in 6–12 months3
Dose escalation or combination therapy is advised if LDL-C target is not reached with a statin alone3
Summary of NHS AAC guidance on the secondary prevention of CVD8
Adapted from NHS Accelerated Access Collaborative.8
This is an excerpt from the guidelines. Please refer to the full national guidance for more information on lipid management for primary and secondary prevention of CVD.
Novartis had no involvement in the development of this guidance. LEQVIO® may not be indicated and/or recommended for all patients in this pathway.
Please consult the SmPC1 and the NICE Guidance2 before prescribing.
The two cholesterol indicators remain within the QOF for 2026/274
INDICATOR | POINTS | THRESHOLDS |
| Ongoing management | ||
| CHOL003. Percentage of patients on the QOF CHD, PAD, stroke/transient ischaemic attack (TIA) or chronic kidney disease (CKD) who are currently prescribed a statin, or where a statin is declined or clinically unsuitable, another LLT | 20(reduced by 18 points from 2025/26†) | 70–95%(no change from 2025/26) |
| CHOL004. Percentage of patients on the QOF CHD, PAD, stroke/TIA or CKD Register, with the most recent cholesterol measurement in the preceding 12 months, showing as ≤2.0 mmol/L if it was an LDL cholesterol reading or ≤2.6 mmol/L if it was a non-HDL cholesterol reading. For multiple readings on the latest date the LDL reading takes priority | 44(no change from 2025/26) | 20–50%(no change from 2025/26) |
Adapted from NHS England.4
Sequencing
Lipid-lowering therapy (LLT) sequencing matters
Approximately 80% of patients stay on the same statin regimen despite not reaching target.9
Considering which add-on therapies to offer and in what order to prescribe them may help to maximise LDL-C lowering.
Lipid optimisation pathway for secondary prevention in primary care/the community10
Developed by the Health Innovation Network in collaboration with NHS England.
Adapted from Health Innovation Network.10
Novartis had no involvement in the development of this pathway. LEQVIO® may not be indicated and/or recommended for all patients in this pathway.
Where an individual qualifies for injectable therapies, as per NICE technology appraisals, consider these in preference to ezetimibe to prevent lipid levels being lowered but remaining above the LDL-C target and below thresholds for initiating injectable therapies.10
Please consult the SmPC1 and the NICE Guidance2 before prescribing.
Lipid optimisation pathway following an acute CV (acute ischaemic stroke/TIA or acute coronary syndrome [ACS]) or PAD event11
Developed by the Health Innovation Network in collaboration with NHS England.
Adapted from Health Innovation Network.11
Novartis had no involvement in the development of this pathway. LEQVIO® may not be indicated and/or recommended for all patients in this pathway.
Please consult the SmPC1 and the NICE Guidance2 before prescribing.
People who suffered a major adverse CV event within 3 months of randomisation were excluded from the pivotal LEQVIO® ORION-9, ORION-10 and ORION-11 clinical trials.12,13 In these trials, the first LDL-C measurement was taken at Month 3 after randomisation.12,13 The effect of LEQVIO® on CV morbidity and mortality has not yet been determined.1
NHS Accelerated Access Collaborative (AAC) statin intolerance pathway14
Adapted from NHS Accelerated Access Collaborative 2024.14
Novartis had no involvement in the development of this pathway.
Please consult the SmPC1 and the NICE Guidance2 before prescribing.
Resource
LEQVIO®: A practical guide
Your Guide to LEQVIO®
A quick-guide to LEQVIO®, with information on NICE guidance and the NHS commercial agreement through to dosing and administration.
