Inclisiran is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemia, as an adjunct to diet:
- 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.2
The agreement between Novartis and the NHSE&I aims to develop and/or optimise patient pathways to support improved lipid management, including activities associated with the implementation of inclisiran in England.3 The introduction of inclisiran will be carried out within primary care* via a population health management approach delivered by the AAC and the AHSN.4 This will help to arm clinicians and patients with an additional option to help in the management of elevated cholesterol.
For more information contact your local AHSN
Why primary care?
Primary care, where cardiovascular disease is predominantly managed, is pivotal for the identification, treatment, and referral of patients at risk.5,6 Prescribing in this setting allows for patients to be reached at scale.7
Inclisiran has been identified by NHSE&I as a medicine to be adopted systematically and at scale to help improve lipid management in a large high-risk patient population.7 The administration profile of inclisiran, and its cost effectiveness within the NICE-recommended population,1 makes it suitable for use in primary care.
The introduction of inclisiran into the lipid management pathway addresses a current gap in the range of treatment options available in primary care for ASCVD patients who can’t meet LDL-C goals on maximally tolerated statins, with or without other lipid-lowering therapies.1
NICE recommends inclisiran, within its licensed indication, as an option for treating adult patients who:1
- Have persistently elevated LDL-C levels (≥2.6 mmol/L) despite maximum tolerated statins with or without ezetimibe, or other lipid-lowering therapies when statins are not tolerated or are contraindicated, and
- Have a history of certain cardiovascular events
The criteria set out by NICE are for use in patients only if there is a history of any of the following cardiovascular events: acute coronary syndrome (such as myocardial infarction or unstable angina needing hospitalisation), coronary or other arterial revascularisation procedures, coronary heart disease, ischaemic stroke or peripheral arterial disease.1
In combination with maximum tolerated statins when these do not appropriately control LDL-C
In combination with maximum tolerated statins with ezetimibe when these do not appropriately control LDL-C
Alone or in combination with other lipid-lowering therapies in patients who are statin intolerant, or for whom a statin is contraindicated
CONSIDER ADDING INCLISIRAN1,2
FP34D is the preferred route†7
Inclisiran is ordered directly to the practice (£45)‡
Patients are called for assessment and a decision to start inclisiran is taken
Inclisiran usage is added to the FP34D submission to NHS BSA and reimbursed at the drug tariff price of £55§
Stock can be ordered directly from the wholesaler (AAH) by calling the AAH customer care team on 0344 561 8899.7
For further information on inclisiran, please refer to the Summary of Product Characteristics by clicking here.
* Inclisiran can be initiated in both primary and secondary care, with prescriptions part-funded from a central NHSE&I budget.7
† Alternatively, inclisiran can be dispensed via an FP10 in primary care.7 In secondary care, stock is ordered directly from the Novartis Customer Care Team, and inclisiran is initiated via an FP10HNC prescription.7
‡ Price per pack. Pack size: one pre-filled syringe.7
§ Done by the practice team at the end of the month. Tariff will revert to £45 after one year.7 Further information on FP34D can be found at https://www.nhsbsa.nhs.uk/nhs-prescription-services.
AAC, Accelerated Access Collaborative; AAH, All About Health; AHSN, Academic Health Science Network; ASCVD, atherosclerotic cardiovascular disease; BSA, Business Services Authority; LDL-C, low-density lipoprotein cholesterol; NHS, National Health Service; NHSE&I , NHS England and NHS Improvement; NICE, National Institute for Health and Care Excellence.
- NICE. Inclisiran for treating primary hypercholesterolaemia or mixed dyslipidaemia. Available at: https://www.nice.org.uk/guidance/ta733/resources/inclisiran-for-treating... [Accessed October 2021].
- Leqvio® Summary of Product Characteristics.
- Novartis.com. NHS England and NHS Improvement. Available at: https://www.novartis.co.uk/nhs-england-and-nhs-improvement [Accessed November 2021].
- Novartis.com. World-first agreement between Novartis and the NHS enables broad and rapid access to first-in-class cholesterol-lowering medicine Leqvio®▼(inclisiran). Available at: https://www.novartis.com/news/media-releases/world-first-agreement-betwe... [Accessed October 2021].
- Hinton W et al. BMJ Open 2018;8(8):e020282.
- NHS England. The NHS Long Term Plan. Available at: https://www.longtermplan.nhs.uk/wp-content/uploads/2019/08/nhs-long-term... [Accessed September 2021].
- AAC. Implementing inclisiran (Leqvio®) into the lipid management pathway. A toolkit for a population health management approach to adopting innovation. September 2021.