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.

The effect of LEQVIO® on cardiovascular morbidity and mortality has not been determined.2,3

 

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To address the clinical priority of improved lipid management, a pathway for acute cardiovascular disease in secondary care has been developed. This pathway aims to provide clear and simple guidance for clinicians on how optimal lipid management may be achieved. It can be used as an additional resource to support patient management and implementation of NICE and other relevant evidence in lipid management in secondary prevention.4

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LEQVIO® is recommended as part of this post-acute event lipid management pathway in secondary care.4

The AHSN network lipid optimisation pathway following an acute cardiovascular event, acute ischaemic stroke/transient ischaemic attack or acute coronary syndrome4

  • Obtain lipid profile on admission preferably LDL-C
  • Review pre-event lipid-lowering therapy including statin therapy tolerance and adherence
  • Provide lifestyle advice
  • Commence/optimise all patients on high-intensity statin unless statin intolerant
  • Use shared decision making and incorporate patient preference in treatment and care decisions
  • Set LDL-C target. Aim is to achieve for most patients LDL-C <1.8 mmol/L;* or non HDL-C <2.5 mmol/L if no LDL-C result available

 

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Adapted from The AHSN Network, 2023.4

After an initial dose, LEQVIO® is administered again at 3 months, followed by every 6 months.2,3

The pathway was developed by a Clinical Advisory Group based on a primary care pathway created by UCL Partners, and was published by the AHSN Network.

The pathway was developed as part of the UCL Partners Proactive Care Frameworks, which include a suite of supporting resources.

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© Oxford Academic Health Science Network. This pathway has been prepared to aid clinical practice and support education activities – it can be used and reproduced for this purpose.

 

NICE PCSK9i recommendations available in TA393 for alirocumab and TA394 for evolocumab.5,6

Before prescribing a medicine, please refer to the Summary of Product Characteristics.2,3

Key takeaways from the pathway4

✓ Aim for LDL-C <1.8 mmol/L*

✓ Check which patients meet the criteria for LEQVIO®7

✓ Review of LDL-C levels at 3–8 weeks

✓ Assess adherence to therapy and any adverse events

✓ Aim for an integrated approach to care

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 Summary of Product Characteristics and the NICE TAG before prescribing.

The effect of LEQVIO® on cardiovascular morbidity and mortality has not yet been determined.2,3

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Understand how the efficacy of LEQVIO® could help your patients reach the <1.8 mmol/L LDL-C target.8

*Following ACS a lowering LDL-C target <1.4 mmol/L may be appropriate.4
LEQVIO® is a NICE-recommended option where LDL-C >2.6 mmol/L despite maximum tolerated statin therapy.4
PCSK9 is a NICE-recommended option for primary non-familial hypercholesterolaemia or mixed dyslipidaemia. In primary heterozygous-familial hypercholesterolaemia without CVD, PCSK9is are recommended only if LDL‑C concentration is persistently above 5.0 mmol/L, and in patients with high risk and very high risk CVD only if LDL‑C concentration is persistently above 3.5 mmol/L.5,6

ACS, acute coronary syndrome; CV, cardiovascular; HDL, high-density lipoprotein; HI, high intensity; LDL-C, low-density lipoprotein cholesterol; LLT, lipid-lowering therapy; NICE, National Institute for Health and Care Excellence; PCSK9i, proprotein convertase subtilisin/kexin type 9; TAG, technology appraisal guidance.

References:

  1. NHS England. Summary of national guidance for lipid management. Available at: https://​www​.england.nhs.uk/aac/publication/​summary-of-national-guidance-for-lipid-management/ [Accessed November 2023].
  2. LEQVIO® Great Britain. Summary of Product Characteristics.
  3. LEQVIO® Northern Ireland. Summary of Product Characteristics.
  4. The AHSN Network. Pathways for optimising lipid management in secondary prevention of cardiovascular disease: purpose and development of the pathways. Available at: https://www.ahsnnetwork.com/wp-content/uploads/2022/11/221104-Clinical-P... [Accessed November 2023]. 
  5. National Institute for Health and Care Excellence. Technology appraisal guidance 393. Alirocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia, 22 June 2016. Available at: https://www.nice.org.uk/guidance/TA393 [Accessed November 2023].
  6. National Institute for Health and Care Excellence. Technology appraisal guidance 394. Evolocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia. Available at: https://www.nice.org.uk/guidance/TA394 [Accessed November 2023].
  7. National Institute for Care and Health Excellence. Technology appraisal guidance 733. Inclisiran for treating primary hypercholesterolaemia or mixed dyslipidaemia. Available at: https://www.nice.org.uk/guidance/TA733 [Accessed November 2023].
  8. Ray KK, et al. N Engl J Med 2020;382(16):1507–1519 and supplementary appendix. 

 

© NICE 2021 Inclisiran for treating primary hypercholesterolaemia or mixed dyslipidaemia. Available from https://www.nice.org.uk/guidance/ta733 All rights reserved. Subject to Notice of rights.

NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.

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

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UK | November 2023 | 301966

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]