Prescribing information

 

LEQVIO®▼ (inclisiran) is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:3,4

  • 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.3,4

 

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The AHSN Network/AAC pathway aims to provide clear and simple guidance for clinicians on how optimal lipid management may be achieved, supporting healthcare professionals in the implementation of NICE guidelines and other relevant evidence in lipid management in secondary prevention.5 It should be considered alongside other applicable guidance.

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LEQVIO® is recommended as part of this lipid management pathway for secondary prevention of cardiovascular disease in primary care.5

The AHSN network lipid optimisation pathway for secondary prevention in primary care5

Optimal high-intensity statin for secondary prevention

(High-intensity statins are substantially more effective at preventing cardiovascular events than low/medium-intensity statins)

 

Atorvastatin

80 mg

Rosuvastatin

20 mg

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Adapted from The AHSN Network, 2023.5

LEQVIO® should be used with caution in patients with severe renal impairment or severe hepatic impairment. Please refer to the SmPC for further important information.3,4

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.

Based on a pathway developed by:

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© UCLPartners 2022. This pathway is based upon the UCLPartners Proactive Care frameworks lipid optimisation clinical practice aid clinical support education activities – it can be used and reproduced for this purpose.

 

Before prescribing a medicine, please refer to the Summary of Product Characteristics.3,4

Key takeaways from the pathway5

✓ Initiate/increase to high-dose high-intensity statin

✓ Aim for LDL-C <1.8 mmol/L

✓ Check which patients meet the criteria for LEQVIO®6

✓ Review annually for medication adherence and provide support for lifestyle measures

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.3,4

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

*Dose may be limited, for example, due to: eGFR <30 ml/min; drug interactions; intolerance; older age/fragility.
See NICE CG181 clinical guidance for information on high-intensity statins. Use shared decision making and incorporate patient preference in treatment and care decisions.7
Non-HDL LDL targets are identified in order to aid optimal lipid management; current NICE guidance (under review) recommends a greater than 40% reduction in non-HDL cholesterol.7
§If statin not tolerated, follow statin intolerance pathway and consider ezetimibe 10 mg daily ± bempedoic acid 180 mg daily. If non-HDL-C remains ≥2.5 mmol/L despite other lipid-lowering therapies, consider injectable therapies.8–10
NICE guidance: evolocumab, alirocumab.11,12

AAC, Accelerated Access Collaborative; AHSN, Academic Health Science Networks; eGFR, estimated glomerular filtration rate; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; mAB, monoclonal antibody; NICE, National Institute for Health and Care Excellence; PCSK9i, proprotein convertase subtilisin/kexin type 9 inhibitor; TAG, technology appraisal guidance.

References:

  1. National Health Service. NHS Long Term Plan. Available at: http​s://ww​w.longtermplan.nhs.uk/publication/nhs-long-term-plan/ [Accessed October 2023].
  2. Hinton W et al. BMJ Open 2018;8(8):e020282.
  3. LEQVIO® Great Britain. Summary of Product Characteristics.
  4. LEQVIO® Northern Ireland. Summary of Product Characteristics.
  5. 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/2023/03/Lipid-Optimisatio... [Accessed October 2023]. 
  6. 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-primary-hypercholesterolaemia-or-mixed-dyslipidaemia-pdf-82611252825541 [Accessed October 2023].
  7. National Institute for Care and Health Excellence. Cardiovascular disease: risk assessment and reduction, including lipid modification. Available at: https://​www​.nice.org.uk/guidance/cg181/chapter/​recommendations#high-intensity-statin [Accessed October 2023].
  8. National Health Service. Statin intolerance pathway. Available at: https://​www​.nottsapc.nhs.uk/media/​yq3bq3ls/statin-intolerance-pathway.pdf [Accessed October 2023].
  9. National Institute for Care and Health Excellence. Ezetimibe for treating primary heterozygous-familial and non-familial hypercholesterolaemia. Available at: https://www.nice.org.uk/guidance/ta385 [Accessed October 2023].
  10. National Institute for Care and Health Excellence. Bempedoic acid with ezetimibe for treating primary hypercholesterolaemia or mixed dyslipidaemia. Available at: https://www.nice.org.uk/guidance/ta694 [Accessed October 2023].
  11. National Institute for Care and Health Excellence. Evolocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia. Available at: https://www.nice.org.uk/guidance/ta394 [Accessed October 2023].
  12. National Institute for Care and Health Excellence. Alirocumab for treating primary hypercholesterolaemia and mixed dyslipidaemia. Available at: https://www.nice.org.uk/guidance/ta393 [Accessed October 2023].

 

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 | 301965

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]