Prescribing information

 

LEQVIO®▼ (inclisiran) is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:2,3

  • in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach 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 GB and NI Summary of Product Characteristics.

 

LEQVIO®▼ (inclisiran) is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:1,2

  • in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach 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 GB and NI Summary of Product Characteristics.

 

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Check if your patients meet the NICE-recommended criteria for LEQVIO®3

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NICE recommends LEQVIO® within its licensed indication, as an option for the treatment of adult patients who:

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Have already had certain cardiovascular events (acute coronary syndrome such as myocardial infarction [MI] or unstable angina needing hospitalisation, coronary or other arterial revascularisation procedures, coronary heart disease, ischaemic stroke or peripheral arterial/artery disease [PAD])

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Have persistently elevated LDL-C levels (≥2.6 mmol/L) despite maximum tolerated statins with or without other lipid-lowering therapies, or other lipid-lowering therapies when statins are not tolerated or are contraindicated

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You can easily identify patients in primary care who are eligible for lipid optimisation with LEQVIO®. See three different illustrative scenarios below:

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Patient has been discharged from hospital following a recent cardiovascular event.* LDL-C still not at target despite maximally tolerated dose of statin

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Patient has been identified in primary care at a routine appointment. Patient has suffered a cardiovascular event* and has LDL-C persistently above 2.6 mmol/L despite lipid-lowering therapy

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Patient has been identified via proactive practice register search and meets NICE recommendation criteria

Tools to help you identify eligible patients

The AHSN Network has a comparative document, containing tools that provide additional information to help you identify eligible patients.4

Name NHS Digital – Lipid Management Audit4 Greater Manchester CVD Prevention – Lipids Searches4 UCLP: cholesterol – Secondary prevention5 Ardens Inclisiran search‡4 Clinical Digital Resource Collaborative (CDRC)4
Audit NHS Digital5 Greater Manchester Integrated Care Partnership4 University College London Partners4 Ardens4 NENC Collaboration4
Cost No4 No4 No4 Subscription4 No4
Location Integrated by NHS Digital to EMIS AND SYS1 At AHSN website At AHSN Website Within Ardens Resource Suite4 At CDRC website
LEQVIO® eligible cohort Yes (combined groups of possible options)5 Yes (Cohort 4a)6 No7 Yes4 Yes – lipids 5.5–5.7 mmol/L4,8
Cholesterol thresholds aligned to QOF target levels Yes + total cholesterol <4.0 mmol/L9 Yes6 Yes (priority 3 only – non-HDL-C only)4 No4 No (linked to 40% non-HDL-C reduction)10

Adapted from The AHSN Network Patient Search Tool Resource Review, 2023.4

Please note that patient ID tools do not replace the need for individual clinical decision making and therapy eligibility checks as per NICE recommendations.

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LEQVIO® is part-funded through a central NHS budget to reduce impact on local prescribing budgets11

To order LEQVIO®, the practice is required to have an AAH account. If you do not have an account, you can open one online at: https://www.aah.co.uk/s/opening-an-aah-account (please note that Novartis has no control over the content of the linked website provided here).

LEQVIO® can be ordered for same or next day delivery directly from AAH (using AAH Point or your PMR system) with the codes below:12

Product name   EAN code   PIP code
LEQVIO® (inclisiran)   7613421044237   4174751

LEQVIO® costs £45 per syringe.12 Follow the steps outlined in the LEQVIO® Reimbursement Guide to learn how to apply for reimbursement.

If you need any support, you can contact AAH Customer Care on 0344 5618899 or live chat with an agent via AAH Point from 9am to 5pm Monday to Friday.12

LEQVIO® could easily fit into your and your patients’ routine1,2

With straightforward, twice-yearly maintenance dosing and no refrigeration required, LEQVIO® can be administered during your patient’s existing routine appointments.1,2 After an initial dose, LEQVIO® is administered again at 3 months, followed by every 6 months.1,2

 

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Need more support with identifying and initiating LEQVIO®?

