Prescribing information (external link)
LEQVIO® (inclisiran) may help you achieve the Quality and Outcomes Framework (QOF) LDL-C targets1,2
LEQVIO® 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).
QOF has been updated for 2026/27
The 2026/27 QOF includes two cholesterol indicators.2
Percentage of patients on the QOF coronary heart disease (CHD), peripheral arterial disease (PAD), stroke/transient ischaemic attack (TIA) or chronic kidney disease (CKD) register, who are currently prescribed a statin, or where a statin is declined or clinically unsuitable, or who are on another lipid lowering therapy.2 The CHOL003 threshold is 70–95%.†2
Percentage of patients on the QOF CHD, PAD or TIA register, with the most recent cholesterol measurement in the preceding 12 months, showing as ≤2.0 mmol/L if it was an LDL-C reading or ≤2.6 mmol/L if it was a non-high-density lipoprotein cholesterol reading. For multiple readings on the latest date, the LDL reading takes priority.2
The CHOL004 threshold is 20–50%.†2
LEQVIO lowers LDL-C by ~50% from baseline vs placebo, in as little as 3 months and maintains it between HCP administered 6-monthly injections, after loading doses1,3
Discover more about the efficacy data of LEQVIO®
Learn more about the safety profile of LEQVIO®
The LDL-C reductions possible with LEQVIO® may assist in meeting QOF targets in 2026/27
LEQVIO® showed placebo-adjusted LDL-C reductions of ~50% on average, on top of a maximally tolerated dose of statin‡3
In ORION-10 and 11 with patients on a maximally tolerated statin, LEQVIO® reduced LDL-C relative to placebo from baseline by 52% (LDL-C reduction of −51% with LEQVIO®, +1% with placebo, p<0.001) and 50% (LDL-C reduction of −46% with LEQVIO® and +4% with placebo, p<0.001), respectively. Efficacy was seen as early as 90 days after initiation. In ORION-10, baseline LDL-C levels were 2.70±1.02 mmol/L and 2.71±0.96 mmol/L for the LEQVIO® and placebo groups, respectively. In ORION-11, baseline LDL-C levels were 2.77±1.08 mmol/L and 2.68±0.94 mmol/L for the LEQVIO® and placebo groups, respectively3
Adverse reactions at the injection site were the only common adverse reactions (8.2% vs placebo 1.8%). Hypersensitivity including
anaphylactic reaction, angioedema, rash, urticaria and pruritus have been reported (frequency: not known).1 Please refer to the SmPC for the full safety profile1
LDL-C should be <1.4 mmol/L for secondary CVD prevention4
Thresholds and targets in secondary CVD prevention
The 2025 ESC/EAS Guidelines provide a clinical target of <1.4 mmol/L (<55 mg/dL) and ≥50% reduction from baseline LDL-C for patients at very high CV risk, whether in secondary prevention or (rarely) in primary prevention.4
The CHOL004 QOF indicator target of ≤2.0 mmol/L is not a clinical guideline
For a full description of risk factors, please see the 2025 ESC/EAS Guidelines.4
The impact of LEQVIO® on cardiovascular morbidity and mortality has not been yet determined.1
Clinical challenges can get in the way of long-term target attainment8
For patients struggling to reach and remain at target LDL-C, statins may not be enough.8
of patients on statins fail to reach their guideline-recommended target8
of patients stay on the same statin regimen despite not reaching target8
Adding a non-statin lipid-lowering therapy can help patients reach and remain at LDL-C targets.4
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.
The effect of LEQVIO® on cardiovascular morbidity and mortality has not yet been determined.1
*Points decreased for consistency with lipid lowering indicators.9
†No change from QOF 2025/26.2,9
‡ASCVD risk equivalents included type 2 diabetes, heterozygous FH, or a 10-year risk of a cardiovascular event of ≥20% as assessed by the Framingham Risk Score for Cardiovascular Disease or equivalent.3
ASCVD, atherosclerotic cardiovascular disease; CHD, coronary heart disease; CKD, chronic kidney disease; CV, cardiovascular; CVD, cardiovascular disease; DM, diabetes mellitus; EAS, European Atherosclerosis Society; ESC, European Society of Cardiology; FH, familial hypercholesterolaemia; LDL-C, low-density lipoprotein cholesterol; PAD, peripheral arterial disease; QOF, Quality and Outcomes Framework; SCORE, Systemic Coronary Risk Estimation; SmPC, summary of product characteristics; TIA, transient ischaemic attack.
References
LEQVIO® (inclisiran) Summary of Product Characteristics.
National Health Service England. Quality and Outcomes Framework guidance for 2026/27. Available at: https://www.england.nhs.uk/publication/quality-and-outcomes-framework-guidance-for-2026-27/ [Accessed October 2026].
Ray KK, et al. N Engl J Med 2020;382(16):1507–1519 and supplementary appendix.
Mach F, et al. Eur Heart J 2025;46(42):4359–4378.
National Institute for Health and Care Excellence. Cardiovascular disease: risk assessment and reduction, including lipid modification. Available at: https://www.nice.org.uk/guidance/ng238/resources/cardiovascular-disease-risk-assessment-and-reduction-including-lipid-modification-pdf-66143902851781 [Accessed October 2026].
Ray KK, et al. 2023. Lancet Reg Health Eur 2023;29:100624.
Family Heart Foundation. Prioritizing LDL-Cholesterol Control. Available at: https://familyheart.org/prioritizing-ldl-cholesterol-control [Accessed October 2026]
Fox KM, et al. Clin Res Cardiol 2018;107(5):380–388 and supplementary appendix.
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 October 2026].
UK | October 2026 | FA-11668972
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.
