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® reimbursement
>94,000 LEQVIO® injections prescribed in primary care (England, November 2021–December 2025)2
LEQVIO® lowers LDL-C by ~50% from baseline in as little as 3 months, and maintains it between 6-monthly injections in patients on a maximally tolerated statin3
The baseline mean LDL-C levels in ORION-10 were 2.7±1.02 mmol/L with LEQVIO® and 2.71±0.96 mmol/L with placebo.3
Effective LDL-C reduction of 52%3
From baseline vs placebo in patients on maximally tolerated statin/LLT*
Maintained LDL-C reductions3
from baseline between 6-monthly maintenance doses up to Day 540
Well tolerated1
LEQVIO® has a safety profile comparable to placebo, with injection-site reactions being the only reported treatment-associated adverse reaction (8.2% vs 1.8% for LEQVIO® and placebo, respectively)
At Month 17, LEQVIO® delivered placebo-corrected LDL-C reductions of 52.3%, as compared with baseline (−51.3% with LEQVIO® vs +1.0% with placebo; 95% Cl: −55.7 to −48.8; p<0.001; co-primary endpoint), with a time-adjusted LDL-C reduction of 53.8% (−51.3% with LEQVIO® vs +2.5% with placebo; 95% Cl: −58.2 to −51.3: p<0.001) from baseline between Months 3 and 18 relative to placebo (co-primary endpoint).3
- Reimbursement supplement of £15 to support LEQVIO® implementation
- No discount deductions (‘clawback’)
- Net income of up to ~£17.40 per injection for general practice providers
- Reimbursement supplement of £15 to support LEQVIO® implementation
- No discount deductions (‘clawback’)
- Net income of up to ~£17.40 per injection for general practice providers
The LEQVIO® commercial agreement supports implementation in general practice
The enhanced NHS England Commercial Agreement for LEQVIO®:4
Reimbursement supplement |
| Dispensing fee |
| Net income per injection |
£15(Reimbursement of £60 minus a nominal charge of £45) | + | Up to ~£2.40 | = | Up to ~£17.40 |
Ordering and reimbursement
Preferred route: FP34D/PD*
The LEQVIO® commercial agreement supports implementation in general practice
The enhanced NHS England Commercial Agreement for LEQVIO®:4
Outpatient appointment | Referral to primary care | |
LEQVIO® initiatedFully reimbursed by NHS England, with no impact on secondary care budgets4 | Month 3Second dose of LEQVIO® administered1 | Every 6 monthsLEQVIO® maintenance dose administered1 |
Reimbursement supplement of £15, with a net income of up to ~£17.40 per injection4 | ||
Ordering LEQVIO® in secondary care
Preferred route: FP10HNC§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.
Learn about LEQVIO® dosing and administration
Click here to access resources about LEQVIO® for you and your patients
*Free delivery and no minimum order from AAH.4
†Pack size: one pre-filled syringe.4
‡Further information on FP34D/D can be found at: https://www.nhsbsa.nhs.uk/nhs-prescription-services.
§No prescription fee if prescribed and administered in hospital.4
¶As of April 2022, LEQVIO® was added to the PbR excluded drug list and is reimbursed centrally by NHS England.4
AAH, All About Health; BSA, Business Services Authority; DrPLCM, drugs patient level monitoring data submission; EAN, European Article Number; GP, general practitioner; LDL-C, low-density lipoprotein cholesterol; NHS, National Health Service; NICE, National Institute for Health and Care Excellence; PbR, payment by results; PCN, primary care network; PIP, product information pack; SmPC, summary of product characteristics; VAT, value added tax.
References
LEQVIO® Summary of Product Characteristics.
Novartis Data on File. Inclisiran – INC006. December 2025.
Ray KK, et al. N Engl J Med 2020;382:1507–1519.
NHS England. Funding and supply of inclisiran (Leqvio®). Available at: www.england.nhs.uk/long-read/funding-supply-inclisiran-leqvio [Accessed April 2026].
NHS Business Services Authority. How do I submit my end of the month submission? https://faq.nhsbsa.nhs.uk/knowledgebase/article/KA-03236/en-us [Accessed April 2026].
Novartis Data on File. Novartis Pharmaceuticals Corp; 2023. Implementing inclisiran (LEQVIO®) into the lipid management pathway.
LEQVIO® and the LEQVIO® logo are registered trademarks of Novartis AG. Licensed from Alnylam Pharmaceuticals, Inc.
UK | April 2026 | FA-11605506
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.