 

 

*Events including but not limited to myocardial infarction, acute ischaemic stroke and transient ischaemic attack.
Setting including but not limited to long-term condition clinic, diabetes review clinic and heart failure clinic.
Ardens includes a search for ‘?Inclisiran ind as CVD + LDL>2.5 or non HDL >3.4 + not max. tol lipid lowering’ which can identify patients who might be eligible for consideration of inclisiran therapy for additional secondary prevention.4

AAH, All About Health; AHSN, Academic Health Science Networks; CVD, cardiovascular disease; EAN, European article number; EMIS, Egton medical information systems; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; NENC, North East And North Cumbria Region; NHS, National Health Service; NICE, National Institute for Health and Care Excellence; PIP, pharmacists interface product; PMR, patient medication record; QOF, quality and outcomes framework; SYS1, System One; UCLP, University College London partners.

References:

  1. LEQVIO® Great Britain. Summary of Product Characteristics.
  2. LEQVIO® Northern Ireland. Summary of Product Characteristics.
  3. National Institute for Care and Health Excellence. Inclisiran for treating primary hypercholesterolaemia or mixed dyslipidaemia. Available at: https://www.nice.org.uk/guidance/ta733/resources/inclisiran-for-treating... [Accessed January 2024].
  4. The AHSN Network. Patient Search Tool Resource Review. Available at: https://thehealthinnovationnetwork.co.uk/programmes/cardiovascular-disea... [Accessed January 2024].
  5. National Health Service Digital. Lipid management searches. Available at: https://digital.nhs.uk/services/lipid-management-searches [Accessed January 2024].
  6. National Health Service Greater Manchester. CVD Prevention – Lipids Searches – TTP SystmOne. Available at https://healthinnovationmanchester.com/wp-content/uploads/2023/08/CVD-Pr... [Accessed January 2024].
  7. UCLPartners Proactive Care Framework: Lipid Management including Familial Hypercholesterolaemia, UCLP UCLPartners Proactive Care Framework: Lipid Management including Familial Hypercholesterolaemia. Available at: https://uclpartners.com/wp-content/uploads/Lipids-and-FH-Framework_UCLPa... [Accessed January 2024].
  8. Lipids, Familial Hypercholesterolaemia (FH), PCSK9i & Inclisiran Search Guide for SystmOne, CDRC, Lipids, Familial Hypercholesterolaemia (FH), PCSK9i & Inclisiran Search Guide for SystmOne – Clinical Digital Resource Collaborative. Available at: https://cdrc.nhs.uk/resources/systmone-resource-centre/specialties/lipid... [Accessed January 2024].
  9. Lipid management business rules and expanded cluster list, NHSD, Quality and Outcomes Framework (QOF), enhanced services and core contract extraction specifications (business rules) – NHS Digital. Available at: https://digital.nhs.uk/data-and-information/data-collections-and-data-se... [Accessed January 2024].
  10. Lipid Details and Lipid Lowering Templates, CDRC, Lipid Details and Lipid Lowering Templates – Clinical Digital Resource Collaborative. Available at: https://cdrc.nhs.uk/resources/systmone-resource-centre/specialties/lipid... [Accessed January 2024].
  11. AAC. Implementing inclisiran (LEQVIO®) into the lipid management pathway. A toolkit for a population health management approach to adopting innovation. Available at: https://www.england.nhs.uk/aac/wp-content/uploads/sites/50/2020/04/lipid... [Accessed January 2024].
  12. National Health Service. Summary information on the funding and supply of Inclisiran. Available at: https://www.england.nhs.uk/aac/publication/summary-information-on-the-fu... [Accessed January 2024]. 

 

LEQVIO® and the LEQVIO® logo are registered trademarks of Novartis AG. Licensed from Alnylam Pharmaceuticals, Inc.

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UK | January 2024 | 301972

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 via [email protected] or online through the pharmacovigilance intake (PVI) tool at www.novartis.com/report
If you have a question about the product, please contact Medical Information on 01276 698370 or by email at [email protected]