Learn about LEQVIO® dosing and administration
Find out about LEQVIO® reimbursement
LEQVIO® safety profile
*For patients with ASCVD who experience a second vascular event within 2 years, not necessarily of the same type as the first event.3
†Points decreased for consistency with lipid lowering indicators.15
AAC, Accelerated Access Collaborative; ACS, acute coronary syndrome; ASCVD, atherosclerotic cardiovascular disease; CHD, coronary heart disease; CK, creatine kinase; CKD, chronic kidney disease; CRP, C-reactive protein; CV, cardiovascular; CVD, cardiovascular disease; EAS, European Atherosclerosis Society; ESC, European Society of Cardiology; eGFR, estimated glomerular filtration rate; FH, familial hypercholesterolaemia; HbA1c, glycated haemoglobin; HDL, high-density lipoprotein; HI, high intensity; LDL-C, low-density lipoprotein cholesterol, LLT, lipid-lowering therapy; mAb, monoclonal antibody; MI, myocardial infarction; NICE, National Institute for Health and Care Excellence; NHS, National Health Service; non –HDL-C, high-density lipoprotein cholesterol; OD, once daily; PAD, peripheral artery disease; PCSK9i, proprotein convertase subtilisin/kexin type 9 inhibitor; PMR, polymyalgia rheumatica; QOF, Quality and Outcomes Framework; SmPC, summary of product characteristics; SRM, statin-related muscle toxicity; TC, total cholesterol; TG, triglyceride; TIA, transient ischaemic attack; ULN, upper limit of normal; Vit D, vitamin D.
References
LEQVIO® Summary of Product Characteristics.
National Institute for Health and Care Excellence. Inclisiran for treating primary hypercholesterolaemia or mixed dyslipidaemia. Available at: www.nice.org.uk/guidance/ta733 [Accessed April 2026].
Mach F, et al. Eur Heart J 2020;41:111–188.
NHS England. Quality and Outcomes Framework guidance for 2026/27. Available at: https://www.england.nhs.uk/wp-content/uploads/2026/03/PRN02356-quality-and-outcomes-framework-guidance-26-27.pdf [Accessed April 2026]
National Institute for Health and Care Excellence. Cardiovascular disease: risk assessment and reduction, including lipid modification. Available at: Available at: www.nice.org.uk/guidance/ng238 [Accessed April 2026].
Ray KK, et al. Lancet Reg Health Eur 2023;29.
Family Heart Foundation. Prioritizing LDL-Cholesterol Control. Available at: familyheart.org/prioritizing-ldl-cholesterol-control [Accessed April 2026].
NHS Accelerated Access Collaborative. Summary of National Guidance for Lipid Management for Primary and Secondary Prevention of CVD. Available at: www.england.nhs.uk/aac/wp-content/uploads/sites/50/2020/04/lipid-management-pathway-v7.pdf [Accessed April 2026].
Fox KM, et al. Clin Res Cardiol 2018;107:380388.
Health Innovation Network. Pathways for optimising lipid management in secondary prevention of cardiovascular disease: purpose and development of the pathways: Lipid optimisation pathway for secondary prevention in primary care / the community. Available at: https://thehealthinnovationnetwork.co.uk/wp-content/uploads/2024/06/Lipid-optimisation-pathway-for-secondary-prevention-in-primary-care-and-the-community.pdf [Accessed April 2026].
Health Innovation Network. Pathways for optimising lipid management in secondary prevention of cardiovascular disease: purpose and development of the pathways: Lipid Optimisation pathway following an acute cardiovascular [acute ischaemic stroke / transient ischaemic attack (TIA) or acute coronary syndrome (ACS)] or peripheral arterial disease event. Available at: https://thehealthinnovationnetwork.co.uk/wp-content/uploads/2024/06/Pathway-for-secondary-care-following-an-Acute-Cardiovascular-event.pdf [Accessed April 2026].
Ray KK, et al. N Engl J Med 2020;382:1507–1519 (including supplementary appendix).
Raal FJ, et al. N Engl J Med 2020;382:1520–1530 (including supplementary appendix).
NHS Accelerated Access Collaborative. Statin intolerance pathway. Available at: www.england.nhs.uk/aac/wp-content/uploads/sites/50/2020/04/statin-intolerance-pathway-v2.pdf [Accessed April 2026].
NHS England. Changes to the GP Contract in 2026/27. Available at: https://www.england.nhs.uk/long-read/changes-to-the-gp-contract-in-2026-27/ [Accessed April 2026].
LEQVIO® and the LEQVIO® logo are registered trademarks of Novartis AG. Licensed from Alnylam Pharmaceuticals, Inc.
UK | April 2026 | FA-11606219
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Novartis online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report, or alternatively email [email protected] or call 01276 698370.
